January 2017 – A Randomized, Controlled Study of DTaP-IPV-HB-PRP-T, a Fully Liquid Hexavalent Vaccine, Administered in a 3-, 5- and 11- to 12-month Schedule “Sanofi Pasteur has developed a range of 2-component acellular pertussis combination vaccines including a tetravalent vaccine DTaP-IPV (Tetravac/Tetraxim), and a pentavalent vaccine DTaP-IPV//PRP~T (Pentavac/Pentaxim), which have been studied extensively.7,8 A new hepatitis B (HB) antigen,9 which is Hansenula polymorpha-derived and includes 10 μg HB surface antigen (HBsAg), was added to the antigens included in the pentavalent vaccine to produce a fully liquid hexavalent DTaP-IPV-HB-PRP-T vaccine, which was first licensed in 2012 for use in several primary schedules ranging from 6, 10, 14 weeks (the expanded program on immunization schedule) to 2, 4, 6 months, and with a booster in the second year of life.” 

• Address for correspondence: Emmanuel Feroldi, MD, Global Clinical Sciences, Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France. E-mail: emmanuel.feroldi@sanofipasteur.com.

December 20, 2016 – Vaccine development: From concept to early clinical testing (full text) “Detoxification may be required before an antigen (for example, pertussis toxin) can safely be administered to humans, but some detoxification methods may destroy epitopes in the process, and impact immunogenicity. Furthermore, purification of antigens away from other viral and bacterial components such as lipids and nucleic acids may exclude PAMPS, altering the nature of the immune response. Initial in vitro studies may evaluate antigen-antibody binding capacity and function, and early investigation of the immune response to the candidate antigen may be assessed in animals.  Comment: There is a new animal rule allowing testing on animals. If the animal trials are satisfactory, it will be given to humans. A vaccine fast-tracked without human testing.

December 20, 2016 – Vaccine provision: Delivering sustained & widespread use (full text)

• Disclosures:SP and LRF are employees of the GSK group of companies, and report ownership of shares/stock options from the GSK group of companies.
• NG was previously an employee of the GSK group of companies, declares stock ownership and is also inventor on patents owned by the GSK group of companies.
• ALