HPV

 

Human papillomavirus (HPV) is a viral infection that passes between people through skin-to-skin contact. There are more than 140 varieties of HPV. The infection is so common that most sexually active people will be infected at some point. In fact, the CDC states that HPV is the most common sexually transmitted infection (STI). Most infections will respond spontaneously on their own. However, if HP16, 18, 31 or 45 remain more than two years, there is an increased risk of cervical cancer 10 to 30+ years in the future.

The case for vaccinating boys against human papillomavirus. Public health genomics 12(5-6): 362-7, 2009. A proposed ethical framework for vaccine mandates: competing values and the case of HPV. Kennedy Institute of Ethics journal 18(2): 111-24,

Bioethicists Miles and Caplan challenge Bachmann’s HPV-vaccine claim 9/15/11 and Arthur L. Caplan Description of Bioethics Expertise

VAERS Found 12 cases where Onset Interval is 0 and Vaccine is HPV2 or HPV4 and Patient Died

May 26, 2022 Using observational data to explore the hypothesis that a single dose of current HPV vaccines can provide durable protection “Despite use of statistical techniques to address potential biases, the adjusted vaccine efficacy against infection with non-vaccine types HPV31/33/45 was quite similar to the adjusted efficacy for vaccine types HPV 6/11/16/18, a finding not aligned with clinical trial efficacy and real-world evidence of the vaccine’s impact and effectiveness.”

February 28, 2020 – Benefits and harms of the human papillomavirus (HPV) vaccines: systematic review with meta-analyses of trial data from clinical study reports “At 4 years follow-up, the HPV vaccines decreased HPV-related cancer precursors and treatment procedures but increased serious nervous system disorders (exploratory analysis) and general harms. As the included trials were primarily designed to assess benefits and were not adequately designed to assess harms, the extent to which the HPV vaccines’ benefits outweigh their harms is unclear.

August 16, 2019 – Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices “Special populations and medical conditions. These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.§ For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination. Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed.”

January 4, 2018 – HPV vaccination strategies targeting hard-to-reach populations: Out-of-school girls in LMICs (full text) “Opportunities exist for local health authorities and partners to design, implement, and evaluate these strategies in various combinations relevant to local contexts in future demonstration projects or pilot studies to assess which modalities are most effective in vaccinating out-of-school girlsAs additional countries consider implementing school-based HPV vaccination programs, efforts should also be undertaken to identify best practices for ensuring that out-of-school girls also benefit from national HPV vaccination programs. …

  • Conflict of interest CB has received funding from Merck to conduct other HPV research, outside the scope of this study.

January 2, 2018 – Immunization effects of a communication intervention to promote preteen HPV vaccination in primary care practices (full text) “In the teens, the intervention had a positive impact on initiation during both periods and on completion during the intervention. There appeared to be no intervention benefit in the 9–10-year-olds and there was some evidence that intervention practices were less likely to initiate vaccination in the younger children. These stratified analyses should be interpreted with caution. In the younger children, power may be limited because less than 5% completed the vaccine during the 27-month period. The teens had about half the initiation rate of the 11–12-year-olds; presumably those who were most likely to get vaccinated did so when they were 11–12. … The objective of our study was to conduct and measure a practice-based intervention with communication tools to motivate preteen HPV vaccination through provider/parent/preteen conversations about HPV as a sexually transmitted infection preventable by vaccination.”

January 2, 2018 – Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9–14 years: Results to month 36 from a randomized trial  “None of the SAEs were considered by the investigator to be vaccine-related. All SAEs resolved, except ulcerative colitis with relapse episodes, food-dependent exercise induced anaphylaxis, tension headache and juvenile idiopathic arthritis events, which were on-going at the time of the M36 database lock point.”.

Table 3. Safety data at M36.

AS04-HPV-16/18 [2D] (N = 359) 4vHPV [2D] (N = 358) 4vHPV [3D] (N = 358)
≥1 medically significant AE*n(%) 77 (21.4) 79 (22.1) 63 (17.6)
Pyrexia 5 (1.4) 7 (2.0) 5 (1.4)
Influenza 5 (1.4) 3 (0.8) 7 (2.0)
Varicella 5 (1.4) 5 (1.4) 3 (0.8)
Cough 2 (0.6) 4 (1.1) 4 (1.1)
Ligament sprain 2 (0.6) 4 (1.1) 4 (1.1)
Oropharyngeal pain 2 (0.6) 4 (1.1) 4 (1.1)
≥ 1 SAE ** n (%) 21 (5.8) 11 (3.1) 14 (3.9)
Asthma 2 (0.6) 1 (0.3) 0
Gastroenteritis 3 (0.8) 0 0
Upper respiratory tract infection 2 (0.6) 0 1 (0.3)
Appendicitis 1 (0.3) 1 (0.3) 0
Foot fracture 2 (0.6) 0 0
Pneumonia 1 (0.3) 0 1 (0.3)

Those occurring in ≥10 subjects overall are listed.

Those occurring in ≥2 subjects overall are listed. 2-doses (2D) and 3-doses (3D) schedule of AS04-HPV-16/18 or HPV-6/11/16/18 (4vHPV) vaccine; AE, adverse event; SAE, serious adverse event.

December 19, 2017 – Differences between vaccinated and unvaccinated women explain increase in non-vaccine-type human papillomavirus in unvaccinated women after vaccine introduction “For women recruited from a health department clinic, older age (OR = 1.4, 95% CI: 1.2–1.6) and consistent condom use with main partner in the past 3 months (OR = 11.6, 95% CI: 3.4–40) were associated with being unvaccinated. For women recruited from a teen health center African American race (OR = 0.2, 95% CI: 0.07–0.7) and having Medicaid health insurance (OR = 0.3, 95% CI: 0.1–0.7) were inversely associated with being unvaccinated. The observed increase in non-vaccine-type HPV prevalence in unvaccinated women may be explained by differences between unvaccinated and vaccinated women.” Comment: This sounds like strain replacement. In the future look for more strains of HPV to be added to the vaccine.

December 15, 2017 – A behavioral economics approach to the failed HPV vaccination program in Japan (full text) “This became such an anti-HPV-vaccine publicity nightmare that, in June of 2013, the MHLW reluctantly announced a ‘temporary suspension’ of its proactive recommendation for HPV vaccination. As a result of these two events, HPV vaccination in Japan in 2014 came to an almost virtual halt, falling to under 1%, with respect to the vaccination rate of girls aged twelve in 2014, …”

December 4, 2017 – Antibody response to human papillomavirus vaccination and natural exposure in individuals with Fanconi Anemia “It is unclear if these titers sufficiently protect from new infection since protective serologic cut offs have not yet been defined for the HPV vaccine. Individual immune functions were not associated with HPV seropositivity, however, underlying heterogeneous immune deficiency may explain higher rates of seropositivity in our younger unvaccinated participants (age 4–13 years). To better measure the efficacy of HPV vaccination in those with FA and other immune-compromised or cancer-prone disorders, future well-controlled vaccine studies are required.

November 30, 2017 – Modelling the effects of quadrivalent Human Papillomavirus (HPV) vaccination in Puerto Rico (full text) ” Notwithstanding, it is important to foster direct attention to the importance of the vaccination and in order to be fully protected, completing the vaccination schedule. As stated before, in Puerto Rico local legislation requires insurance companies to cover the vaccine but the vaccination itself is not mandatory according to the local vaccination list. Public health advocates and decision-makers can use the results of this model adaptation to develop strategies to increase vaccination rates in order to potentially avoid additional healthcare expenditures associated with HPV-related disease.”

  • Funding: Financial support was provided by Merck & Co. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
  • Competing interests: We have the following interests. Financial support was provided by Merck & Co. AK and MP are employees of Merck & Co. and were responsible for running the economic model using the inputs provided by the Principal Investigator and her team and for data analysis.
  • AL is a consultant for Merck & Co. and was responsible for data analysis.
  • HAM and CMG are employees of MSD (IA) Corp., a subsidiary of Merck & Co., and were responsible for overseeing the project from the sponsor’s side, the decision to publish and the preparation of the manuscript. APO institution received a grant from Merck to conduct the proposed work under a collaborative contract agreement.

November 24, 2017 – Analysis of memory B cell responses reveals suboptimal dosing schedule of a licensed vaccine “Moreover, high titers of antigen-specific serum antibody at vaccination inversely correlated with Bmem responses. As the purpose of additional doses/boosters is to stimulate Bmem to rapidly boost Ab levels, these results indicate the timing of the third dose is suboptimal and lend support to a two-dose HPV vaccine for young adults. Our findings also indicate more broadly that multi-dose vaccine schedules should be rationally determined on the basis of Bmem response rates.

October 27, 2017 – Using the 4 Pillars™ Practice Transformation Program to increase adolescent human papillomavirus, meningococcal, tetanus-diphtheria-pertussis and influenza vaccination “To report the results of an intervention using the 4 Pillars™ Practice Transformation Program (4 Pillars™ Program) to increase adolescent vaccinations including human papillomavirus vaccine (HPV) and influenza vaccines, which remain underutilized in this populationComment: 4 Pillars™ Practice Transformation Program A step-by-step guide to improving vaccine uptake in outpatient settings. Allegheny County in Pittsburgh PA tried to make HPV mandatory. This is relatively unheard of for a county to try and mandate a vaccine. This particular study was done in part by the University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

October 27, 2017 – Association of both consistency and strength of self-reported clinician recommendation for HPV vaccination and HPV vaccine uptake among 11- to 12-year-old children “Consistency and strength of recommending the HPV vaccine was significantly higher among those practicing in pediatrics and board certified in pediatrics compared to family medicine. Higher rates of initiation (1 dose) [Incidence Rate Ratio (IRR) = 1.05; 95% CI (1.01–1.09)] and completion (3 doses) [IRR = 1.08; 95% CI (1.02–1.13)] were observed among clinical sites where, on average, clinicians more frequently reported always or usually recommending the vaccine for females compared to sites where, on average, clinicians reported recommending the vaccine less frequently.” Comment: Pediatricians receive bonuses from the health insurance companies to make sure all the vaccines are given.

October 5, 2017 – Examining word association networks: A cross-country comparison of women’s perceptions of HPV testing and vaccination “The results show that both the U.S. and Australian country samples drew links between the trigger words “HPV and cervical vaccination” and sexually transmitted infections (STIs), with the terms “sex”, “std”, “virus” and “disease” reported by the participants. Both country samples also identified a correct association between the triggers word “HPV vaccination” and the n-grams “warts”. This shows that there is knowledge in each country sample that HPV can cause genital warts and is an STI. However, both country samples identified incorrect STI associations between these trigger words (“HPV vaccination”) and the n-grams “HIV”, “herpes” and “AIDS”. Suchfindings might indicate that women across both country samples do not differentiate between STIs, as well as holding false assumptions about HPV testing using the same medical procedures as HIV testing (a ‘simple blood test’). Therefore, this finding illustrates potential health themes for educational public service announcements and intervention programs that encourage adoption of the HPV vaccine and preventative sexual behaviors.”

October 13, 2017 – Human papillomavirus vaccines: WHO position paper, May 2017–Recommendations“New recommendations are proposed regarding vaccination strategies targeting girls only or both girls and boys, and vaccination of multiple birth cohorts.

September 12, 2017 – The Impact of Human Papillomavirus Catch-Up Vaccination in Australia: Implications for Introduction of Multiple Age Cohort Vaccination and Postvaccination Data Interpretation “Our results suggest that vaccinating multiple cohorts produced markedly faster direct/herd effects, and it added benefits that last for 20–70 years. Furthermore, the number needed to vaccinate to prevent 1 anogential warts (AGW) case or cervical cancer (CC) was similar for routine + catch-up (AGW = 9.9, CC = 678) and routine-only vaccination (AGW = 9.9, CC = 677), thus providing similar levels of efficiency per person vaccinated.” Comment: Is vaccinating worth the risk of  the HPV vaccine side effects to prevent 1 case of anogenitial warts?

September 5, 2017 – Implementation of HPV vaccination guidelines in a diverse population in Los Angeles: Results from an environmental scan of local HPV resources and needs “Controversies exist regarding HPV vaccination in several communities; which may in part explain why although rates of HPV vaccination are increasing nationwide, Los Angeles County (LAC) data show that many adolescents are still not vaccinated.”

September 5, 2017 – Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine “A three-dose regimen of the 9vHPV vaccine induced persistent HPV antibody response through 5 years post-vaccination. Administration of a fourth dose resulted in a strong anamnestic response to all 9 vaccine types. These findings suggest that the efficacy of the 9vHPV vaccine will be long lasting.”

September 5, 2017 – Incorporation of RG1 epitope concatemers into a self-adjuvanting Flagellin-L2 vaccine broaden durable protection against cutaneous challenge with diverse human papillomavirus genotypesVaccination in the absence of exogenous adjuvant with Fla-HPV16 L2 11-200 fusion protein elicited durable protection against HPV16, but limited cross-protection against other HPV types.”

September 2, 2017 – Naturally Occurring Single Amino Acid Substitution in the L1 Major Capsid Protein of Human Papillomavirus Type 16: Alteration of Susceptibility to Antibody-Mediated Neutralization “Each vaccine for human papillomavirus type 16 (HPV16) has been developed on the basis of a single variant, and whether these vaccines can prevent infection due to naturally occurring variants was not clear. … Conclusions: These results suggest that the current HPV vaccines may not offer equal protection against all of the naturally occurring HPV16 variants discovered so far.

August 18, 2017 – Nurses’ Knowledge and Opinions on HPV Vaccination: a Cross-Sectional Study from Istanbul “There was a statistical relationship between “HPV knowledge score” and answering “Yes” to “Do you want your children/future children to be vaccinated? (p = 0.001) and “Do you think including the vaccine in the Turkish immunization program is necessary?” (p = 0.001). Nurses in our cohort seem to have satisfactory basic knowledge regarding HPV infection; however, their viewpoints on vaccination were not favorable. Strategies and intervention materials for HPV vaccination will be necessary if a national immunization program will be initiated.”

August 16, 2017 – Increasing Parental Knowledge Related to the Human Papillomavirus (HPV) Vaccine “Discussion – In the 10 years since the HPV vaccine has been on the market, there is a continued need to increase parental knowledge about the HPV vaccine to close the gap on vaccine nonadherenceA self-directed, computer-based learning tablet appears to be an effective tool to educate parents or legal guardians about the purpose, efficacy, and safety of the HPV vaccine.

August 14, 2017 – Evaluation of vaccination herd immunity effects for anogenital warts in a low coverage setting with human papillomavirus vaccine—an interrupted time series analysis from 2005 to 2010 using health insurance data (full text) “Despite the fact that the recommendation for HPV vaccination only includes females in Germany, we observed parallel effects among males of nearly the same age. Here, the most pronounced decrease was seen in 16- to 18-year-olds which is plausible as females have, on average, similarly aged or one to 2 years older sexual partners during adolescence.”

  • Competing interests: As employees of the Leibniz Institute for Prevention Research and Epidemiology – BIPS the authors have performed research studies paid by pharmaceutical companies (Bayer Pharma AG (RM), Sanofi-Pasteur MSD (RM, JH, KT), and Takeda (KT), outside of the current work.

August 3, 2017 – Persuasive texts for prompting action: Agency assignment in HPV vaccination reminders “Reminder messages framing transmission as an action of the virus prompted mothers to perceive the threat as more severe than messages describing their daughters as the cause. Assigning transmission agency to the virus also held a persuasive advantage in boosting mothers’ intentions to seek vaccination, particularly when the message cast mothers as agents of protection rather than the vaccine.”

August 1, 2017 – Different Challenges in Eliminating HPV16 Compared to Other Types: A Modeling Study (full text) “In conclusion, the characteristics of individual HR HPV types strongly influence herd immunity and determine the level of coverage and type-specific vaccine efficacy (including cross-protection) that are required to reduce or eliminate the infection through HPV vaccination. HPV16 is harder to eliminate than HPV45 and, probably, any other typeOur findings are particularly relevant to low- and middle-income countries that are especially challenged by programmatic difficulties and increases in the cost of vaccines according to the number of targeted types.

  • Potential conflicts of interests. J. D. has received previous grants to his institution from Merck, a manufacturer of HPV vaccines.

July 24, 2017 – HPV vaccination and risk of chronic fatigue syndrome/myalgic encephalomyelitis: A nationwide register-based study from Norway (full text) “The major limitation of this study is the lack of validation of the diagnoses. We did not have access to patient records for verification of the CFS/ME diagnoses retrieved from the NPR. Diagnosing CFS/ME may be challenging since there are no biomarkers for the disease, and the diagnosis is based on reported symptoms and exclusion of other illnesses. Also, different criteria for the CFS/ME diagnosis may be used. Furthermore, since several conditions have symptoms partly overlapping with CFS/ME, e.g. ICD-10 codes F48.0 (neurasthenia) and R53 (malaise and fatigue), some misclassification may occur. The ICD-10 code F48.0 is primarily used in mental healthcare. According to national guidelines, CFS/ME patients are diagnosed and treated in somatic healthcare, where the ICD-10 code G93.3 is used. The use of the ICD-10 codes F48.0 and R53 both exclude the G93.3 code, according to ICD-10 guidelines. Since 2007, national guidelines have recommended the use of ICD-10 code G93.3 for CFS/ME, regardless of suspected causeAccording to guidelines, children and adolescents should have experienced symptoms for at least three months prior to diagnosis.

July 24, 2017 – The number of injected same-day preschool vaccines relates to preadolescent needle fear and HPV uptake “Fear of needles develops at approximately five years of age, and decreases compliance with healthcare. We sought to examine the relationship of preschool vaccine history, parent and preadolescent needle fear, and subsequent compliance with optional vaccines. … Conclusions The more same-day preschool injections between 4 and 6 years of age, the more likely a child was to fear needles five years later. Preadolescent needle fear was a stronger predictor than parent vaccine anxiety of subsequent HPV vaccine uptake.

July 20, 2017 – Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.”Most HPV vaccine randomized trials did not use inert placebo in the control groupTwo of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the studyCompared to 2871 women receiving aluminum placebothe group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 796–53). The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related.”

July 17, 2017 – Modeling of US HPV Seroprevalence by Age and Sexual Behavior Indicates an Increasing Trend of HPV Infection Following the Sexual Revolution “The age-specific HPV seroprevalence data were best explained by a partner acquisition model that explicitly accounted for cohort-dependent changes in sexual behavior. Estimates of the mean time to loss of natural antibodies varied by model, ranging from 49 to 145 years. Inferred trends in sexual behavior over the past decades paralleled the increasing incidence of HPV-related cancers in the US.” … “Our results emphasize the importance of continuing surveillance of sexual behaviors, alongside vaccine status, to predict future disease burden.” Comment: Parents are told the vaccine will not make adolescents more promiscuous, that isn’t true with the findings in this study.

June 7, 2017 – Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9–14 Years: A Randomized Trial “The subject only received 1 dose of vaccine, and the event was not resolved at end of study. None of the other SAEs were considered to be causally related to vaccination by the investigator. There was 1 withdrawal due to a nonserious adverse event in the 2D_M0,12 group at month 12 (the subject was diagnosed with celiac disease). There were no additional withdrawals due to SAEs during the course of the study. There was 1 withdrawal due to a nonvaccine-related SAE: immunoglobulin A–mediated nephritis.” … “The investigator considered that there was a reasonable possibility the systemic lupus erythematosus may have been caused by the vaccine, although no rationale was provided for the assessment and the systemic lupus erythematosus diagnosis could not be confirmed based on the information provided. Also, as previously described, a nonserious potential immune-mediated disease (VIIth nerve paralysis) reported in the 3-dose group was considered to have a possible causal relationship to vaccination and resolved 13 days after the first vaccination.” Comment: Not related, or not confirmed, when each event  mentioned can be caused by vaccination.

May 29, 2017 – Elimination of Cancer Health Disparities through the Acceleration of HPV Vaccines and Vaccinations: A Simplified Version of the President’s Cancer Panel Report on HPV Vaccinations (full text)
Goal 1: Reduce Missed Clinical Opportunities to Recommend and Administer HPV Vaccines
The CDC cites in a recent report that missed clinical opportunities are the most important reason why vaccine uptake remains low in the United States. Many vaccine-eligible adolescents do not receive HPV vaccines during visits with their healthcare providers. The report states that many times, adolescents received other recommended vaccines yet did not receive the HPV vaccine. Factors contributing to providers’ hesitancy include:
Limited understanding of HPV-associated diseases and benefits of HPV vaccination, particularly for males
• Concerns about safety
• Concerns about inadequate reimbursement for vaccines
• Personal attitudes and beliefs
• Discomfort talking to parents and adolescents about a topic related to sexual behavior
• Concerns about parental resistance
• Preference for vaccinating older vs. younger adolescents
• Lack of time or incentives to educate parents and patients about HPV and HPV vaccines
• Lack of systems to remind providers to offer vaccines to ageeligible patients

May 25, 2017 – Mapping information exposure on social media to explain differences in HPV vaccine coverage in the United States (full text) “Measures of exposure to HPV related tweets explained more of the variance in state level HPV vaccine coverage than was explained by socioeconomic factors. Our study suggests that in states where negative opinions about HPV vaccines are popularized by mainstream media, the coverage is often lower than would be expected by socioeconomic differences alone. These differences suggest that news media may reflect, amplify, or influence vaccine acceptance, and that measures of information exposure derived from Twitter may be a surrogate indicators for localized differences in acceptance.”

May 19, 2017 – Two-dose schedules for human papillomavirus vaccine: Systematic review and meta-analysis (full text) “Trials to evaluate the clinical efficacy of two-dose and even one-dose schedules have been proposed and clinical outcome data are needed, even though immunological outcomes in adolescents are judged to provide sufficient evidence of bridging to clinical efficacy in adults. The available evidence from this review show that a two-dose HPV vaccine schedule provides satisfactory immunological responses in adolescent girls, but uptake globally is limited, particularly in countries with the highest burden of cervical cancer.”

May 9, 2017 – Physicians’ current use and preferences for male HPV vaccine-related patient education materials “Peds preferred using a factsheet as the medium of information more often than FM (85.6% vs. 68.0%; p < 0.0001). When asked about preferences for targeted materials, 74.8% of providers indicated they would prefer materials targeted towards patients, 63.2% preferred information targeted towards parents, and 20.7% indicated they prefer non-targeted materials. Future research should focus on the development and testing of new HPV vaccine-specific materials and communication strategies for Peds and FM physicians.”

May 9, 2017 – Ecological validity of cost-effectiveness models of universal HPV vaccination: A systematic literature review “A relatively small (15–20%) over-estimation of quality-adjusted life years (QALYs) gained with selective immunisation programmes could induce a significant error in the estimate of cost-effectiveness of universal immunisation, by inflating its incremental cost effectiveness ratio (ICER) beyond the acceptability threshold. The results modelled here demonstrate the limitations of the cost-effectiveness studies for HPV vaccination, and highlight the concern that public healthcare policy might have been built upon incomplete studies.”

April-June 2017 – Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective “Public health and human rights have an intrinsic link, and any public health programme can be successful if the rights of people are respected, and upheld. A routine or compulsory vaccine programme tends to ignore rights of people that augment the legal and ethical issues relating to vaccinations. This article aims to identify the legal and ethical issues in the development of vaccines and in vaccination processes.”

April 4, 2017 – Health professional feedback on HPV vaccination roll-out in a developing country “Five main themes emerged; medical misconceptions about the HPV vaccination, particularly with regards to infertility; fear of the unknown, including possible side effects and inadequate empirical research; need for prior desensitisation to resolve cultural barriers prior to vaccination rollout; a rural-urban divide in health awareness, particularly in relation to cancer vaccines; and economic concerns associated with access to the HPV vaccination for most of the Zambian population.” COMMENT: Desensitisation is another word for brainwashing.

March 13, 2017 – GTL001 and bivalent CyaA-based therapeutic vaccine strategies against human papillomavirus and other tumor-associated antigens induce effector and memory T-cell responses that inhibit tumor growth (full text) “GTL001 is a bivalent therapeutic vaccine containing human papillomavirus (HPV) 16 and HPV18 E7 proteins inserted in the Bordetella pertussis adenylate cyclase (CyaA) vector intended to prevent cervical cancer in HPV-infected women with normal cervical cytology or mild abnormalities.”

March 8, 2017 – Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope “During 2015 and 2016, case reports have been published of young women presenting with diverse physical and neurological symptoms following immunisation including symptoms similar to fibromyalgia, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).”

March 1, 2017 – US medical students’ willingness to offer the HPV vaccine by vaccination status “Knowledge did not vary by vaccination status, but anticipated behaviors did. Vaccinated students reported greater willingness to vaccinate adolescents before 15–16 years of age (92.1% vs. 78.6%, p = 0.008) and discuss vaccination at any type of medical visit (100% vs. 89.7%, p < 0.001). Our findings suggest that prior experiences with the HPV vaccine may influence a provider’s future actions.

March 1, 2017 – US medical students’ willingness to offer the HPV vaccine by vaccination status “Knowledge did not vary by vaccination status, but anticipated behaviors did. Vaccinated students reported greater willingness to vaccinate adolescents before 15–16 years of age (92.1% vs. 78.6%, p = 0.008) and discuss vaccination at any type of medical visit (100% vs. 89.7%, p < 0.001). Our findings suggest that prior experiences with the HPV vaccine may influence a provider’s future actions.

February 16, 2017 – Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial “The innovative nine-valent HPV dose has more than double HPV virus-like particles and aluminum adjuvant than the previous formulation. Double-blind safety analysis contrasted 7071 subjects immunized with the nine-valent vaccine vs. 7078 who had the four-valent dose. The nine-valent cohort had significantly more systemic serious adverse events; n = 233 (3.3%) vs. n = 183 (2.6%) in the other group. Our calculated 2 × 2 contingency table p value was 0.0125. Oddly, only two subjects (0%) in each group were judged to have a vaccine-related serious adverse event. The authors did not comment on this incongruity. This discrepancy arising from a pivotal large randomized double-blind trial suggests that nine-valent HPV vaccine-related serious adverse events were under-recognized. This emerging information casts further doubt on HPV vaccine safety.”

February 9, 2017 – Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance (full text)

  • Declaration of interest LG-B reports grants received from the GSK group of companies and Sanofi Pasteur MSD during the conduct of the study and grants received from Hisamitsu, Johnson&Johnson Santé Beauté France SAS, Pfizer Santé Familiale, Laboratoires Urgo, Therabel Lucien Pharma, Zambon France, Sanofi-Aventis France, Laboratoires Bouchara-Recordati, Laboratoires Jolly-Jatel, Reckitt Benckiser Healthcare France, Novartis Pharma SAS, Coopération Pharmaceutique Française, Astra-Zeneca and Boehringer Ingelheim outside of the submitted work.
  • IK-P reports personal fees received from AbbVie, Novartis and Sobi for consultancy and meetings outside of the submitted work.
  • BG reports personal fees received from Sanofi during the conduct of the study.
  • TP reports personal fees received from the GSK group of companies during the conduct of the study.
  • PV reports personal fees and other fees for meeting registration, travel and accommodation from Biogen, Genzyme-Sanofi, Teva and Almirall and grants, personal fees and other fees for meeting registration, travel and accommodation from Merck, Novartis and Bayer outside of the submitted work.
  •  LA reports grants received from the GSK group of companies and Sanofi Pasteur MSD during the conduct of the study and grants received from Hisamitsu, Johnson&Johnson Santé Beauté France SAS, Pfizer Santé Familiale, Laboratoires Urgo, Zambon France, Sanofi-Aventis France, Laboratoires Bouchara-Recordati, Laboratoires Jolly-Jatel, Reckitt Benckiser Healthcare France, Novartis Pharma SAS, Coopération Pharmaceutique Française, Astra-Zeneca and Boehringer Ingelheim outside of the submitted work.
  • Funding The present study (NCT01498627) is a post-authorization safety study requested by the French Health authorities (HAS, Haute Autorité de Santé) and was sponsored by GlaxoSmithKline Biologicals SA. The study used data from and tools developed for the PGRx program, which is owned by LASER. LASER received an unrestricted grant from GlaxoSmithKline Biologicals SA for the conduct of this study. The collection of data from clinical centers, the patient interviews, the statistical analyses and reporting of findings were all conducted independently of GlaxoSmithKline Biologicals SA, under the review of the Scientific Committee for this study.
  • Role of the funding source GlaxoSmithKline Biologicals SA had no input into the design and conduct of the study or the reporting of results.

February 7, 2017 – Human papillomavirus vaccine series completion in boys before and after recommendation for routine immunization “Despite the ACIP routine use recommendation in males, 4vHPV series completion remained low. 4vHPV initiation at 11–12 years and identification of a provider responsible for the adolescents’ health care may increase 4vHPV series completion. Given the rapidly increasing incidence of HPV-related cancers in males, it is important to identify measures to increase HPV vaccine series completionparticularly among non-Hispanic Black and Hispanic males.” Comment: Anyone on entitlements receives the vaccine for fear of loss of entitlements.

February 1, 2017 – Associations of trust and healthcare provider advice with HPV vaccine acceptance among African American parents “In multivariable analysis, children whose parents were “very strongly” recommended the HPV vaccine had over four times higher odds of vaccine receipt compared with those whose parents were “not very strongly” recommended the vaccine. Having a parent with “a lot of” versus “none” or only “some” trust in HCPs was associated with over twice the odds of receiving HPV vaccine.”

February 2017 – Role of ethnicity in human papillomavirus vaccination uptake: a cross-sectional study of girls from ethnic minority groups attending London schools (pdf) “No significant differences in vaccination uptake were found by ethnicity or ethnicity-related factors, although descriptive differences were apparent. Schools in areas where black ethnicities were the most prevalent non-white British ethnicities had consistently low rates of uptake for all doses.” … “Replication of this study with a larger sample and using complete individual-level data, collected on a national level, would provide a clearer indication of where ethnic differences in HPV vaccination uptake exist.”

February 2017 – Parents’ views of including young boys in the Swedish national school-based HPV vaccination programme: a qualitative study (full text) “More information about the health benefits of HPV vaccination for males is necessary to increase HPV vaccination among boys. This may eventually lead to increased HPV vaccine coverage among both girls and boys.” … “Some parents expressed scepticism towards the female-only vaccination programme and compared it to an experiment on girls.”

February 2017 – The Need to Optimize Adolescent Immunization (full text) “Parents prefer clear, unambiguous recommendations; offering the HPV vaccine without strongly recommending it appears to confuse and frustrate parents. One of the most powerful messages that health care providers can transmit is that vaccination against HPV is a critical strategy for cancer prevention. Hull et al64 demonstrated that mothers and adolescent daughters were more willing to receive the HPV vaccine when it was recommended as a routine vaccine that prevents cancer.”

January 3, 2017 – Clinician knowledge, clinician barriers, and perceived parental barriers regarding human papillomavirus vaccination: Association with initiation and completion rates “Clinician knowledge and their report of the frequency of experiencing parental barriers are associated with HPV vaccine delivery rates—initiation and completion. Higher measures of knowledge correlated with higher rates. Fewer perceived occurrences of parental barriers correlated with lower rates.”

January 3, 2017 – Improving adolescent HPV vaccination in a randomized controlled cluster trial using the 4 Pillars™ practice Transformation Program “Objective Uptake of meningococcal vaccine (MCV) and tetanus, diphtheria and pertussis (Tdap) vaccine among adolescents has approached Healthy People 2020 goals, but human papillomavirus (HPV) vaccination has not.”…”Implementation of >10 strategies to improve rates significantly increased the likelihood of HPV series initiation (OR = 2.06, 95% CI = 1.43, 2.96).”

January 1, 2017  Endocervical Carcinogenesis and HPV Vaccination: An Occasional Circumstance or a Gap in the Chain? (full text) “We present a case of cervical adenocarcinoma in situ (AIS) in a 30-year-old female with a positive HPV 16 typing test though fully vaccinated against HPV after the onset of her sexual life. This is a rare incident that is raising many questions about the efficacy and the safety of HPV vaccines.”

January 1, 2017 – HPV vaccinations: a Middle Eastern and north African dilemma “Although everyone agrees that something must be done internationally against HPV infections, the logistics seem extremely muddled. On one hand, low incidence of cervical cancer coupled with high cost for vaccination might make introduction of HPV vaccines highly cost-ineffective, and on the other hand, not providing the same health opportunities in less developed countries seems unethical and inequitable. To make matters worse, acceptance and implementation of vaccines by the society in the Middle East and north Africa region is not guaranteed due to stigmatisation based on traditional values.

January 2017 – Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase® (pdf available) “Cluster analysis reveals additional reports of AEs following HPV vaccination that are serious in nature and describe symptoms that overlap those reported in cases from the recent safety signals (POTS, CRPS, and CFS), but which do not report explicit diagnoses. While the causal association between HPV vaccination and these AEs remains uncertain, more extensive analyses of spontaneous reports can better identify the relevant case series for thorough signal evaluation.

December 30, 2016 – CDC Pink Book Supplement Chapter 11: Human Papillomavirus 9-Valent Human Papillomavirus Vaccine “Males had fewer injection site adverse events. In males aged 9 through 15 years, injection site swelling and erythema in Gardasil 9 recipients occurred in 26.9% and 24.9%, respectively. Rates of injection-site swelling and erythema both increased following each successive dose of Gardasil 9Comment: Gardasil 9 contains twice the amount of aluminum adjuvant than Gardasil. Each 0.5-mL dose of the vaccine contains approximately 500 mcg of aluminum See here. Each 0.5-mL dose of  Gardasil vaccine contains approximately 225 mcg of aluminum here.

December 16, 2016 – CDC MMWR Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices “For persons initiating vaccination on or after their 15th birthday, the recommended immunization schedule is 3 doses of HPV vaccine. The second dose should be administered 1–2 months after the first dose, and the third dose should be administered 6 months after the first dose (0, 1–2, 6 month schedule).”…”ACIP recommends vaccination with 3 doses of HPV vaccine (0, 1–2, 6 months) for females and males aged 9 through 26 years with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity,*** such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy, because immune response to vaccination might be attenuated (Table) (7).

December 7, 2016 – Providers’ time spent and tools used when discussing the HPV vaccine with parents of adolescents “Providers use only limited types of adolescent HPV vaccine communication tools, and frequently do not use preferred vaccine communication strategies. Better engagement with existing HPV vaccine communication tools, and/or the creation of new tools may be needed to enhance providers’ ability to provide high quality HPV vaccine recommendations.”

December 5, 2016 – Safety concerns and hidden agenda behind HPV vaccines: another generation of drug-dependent society? “American health status ranks last among other developed nations despite the highest amount that USA invests in healthcareThis is a wake-up call to make sure that the evil part of human being does not prevent the health services that the public deserves. Otherwise, ‘it does not matter how many resources you have, if you don’t know, or don’t want to know, how to use them, they will never be enough’.”

December 2016 – Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial “Patients in clinics receiving conversation training did not differ from those in control clinics with respect to changes in HPV vaccination coverage. Neither training was effective for changing coverage for other vaccination outcomes or for adolescents aged 13 through 17 (n = 37 796). CONCLUSIONS: Training providers to use announcements resulted in a clinically meaningful increase in HPV vaccine initiation among young adolescents.”

December 2016 – The Uncertain Future of Human Papillomavirus Vaccination School Requirements “School vaccination requirements have long been viewed by proponents of vaccination as effective and essential tools in promoting and sustaining high vaccination rates. In this issue of Pediatrics, Moss and colleagues show that requirements for meningococcal and tetanus, diphtheria, and pertussis vaccines result not only in substantial direct …

December 2016 – Herd protection from the female HPV vaccination programme – Authors’ reply “We stand by our findings and those of others that show that genital warts and vaccine-targeted HPV genotypes in men declined substantially after the introduction of female HPV vaccination. We consider the evidence support herd protection from vaccinated women to be overwhelming.

  • EPFC is supported by the Australian National Health and Medical Council (NHMRC) Early Career Fellowship (number 1091226). EPFC has received education grants from Seqirus and bioCSL to assist with education, training, and academic purposes in human papillomavirus. CKF has received honoraria and research funding from CSL Biotherapies and Merck. CKF owns shares in CSL Biotherapies.”

November 11, 2016 – Murine hypothalamic destruction with vascular cell apoptosis subsequent to combined administration of human papilloma virus vaccine and pertussis toxin (full text) “There might be hypersensitive girls to HPV vaccine because of unclear predisposing factors and/or environmental concomitant events causing a damage to the BBB probably (similar to the damage that is induced by Ptx in the current study). A variable combination of these factors might result in individual suffering from HANS. Further analyses are required for verifying this possibility; however our data provide the first pathological model of HANS and will allow us in the future to explore a way to treat patients suffering from HANS.”

November 2016 – Achieving High Adolescent HPV Vaccination Coverage “Denver Health is an integrated urban safety net health system serving >17 000 adolescents annually. The process for achieving high vaccination rates in our health system includes “bundling” of vaccines, offering vaccines at every visit, and standard orders.”

October 2016 – Population-Level Effects of Human Papillomavirus Vaccination Programs on Infections with Nonvaccine Genotypes “Studies have shown this potential unmasking effect (35,36); some increases in nonvaccine types that we observed could result from unmasking. Given the low prevalence of some nonvaccine HPV types, assessing changes in prevalence for individual types since the introduction of HPV vaccination has been challenging. By combining data from several studies, we enhanced our power to consider changes in individual HPV types. However, even with data from 13,886 girls and women <19 years of age and 23,340 women 20–24 years of age, we still had limited power to consider changes in very rare HPV types or to investigate reasons for the heterogeneity in findings for some HPV types because of inconsistent evidence for increases of specific nonvaccine types between age groups and the 2 (i.e., bivalent and quadrivalent) vaccines.”

September 23, 2016 – Measuring Adolescent Human Papillomavirus Vaccine Coverage: A Match of Sexually Transmitted Disease Clinic and Immunization Registry Data. “HPV vaccine initiation and completion were low among adolescent STD clinic patients; coverage was lower compared with other recommended vaccines. STD clinics may be good venues for delivering HPV vaccine, thereby enhancing efforts to improve HPV vaccination.

September 9, 2016 – Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study (full text) “Because of the high prevalence, medically unexplained physical symptoms are likely to be present in a considerable proportion of vaccinated femalesThe temporal association may, in the mindset of the parents or the vaccinated, be linked to vaccination. Furthermore, cases had an increased odds ratio of contact to psychologist or psychiatrist but not an increased odds of hospital diagnoses in the F-chapter of ICD-10, mental and behavioural disorders. The most common psychiatric diagnosis was emotionally unstable personality disorder including borderline disorder but this diagnosis was not more frequent in cases than in controls.

September 2016 – The Role of Cognitive Bias in Suboptimal HPV Vaccine Uptake “Many studies have demonstrated that a key factor hindering better coverage for HPV vaccine is lack of strong recommendations from clinicians. Clinicians have reported several reasons for this, including anticipated parental hesitancy, lack of perceived risk among their patients, and concern about the need for time-consuming conversations or discussions about sexual activity. Another factor that potentially limits higher coverage is clinicians’ cognitive biases against HPV-associated diseases. This topic is receiving substantially less (if any) attention in the scientific literature because it is not likely to be reported by clinicians themselves who may be unaware of the impact of these preconceived notions.”  COMMENT:: Of course no mention of the horrendous adverse events from the HPV vaccine:

August 31, 2016 – Are state laws granting pharmacists authority to vaccinate associated with HPV vaccination rates among adolescents? As currently implemented, state laws allowing pharmacists to administer HPV vaccine to adolescents were not associated with uptake. Possible explanations that need further research include restrictions on pharmacists’ third-party billing ability and the lack of promotion of pharmacy vaccination services to age-eligible adolescents.”

August 25, 2016 – Postural tachycardia syndrome (POTS) with anti-NMDA receptor antibodies after human papillomavirus vaccination “Her symptoms improved significantly with immunomodulatory therapy and re-occurred after immunomodulatory therapy was stopped, suggesting an autoimmune etiology of POTS after vaccination.”

August 17, 2016 – Quantitative and epitope-specific antigenicity analysis of the human papillomavirus 6 capsid protein in aqueous solution or when adsorbed on particulate adjuvants “Due to the particulate nature of the alum adjuvantsthe vaccine antigen adsorbed on adjuvants was considered largely as “a black box” due to the difficulty in analysis and visualizationHere, a novel method with fluorescence-based high content imaging for visualization and quantitating the immunoreactivity of adjuvant-adsorbed VLPs with neutralizing mAbs was developed, in which antigen desorption was not needed.” Comment: Virus-like particles (VLPs) are multiprotein structures that mimic the organization and conformation of authentic native viruses but lack the viral genome, potentially yielding safer and cheaper vaccine candidates.

August 13, 2016 – Expanding the benefits of HPV vaccination to boys and men “Clearly, direct evidence from randomised clinical trials would be the gold standard, but the rarity and clinical heterogeneity of the problem, the timescale for significant outcomes (eg, progression to frank invasive squamous carcinoma and death), and the cost of the research, militate against such studies ever being undertaken or them ever yielding clinically applicable results in a meaningful timeframe for current patients.”

August 9, 2016 – Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature (full text) “We retrospectively described a case series including 18 girls (aged 12–24 years) referred to our “Second Opinion Medical Network” for the evaluation of “neuropathy with autonomic dysfunction” after HPV vaccination. All girls complained of long-lasting and invalidating somatoform symptoms (including asthenia, headache, cognitive dysfunctions, myalgia, sinus tachycardia and skin rashes) that have developed 1–5 days (n = 11), 5–15 days (n = 5) and 15–20 days (n = 2) after the vaccination. These cases can be included in the recently described immune dysfunction named autoimmune/inflammatory syndrome induced by adjuvants (ASIA). … Moreover, the HPV vaccine formula, containing also high polysorbate 80 (50 mcg) concentration, might also induce a greater meningeal permeability leading to a facilitated entrance of many substances to the central nervous system. Based upon these observations, it might be speculated that this vaccine—and not others—could induce some abnormal activation of immune competent cells in the central nervous system, such as the glia.”

August 2016 – Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials “The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related.” Comment: Vaccination = no causation at all NEVER. If the studies were done unbiased these percentages of deaths would show related deaths to the vaccine

August 06, 2016 – Disparities in Provider Recommendation of Human Papillomavirus Vaccination for U.S. Adolescents “This study highlights significant disparities in provider recommendation of human papillomavirus vaccination for U.S. adolescents. Findings suggest possible areas for tailored interventions to bridge the gap in vaccine recommendation and uptake in high-risk populations.

August 06, 2016 – Human Papillomavirus (HPV): Making the case for “Immunisation for All” “Few countries have implemented a universal HPV vaccination programme for males and females, with many countries arguing that female only vaccination programmes protect males via herd immunity, and that men-who-have-sex-with-men will be protected via targeted vaccination programmes. We argue these may be limited in their effectiveness. We propose that the most effective, practical, ethical and potentially cost effective solution is universal HPV vaccination that might lead to control of HPV-related diseases in men and women alike.

July 30, 2016 – HPV vaccination: a decade on “These misunderstandings have weakened political will to mandate the vaccine. Often, parents have not heard about the vaccine or believe that it is not needed. Politicians, health-care professionals, and parents all need to understand the importance of the vaccine. To deny girls and boys the full protection of the vaccine can no longer be tolerated.” Comment: Where is the authors name in this editorial after making such scathing statements?

July 29, 2016 – A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men
Disclosures and contributions 

  • AL is employee of Merck & Co., Inc., and may own stock and/or stock options in the company.
  • PVD acts as coordinating and principal investigator for vaccine trials conducted on behalf of the University of Antwerp, for which the University obtains research grants from vaccine manufacturers; speakers fees for presentations on vaccines are paid directly to an educational fund held by the University of Antwerp. PVD receives no personal remuneration for this work.
  • CJLM received speakers fees from GSK, Qiagen, SPMSD/Merck, Roche, Menarini and Seegene, served occasionally on the scientific advisory board (expert meeting) of GSK, Qiagen, SPMSD/Merck, Roche and Genticel, and on occasion as consultant for Qiagen and Genticel. He is minority stockholder of Diassay b.v. and of Self-Screen b.v., a spin off company of Free University Medical Center, Amsterdam, the Netherlands. Until 2014 he held a small number of certificates of shares in Delphi Biosciences, which went into receivership in 2014. He received research funding via his institution from Gen Probe and Abbott.
  • DK has obtained grants from Sanofi Pasteur MSD, Lyon, France to conduct the study. MB, ST and AS are/were employees of Sanofi-Pasteur MSD at the time the study was conducted.
  • Role of the funding source Sanofi Pasteur MSD provided financial support for the conduct of the research and preparation of the article and were involved in the study design, in the collection, analysis and interpretation of data and in the writing of the trial report.

Summary of safety for days 1-15 following either vaccination safety set.

9vHPV vaccine N = 248 qHPV vaccine N = 248
n (%) n (%)
No adverse events 44 (17.7) 45 (18.1)
One or more adverse events 204 (82.3) 203 (81.9)
One or more vaccine-related adverse reactions 202 (81.5) 196 (79.0)
Injection-site adverse reaction 196 (79.0) 179 (72.2)
Solicited injection-site adverse reaction 195 (78.6) 177 (71.4)
Injection site erythema 38 (15.3) 43 (17.3)
Injection site swelling 36 (14.5) 23 (9.3)
Injection site pain 193 (77.8) 174 (70.2)
Other injection-site adverse reaction 24 (9.7) 23 (9.3)
Severe injection-site adverse reaction 3 (1.2) 4 (1.6)
Systemic adverse events 101 (40.7) 100 (40.3)
Vaccine-related systemic adverse event 57 (23.0) 54 (21.8)
Serious adverse events 0 (0) 0 (0)
Vaccine-related serious adverse event at any time 0 (0) 0 (0)
Serious adverse events leading to death 0 (0) 0 (0)
Withdrawn due to an adverse event 0 (0) 0 (0)

Comment:  The amount of aluminum in the new HPV9 has doubled and it is causing a huge uptick in the number of side effects and reactions. And this study used another HPV vaccine as the placebo – which is outrageous. Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum. HPV4 (Gardasil) contains 225 mcg of aluminum, which caused a lot of reactions too.
You really have to check the abstract to this study. I’m floored by the number of conflicts of interest. States and even counties within states are trying to mandate HPV vaccines. Pharma is infiltrating county board seats. When are more citizens going to rise up? First infants, now adolescents. Adults are next.

July 19. 2016 – Human papillomavirus vaccination guideline update: American Cancer Society guideline endorsement “Although not included in the search terms for this review, reported adverse events potentially associated with vaccination were included as outcomes of interest (see online supporting information).

July 2016 – Primary Care Physicians’ Adherence to Expert Recommendations for Cervical Cancer Screening and Prevention in the Context of Human Papillomavirus Vaccination “Contrary to expert recommendations, a considerable minority of physicians reported recommending HPV vaccination based on HPV and Pap test results. If these clinical practices persist, many young adult women will not realize the benefits of HPV vaccination. Additional efforts are needed to ensure all young women are screened and vaccinated appropriately.”

July 2016 – Informed Consent in Decision-Making in Pediatric Practice “Primary prevention is available in the form of vaccination, which is recommended for both boys and girls ages 11 through 12 years by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. It is unknown whether most states will include the HPV primary prevention vaccination in the category of protected STI treatment or general vaccination for which minors may not provide consent. The majority of states allow some or all adolescents 12 years or older access to contraceptive services and usually do not require parental notification.

July 19. 2016 – Human papillomavirus vaccination guideline update: American Cancer Society guideline endorsement “Although not included in the search terms for this review, reported adverse events potentially associated with vaccination were included as outcomes of interest (see online supporting information).

July 2016 – Awareness of HPV and Uptake of Vaccination in a High-Risk Population “Within 1 year, <16% of adolescents received vaccination. The relationship between awareness and subsequent vaccination was either not statistically significant or not meaningful in magnitude, with R2 = 0.004 to 0.02. The predicted probability of getting vaccination was <0.50 for all awareness levels and prediction accuracy was poor (area under the curve = 0.56–0.64).”

July 2016 – Immunization in the United States: Recommendations, Barriers, and Measures to Improve Compliance (full text) “Issuing financial incentives to parents or patients, such as an entry into a lottery for a gift certificate or providing vaccines for free to the uninsured, are other strategies that may improve immunization rates. However, studies published regarding adolescent HPV vaccination suggest that providing free vaccines has a limited effect. With respect to incentivized vaccination, one study determined that providing a shopping voucher to girls 16 to 18 years old at each of the three visits required for the HPV vaccine led to significant and substantial increases in series completion, with double to quadruple the rates found in the control group. However, the low overall completion rates (12.4%–22.4%) indicate that additional approaches may be required to achieve higher vaccination rates. A literature review regarding the influence of financial incentives on parents in increasing preschool vaccination also found insufficient evidence to conclude that this strategy was effective, suggesting that more research may be necessary.”

June 24, 2016 – Human papillomavirus vaccine series completion: Qualitative information from providers within an integrated healthcare organization “Interventions to improve HPV vaccination completion rates should address both individual- and system-level factors. Improving communication skills, encouraging a supportive medical culture, and addressing resource issues is likely to improve vaccine adherence.”

June 15, 2016 – Association Between Serum 25-Hydroxyvitamin D Level and Human Papillomavirus Cervicovaginal Infection in Women in the United States “Similarly, the odds ofvaccine-type HPV infectionwere increased in women with vitamin D levels that were severely deficient (serum 25[OH]D level, <12 ng/mL; aOR, 2.90; 95% CI, 1.32–6.38), deficient (12–19 ng/mL; aOR, 2.19; 95% CI, 1.08–4.45), and insufficient (20–29 ng/mL; aOR, 2.19; 95% CI, 1.22–3.93), compared with those with vitamin D levels that were sufficient (≥30 ng/mL).”

June 13, 2016 – Monitoring for Human Papillomavirus Vaccine Impact Among Gay, Bisexual, and Other Men Who Have Sex With Men—United States, 2012–2014 “Most young MSM lacked evidence of current or past infection with all vaccine-type HPV types, suggesting that they could benefit from vaccination. The impact of vaccination among MSM may be assessed by monitoring HPV prevalence, including in self-collected specimens.”

June 2, 2016 – Cervical Infection With Vaccine-Associated Human Papillomavirus (HPV) Genotypes as a Predictor of Acquisition and Clearance of Other HPV Infections “Females infected with vaccine-targeted types were generally at higher risk of acquiring additional types (HRs, > 1.0) and at equal risk of clearing existing infections. Accounting for multiple comparisons, none of the HRs of < 1.0 or >1.0 were statistically significant in our analyses of acquisition or clearance.”

June 1, 2016 – Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccination (full text) “Furthermore, the percentage of non‑vaccine HR‑HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low‑risk’ or ‘probably high‑risk’ are in fact HR‑HPV types. Therefore, it may be important to monitor non‑vaccine HPV types in future studies, and an investigation concerning several HR‑HPV types as risk factors for the development of cervical cancer is required.”

May 1, 2016 – Natural Acquired Immunity Against Subsequent Genital Human Papillomavirus Infection: A Systematic Review and Meta-analysis “Conclusions. HPV antibodies acquired through natural infection provide modest protection against subsequent cervical HPV infection in female subjects.”

April 2016 – Postural Orthostatic Tachycardia Syndrome (POTS) – A novel member of the autoimmune family (pdf) “There are several plausible explanations for the appearance of abnormal cardiac including death, following HPV vaccination. Namely, in exploring the primary sequence of the HPV major capsid L1 protein (one of the four antigens in Gardasil) for peptide sharing with human proteins, Kanduc found that pentamers from the HPV viral capsid protein are shared with human proteins that, when altered, have been linked to arrhythmias, cardiovascular diseases and sudden death. In particular,  out of the viral pentamers are present in the human protein, Titin, alterations of which have been linked to cardiac failure and sudden cardiac death.

April 2016 – A sequential logit model of caretakers’ decision to vaccinate children for the human papillomavirus virus in the general population “Parents and guardians of children between the ages of 9 and 17 years who completed the 2010 Behavioral Risk Factor Surveillance System survey collected by the Center for Disease Control (CDC, 2010) were analyzed. Utilizing Andersen’s health care beliefs model, we explored the sequential nature of the decision to vaccinate (i.e., the decision to receive the first, second, and third dose), thereby allowing the independent variables to vary across each transition.”…”Our analysis underscores the importance of modeling the vaccination decision in a manner that is consistent with how primary caregivers navigate real-life health care decisions for their children.”

March 8, 2016 – A qualitative study of healthcare provider awareness and informational needs regarding the nine-valent HPV vaccine “Over half were aware of the vaccine but few HCPs claimed to be familiar with it. HCPs indicated several questions with common themes pertaining to efficacy, side effects, and cost. Only half of HCPs believed patients or parents would have questions. The results suggest strategies and areas for health systems and public health organizations to target in order to resolve unmet educational needs among HCPs regarding 9vHPV.”

March 4, 2016 – Motor and sensory clinical findings in girls vaccinated against the human papillomavirus from Carmen de Bolivar, Colombia. “We discuss mechanisms that might underlie many of these symptoms and suggest some tests that could help victims better document their disease. We cannot rule out the presence of genetic or environmental susceptibilities in the cluster of Carmen de Bolivar, Colombia. – Because there are susceptible individuals in every population, we must exercise the century-old medical principle “primum non nocere” or more modernly, “assess before vaccinating“We should also ask for informed consent to spare unnecessary disability in people with recognized immunological derangementsMassive and indiscriminate immunizations should be avoided because no medical or health intervention is 100% effective and we expect a small percentage of people who might be unnecessarily subjected to pain and suffering. Additionally, we should stop defending a yet unproven risk-benefit balance that justifies ‘a small number of victims’.”

March 2016 – Improving HPV Vaccination Rates Using Maintenance-of-Certification RequirementsParticipating clinicians missed fewer opportunities for HPV vaccination than nonparticipants. MOC participants significantly increased their captured opportunities relative to nonparticipating clinicians by 5.7 percentage points for HPV dose 1 at preventive visits and by 0.7 and 5.6 percentage points for doses 1 and 2, respectively, at acute visits. There were no significant differences for other doses. The estimated program cost was $662/participant. Of the participating pediatricians, 96% felt the effort to participate was warranted, and half would not have joined the project without the MOC requirement.

February 26, 2016 – Adverse events following HPV vaccination, Alberta 2006–2014 “We identified all reported adverse events following immunization (AEFI) and all emergency department (ED) utilization or hospitalizations within 42 days of immunization. We calculated the frequency of AEFI by type, rates per 100,000 doses of HPV vaccine administered and the frequencies of ICD-10-CA codes for hospitalizations and emergency department visits.”…”192 reported one or more AEFI events (198 AEFI events), i.e., 37.4/100,000 doses administered (95% CI 32.5–43.0). None were consistent with VTE. Of the women who received HPV vaccine 958 were hospitalized and 19,351 had an ED visit within 42 days of immunization. Four women who had an ED visit and hospitalization event were diagnosed with VTEThree of these had other diagnoses known to be associated with VTE; the fourth woman had VTE among ED diagnoses but not among those for the hospitalization.” Comment: Conclusions say rates are low. So that is okay? 958 women hospitalized and over 19k had an emergency department visit. What is good for some is not good for everyone. HPV has to stop!

February 24, 2016 – Provider communication and HPV vaccination: The impact of recommendation quality“Almost half (48%) of parents reported no provider recommendation for HPV vaccination, while 16% received low-quality recommendations and 36% received high-quality recommendations.”…   “High-quality recommendations were strongly associated with HPV vaccination behavior, but only about one-third of parents received them. Interventions are needed to improve not only whether, but how providers recommend HPV vaccination for adolescents.”

February 17 2016 – A human papillomavirus vaccination program for low-income postpartum women “Those who were Hispanic or had received an influenza vaccination in the last year were more likely to initiate and complete the series through this program. Patients who missed 1 or more follow-up appointments were less likely to complete the vaccine series. Conclusions: Offering the human papillomavirus vaccine postpartum dramatically increased initiation rates among postpartum patients. Patient navigation and text messages ensured that a high percentage completed all 3 doses.

February 15, 2016 – Impact of Human Papillomavirus (HPV) 16 and 18 Vaccination on Prevalent Infections and Rates of Cervical Lesions After Excisional Treatment “Among treated women, 34.1% had oncogenic infection and 1.6% had cervical intraepithelial neoplasia 2+ detected after treatment, respectively, and of these 69.8% and 20.0% were due to new infections. We observed no significant effect of vaccination on rates of infection/lesions after treatment. Vaccine efficacy estimates for human papillomavirus 16/18 associated persistent infection and cervical intraepithelial neoplasia 2+ after treatment were 34.7% (95% confidence interval=-131,82) and -211% (95% confidence interval=-2901,68), respectively. We observed evidence for a partial and non-significant protective effect of vaccination against new infections absent before treatment.”…”Conclusions: We find no evidence for a vaccine effect on the fate of detectable human papillomavirus infections. We show that vaccination does not protect against infections/lesions post-treatment. Evaluation of vaccine protection against new infections and resultant lesions warrants further consideration in future studies.

Conflicts of Interest and Role of Funding Source

  • John T. Schiller and Douglas R. Lowy report that they are named inventors on US Government-owned HPV vaccine patents that are licensed to GlaxoSmithKline and Merck and for which the National Cancer Institute receives licensing fees.

February 9, 2016 – The Impact and Cost-Effectiveness of 3 doses of 9-Valent Human Papillomavirus (HPV) Vaccine among US Females Previously Vaccinated with 4-Valent HPV Vaccine “The average cost per QALY gained by additional 9vHPV vaccination exceeded $100,000 in both models. However, the results varied considerably in sensitivity and uncertainty analyses. Additional 9vHPV vaccination is likely not as efficient as many other potential HPV vaccination strategies, such as increasing primary 9vHPV vaccine coverage.”

February 9, 2016 – Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9–14 Years Versus a 3-Dose Regimen in Women Aged 15–25 Years (full text) “One nonserious potential immune-mediated disease of seventh cranial nerve paralysis in the 3D group was considered to have a possible causal relationship to vaccination; the onset of this event was 18 days after the first vaccine dose, and the event resolved after 13 days without sequelae. Twenty-five pregnancies were reported (24 in the 3D group and 1 in the 2D [M0,12] group). Of these, 18 resulted in the delivery of a normal infant (including the pregnancy in the 2D [M0,12] group), 1 was an ectopic pregnancy, 1 was terminated by elective abortion, 1 was a stillbirth, and pregnancies 4 were ongoing at the time of reporting. No apparent congenital anomalies were reported.
Disclaimer. GlaxoSmithKline Biologicals designed the study in collaboration with investigators and coordinated gathering, analysis, and interpretation of data and writing of the report. Investigators from the study group gathered data for the trial and cared for the study subjects. All authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The manuscript was developed and coordinated by the authors in collaboration with an independent medical writer and publication managers, working on behalf of GSK Vaccines. Financial support.This work was supported by GlaxoSmithKline Biologicals SA.
Potential conflicts of interest.

  • T. P. and M. K. received a grant through their respective institutions from the GSK group of companies.
  • L.-M. H. received grants through his institution from the GSK group of companies and also received consultancy fees for participation to HPV expert board, and payment for educational presentation from the GSK group of companies.
  • R.-B. T. received funding from the GSK group of companies through his institution.
  • T. F. S. received fees for board membership, consultancy, and payment for lectures including service on speakers bureaus, from the GSK group of companies.
  • S. E. received grants from the GSK group of companies, Crucell, Novartis, Pfizer and Roche through her institution; payment for lectures including service on speakers bureaus from the GSK group of companies, Crucell, Novartis, and Astrazeneca and also received support for travel to meetings for the study from the GSK group of companies.
  •  L. F. received support for travel to meeting for the study from the GSK group of companies.
  • C. G. received payments for board membership and lectures including service on speakers bureaus from Sanofi Pasteur MSD, Merck and GSK group of companies.
  • S. M. received grants through her institution from the GSK group of companies, Pfizer, and Sanofi Pasteur MSD; consultancy fees from Pfizer; and payment for lectures from Merck and Pfizer, including service on speakers bureaus.
  • P. R. received funding through his institution for the conduct of the clinical trial and support for travel to meetings for the study from the GSK group of companies; he also holds stock option from the GSK group of companies.
  • P. D. received a grant from the GSK group of companies through his institution for the conduct of this trial; received grants through his institution from Sanofi Pasteur MSD, Berna Crucell, Novartis, and Pfizer for the conduct of other clinical trials; and received support for travel to meetings from the GSK group of companies, consultancy fees for participation to advisory boards and payment for lectures, including service on speakers bureaus, from Pfizer and Sanofi Pasteur MSD.
  • M. Horn received consultancy fees from the GSK group of companies and Novartis; support for travel to meetings for the study from the GSK group of companies; payment for board membership from Novartis; payment for lectures, including service on speakers bureaus, development of educational presentations, and travel, accommodation, and meeting expenses from the GSK group of companies, Sanofi Pasteur MSD, and Novartis.
  • S. P., S. D. S., D. F., B. D. M., P. V. S., D. D., F. T., and F. S. are employees of the GSK group of companies.
  • M. Hezareh is a Chiltern International consultant for the GSK group of companies. F. T. holds stock options from the GSK group of companies. D. D. and F. S. hold shares and stock options from the GSK group of companies.

Comment: This is one of the longest list of Conflicts of Interest I’ve have ever seen.

February 3, 2016 – General practitioners’ attitudes and behaviors toward HPV vaccination: A French national survey “Overall, 72% of participants reported frequently recommending HPV vaccination; 60% considered that not enough is known about its risks. The model averaging showed that the factors most associated with infrequent recommendation of this vaccine by GPs were: unfavorable perceptions of its risk-benefit balance (OR = 0.13; 95%CI = 0.09–0.21; partial R2 = 0.10), a decision not to vaccinate one’s own daughter(s) with this vaccine (OR = 0.13; 95%CI = 0.07–0.24; partial R2 = 0.05), and doubts about vaccine utility in general (OR = 0.78; 95%CI = 0.71–0.86; partial R2 = 0.03).”

February 3, 2016  Use of the nonavalent HPV vaccine in individuals previously fully or partially vaccinated with bivalent or quadrivalent HPV vaccines (full text) “Simultaneously, antibody responses to HPV-6, 11, 16, and 18 were non-inferior to those generated by the 4vHPV vaccine. Consequently, efficacy for 9vHPV against persistent infection and disease related to HPV types 6, 11, 16, or 18 can be inferred to be comparable to that of 4vHPV [17]. Finally, immunization with 9vHPV was shown to be well tolerated and safe in the pivotal RCT, and although it resulted in more adverse local reactions than vaccination with the 4vHPV vaccine, as expected due to the higher dose of antigen and/or adjuvant, more than 90% of these reactions were mild to moderate in intensity. Comment: GARDASIL 9 vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride.

January 24, 2016 – Provider communication and HPV vaccination: The impact of recommendation quality “High-quality recommendations were strongly associated with HPV vaccination behavior, but only about one-third of parents received them. Interventions are needed to improve not only whether but how providers recommend HPV vaccination for adolescents.

January 18, 2016 – The role of anticipated regret and health beliefs in HPV vaccination intentions among young adults “Anticipated regret was associated with HPV vaccine intentions above and beyond the effects of HBM variables among men. Among women, neither anticipated regret nor HBM variables showed consistent associations with HPV vaccine intentions. Findings suggest that anticipatory emotions should be considered when designing interventions to increase HPV vaccination among college men.”

January 9, 2016 – Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil “Moreover, anti-HPV antibodies from the sera of Gardasil and Gardasil + Pt-injected mice showed cross-reactivity with the mouse brain protein extract. Immunohistochemistry analysis revealed microglial activation in the CA1 area of the hippocampus of Gardasil-injected mice compared to the control. It appears that Gardasil via its Al adjuvant and HPV antigens has the ability to trigger neuroinflammation and autoimmune reactions, further leading to behavioral changes.”

January 2, 2016 – Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008–2011 “We identified 313 potential cases of VTE among HPV4 vaccinees, and 291 (93%) had sufficient medical records for review. Of these, we confirmed 156 (54%) cases. VTE was uncommon among males (n = 3) and 9–12 year olds (n = 4). Nearly all confirmed cases (97%) had at least one known risk factor for VTE, including hormonal contraceptive use, obesity, and hypercoagulability. Sixteen (10%) confirmed cases occurred in the 1–60 days following HPV4 exposure. The risk of VTE varied from 1.47 (95% CI: 0.47–4.64) in the 1–7 days following HPV4 exposure to 0.92 (95% CI: 0.54–1.57) in the 1–60 days following vaccination. It was not possible to calculate a stratified IRR for males due to small sample size; the other risk factors evaluated did not significantly affect the risk of VTE after HPV4 exposure.”

January 2016 – Human Papillomavirus Vaccination at a Time of Changing Sexual Behavior “Our model shows that early implementation of HPV vaccination attenuates increased risk of HPV infection that accompanies transition to gender-similar sexual behavior. This finding affects the interpretation of studies on the surveillance of HPV vaccination. For example, in the absence of reliable data regarding the sexual behavior of a population and on vaccination coverage, increased HPV prevalence might be erroneously interpreted as a lack of vaccine effectiveness.”

  • Acknowledgments: “This work was supported by the European Community’s Seventh Framework Programme (FP7-HEALTH-2013) under grant agreement no. 603019 and by the Bill & Melinda Gates Foundation, grant no. OPP1053353.

Comment: There have been 9 articles in the Vaccine Research Library since January 2016 on the big push for the HPV vaccine. Articles pertaining to increasing physician recommendations, parental influence, sibling influence, and now gender specifics. Gardasil 9 has increased Aluminum. Now a study has been withdrawn from the journal Vaccine that showed dangers of aluminum with Gardasil. The adverse events are real – see VAERS.

January 2016 – New Concerns about the Human Papillomavirus Vaccine “It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF)also known as premature menopause. There have been two case report series (3 cases each) published since 2013 in which post-menarcheal adolescent girls developed laboratory documented POF within weeks to several years of receiving Gardasil, a four-strain human papillomavirus vaccine (HPV4).

December 1, 2015 – The world must accept that the HPV vaccine is safe But the science alone will not be enough to build public and political confidence. “The HPV vaccine touches nerves, and acceptance needs strategies that vary between cultural and political settings. Despite the challenges, more than 80 million girls and women around the world have received the vaccination. We should not underestimate the potential for progress to be disrupted by the mass spread of vaccine reactions and concerns, the amplification that can follow through social media and the vulnerability of political processes, which sometimes find themselves paralyzed between public and scientific opinion.”

December 2015 – An appraisal of theoretical approaches to examining behaviours in relation to Human Papillomavirus (HPV) vaccination of young women (full text) “Theoretical models related to individuals’ health-related behaviour were predominantly used by the primary studies, of which the Theory of Reasoned ActionTheory of Planned Behaviour and the Health Belief Model were the most frequently reported. Behavioral theories and models are considered an important tool in effective behavior change interventions and programmes (Craig et al., 2008 and Campbell et al., 2000). Across a wide range of settings, relationships between internal constructs from the Theories of Planned Behaviour and Reasoned Action which measure individual motivational factors based on behavioral, normative and control beliefs were identified. Relationships between individuals’ beliefs in relation to threat perception and behavioral evaluation, informed by the Health Belief Model, were also widely reported. These potentially modifiable beliefs can shape individual behavior and can be targeted in order to bring about health-related behavior changes.” Comment: People need to wake up and see how far Pharma is willing to go to change behavior and inject you with these vaccines.

November/December – Human Papillomavirus Vaccination Among Adults and Children in 5 US States A total of 612 (24.6%) girls and 86 (5.2%) boys received 1 or more doses of HPV vaccines; 308 (50.3%) vaccinated girls and 14 (10.8%) vaccinated boys completed the vaccine series. Younger age (9-12 years: aOR = 0.09) and not receiving a seasonal influenza vaccine (aOR = 0.44) were negatively related to HPV vaccine initiation in girls. Girls were less likely to initiate and complete HPV vaccination if their parents did not have a routine checkup within 1 year. Conclusion: HPV vaccination in the United States remains below the Healthy People 2020 objective (80%). To increase HPV vaccination, strategies still need to focus on improving access to HPV vaccines and utilization of health services.

November 16, 2015 – Cross-sectional study about primary health care professionals views on the inclusion of the vaccine against human papillomavirus in the vaccine schedules (full text) “There is a strong controversy among health professionals regarding the marketing and inclusion of HPV vaccine in immunization schedules. However, the knowledge of the primary care health professionals on key aspects of infection and vaccine protection are insufficient. The training of professionals in vaccination, cervical pathology and HPV infection should be improved to provide objective information on the use as this vaccine for patients.”

November 2015 – Does human papillomavirus-negative condylomata exist? “We found 75 different HPV types, out of which 43 represented novel putative HPV types. Three types were cloned and established as HPV types 200, 201 and 202. Molluscum contagiosum virus was detected in 24 of the 40 samples. In summary, deep sequencing enables detection of HPV in almost all condylomata. “HPV-negative” condylomata might largely be explained by clinical misdiagnosis or the presence of viral variants, distantly related HPV types and/or low viral loads.” Comment: Will we soon have an HPV75 vaccine?

October 13, 2015 – Immunogenicity and safety of Gardasil among mid-adult aged men (27–45 years)—The MAM Study “100% of men seroconverted to each of the four HPV vaccine components, and the vaccine was generally well-tolerated.”…”Funding Merck & Co. Inc. was the main sponsor of this trial (IISP39256) and provided the study product.

October 2015 – Gender-neutrality, herd effect and resilient immune response for sustainable impact of HPV vaccination “Summary: Gender-neutral vaccination based on comparative effectiveness research will hopefully soon tackle the whole spectrum of HPV cancers in both sexes. The remaining challenges are how to ensure resilience of HPV vaccine-induced immunity and herd effect to guarantee population-level impact of HPV vaccination, and how to guard against HPV type replacement.”

September 16, 2015 – Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years) “The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). ”

September 14, 2015 – The safety of human papilloma virus-blockers and the risk of triggering autoimmune diseases. “Expert opinion: The current HPVv are both effective and generally safe. However, it should be noted that autoimmune side effects have been reported in several studies. Further research should be done to understand the relationship between HPVv and autoimmunity.”

September 2015 – Monitoring Effect of Human Papillomavirus Vaccines in US Population, Emerging Infections Program, 2008–2012 “Because of the slow natural history of HPV oncogenesis, the effect of vaccination on invasive cancers will not be evident for decades.”

August 26, 2015  Human papillomavirus vaccines: WHO position paper, October 2014—Recommendations (full text) “Breastfeeding is not a contraindication for HPV vaccination. Available evidence does not indicate an increased risk of adverse events linked to the vaccine in either the mothers or their babies after administration of HPV vaccine to lactating females. HPV vaccines should not be given to anyone who has experienced a severe allergic reaction after a previous vaccine dose, or to a component of the vaccine. Travelers and health-care workers: Travellers and health-care workers are not at special risk of contracting HPV infection and there are no specific vaccination recommendations for these groups.” Comment: HPV isn’t infectious with normal contact, “like those in a classroom.

August 10, 2015 – Interventions to Improve Adolescent Vaccination: What May Work and What Still Needs to Be Tested (full text) “Some groups have  recently begun to explore the potential for pharmacies to improve adolescent vaccination, particularly for HPV. Multiple barriers have been identified, including reimbursement for vaccination and tracking of provided vaccines. However, given the proven success of pharmacists as vaccinators of adults, finding ways to implement a similar approach for adolescent vaccination may be a fruitful area for future study.”

August 7, 2015 – A model of health care provider decision making about HPV vaccination in adolescent males “Most providers agreed with the ACIP recommendations, however, several expressed that providers’ preexisting opinions might remain unchanged despite the recommendations. Consistent with the literature on determinants of HPV vaccination, providers believed that their own recommendation was a major factor in a family’s decision to vaccinate. Barriers to vaccination included the “newness” and sexual nature of the vaccine, lack of insurance coverage, and the vaccine not being mandated.” Comment: Parents and some providers are against the HPV vaccine, so why not mandate the vaccine by law, taking the choice away from parents and providers. Pharma can triple profits.

August 3, 2015 – Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines “This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or nonconcomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis]).”…”Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually.

August 2015 – Evaluation of the Long-Term Anti-Human Papillomavirus 6 (HPV6), 11, 16, and 18 Immune Responses Generated by the Quadrivalent HPV Vaccine (full text) “The development of preinvasive cervical intraepithelial neoplasia grades 2 and 3 (CIN2 and CIN3) to invasive cancer (from incident high-risk HPV infections) takes 10 to 15 years minimum and 20 to 25 years on average. Because of this, the ability of vaccine-induced immunity to prevent cervical preinvasive lesions and cancer in preadolescent girls is best measured years after immunization.” …”Support for this study was provided by Merck & Co., Inc. (Whitehouse Station, NJ, USA). We thank Karyn Davis (Merck) for help with formatting and editing for submission.

  • C.M. has received support for conference participation and speaker’s fees from Sanofi Pasteur MSD.
  • S.K.K. received advisory board, speaker’s fees, and unrestricted research grants through her institution from Sanofi Pasteur MSD and Merck.
  • M.N. and J.D. report receiving funding from Merck & Co., Inc. through their respective institutions to conduct clinical trials of this vaccine.
  • M.H. is working with clinical trials of this vaccine, sponsored by Merck & Co.
  •  A.S., Karyn Davis, and S.V. are employees of Merck & Co., Inc. and may own stock and or stock options. No other potential conflicts of interest are reported.

August 2015 – Early Defensive Mechanisms against Human Papillomavirus Infection (full text) “The fact that 90% of HPV infections are cleared within 2 years speaks to the success of immune effector mechanisms. Nevertheless, some women harbor persistent HPV infections for years. A prospective study by Scott et al.”

August 2015 – Implementation and Evaluation of a School-Based Human Papillomavirus Vaccination Program in Rural Kentucky “At the beginning of the school year, all 935 students at the two schools were given HPV vaccination parental consent forms. Five hundred eleven students returned consent forms (55% return rate), and 447 of these students were HPV vaccine naïve (87%). Of these students, 315 (70%) initiated the vaccine series, with 276 (62%) completing the entire three-dose series, so that 88% of students initiating the vaccine series successfully completed the series. In estimating rates for the entire school body, 45% of students had received all three doses by the end of the project. Conclusions Despite study design limitations, results of this project provide further evidence about school-based immunization programs as an effective strategy for improving HPV vaccination rates among Kentucky and U.S. adolescents.

August 2015 – Organizational Variation in Implementation of an Evidence-Based Human Papillomavirus Intervention “Although analysis conducted in October 2014 found that the pilot study did not generate significant changes in HPV vaccine rates, data yielded from the Organizational Readiness to Change Assessment survey instrument and process evaluation interviews revealed variation in pre-study planning and in the use and coordination of staff, the adaptation of materials provided for implementation, and sites’ ability to access HPV vaccine rate data throughout the study.”

August 2015 – Physician communication about adolescent vaccination: How is human papillomavirus vaccine different? “Our findings suggest that primary care physicians perceived HPV vaccine discussions to be burdensome, requiring more time and engendering less parental support than other adolescent vaccines. Perhaps for this reason, physicians in our national study recommended HPV vaccine less strongly than other adolescent vaccines and often chose to discuss it last. Communication strategies are needed to support physicians in recommending HPV vaccine with greater confidence and efficiency.”

July 15, 2015 – Do Vitamin D Levels Affect Antibody Titers Produced in Response to HPV Vaccine? “In linear regression analyses, antibody titers for all HPV strains were significantly higher among those with lower vitamin D levels and among younger participants (P<0.05). These relationships add to the body of knowledge of the complex role of vitamin D in immunoregulation.”

July 9, 2015 – Immunogenicity and safety of the human papillomavirus vaccine in patients with autoimmune diseases: A systematic review “The results of our literature revision suggest that the HPV vaccines are efficacious and safe in most of the patients affected by autoimmune diseases. Yet, some points of concern remain to be tackled, including the effects of concomitant therapies, the risk of disease exacerbation and the cost-effectiveness of such immunisation programmes in these populations.”

July 7, 2015I didn’t even know boys could get the vaccine’: Parents’ reasons for human papillomavirus (HPV) vaccination decision making for their sons “Using the precaution adoption process model (PAPM), parents were classified according to one of six stages of decision making: unaware, unengaged, undecided, decided not to vaccinate, decided to vaccinate, or vaccinated. Parents responded to an open-ended question: ‘What would influence your decision to have your son vaccinated or not against HPV?’

July 2015 – Hypothesis: Human papillomavirus vaccination syndrome—small fiber neuropathy and dysautonomia could be its underlying pathogenesis “Different isolated cases and small series have described the development of complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and fibromyalgia after HPV vaccination. These are illnesses often difficult to diagnose that have overlapping clinical features. Sympathetic nervous system dysfunction seems to play a major role in the pathogenesis of these syndromes. Also, small fiber neuropathy has been recently recognized in CRPS, POTS, and fibromyalgiaThis article forwards the hypothesis that small fiber neuropathy and dysautonomia could be the common underlying pathogenesis to the group of rare, but severe reactions that follow HPV vaccination.”

June 22, 2015 – Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System “The three most common vaccines in these reports were 2009 H1N1 inactivated influenza, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported.”

June 10, 2015 – Associations Between Exposure to and Expression of Negative Opinions About Human Papillomavirus Vaccines on Social Media: An Observational Study (full text) “Conclusions: The heterogeneous community structure on Twitter appears to skew the information to which users are exposed in relation to HPV vaccines. We found that among users that tweeted about HPV vaccines, those who were more often exposed to negative opinions were more likely to subsequently post negative opinions.” Comment: Wonder how much money went into this conclusion?

June 2015 – Associations Between Exposure to and Expression of Negative Opinions About Human Papillomavirus Vaccines on Social Media: An Observational Study “During the 6-month period, 25.13% (20,994/83,551) of tweets were classified as negative; among the 30,621 users that tweeted about HPV vaccines, 9046 (29.54%) were exposed to a majority of negative tweets. The likelihood of a user posting a negative tweet after exposure to a majority of negative opinions was 37.78% (2780/7361) compared to 10.92% (1234/11,296) for users who were exposed to a majority of positive and neutral tweets corresponding to a relative risk of 3.46 (95% CI 3.25-3.67, P<.001).”

June 2015 – The first steps towards the era of personalised vaccinology: predicting adverse reactions (full text) “As an example, we estimated recently the incidence of post-HPV vaccine ADEM to be of 0.26/106 vaccinations (CI 95%: 0.16/106–0.37/106). Even assuming a 10-fold higher incidence because of biases such under-reporting to the surveillance databases, still the retrieving of a number of case large enough would require a large scale, national or international study.”…”On the basis of the data reviewed above we feel that that a correlation between vaccine adverse reactions and genetics exists and deserves further studies. The idea of identifying the genetic variants predictive for vaccine adverse events and suitable for the introduction in clinical practice is, in our opinion, feasible as the cost of genotyping is falling rapidly and large-scale genotyping at birth is not too far off the horizon.”

June 2015 – Updated, augmented vaccines compete with original antigenic sin “What worries some researchers is that individuals who already received vaccination against HPV will not respond to the augmented vaccine version with more strains because of an immunological concept known as ‘original antigenic sin.’?

June 2015 – An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccines to Healthy Adolescents 11–15 Years of Age (full text)

  • This study was funded by Merck and Co., Inc.
  • P.K. reports receiving past grant support from Merck through his institution.
  • J.M. reports grants and personal fees from Merck.
  • T.V. received speaker fees from Merck and GSK and is a member of advisory boards of Merck, Sanofi Pasteur MSD, Novartis and Pfizer.
  • P.V.D. acts as chief and principal investigator for vaccine trials conducted on behalf of the University of Antwerp, for which the University obtains research grants from vaccine manufacturers; speaker fees for presentations on vaccines are paid directly to an educational fund held by the University of Antwerp. P.V.D. receives no personal remuneration for this work.
  • E.A.J. reports grants, personal fees and nonfinancial support from Merck, grants, personal fees and nonfinancial support from Sanofi Pasteur MSD and GlaxoSmithKline and personal fees fromRoche Diagnostics.
  • K.C., R.M., A.L. and A.S.M. are current or former employees of Merck and may own stock/stock options.

June 2015 – Cost-effectiveness of Chlamydia Vaccination Programs for Young Women “Models of the effect and cost-effectiveness of human papillomavirus (HPV) vaccine were developed before HPV vaccines were approved for use in the United States. These models, as well as subsequent models they helped to inform, proved valuable to public health officials and policy makers. Our exploratory model is intended to help advance the discussion surrounding development of a successful chlamydia vaccine, to inform the business case for investing in research and development of chlamydia vaccines, and to promote development of more detailed models so that the necessary tools are in place for chlamydia vaccine recommendations.”

May 21, 2015 
– Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus“Twenty-one of the referred patients fulfilled the criteria for a diagnosis of POTS (60%, 95%CI 43–77%). All patients had orthostatic intolerance, 94% nausea, 82% chronic headache, 82% fatigue, 77% cognitive dysfunction, 72% segmental dystonia, 68% neuropathic pain.”…”In a population referred for symptoms of orthostatic intolerance and other symptoms consistent with autonomic dysfunction that began in close temporal association with a quadrivalent HPV vaccination, we identified a 60% prevalence of POTS.Further work is urgently needed to elucidate the potential for a causal link between the vaccine and circulatory abnormalities and to establish targeted treatment options for the affected patients.”

May 15, 2015 – Actions improving HPV vaccination uptake – Results from a national survey in Italy “The synergy of multiple interventions is necessary for a successful vaccination programme. Practices such as pre-assigning vaccination date and repeatedly recalling non-respondents could improve vaccination uptake. Efforts are required to strengthen the training of different professional profiles and services and encourage their collaboration. Economical resources are needed to promote vaccination.”

May 2015 – Next generation prophylactic human papillomavirus vaccines “Substantial interest exists in both the academic and industrial sectors in the development of second-generation L1 VLP vaccines in terms of cost reduction—eg, by production in Escherichia coli or alternative types of yeast. However, Merck’s nonavalent vaccine, produced via the Saccharomyces cerevisiae production system that is also used for their quadrivalent vaccine, is the first second-generation HPV VLP vaccine to be available on the market.

May 2015 – Seroprevalence and Seroincidence of Herpes Simplex Virus (2006–2010), Syphilis (2006–2010), and Vaccine-Preventable Human Papillomavirus Subtypes (2000–2010) Among US Military Personnel “Conclusions: Sexually transmitted infections in military populations are highly prevalent, incident, and epidemiologically distinct. Our data show the rates of HPV and HSV-1/2 acquisition that are higher than those seen in the general public, again highlighting the need for continued preventive efforts. Consideration of universal HPV vaccination among men is warranted.”

May 2015 – Association between mother-child sexual communication and HPV vaccine uptake

  • Mother–child communication on sexual topics was associated with HPV vaccine uptake.
  • For daughters, the association was for discussing sex, STDs and contraception.
  • For sons, the association was for discussing STDs and condoms, but not sex.
  • These positive associations were for child HPV vaccine initiation, not completion.
  • Teaching mothers how to discuss sexual topics may improve child HPV vaccine uptake.

April 24, 2015 – Determination of freeze damage on HPV vaccines by use of flow cytometry “Additional experiments showed that the HPV vaccines could be degraded to smaller particles by citric acid/phosphate buffer treatment. The majority of particles detected in degraded Gardasil were very small indicating that the particles are HPV virus like particle (VLPs) labeled with antibodies, but Cervarix could only be degraded partially due to the presence of another type adjuvant in this vaccine.”

April 8, 2015 – Acceptability of using standing orders to deliver human papillomavirus vaccines in the outpatient obstetrician/gynecologist setting “Acceptability of standing orders for HPV vaccines was higher for series completion than initiation (88% vs. 70%, p < 0.001) and was more commonly supported for adult patients (79%) than for adolescents (43%). Acceptability of standing orders increased if the patient was first told that the provider ‘strongly recommended the vaccine’, even for a majority (52%) of those who generally were not comfortable receiving the vaccine using standing orders.”

April 2015 – Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04- Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, DoubleBlind PATRICIA Trial (pdf) “The study was funded by GlaxoSmithKline Biologicals SA, which designed the trial in collaboration with investigators and coordinated gathering, analysis, and interpretation of data. The development of the manuscript was supported and coordinated by GlaxoSmithKline Biologicals SA.”…”All investigators at study clinical sites were funded through their institutions to do the study protocol. B.R., C.M.W., D.A., F.Y.A., J.C.T., J.P., J.S., M.L., P.N., S.M.G., S.R.S., U.J., and X.C. have received funding to do other HPV vaccine studies for GlaxoSmithKline Biologicals ”

March–April, 2015 – Why Are U.S. Girls Getting Meningococcal But Not Human Papilloma Virus Vaccines? Comparison of Factors Associated with Human Papilloma Virus and Meningococcal Vaccination Among Adolescent Girls 2008 to 2012 “However, White girls were 10% more likely to report provider recommendation than Black or Hispanic girls (p < .01), yet did not have higher vaccination rates, implying a role for parental refusal. No factors predicted consistently the completion of the HPV vaccine series among those who started.”…”Improving provider recommendation for co-administration of HPV and meningococcal vaccines would reduce missed opportunities for initiating the HPV vaccine series. However, different interventions may be necessary to improve series completion.”

March 31, 2015 – An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis, and Poliomyelitis Vaccines to Healthy Adolescents 11 to 15 Years of Age. “There were no vaccine-related serious AEs. Conclusion: Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually. NCT01073293” “Sponsor: Merck Sharp & Dohme Corp.” Comment: The statement there were no vaccine-related serious AE’s is a stretch to say the least. How do they get away with this? What is their criteria? See here Other Adverse Events

March 30, 2015 – Vaccine hesitancy among parents of adolescents and its association with vaccine uptake “We determined the vaccination status of the parents’ adolescents for 3 vaccines (Tetanus–diphtheria–acellular pertussis [Tdap], meningococcal conjugate [MCV4], and human papillomavirus [HPV] vaccines). We used Fisher’s exact tests to compare vaccination status with each survey item and with an overall general hesitancy scale that we constructed. Results We analyzed 363 surveys. At the time of the visit, vaccination coverage was 84% for Tdap, 73% for MCV, and 45% for any dose of HPVThirty-nine percent of parents expressed concern about vaccine efficacy and 41% expressed concern about side effectsForty-five percent of parents disagreed with the statement that “teens can get all of the vaccines that are due at a single visit.”

March 14, 2015 – The impact of non-financial and financial encouragements on participation in non school-based human papillomavirus vaccination: a retrospective cohort study “The combined personal information and financial incentive campaign increased vaccination initiation among certain age groups. One year after the campaign the difference in percentage points for HPV vaccination initiation between intervention and control groups varied between 18.5 % (z = 3.65, p = 0.0002) and 5.1 % (z = 1.12, p = 0.26).”

March 3, 2015 – Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial (full text) “Funding: This study was funded by GlaxoSmithKline Biologicals

  • Conflict of interest statement: ML, DA and JP have received grants form Merck & Co. Inc., and from the GSK group of companies for their HPV vaccination studies through their employers: University of Tampere, Family Federation of Finland and University of Helsinki, respectively.
  • DB, SKD, MPD, GD and FS are employees of the GSK group of companies.
  • DB, SKD, MPD, GD, and FS receive stock options/restricted shares from the GSK group of companies.
  • GD has previously received patent royalties from Wyeth Vaccines.

February 2015 – Pain in Adolescent Girls Receiving Human Papillomavirus Vaccine With Concomitantly Administered Vaccines (full text) “Nonetheless, anecdotal reports suggest that HPV hurts more than other vaccines. In clinical investigations, injection site pain following HPV is generally assessed by the use of daily diary cards completed by either the participant or their parent up to 7 days after vaccination.”…”In our study, young girls reported a modestly higher pain score in the arm where HPV4 was administered in the period immediately following receipt of HPV4 when contrasted to the pain score in the arm where other vaccines were concomitantly administered.”

January 29, 2015 – Age at HPV vaccine initiation and completion among US adolescent girls: Trend from 2008 to 2012 “Additional efforts are needed to increase HPV vaccine uptake among adolescent girls as only half of them receive this vaccine at ACIP recommended age.”

January 15, 2015 – The Cost-effectiveness of Human Papillomavirus Vaccine Catch-up Programs for Women (full text) “For example, what if the population of young adult women who have acquired and cleared HPV consists disproportionately of those who are predisposed not to develop HPV-related sequelae? In such instances, the cost-effectiveness of vaccinating these young adults might be less favorable than suggested by models that do not allow for this possibility.

January 15, 2015 – Too Late to Vaccinate? The Incremental Benefits and Cost-effectiveness of a Delayed Catch-up Program Using the 4-Valent Human Papillomavirus Vaccine in Norway “The incremental benefits and cost-effectiveness decreased as the upper age limit for catch-up increased. Assuming a vaccine cost of $150/dose, vaccination up to age 20 years remained below Norway’s willingness-to-pay threshold (approximately $83 000/quality-adjusted life year gained); extension to age 22 years was cost-effective at a lower cost per dose ($50–$75).”

MEDINFO 2015 – Using social connection information to improve opinion mining: Identifying negative sentiment about HPV vaccines on Twitter “The manner in which people preferentially interact with others like themselves suggests that information about social connections may be useful in the surveillance of opinions for public health purposes. We examined if social connection information from tweets about human papillomavirus (HPV) vaccines could be used to train classifiers that identify anti-vaccine opinions.”

December 26, 2014 – Vaccinating Sons against HPV: Results from a U.S. National Survey of Parents – Previous publications representing data on both males and females suggest that having public insurance is related to increased HPV vaccine initiation which may be related to public vaccine programs such as the Vaccines for Children Program.

December 23, 2014 – A case–control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events ” It was observed that cases with the SAAE outcomes of gastroenteritis (odds ratio (OR) = 4.6, 95 % confidence interval (CI) = 1.3–18.5), arthritis (OR =  2.5, 95 % CI = 1.4–4.3), systemic lupus erythematosus (OR = 5.3, 95 % CI = 1.5–20.5), vasculitis (OR  = 4, 95 % CI = 1.01–16.4), alopecia (OR = 8.3, 95 % CI = 4.5–15.9), or CNS conditions (OR = 1.8, 95 % CI = 1.04–2.9) were significantly more likely than controls to have received HPV4 vaccine (median onset of SAAE symptoms from 6 to 55 days post-HPV4 vaccination).”

December 12, 2014 – Anti-Cancer Vaccines — A One-Hit Wonder? (full text) “In terms of drawbacks to the vaccines themselves, there have been side effects reported after vaccine administration. One of the biggest fears is the lack of selectivity of TAAs that can potentially lead to autoimmunity occurring in the patient. For example, cases of vitiligo (a condition that results in blotches of pigmentation loss in the skin) have been reported in patients receiving a melanoma vaccine.”…”Examples of anti-cancer vaccine adjuvants currently approved for use in clinical practice include aluminum salts (alum), monophosphoryl lipid A (MPL) in an oil-in-water emulsion (known as MF59), and a combination of MPL and alum known as AS04Alum and oil-in-water emulsions both act as a vehicle, delivering and controlling the release of the vaccine antigen to the host immune system. They can also directly stimulate the innate immune system through an inflammatory response, which, in turn, facilitates and amplifies a cell-mediated or humoral immune response. MPL is derived from lipopolysaccharide (LPS), a pattern-associated molecular pattern (PAMP) recognized by a pattern recognition receptor (PRR), Toll-like receptor 4 (TLR4) [49]. AS04 is licensed for use as an adjuvant in Fendrix (a HBV vaccine) and Cervarix (a HPV vaccine).

November 13, 2014 – Docosahexaenoic acid induces the degradation of HPV E6/E7 oncoproteins by activating the ubiquitin–proteasome system (full text) “Docosahexaenoic acid (DHA), the most unsaturated omega-3 fatty acid, has been demonstrated to possess pro-apoptotic activity against tumor cells.”

October 29, 2014 – Invited Commentary: Multiple Human Papillomavirus Infections and Type Replacement—Anticipating the Future After Human Papillomavirus Vaccination “In this issue of the Journal, Yang et al. (Am J Epidemiol. 2014;000(00):000–000) report on concurrent infections with multiple HPV types in unvaccinated women who underwent cervical screening in New Mexico (December 2007–April 2009) to identify possible interactions between HPV types, which if present could suggest the possibility of type replacement.

October 20, 2014 – Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases “The short-term increase in risk suggests that vaccines may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. Our findings support clinical anecdotes of CNS ADS symptom onset shortly after vaccination but do not suggest a need for a change in vaccine policy.”Type replacement may be of less concern with the introduction of multivalent vaccines that include most of the carcinogenic HPV types; continued surveillance postvaccination should improve our understanding of the impact of HPV vaccination on type distribution and screening performance

October 21, 2014 – Parent perceptions important for HPV vaccine initiation among low income adolescent girls “Compared to parents without recommendations, parents with strong recommendations had 2 to 7 times higher odds of agreeing that: vaccines are safe, the HPV vaccine is safe, not concerned about side effects, and the vaccine prevents cervical cancer. Even when considering provider recommendation strength, HPV vaccine series initiation was more likely among girls of parents who agreed rather than disagreed that the HPV vaccine was safe” Comment: Note “low” income. Why are they breaking this down by income? It’s been proven in studies before higher income, and higher education = less HPV vaccination.

October 19, 2014 – Human papillomavirus vaccine uptake among males 11–26 years in United States: Findings from the National Health and Nutrition Examination Survey, 2011–2012 “The corresponding HPV vaccine completion rates were 39.3% (16.7–67.7%) for the 11–17 year old males and 59.1% (37.2–77.6) for the 18–26-year-old males. Despite a slight increase, HPV vaccine uptake remained low among males. These findings can help in HPV vaccination policy in the United States, with a focus on informational messages directed toward young males and their parents in order to increase uptake of HPV vaccine.”

October 12, 2014 – Individual- and Regional-level determinants of Human Papillomavirus (HPV) vaccine refusal: the Ontario grade 8 HPV vaccine cohort study (pdf) “Our cohort consisted of 144,047 girls, 49.3% of whom refused HPV vaccination. Factors associated with refusal included a previous diagnosis of Down’s syndrome (OR = 1.37, 95% CI 1.16-1.63) or autism (OR = 1.60, 95% CI 1.34-1.90), few physician visits (OR = 1.45, 95% CI 1.35-1.55), and previous refusal of mandatory (OR = 2.23, 95% CI 2.07-2.40) and optional (OR = 3.96, 95% CI 3.87-4.05) vaccines. Refusal was highest among the lowest and highest income levels.”

October 7, 2014 – Comparing the cost-effectiveness of two- and three-dose schedules of human papillomavirus vaccination: A transmission-dynamic modelling study (full text) “Two-dose HPV vaccination is likely to be cost-effective if its duration of protection is at least 10 yearsA third dose of HPV vaccine is unlikely to be cost-effective if two-dose duration of protection is longer than 30 years. Finally, two-dose girls & boys HPV vaccination is unlikely to be cost-effective unless the cost per dose for boys is substantially lower than the cost for girls.”

October 6, 2014 – Adult Vaccination Disparities Among Foreign-Born Populations in the U.S., 2012 “Among the foreign born, vaccination coverage was generally lower for non-U.S. citizens, recent immigrants, and those interviewed in a language other than English. Foreign-born individuals were less likely than U.S.-born people to be vaccinated for pneumococcal (≥65 years), tetanus, Tdap, and HPV (women) after adjusting for confounders. Conclusions: Vaccination coverage is lower among foreign-born adults than those born in the U.S. It is important to consider foreign birth and immigration status when assessing vaccination disparities and planning interventions.”

October 3, 2014 – Effective Nonvaccine Interventions to Be Considered Alongside Human Papilloma Virus Vaccine Delivery “World Health Organization recommends that girls, ages 9–13 years, get the human papilloma virus (HPV) vaccineGlobal Alliance for Vaccines Initiative, which provides low-cost vaccine to eligible countries, requires that an additional intervention to be offered alongside the vaccine. We systematically searched and assessed the published literature in lower- and middle-income countries to identify effective interventions.”

October 2, 2014  Evaluation of Human Papillomavirus Type Replacement Post-vaccination Must Account for Diagnostic Artifacts: Masking of HPV52 by HPV16 in Anogenital Specimens “We observed a positive association between HPV16 viral load (tertiles) and detection of HPV52 (P for trend=0.003). These results indicate that diagnostic artifacts, resulting from unmasking of HPV52, may occur in some settings in the evaluation of HPV type replacement. Additional studies exploring the extent and severity of unmasking are needed.” Comment: There are more than 100 strains of HPV. Will this become the next adult pneumococcal vaccine, with 23 antigens? Nature abhors a vacuum. As the viruses are pushed out of the way, more aggressive and virulent viruses fill in the gap. Hey! I have a novel idea: Instead of striving to eliminate a virus, why not improve the underlying health of the cervix? As an exposed organ, it can develop nutritional and hormone deficiencies. If the organ was healthy, the virus would not adhere. Oh, silly me. I forgot that the money is in the cure, not in eliminating the cause. Back to more vaccines and drugs. Health be damned… 

October 2014 – Attribution of 12 High-Risk Human Papillomavirus Genotypes to Infection and Cervical Disease  “A total of 10,656 women ages 15 to 26 years and 1,858 women ages 24 to 45 years were enrolled in the placebo arms of one of three clinical trials of a quadrivalent HPV vaccine. We estimated the cumulative incidence of persistent infection and the proportion of CIN/AIS attributable to individual carcinogenic HPV genotypes, as well as the proportion of CIN/AIS lesions potentially preventable by a prophylactic 9-valent HPV6/11/16/18/31/33/45/52/58 vaccine.”

September 15, 2014 – Parent and Adolescent Knowledge of HPV and Subsequent Vaccination “Those with higher levels of knowledge were not more likely to obtain vaccination for themselves or their daughters. Ideally, future interventions will target factors related to vaccination.

September 2, 2014 – Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study “Serious adverse events occurred in 285 (10%) of 2881 women in the vaccine group and 267 (9%) of 2871 in the control group; five (<1%) and eight (<1%) of these events, respectively, were believed to be related to vaccination.” Comment: Please look at the full study results here. The control group was given 3 doses of Aluminum Hydroxide.

September 2014 – Immune Responses in Macaques to a Prototype Recombinant Adenovirus Live Oral Human Papillomavirus 16 Vaccine “Here, we characterize the immune response to the recombinant after dual oral and intranasal immunization of pigtail macaques, in which the virus replicates as it would in immunized humans. The immunization of macaques induced vigorous humoral responses to adenovirus capsid and nonstructural proteins, although, surprisingly, not against HPV L1. In contrast, immunization elicited strong T-cell responses to HPV VLPs as well as adenovirus virions. T-cell responses arose immediately after the primary immunization and were boosted by a second immunization with recombinant virus”

August 23, 2014 
– HPV catch-up vaccination of young women: a systematic review and meta-analysis (full text) “We examined also adverse events possibly linked to HPV vaccination. We considered only adverse events reported as serious adverse events in the included publications.” Comment in the table below study group Patricia had the most serious events. This study is posted in full here Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

August 18, 2014 – Missed Opportunities for HPV Vaccination in Adolescent Girls: A Qualitative Study “In contrast, providers with high vaccination rates presented HPV vaccination as a routine vaccine with proven safety to prevent cancer, and parents responded positively to these messages.”…”Routinely recommending HPV vaccination as cancer prevention to be coadministered with other vaccines at age 11 years can improve vaccination rates.”

August 15, 2014 – Naturally Acquired Immunity Against Human Papillomavirus (HPV): Why It Matters in the HPV Vaccine Era “The measurement of HPV antibodies is also important for identifying unvaccinated women who have mounted an antibody response following previous exposure to HPV infection and may, therefore, be naturally protected. However, only approximately half of women seroconvert within 18 months after HPV infection. The interpretation of HPV serology is additionally complicated by substantial differences across assays used in different studies (eg, detection ranges, targeted HPV types, and epitopes). Comment: If woman that have already had HPV do not attain immunity by 18 months after the vaccination clearly it isn’t working in these women. How many women are getting the vaccine with immunity from natural infection who don’t know they even had HPV?

August 15, 2014 – Risk of Newly Detected Infections and Cervical Abnormalities in Women Seropositive for Naturally Acquired Human Papillomavirus Type 16/18 Antibodies: Analysis of the Control Arm of PATRICIA  (full text) “In conclusion, this study confirms the utility of control arm data from vaccine efficacy trials in understanding acquisition and progression of HPV infections and related cervical abnormalities. The results suggest that naturally acquired antibodies to HPV-16, and to a lesser extent HPV-18, reduce the risk of subsequent infection and associated cervical abnormalities with the same HPV type.”

August 6, 2014 – Engaging parents and schools improves uptake of the human papillomavirus (HPV) vaccine: Examining the role of the public health nurse “HPV vaccine initiation was significantly associated with Public Health Nurses providing reminder calls for: consent return (p = 0.017) and missed school clinic (p = 0.004); HPV education to teachers (p < 0.001), and a thank-you note to teachers (p < 0.001). Completion of the HPV series was associated with vaccine consents being returned to the students’ teacher (p = 0.003), and a Public Health Nurse being assigned to a school (p = 0.025). Conclusions These findings can be used to help guide school-based immunization programs for optimal uptake of the HPV vaccine among the student population.

July 31, 2014 – Achieving high uptake of human papillomavirus vaccine in Cameroon: Lessons learned in overcoming challenges “With adequate education of all stakeholders, HPV vaccination is acceptable and feasible in Cameroon. Following this demonstration project, in 2014 the Global Access to Vaccines and Immunization (GAVI) Alliance awarded the Cameroon MOH HPV vaccine at a price of US$4.50 per dose to immunize sixth grade girls and girls aged 10 years who are not in school in two districts of Cameroon.”

July 25, 2014  CDC MMWR Human Papillomavirus Vaccination Coverage Among Adolescents, 2007–2013, and Postlicensure Vaccine Safety Monitoring, 2006–2014 — United States (full text) “During June 2006–March 2014, the Vaccine Adverse Event Reporting System (VAERSreceived a total of 25,176 adverse event reports after HPV vaccination in the United States. Among these, HPV4 was cited in 99% of reports (22,867 and 2,196 reports among females and males, respectively); 92.4% of the HPV4 reports were classified as nonserious. Since October 2009, when HPV4 was licensed for males, the most commonly reported symptoms among males were similar to those among females, including injection site reactions, dizziness, syncope, nausea, and headache. Overall, reporting of adverse events to VAERS is consistent with prelicensure clinical trial data and consistent with the 2009 published summary of the first 2.5 years of postlicensure reporting to VAERS.

July 25, 2014 – National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2013 (full text) ‘Finally, some of the state-specific and racial/ethnic-specific analyses might be unreliable because of small sample sizes. Estimates with confidence half-widths wider than 10 are less reliable, and this impacts estimates for some racial and ethnic populations. For HPV coverage analyses by state and sex, small sample sizes decrease the power to detect differencesHigh Tdap coverage levels among adolescents aged 13–17 years indicate that similar coverage levels are attainable for other vaccines recommended for adolescents. Improved adherence of clinicians and parents to the ACIP recommendation to administer all age-appropriate vaccines during a single visit could substantially increase lagging vaccination coverage levels.” Comment: High Tdap coverage levels are high because the vaccinations are mandatory for school attendence. The intention is implied all adolescent vaccines should be mandatory.

July 24, 2014 – The Cost-effectiveness of Human Papillomavirus Vaccine Catch-up Programs for WomenHPV vaccination of young women becomes less cost-effective as the age of vaccination increases, although the importance of age at vaccination can vary considerably across models and there is no consensus on a threshold age at which HPV vaccination ceases to be cost-effective. Third, adding males to a female-only vaccination program is not as cost-effective as female-only vaccination.”

July 16, 2014 – Intervention effects from a social marketing campaign to promote HPV vaccination in preteen boys “The Cox model showed an intervention effect (β = 0.29, HR = 1.34, p = .0024), indicating that during the intervention the probability of vaccination increased by 34% in the intervention counties relative to the control counties. Comparisons with HPV vaccination in girls and Tdap and meningococcal vaccination in boys suggest a unique boost for HPV vaccination in boys during the intervention.”

July 16, 2014 – Identifying human papillomavirus vaccination practices among primary care providers of minority, low-income and immigrant patient populations “Of 156 physicians randomly selected, 121 eligible providers responded to the survey; 64% were pediatricians, 19% were internists and 17% were family practitioners. Thirty-four percent of respondents reported that they routinely offered HPV vaccine to their eligible patients. Seventy percent of physicians reported that the lack of preventive care visits for patients in the eligible age group limited their ability to recommend the HPV vaccine and 70% of those who reported this barrier do not routinely recommend HPV vaccine.”

July 15, 2014 – Physicians’ Human Papillomavirus Vaccine Recommendations in the Context of Permissive Guidelines for Male Patients: A National Study “The purpose of this study was to examine and explore factors associated with U.S. physicians’ HPV vaccine recommendations to early (ages 11-12), middle (13-17), and late adolescent/young adult (18-26) males.”…”Less than 15% of physicians surveyed reported “always” recommending HPV vaccine to male patients following national guidelines for permissive vaccinationVaccine financing may have affected physicians’ vaccine recommendations. Impact: If these recommendation practices continue following the ACIP’s routine recommendation for males in October 2011, then interventions designed to increase recommendations should target family physicians and possibly utilize early adopters to encourage support of HPV vaccination guidelines.”

July 9, 2014 – Effect on HPV vaccination in Japan resulting from news report of adverse events and suspension of governmental recommendation for HPV vaccination “The recognition rate of the news of the vaccine’s adverse events was 80 %; it was 68 % for awareness of the government’s announcement of the suspension of its recommendation for the vaccine. Among those who had a chance to hear or see the negative news during their vaccination period, 46 (60 %) continued vaccination while knowing of the news, 22 (29 %) discontinued vaccination, and 9 (11 %) continued vaccination without an awareness of the news. Reports of the vaccine’s adverse events were the main reason for not continuing the vaccination series.” Comment:  After knowing the vaccine was suspended how could you still receive it?

July 9, 2014 – Barriers and facilitators to HPV vaccination of young women in high-income countries: a qualitative systematic review and evidence synthesis (pdf) “In the USA, routine HPV vaccination was recommended for girls between ages 11 and 12 by  the National Advisory Committee on Immunisation Practices (ACIP) in 2006. However,  whether a vaccine should be mandatory for school attendance is predominantly decided by  state legislatures and is subject to debate. At the time the studies were undertaken, policymakers in the USA were not clear that a school-based mandate for the HPV vaccine was  appropriate. Lack of transmissibility in the school-setting was felt to undermine the need to a  mandate: “I can completely support it in certain kinds of infectious diseases that are a threat  in terms of morbidity and mortality, and are easily transmitted within a classroom, for  example, but HPV is not one of the things” [Policy maker, USA]. Policymakers also  considered likely opposition from ‘anti-vaccination’ groups.”

July 7, 2014 
– Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial “At the 5-month follow-up, AFIX consultations increased vaccine coverage among younger adolescents. Patients in the in-person arm experienced coverage changes that exceeded those in the control arm for Tdap (3.4% [95% confidence interval (CI): 2.2 to 4.6]), meningococcal (4.7% [95% CI: 2.3 to 7.2], and HPV (1.5% [95% CI: 0.3 to 2.7]) vaccines. Patients in the webinar versus control arm also experienced larger changes for these vaccines. AFIX did little to improve coverage among older adolescents.”…”AFIX consultations for adolescents need improvement to have a stronger and more durable impact, especially for HPV vaccine.”

June 30, 2014 – Acceptability of the human papillomavirus vaccine and reasons for non-vaccination among parents of adolescent sons “Parents citing only logistical reasons for non-vaccination (e.g., lack of recommendation, access, or education, n = 384) reported significantly higher vaccine acceptability than parents reporting a combination of attitudinal (e.g., concerns about vaccine safety or efficacy) and logistical barriers (n = 92), while parents citing only attitudinal barriers (n = 73) reported the lowest level of vaccine acceptability.” Comment: Smart parents would give a benign short answer to a question about HPV for boys, and have no intentions of considering the vaccine for their son.

June 26, 2014 – Costs of Introducing and Delivering HPV Vaccines in Low and Lower Middle Income Countries: Inputs for GAVI Policy on Introduction Grant Support to Countries (full text) “Average recurrent financial costs for nationwide introduction ranged from $3.51 per eligible girl for implementation of HPV vaccination through health facilities in Tanzania to $4.78 for HPV vaccination through schools in Tanzania. Similar to introduction costs, the recurrent costs for nationwide scale-up differed from those of pilot projects, since more national costs such as supervision and monitoring and evaluation are included than would be found in pilot projects. In addition, two out of three of these countries are African and have lower population density, driving up the recurrent costs.”
Comment: Consider this, in the US, the government pays $91.20 for 10 doses of Gardsil; the private sector pays $141.38. For Cerarix, the government pays $86.59 for 10 doses; private sector doctors pay $128.75. The only reason it is possible to manufacture, distribute and administer this expensive, toxic vaccine for less than $5/dose is through expenditure of the US Government (taxpayer money) and US medical patients (insurance)…and the money put into country-wide programs by  GAVI and the Gates Foundation. Bottom line? Pharma wins and children around the world are put at risk of side effects and infertility in countries with marginal medical services to care for serious reactions, if they are even recognized.
http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/

June 26, 2014 –  Is expanding HPV vaccination programs to include school-aged boys likely to be value-for-money: a cost-utility analysis in a country with an existing school-girl program (pdf) “At an assumed local willingness-to-pay threshold of US$29,600, vaccination of 12-year-old boys to achieve the current coverage for girls would not be cost-effective, at US$61,400/QALY gained (95% UI $29,700 to $112,000; OECD purchasing power parities) compared to the current girls-only program, with an assumed vaccine cost of US$59 (NZ$113).”

June 24, 2014 – Mind the gaps: What’s missing from current economic evaluations of universal HPV vaccination? “Decisions to invest in universal HPV vaccination need to be based on a complete assessment of the value that it generates. This is not provided by existing economic evaluations. Further work is required to understand this value. First, research is required to understand how HPV-related health outcomes impact on society including, for instance, their impact on productivity. Second, consideration should be given to alternative approaches to capture this broader set of values in a manner useful to decision-makers, such as multi-criteria decision analysis.”

June 19, 2014 – Uptake of Human Papillomavirus Vaccine Among Adolescent Males and Females: Immunization Information System Sentinel Sites, 2009–2012 “HPV vaccination coverage increased among adolescents between 2009 and 2012. However, increases among girls were small, and coverage for boys and girls remained below target levels.”

June 11, 2014 – Early Policy Responses to the Human Papillomavirus Vaccine in the United States, 2006–2010 “All but five states (Alaska, Delaware, Idaho, New Hampshire, and Wyoming) introduced HPV vaccine bills between 2006 and 2010. Two-thirds of all bills were introduced in 2007. In all, 141 bills were introduced and 23% or 32 bills were enacted. Of the bills that were enacted, 43.8% provided information for parents and schools about the vaccine; 37.5% provided public financing for HPV vaccines; 34.4% were classified as other policies; 25% created awareness campaigns; 25% required private insurance coverage of the HPV vaccination; 12.5% included voluntary vaccination, and 9.4% mandated vaccination for school entryOne bill reversed prior mandatory vaccination policies. Overall, 91% of enacted HPV vaccine bills did not refer to mandated vaccinations but adopted alternate policy strategies in response to the availability of the new HPV vaccine.”

June 2014 – A case of lipoatrophy following quadrivalent human papillomavirus vaccine administration (full text) “A 27-year-old woman presented to the dermatology clinic with a circular depression on her right arm without any local symptoms or previous inflammation. She had no medical problems and was not taking any medication. She reported a history of 3 intramuscular Gardasil injections on a 0-, 2-, and 6-month-schedule in the same arm, with the last injection given 9 months before the appearance of the lesion.”…”We did not find in this case any other cause that could be related to lipoatrophy unless trauma of the injection itself is an etiology. We estimate that the injection was subcutaneous instead of intramuscular and that the aluminium granulations found in the macrophages correspond to the adjuvant found in the vaccine.

May 28, 2014 – School-Based Vaccination Programs and the HPV Vaccine in 16 Appalachian Kentucky School Districts: Results from a Pilot Study “Results suggest that few schools have school-based vaccination programs, and of those that do, very few programs include the HPV vaccine. A majority of respondents reported that information leaflets about HPV are available in the schools, whereas few schools include discussions of HPV in their health programs. Almost all respondents reported an excellent relationship with their county health departments, school nurses, and school social workers, although most schools lacked the presence of a school social worker. Implications for social work practice and policy and directions for future research are also discussed.” Comment: Will more parents be reported to Child health services who refuse the vaccine?

May 1, 2014 – Staying on track: A cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion ? “Intervention participants selected their preferred method of reminders – text, e-mail, phone, private Facebook message, or standard mail. We compared vaccine completion rates between groups over a period of 32 weeks.”…”The study intervention did not increase HPV vaccine series completion. Despite great public health interest in HPV vaccine completion and reminder technologies, completion rates remain low.”

May 2014 – Vaccination Interest and Trends in Human Papillomavirus Vaccine Uptake in Young Adult Women Aged 18 to 26 Years in the United States: An Analysis Using the 2008–2012 National Health Interview Survey “Conclusions. Uptake of HPV vaccine has increased from 2008 to 2012 in young women. Yet vaccination rates remain low, especially among women with limited access to care. However, unvaccinated women with limited health care access were more likely to be interested in receiving the vaccine.”

April 19, 2014 – Prevaccine era human papillomavirus types 6, 11, 16 and 18 seropositivity in the USA, National Health and Nutrition Examination Surveys, 2003–2006 “Background A vaccine is available to prevent human papillomavirus (HPV) 6, 11, 16 and 18; in the prevaccine era, seropositivity to vaccine types is a measure of natural exposure.”…”Almost a quarter of the participants were seropositive to any HPV vaccine type but few were seropositive to at least three vaccine HPV types in the prevaccine eraFurther study is needed to assess if seropositivity would be useful as a biological marker of vaccination.”

April 7, 2014 – HPV vaccination: Are we initiating too late? “Of the subcohort, 36.9% underwent Chlamydia screening before HPV1 receipt (19.1% with ≥1 positive result). Of those with prior Papanicolaou screening (16.6%), 32.1% had ≥1 abnormal result. These low-income, minority females frequently delayed initiation of HPV vaccination. Many had evidence of prior sexual experience and associated morbidity, placing them at risk of HPV-related complications. Promoting timely HPV vaccination and reducing missed vaccination opportunities are crucial.

March 25, 2014 – Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials “One month after the third injection (Month 7), there was a consistent trend for lower anti-HPV-16 and -18 geometric mean antibody titers (GMTs) for tetravalent AS04-adjuvanted vaccines compared with controlGMTs were statistically significantly lower for an HPV-16/18/31/45 AS04 vaccine containing 20/20/10/10 μg VLPs for both anti-HPV-16 and anti-HPV-18 antibodies, and for an HPV-16/18/33/58 AS04 vaccine containing 20/20/20/20 μg VLPs for anti-HPV-16 antibodies. There was also a trend for lower HPV-16 and -18-specific memory B-cell responses for tetravalent AS04 vaccines versus control.”

March 20, 2014 – Toward global prevention of sexually transmitted infections (STIs): The need for STI vaccines (full text) “A great deal will be learned from current implementation of HPV vaccine to inform delivery of future STI vaccines. Most STI vaccines are being developed for early adolescents, to provide maximal protection before and during the time of highest risk. For some vaccines, there may be compelling reasons for infant vaccination in addition to implementation issues, for example, an HSV vaccine that would also protect against HSV-1 infection. Nonetheless, new adolescent platforms for health intervention delivery are needed to respond to a global agenda to improve adolescent health, especially sexual and reproductive health. HPV vaccine implementation is an opportunity to develop these adolescent platforms, which can be used not only for currently recommended prevention services, but also for future STI vaccines. Given common risk factors, high rates of co-infection, and epidemiologic overlap in STI-related complications, combination STI vaccines for adolescents would be an important future goal. HPV vaccine implementation will also provide insight on monitoring vaccine impact, which will need to be considered for other STI vaccines well in advance of vaccine availability.”

March 20, 2014 – Microbiome, sex hormones, and immune responses in the reproductive tract: Challenges for vaccine development against sexually transmitted infections (full text) “The success of the HPV vaccine has re-energized the field of STI vaccine research after earlier disappointing results with HSV and gonorrhea vaccines. There are currently several new candidate HSV and chlamydia vaccines in various stages of development and recent advances in the fields of immunology and vaccine design offer hope for the development of vaccines targeting gonorrhea and syphilis. To optimize vaccine responses against STIs, in addition to optimizing antigen types, formulations, adjuvants, and delivery methods, we need a clear understanding of the interactions taking place at the mucosal surfaces. Vaccine development must take into account the differences between the systemic and mucosal immune responses, the compartmentalization of the mucosal immune responses, the unique characteristics of the reproductive tract mucosae, the role of the microbiome, the impact of sex hormones, and the interactions among all of these factors. We are just beginning to decipher these complex relationships.

March 18, 2014 – Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants” – Case Report and Literature Review (full text) “Ours is the seventh case of POTS associated with the qHPV vaccine Gardasil reported in the literature. In addition, POTS following administration of the novel H1N1 influenza vaccine was reported recently. Recently, Blitshteyn reported six cases of POTS following HPV vaccination. In this case series, all six previously healthy young women (aged 12 to 22 years) developed symptoms of POTS within 6 days to 2 months after vaccination with the Gardasil HPV vaccine.”…”It is of further relevance to note that the safety trials for Gardasil (which is an aluminum-adjuvanted vaccine) did not include a true inactive placebo but rather an aluminum-adjuvant-containing placebo, despite much data showing that aluminum in vaccine-relevant exposures can be toxic to humans.

March 2014 – The spectrum of post-vaccination inflammatory CNS demyelinating syndromes “In terms of the clinical presentation and the affected CNS areas, there is a great diversity among the reported cases of post-vaccination acute demyelinating syndromesOptic neuritis was the prominent clinical presentation in 38 casesmultifocal disseminated demyelination in 30, myelitis in 24 and encephalitis in 17. Interestingly in a rather high proportion of the patients (and especially following influenza and human papiloma virus vaccination-HPV) the dominant localizations of demyelination were the optic nerves and the myelon, presenting as optic neuritis and myelitis (with or without additional manifestations of ADEM), reminiscent to neuromyelitic optica (or, more generally, the NMO-spectrum of diseases). Seven patients suffered an NMO-like disease following HPV and we had two similar cases in our Center. One patient with post-vaccination ADEM, subsequently developed NMO.”

February 19, 2014 – Adverse events following immunization in Ontario’s female school-based HPV program“Between 2007 and 2011, 133 confirmed AEFIs were reported while 691,994 HPV4 vaccine doses were distributed in the school-based program. The overall reporting rate was 19.2 HPV4 AEFI per 100,000 doses distributed. Annual reporting rates decreased from 30.0 to 18.3 per 100,000 doses distributed. Frequently reported events included ‘allergic reaction—dermatologic/mucosa’ (25%), ‘rash’ (22%), and ‘local/injection site reaction’ (20%); 26% of reports had a non-specific event of ‘other severe/unusual events’ selected. Ten serious AEFIs were reported (7.5% of reports) including 2 anaphylaxis, 2 seizures, 1 thrombocytopenia and 1 death.”

February 3, 2014 – Overcoming barriers to HPV vaccination: Non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months “The reduction in the number of doses from the current three-dose schedule may lower overall costs associated with the vaccination and increase accessibility and compliance with the recommended dosing of the HPV vaccine.”

February 1, 2014 – Multiple evanescent white dot syndrome after human papillomavirus vaccination (full text) “This case of MEWDS after HPV vaccination showed progressive concentric visual field loss. FA revealed a dramatic response to immunosuppressive therapy. This supports the hypothesis that the cause of MEWDS is related to immune function.

January 31, 2014  School-based vaccination of young US males: Impact of health beliefs on intent and first dose acceptance “Little is known about adolescent males and their parents with respect to intent and first dose uptake of the human papillomavirus (HPV) vaccine outside of primay care settings. The purpose of this study was to evaluate potential predictors of parental intent to vaccinate (study was conducted in November 2010–December 2012) and of first dose uptake of HPV vaccine among a sample of young adolescent males, 11–15 years of age, who received care at a school-based health center (SBHC).”

January 24, 2014 – Delay and Refusal of Human Papillomavirus Vaccine for Girls, National Immunization Survey–Teen, 2010 “A significantly higher proportion of parents of girls who were non-Hispanic white, lived in households with higher incomes, and had mothers with higher education levels, delayed and/or refused vaccination. The most common reasons for nonvaccination were concerns about lasting health problems from the vaccine, wondering about the vaccine’s effectiveness, and believing the vaccine is not needed.”

January 24, 2014 – On the relationship between human papilloma virus vaccine and autoimmune diseases “We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the risk vs. benefit of vaccination is still to be solvedThe on-going vigilance for the safety of this vaccine remains thus of paramount importance.

January 2014 – Physicians’ Human Papillomavirus Vaccine Recommendations, 2009 and 2011 “Results suggest a modest increase in recommendations for HPV vaccination of girls aged 11 or 12 years over a 2-year period; however, recommendations remain suboptimal for all age groups despite national recommendations for universal immunization.

December 31, 2013 – Human Papillomavirus Prevalence and Type-Distribution, Cervical Cancer Screening Practices and Current Status of Vaccination Implementation in Central and Eastern Europe “The key reasons for lack of implementation of HPV vaccination into the national immunization programme are high vaccine cost and negative public perception.”

December 17, 2013 – Acceptability and uptake of female adolescent HPV vaccination in Hong Kong: A survey of mothers and adolescents “Policymakers should devise tailored, targeted and efficient vaccination strategies to achieve universal coverage for an effectively organized HPV vaccination program.”

December 16, 2013 – Overcoming barriers to HPV vaccination: Non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months (full text)

Adverse Events
Study staff recorded safety profile assessments of local symptoms (pain and redness at the injection site) and general symptoms (fever, headache, fatigue, and gastrointestinal symptoms that included nausea, vomiting, diarrhea and/or abdominal pain, arthralgia, myalgia, urticaria and rash) at the next scheduled appointment after administration of each vaccine. Staff also inquired about and recorded any serious adverse events at each contact, and among withdrawals.
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December 16, 2013 – Not the right time: why parents refuse to let their daughters have the human papillomavirus vaccination “The decision-making process was complex. These parents preferred to wait until their daughter was older and believed the information they received from the school health system was insufficient. The results indicate that a more flexible HPV vaccination schedule may improve vaccine uptake. This includes more transparent information about the virus and the vaccine and information about who to contact to get the daughter vaccinated at a later date.”

December 11, 2013 – The Australian Experience With the Human Papillomavirus Vaccine “To achieve this outcome requires government endorsement and commitment; education of the community at large; realization of the safety, efficacy, and immunogenicity of the available prophylactic vaccines in reducing HPV-related infections and disease, especially neoplasia; and governments procuring vaccines at affordable prices through the various options now available (eg, support from the GAVI Alliance to eligible countries, tiered pricing, negotiation with pharmaceutical manufacturers). We have the tools to reach this goal, and it is time these tools were implemented.”

December 3, 2013 – Parent and provider perspectives on immunization: Are providers overestimating parental concerns? “Providers underestimated parental attitudes toward vaccine importance (particularly influenza and HPV), and overestimated the proportion of parents who thought route of administration mattered (63%) and that number of injections per visit was the most important factor (76%) around parental vaccine decisions (P < 0.001 for parent–provider mismatch).”

December 1, 2013 – Literature review of HPV vaccine delivery strategies: Considerations for school- and non-school based immunization program “School-based programs achieved high HPV vaccination coverage rates in 9 to 13-year-old girls across the different studies and geographic locations, suggesting non-health facility-based programs are possible for HPV vaccine introduction. Grade-based, compared to age-based, eligibility criteria may be easier to implement in school settings. More studies are needed to explore the methods to standardize estimates for HPV vaccine coverage so that programs can be appropriately evaluated.”

November 25, 2013 – French link between Gardasil and multiple sclerosis – Gardasil Vaccine: Charges Filed against Laboratoire Sanofi Pasteur MSD “On November 7th, 2013, members of the vaccine injury community held a briefing for congressional staffers to present many of the problems in the Vaccine Injury Compensation Program in preparation for hearings in the House Oversight and Government Reform Committee.
Professor Mary Holland, Head of Graduate Legal Studies at NYU, and Rolf Hazelhurst
Father in one of the test cases In the Omnibus Autism Proceeding, and Assistant District Attorney General, State of Tennessee, present the case against the VICP and call for reform.

November 25, 2013 – Barriers to Human Papillomavirus Vaccination Among US Adolescents “Health care professionals may benefit from guidance on communicating HPV recommendations to patients and parents. Further efforts are also needed to reduce missed opportunities for HPV vaccination when adolescents interface with the health care system. Efforts to increase uptake should take into account the specific needs of subgroups within the population. Efforts that address system-level barriers to vaccination may help to increase overall HPV vaccine uptake.”

November 21, 2013 – A case for immunization of HPV 6/11-infected pregnant women with the quadrivalent HPV vaccine to prevent juvenile-onset laryngeal papilloma “JORRP is a rare disease caused by intrapartum or perinatal transmission of HPV 6/11 from an infected mother to the newborn. Immunization of a pregnant woman who has condyloma or HPV 6/11 infection with the quadrivalent HPV vaccine will result in a high neutralizing antibody response to HPV 6 and HPV 11 in her serum and these antibodies transferred to the newborn will likely protect the child against the development of JORRP.”

November 18, 2013 – The Role of Media and the Internet on Vaccine Adverse Event Reporting: A Case Study of Human Papillomavirus Vaccination “Compared with MNQ, HPV4 had more coverage in the print media and Internet search activity, which corresponded with the frequency of VAERS reports. In February 2007, we observed a spike in print media for HPV4. Although media coverage waned, Internet search activity remained stable and predicted the rise in HPV4-associated VAERS reports.”

November 14, 2013 – Motor palsies of cranial nerves (excluding VII) after vaccination: Reports to the US Vaccine Adverse Event Reporting System (full text) Cranial nerve palsies were reported after a wide variety of vaccines (Table 3). Most reports (43; 63%) listed a single vaccineAmong reports listing single vaccines, the most common vaccines were influenza vaccine seasonal trivalent inactivated, human papillomavirus vaccine quadrivalent, influenza H1N1 vaccine inactivated, and zoster vaccine live. Among reports listing multiple vaccines, the most common vaccines included hepatitis A vaccine; measles, mumps, and rubella vaccine live; diphtheria and tetanus toxoids and acellular pertussis vaccine; Hemophilus influenzae type b vaccine; and pneumococcal conjugate vaccine 7-valent. There was no conspicuous clustering of live or inactivated vaccines with palsies of particular cranial nerves.

November 5, 2013 – Estimation of HPV prevalence in young women in Scotland; monitoring of future vaccine impact (full text) “Baseline pre-immunisation levels of the vaccine specific types were high, with HPV 16 the more common than HPV 18. The aggregate occurrence of non-vaccine types, in particular those deemed to be high-risk, is more prevalent than the vaccine specific types and our results are comparable to those of other recent UK based studies.”

November 3, 2013 – Human Papilloma Virus Vaccine Associated Uveitis. “A total of 24 case reports of uveitis associated with human papilloma virus vaccination were identified, all cases were female, and the median age was 17. Median time from HPV vaccination to reported ADR was 30 days (range 0-476 days). Discussion: According to World Health Organization criteria, the relationship between human papilloma virus vaccination and uveitis is “possible.” Causality assessments are based on the time relationship of drug administration, uveitis development and re-challenge data. Conclusions: Clinicians should be aware of a possible bilateral uveitis and papillitis following HPV vaccination.”

October 25, 2013 – Health Disparities in Human Papillomavirus Vaccine Coverage: Trends Analysis From the National Immunization Survey–Teen, 2008–2011 “We evaluated HPV vaccine uptake patterns over 2008–2011 by race/ethnicity, poverty status, and the combination of race/ethnicity and poverty status, utilizing National Immunization Survey–Teen dataMinority and below-poverty adolescents consistently had higher series initiation than white and above-poverty adolescents.”

October 22, 2013 – Ovarian failure after human papillomavirus vaccination “Limitations of such monitoring systems (called “passive surveillance”) include underreporting, reporting bias, and the absence of denominator data or base rate of each event within the general population. In spite of these limitations, monitoring systems can and do provide early alerts about rare safety issues that only become evident when millions of people are using a vaccine or drug. However,recent articles (Little DT et al 2012 and Colafrancesco S 2013) have raised certain questions that need to be addressed and as scientists we cannot close our minds to the possibility that the vaccines may cause rare but significant problems such as premature ovarian failure (POF) which has significant impact on the mental and physical health of young girls(target population of the vaccine).”

September 26, 2013 – Vaccinating Women Previously Exposed to Human Papillomavirus: A Cost-Effectiveness Analysis of the Bivalent Vaccine (full text) “Competing interests: Geoff Garnett has acted as consultant for and/or received grants for other studies from Sanofi Pasteur MSD, Merck, and GSK. Hugo Turner and Iacopo Baussano have no competing interests. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.”…”The incremental cost of extending the vaccine programme increased with the inclusion of older age groups (see Table 2). However it should be noted that the true incremental cost of extending the vaccine programme will be highly depended on the cost of the vaccine. The vaccination programme generated some cost savings to the health service (approximately £336 million for the current UK strategy) by reducing the number of treatments (for precancerous lesions and cervical cancers), but these savings were outweighed by the cost of the vaccination programme itself.”

September 23, 2013 – A universal virus-like particle-based vaccine for human papillomavirus: Longevity of protection and role of endogenous and exogenous adjuvants “We also show that exogenous and endogenous adjuvants (LPS and encapsidated single-stranded RNA) have minor effects on antibody titers. Immunization with VLPs containing encapsidated ssRNA predominantly shifts the response to a Th1, rather than a Th2-like response. Importantly, immunization with L2-VLPs (without endogenous and exogenous adjuvants) in the presence of alum hydroxide elicited a robust antibody response.”

September 16, 2013 – Postural tachycardia syndrome following human papillomavirus vaccination (full text) “Six patients who developed new onset POTS 6 days to 2 months following human papillomavirus vaccination are reported. Three patients also had neurocardiogenic syncope, and three patients were diagnosed with possible small fiber neuropathy. Symptoms in all patients improved over 3 years with pharmacotherapy and non-pharmacological measures but residual symptoms persistedMolecular mimicry with formation of cross-reacting autoantibodies to the potential targets of the autonomic ganglia, neurons, cardiac proteins or vascular receptors is considered as a possible pathogenesis of new onset POTS after immunization. Conclusion: Correct diagnosis of POTS and awareness that POTS may occur after vaccination in young women is essential for prompt and effective management of this condition.”

September 16, 2013 – Maternal Underestimation of Child’s Sexual Experience: Suggested Implications for HPV Vaccine Uptake at Recommended Ages “Despite official recommendation for routine HPV vaccination of boys and girls at age 11–12 years, parents and providers are more likely to vaccinate their children/patients at older ages. Preferences for vaccinating older adolescents may be related to beliefs about an adolescent’s sexual experience or perceived parental resistance to vaccinating children who are assumed to be sexually inexperienced.”

September 2013 – HPV Vaccination of Boys in Primary Care Practices “Although most physicians support HPV4 for boys, physician education and evidence-based tools are needed to improve implementation of a vaccination program for males in primary care settings.”

August 31, 2013 – HPV vaccination programme in Japan “Although HPV vaccination has just been included in the routine vaccination schedule and publicly funded since April 2013, a new MHLW directive advises prefectural governors not to actively recommend the vaccine, and to cease all vaccine promotion. However, health facilities are to continue to offer parents seeking the vaccine full support, and facilitate vaccine access. Such advice obviously creates enormous confusion for public health officials, doctors, and parents. A joint meeting of the Vaccine Adverse Reactions Review Committee (VARRC) has indicated that they might remove HPV vaccination from the schedule, despite evidence of its cost-effectiveness in Japan.”

August 28, 2013 – Racial Disparities in Human Papillomavirus Vaccination: Does Access Matter? Lower rates of HPV vaccination among African-American females do not appear to be explained by differential access to health careMore research is necessary to elucidate factors contributing to HPV vaccination in this population.”

August 7, 2013 – Safety and immunogenicity of the quadrivalent HPV vaccine in female Systemic Lupus Erythematosus patients aged 12 to 26 years (pdf) “Patients were observed in the clinic for 30  minutes after each vaccine dose for acute allergic reactions or syncope. HPV vaccine-related  side effects were evaluated systematically, including but not limited to pain, erythema,  swelling and itching at the injection site, fever, fatigue, arthralgias, myalgias, headache,  dizziness, syncope, influenza-type symptoms, and signs and symptoms of an acute allergic  reaction including dyspnea and hives. At study entry and at months 2, 4, 6 and 7, patients  were clinically evaluated, and physical examination and laboratory data were recorded.  Clinical manifestations of SLE were carefully analyzed and a SLEDAI score was calculated  at each of the clinic visits.”…”Nine of 27 patients (33.3%) had a mild-moderate flare during the study period,  typically with symptoms similar to those they experienced in flares before vaccine  administration. Five had arthralgias, 4 had rash, 2 had pleuritis, and 1 had peripheral  neuropathy. One of the patients with rash had a severe cutaneous flare after sun exposure,  three months after her second HPV vaccine. She was treated with rituximab as this  medication had successfully controlled her lupus disease activity a few years earlier. Of 12  patients with history of lupus nephritis, two of four with Class IV nephritis experienced  worsening renal function during/after the study and progressed to renal failure within 18  months of the completion of the study.”

August 1, 2013 – HPV vaccine update Immunization rates low despite excellent effectiveness, safety profile (full text) “Among the 21,194 reports in females following HPV4 administration, 92% were classified as “non-serious.” Among non-serious adverse events, the most commonly reported generalized symptoms are syncope (fainting), dizziness, nausea, headache, fever and urticaria (hives); the most commonly reported local symptoms are injection site pain, redness and swelling. Among the 8% of HPV4 VAERS reports coded as “serious,” headache, nausea, vomiting, fatigue, dizziness, syncope and generalized weakness are the most frequently reported symptoms.”

August 2013 – The ‘Trojan horse’ oncogenic strategy of HPVs in childhood “The presence of high-risk HPVs in the neonatal oral mucosa supports the transmission of HPVs from the mother to her newborn. This review presents current evidence that supports the perinatal transmission of high-risk HPVs and suggests that this may be the initial step of the oncogenic strategy of high-risk HPVs in humansThe hypothesis that children are a unique reservoir of silent high-risk HPVs, analogously to the Trojan horse, should be investigated further.”

July 31, 2013 – Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants “Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.”

July 11, 2013 – Transposon leads to contamination of clinical pDNA vaccine “We report an unexpected contamination during clinical manufacture of a Human Papilomavirus (HPV) 16 E6 encoding plasmid DNA (pDNA) vaccine, with a transposon originating from the Escherichia coli DH5 host cell genome. During processing, presence of this transposable element, insertion sequence 2 (IS2) in the plasmid vector was not noticed until quality control of the bulk pDNA vaccine when results of restriction digestion, sequencing, and CGE analysis were clearly indicative for the presence of a contaminant.”

July 9, 2013 – The case for semi-mandatory HPV vaccination in China “China, have failed to adopt the vaccine largely because of its unprecedented high price ($360 for a three dose series in the United States). The price of vaccine will likely take years, if not decades, to drop. Similarly, expecting the Global alliance for Vaccination and Immunization (GAVI) or other global charity organizations to exercise triaged assistance toward worldwide coverage and mandatory HPV vaccination is unrealistic, given the staggering level of funding needed and the lengty political process involved.

July 9, 2013 – Antiviral therapy may trigger some genetic variants of cervical cancer “The study also concludes antiviral treatments or therapeutic vaccines could be dangerous in women whose lesions already show signs of HPV integration. This may help explain why some past studies using the antiviral drug interferon had inconclusive results regarding its value in treating cervical cancer. The researchers suggested that patients with existing HPV lesions may wish to discuss findings of this study with their physicians before starting such treatments.”

July 9, 2013 – Social equity in Human Papillomavirus vaccination: a natural experiment in Calgary Canada(full text) “Vaccine cost is not a barrier to parents in the Alberta program, since the vaccine is provided by the Government of Alberta, and administration of the vaccine is conducted exclusively by Public Health Nurses in Alberta Health Services. However, vaccine cost has been raised as a concern about the program itself. Ironically, the “community” based delivery model in Calgary has proven to be substantially more expensive than the “in-school” model because of the additional staff time required for follow up calls to parents and for vaccine administration (Alberta Health Services: Costs of Human Papillomavirus Vaccination Services (unpublished observations) Alberta; 2012). This model also introduces costs to the parents related to transportation, time away from work and inconvenience.”

July 4, 2013 – HPV vaccine acceptability among men: a systematic review and meta-analysis (full text) “HPV vaccine attitudes: acceptability was positively correlated with perceived HPV vaccine benefits (r=0.51, p<0.001), anticipatory regret (r=0.27, p<0.001), perceived HPV vaccine effectiveness (r=0.19, p<0.001); and negatively correlated with fear of needles (r=−0.11, p<0.05) and fear of side effects (r=−0.09, p<0.01).”

July 2013 – A National Study of HPV Vaccination of Adolescent Girls: Rates, Predictors, and Reasons for Non-Vaccination “The most common reasons for non-vaccination were concerns about vaccine safety, danger to daughter, and provider non-recommendation. Relatively poor HPV vaccine initiation and only modest 3-dose completion continues to be a major public health concern that requires continued efforts to address identified predictors and reasons for non-vaccination.”

June 26, 2013 – Increasing girls’ knowledge about human papillomavirus vaccination with a pre-test and a national leaflet: a quasi-experimental study (pdf)”Methods Participants Girls aged 11–14 years were recruited from three secondary public schools (state funded: one urban, two rural), whilst attending their first year there. One of the authors (PAWHS) approached schools in different regions by telephone and asked if they were willing to cooperate. The number of participants was based on feasibility; however, a post-hoc power analysis showed that the power was 0.992.

June 13, 2013 – Citizen intervention in a religious ban on in-school HPV vaccine administration in Calgary, Canada “The publicly funded Calgary Catholic School District Board voted against in-school HPV vaccine administration. In 2009, vaccine uptake was 70% in Calgary public schools and 18.9% in Calgary Catholic schools. To physician-citizens who requested in-school vaccination, the elected school trustees repeatedly responded that they were “directed” by the bishop. When trustees refused to hear from the city’s chief oncologist, a citizen’s group was created and held a June 2012 media event to help overturn the ban. The Board remained intransigent until the citizen’s group threatened legal action, former senior administrators pressured the Board, Pediatrics reported that the HPV vaccine had no effect on sexual behavior, and the bishop told trustees that they could consult school councils.

June 2013 – Inequalities in the uptake of Human Papillomavirus Vaccination: a systematic review and meta-analysis (full text) “The highest uptake rates reported in this study were achieved through school-based vaccination programmes which have been shown to be acceptable and convenient to parents/carers”…”School-based programmes could be advantageous in overcoming practical barriers to healthcare access in the primary care setting, such as transport issues or appointment restrictions, and promoting more equitable coverage of the HPV vaccine. More detailed understanding of the contextual factors contributing to differences of uptake by vaccination delivery setting would be beneficial to inform future HPV vaccination programmes or other health initiatives.”

May 9, 2013 – Epidemiologic Approaches to Evaluating the Potential for Human Papillomavirus Type Replacement Postvaccination “Although vaccination is expected to reduce the prevalence of these HPV types, there is concern about the effect this could have on the distribution of other oncogenic types. According to basic ecological principles, if competition exists between ≥2 different HPV types for niche occupation during natural infection, elimination of 1 type may lead to an increase in other type(s).”

May 1, 2013  Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women “Sexually active women provided a vaginal swab at study entry for HPV detection and genotyping. Because this was a postlicensure study, data were only collected on serious adverse events occurring within 30 days of each vaccination. This information was collected at the next visit or if the participant called with concerns.”…”Conflict of Interest Disclosures: Dr Dobson serving on the advisory board and consulting for GlaxoSmithKline … travel and accommodations expenses from Merck – Dr McNeil GlaxoSmithKline, receiving payment for lectures from GlaxoSmithKline and Merck, and conducting clinical trials supported by Merck and GlaxoSmithKline – Dr Dionne reports receiving grant support and travel expenses from GlaxoSmithKline – Dr Krajden reports receiving support from Roche, Gen-Probe, Siemens, and Merck – Dr Sauvageau reports receiving consulting and lecture fees from GlaxoSmithKline and Merck, receiving grant support from GlaxoSmithKline – Dr Scheifele reports receiving grant support from Pfizer, GlaxoSmithKline, aventis sanofi, and Novartis, and consulting for Novartis, GlaxoSmithKline, aventis sanofi, and Pfizer – Dr Kollmann reports receiving grant support from Merck and Advaxis, receiving lecture fees from Spimaco, and receiving travel, accommodations, and meeting expenses from GlaxoSmithKline – Dr Halperin reports receiving multiple vaccine manufacturers and receiving consulting fees on ad hoc advisory boards for multiple vaccine manufacturers and provincial and federal advisory committees – Dr Money reports receiving support from, and consulting for, Merck. No other disclosures were reported.

May 1, 2013 – HPV Vaccination Too Soon for 2 Doses? “Consequently, HPV vaccine uptakes and completion of the 3-dose series have been suboptimal in the United States and globallywith the exception of some countries that have used school-based, opt-out vaccination programs. The potential of a reduced-dose HPV vaccine schedule to address logistical barriers and decrease costs combined with the finding that girls have more robust immune responses to vaccination than women have led to discussions about the use of a 2-doses HPV vaccine schedule in girls.

April 30, 2013 – Factors associated with human papillomavirus vaccination among young adult women in the United States “Among women who were not interested in receiving HPV vaccine (n = 920), the main reasons reported included: not needing the vaccine (41.3%); concerns about safety of the vaccine (12.5%); not knowing enough about the vaccine (11.9%); not being sexually active (8.2%); a doctor not recommending the vaccine (7.6%); and already having HPV (2.7%). Among women with health insurance, 10 or more physician contacts within the past

April 11, 2013 – Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons “Behavioral: Health Education Session – The educational messages during the education session will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect—their hairdressers—will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care aboutThe investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during “down times” in each of the salons, on a rotating basis. There will be two types of sessions offered, one for mothers of females ages 9-18 and one for females ages 18-26.” Sponsor: Merck HPV Beauty Salon Campaign “MEE will be implementing an 18-month, non-randomized pilot study to assess the feasibility and effectiveness of using Black beauty salons as settings for culturally-sensitive health education about the impact of HPV and cervical cancer, along with HPV vaccination. The pilot project, which will take place in Philadelphia, is underwritten by Merck, Inc., makers of the Gardasil vaccine.”

April 4, 2013 – Political and News Media Factors Shaping Public Awareness of the HPV Vaccine “Younger people, women, and those with more education were significantly more likely to be aware of the vaccine. Even after controlling for these characteristics, we found that exposure to news media was associated with higher HPV vaccine awareness. Whereas liberals and conservatives were both more aware of the vaccine compared with moderates, the data are suggestive that liberals were more sensitive to news coverage.”

April 2013 – Human papillomavirus vaccine and systemic lupus erythematosus “In the current study, a temporal association between immunization with HPV vaccine and the appearance of a spectrum of SLE-like conditions is reported. Additionally, among the patients described, several common features were observed that may enable better identification of subjects at riskFurther studies are required to assess the safety of immunization with the HPV vaccine in patients with autoimmune-rheumatic diseases or in subject at risk of autoimmunity as well as the potential beneficial effect of preventive immunosuppressants.”

April 2013 – Human Papillomavirus Vaccine Initiation and Awareness: – U.S. Young Men in the 2010 National Health Interview Survey “HPV vaccination initiation among men aged 18–26 years in 2010 was low. HPV and HPV vaccine awareness were also low, and messages in this area directed to men are needed. Since ACIP published a recommendation for routine use of HPV4 among men/boys in December 2011,continued monitoring of HPV vaccination uptake among men aged 18–26 years is useful for evaluating the vaccination campaigns, and planning and implementing strategies to increase coverage.”

March 18, 2013 – Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008–2010 “Despite doctors increasingly recommending adolescent vaccines, parents increasingly intend not to vaccinate female teens with HPV. The concern about safety of HPV grew with each year. Addressing specific and growing parental concerns about HPV will require different considerations than those for the other vaccines.”

February 27, 2013 – Increasing Human Papillomavirus Vaccine Acceptability by Tailoring Messages to Young Adult Women’s Perceived Barriers “The most commonly selected barrier and primary reason for not getting vaccinated was concern about vaccine adverse effects (endorsed by 55%). Knowledge about HPV vaccination increased after exposure to the intervention but did not differ by experimental condition.”

February 2013 – Virus-like particles for the prevention of human papillomavirus-associated malignancies  “HPV vaccines have not been demonstrated as effective to treat existing infections, and efforts to develop a therapeutic HPV vaccine continue. Furthermore, current HPV L1-VLP vaccines provide type-restricted protection, requiring highly multivalent formulations to broaden coverage to the dozen or more oncogenic HPV genotypes. This raises the complexity and cost of vaccine production. The lack of access to screening and high disease burden in developing countries has spurred efforts to develop second-generation HPV vaccines that are more affordable, induce wider protective coverage and offer therapeutic coverage against HPV-associated malignancies.  In this article, the authors examine the progress and challenges of these efforts, with a focus on how they inform VLP vaccine design.”

January 30, 2013 – Female human papillomavirus (HPV) vaccination: Global uptake and the impact of attitudes “In all countries, the success of vaccination programmes is dependent on the support of the public and healthcare professionals. Whilst public acceptance is dependent on multiple factors, it has repeatedly been shown that recommendation by a health professional, particularly clinicians, is key to vaccine uptake. Worryingly, it appears that a proportion of clinicians still have significant reservations about promoting vaccination, particularly for younger age groups. A commitment now, to fully educating both the public and clinicians, has the potential to make a dramatic future impact.”

January 30, 2013 – A survey on human papillomavirus awareness and acceptance of vaccination among nursing students in a tertiary hospital in Ankara, Turkey “Majority of the nursing students knew the causal relationship between HPV and cervical cancer. Seventy-eight percent of the nursing students and 22.4% of the control group stated that they had heard of HPV vaccine. While the rate of the willingness to be vaccinated was 33.7% in the nursing student group, it was only 13.4% in the control group.”

November 30, 2012 – Reframing Cervical Cancer Prevention. Expanding the Field Towards Prevention of Human Papillomavirus Infections and Related Diseases “The hepatitis B virus (HBV) vaccination programs offer a model for HPV introduction in which newborn and infant immunization achieves a rapid reduction in the prevalence of the HBV carrier rates in immunized cohorts of children, and of liver cirrhosis and liver cancer decades later. In contrast, screening for cervical pre-cancer is largely restricted to industrialized populations and upper social classes in developing countries.

November 6, 2012 – “Who will take the blame?”: Understanding the reasons why Romanian mothers decline HPV vaccination for their daughters “Results show as main reasons for not vaccinating their daughters perceiving the vaccine as risky, the belief that the vaccine represents an experiment that uses their daughters as guinea pigs, the belief that the vaccine embodies a conspiracy theory that aims to reduce the world’s population and general mistrust in the ineffective health system. Mothers stated they would need clear, factual information about the HPV vaccine and its link to cervical cancer in order to motivate them to accept it for their daughters.”

November 2012 – An Opportunity for Cancer Prevention During Preadolescence and Adolescence: Stopping Human Papillomavirus (HPV)-Related Cancer Through HPV Vaccination “We conducted a descriptive study of the correlates of refusal and acceptance of human papillomavirus (HPV) vaccination by rural parents of preadolescent and adolescent children.”

October 19, 2012 – Monitoring HPV Vaccine Impact: Early Results and Ongoing Challenges (full text) “Because the major benefit of HPV vaccination—prevention of cervical and other less common HPV-associated cancers—will not be evident for decades, a spectrum of intermediate outcomes are being monitored to assess the early impact of HPV vaccines. Although considered to be the simplest and earliest indicator of vaccine impact, a reduction in HPV vaccine type prevalence may not be sufficient to guide vaccine policy and practices.”

October 8, 2012 – Human Papillomavirus Genotypes in High-Grade Cervical Lesions in the United States “Age and racial/ethnic differences in HPV type distribution may have implications for vaccine impact, and must be considered in monitoring trends.”

October 2012 – Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination “The diagnostic tasks were to determine the reason for her secondary amenorrhoea and then to investigate for possible causes of the premature ovarian failure identified. Although the cause is unknown in 90% of cases, the remaining chief identifiable causes of this condition were excluded. Premature ovarian failure was then notified as a possible adverse event following this vaccination.”

September 14, 2012 – Estimates of the annual direct medical costs of the prevention and treatment of disease associated with human papillomavirus in the United States “The overall annual direct medical cost burden of preventing and treating HPV-associated disease was estimated to be $8.0 billion (2010 U.S. dollars).

September 7, 2012 – Do correlates of HPV vaccine initiation differ between adolescent boys and girls? “Only 14% of sons had received one or more doses of HPV vaccine compared to 44% of daughters (p < 0.01).”…”Among sons, initiation of HPV vaccine was lower for those living in high income households (odds ratio [OR] = 0.22, 95% CI, 0.09–0.53) and higher for those whose race was neither white nor black (OR = 3.26, 95% CI, 1.06–10.04).”

August 7, 2012 – Reevaluation of epidemiological data demonstrates that it is consistent with cross-immunity among human papillomavirus types “This paper demonstrates that cross-immunity between HPV types is consistent with epidemiological data, contrary to previous interpretations. Cross-immunity may cause significant type replacement following vaccination, and therefore should be considered in future vaccine studies and epidemiological models.”

August 7, 2012 – Composition comprising an adenoviral expression vector comprising a CD40L fusion protein for generating immune responses (patent) “Further provided are methods of generating an immune response against cancer expressing a tumor antigen in an individual by administering an effective amount of the invention vector. Still further provided are methods of generating immunity to infection by human papilloma virus (HPV) by administering an effective amount of the invention vector which encodes the E6 or E7 protein of HPV. The immunity generated is long term.

August 3, 2012  – Knowledge about human papillomavirus (HPV), and health beliefs and intention to recommend HPV vaccination for girls and boys among Korean health teachers “Although a school-based HPV vaccine program has yet to be introduced in Koreahealth teachers should possess general knowledge about HPV and HPV vaccination, and differences in attitudes and intentions related to HPV vaccination between girls and boys should be reduced.”

July 27, 2012 – Prevalence of type-specific human papillomavirus infection among women in France: Implications for screening, vaccination, and a future generation of multivalent HPV vaccines “HPV 16 was the type most strongly associated with a diagnosis of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (odds ratio = 11.64 vs. HPV 16 absent, P < 0.001). A high proportion of high-grade cervical lesions (60.6% of genotyping assay-positive CIN2+) were associated with HPV types 31, 33, 45, 52, or 58. These data indicate that almost all young women could benefit from HPV prophylactic vaccination, but confirm the need for continued cervical screening and highlight the potential benefit of future vaccines targeting a wider range of HPV types.”

June 18, 2012 – Vaccine-Relevant HPV Infections and Future Acquisition of High-Risk HPV Types in Men “These prospective data on combinations of HPV infections over time do not suggest the potential for post-vaccination HPV type replacement. Future surveillance studies are needed to definitely determine if elimination of HPV types by vaccination will alter the HPV type distribution in the population.

May 28, 2012 – Sorting through search results: A content analysis of HPV vaccine information online “Health professionals designing online communication with the intent of increasing HPV vaccine uptake should take care to include information about the risks of HPV, including susceptibility and severity. Additionally, websites should include information about the benefits of the vaccine (i.e., effective against HPV), low side effects as a barrier that can be overcome, and ways in which to receive the vaccine to raise individual self-efficacy.”  Comment: What about posting the risks of Gardasil, the long term side effects of polysorbate 80, and the effectiveness of pap-smears for reducing the incidence of cervical cancer?

May 28, 2012 – Do the media provide transparent health information? A cross-cultural comparison of public information about the HPV vaccine “We conclude that the media lack balanced reporting on the dimensions completeness, transparency, and correctness. We propose standards for more balanced reporting on websites and in newspapers.”

January 2012 – The HPV Vaccine and Parental Consent “Dr. Carson continues to describe the vaccine’s efficacy, prevalence, and known side effects. Alex decides she would like to receive the vaccine. Dr. Carson asks Alex’s mother to re-enter the room and begins to discuss the recommendation for the HPV vaccine. Alex’s mother objects. “The HPV vaccine is mandated here in Virginia for 11-year-old girls. I would have chosen to opt out of the mandate because I don’t want my daughter to act irresponsibly or suffer unknown side effects.”…”For example, in Virginia, where Dr. Carson practices and Alex lives, minors can consent to the kinds of medical services listed above in parentheses. At the same time, Virginia parents have a right to obtain their child’s health records unless the disclosure of those records would be reasonably likely to cause substantial harm to the minor or another person. As a result, in some circumstances parental permission and knowledge might be avoided initially, but the minor patient’s privacy and confidentiality may not be entirely protected.”

September 27, 2011 – Comparing bivalent and quadrivalent HPV vaccines“Competing interests: Vaccine was provided for CVT by GSK Biologicals, under a clinical trials agreement with NCI. GSK also provided support for aspects of the trial associated with regulatory submission needs of the company under FDA BB-IND 7920. Douglas Lowy and John Schiller from NCI are named inventors on US government owned HPV vaccine patents that are licensed to GSK and Merck, and so are entitled to limited royalties as specified by federal law. None of the other NCI and Costa Rica co-authors have any potential conflicts of interest to report.”

April 2011– Demyelinating disease and vaccination of the human papillomavirus “We describe the cases of four young women that developed demyelinating disease after the vaccination of the HPV, with a rank of time between the administration of the dose and the development of the clinical of seven days to a month, with similar symptoms with the successive doses. We have described six episodes coinciding after the vaccination.”

February 3, 2011 – Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. Quadrivalent HPV (Gardacil) vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others. ClinicalTrials.gov number, NCT00090285.).

February 3, 2011 – Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males (full text) “Supported by Merck and by grants (M01-RR-00079 and UL1 RR024131, to Dr. Palefsky) from the National Center for Research Resources and by a grant (RO1 CA098803, to Dr. Giuliano) from the National Institutes of Health. Drs. Giuliano, Ferris, Moreira, Penny, and Palefsky report receiving grant support from Merck, either personally or through their institution; Dr. Penny reports receiving grant support from GlaxoSmithKline; Dr. Goldstone reports receiving grant support from Qiagen; Drs. Giuliano, Ferris, Moreira, Hillman, and Chang report receiving speaking fees or fees for board membership from Merck; Dr. Moi reports that his institution has received funding from Merck; Dr. Penny reports having stock or stock options in AstraZeneca; Dr. Palefsky reports receiving consulting fees from GlaxoSmithKline; Drs. Giuliano, Palefsky, Goldstone, Moreira, Moi, and Chang report receiving travel reimbursement from Merck; Dr. Bryan reports having an approved, filed, or pending patent related to subject matter discussed in this article; and Dr. Bryan, Dr. Marshall, Dr. Vuocolo, Dr. Barr, Dr. Haupt, Mr. Radley, and Dr. Guris are employees of Merck and own Merck stock or stock options. No other potential conflict of interest relevant to this article was reported.” Comment: This is one of the cornerstone articles that allowed the use of Gardasil in boys. Nearly every researcher has ties to a vaccine manufacturer or the vaccine’s manufacturer, Merck.

2011 – Potential cross-reactivity between HPV16 L1 protein and sudden death-associated antigens. “In particular, nine out of the 34 viral pentamers are present in a human protein, titin, alterations of which have been linked to cardiac failure and sudden cardiac death. The present data may help evaluate the potential crossreactivity risks in anti-tumor vaccination protocols based on HPV16 L1 protein.

2010 – New needle-free methods of HPV vaccine delivery of aerosols and dry powders Investigator(s): Bob Sievers and Steve Cape

June 1, 2008 – A Proposed Ethical Framework for Vaccine Mandates: Competing Values and the Case of HPV (pdf) “This work was developed in conjunction with the Center for Vaccines Ethics and Policy, a program of the Center for Bioethics at the University of Pennsylvania, The Wistar Institute Vaccine Center, and the Vaccine Education Center of Children’s Hospital of Philadelphia”

Spring 2008 – What Right Does the State Have to Compel Vaccination? Human Papilloma Virus and Its Implications (pdf) “Many bio-ethicists believe that personal autonomy is an inherent and paramount right, and that a state oversteps its authority when it mandates vaccination of all citizens without granting exceptions based on personal autonomy. As already noted, however, courts have specifically declared that personal autonomy is not infinite, and have rejected as a general principle the notion that individual autonomy is paramount.”

January 30, 2008 – Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines “Co-administration of HPV and HBV vaccines induced robust anti-HPV-6, HPV-11, HPV-16, HPV-18 geometric mean titers (GMTs) and ≥99% seroconversion rates (Month 7) that were both non-inferior (p < 0.001) to those induced by HPV vaccine alone.”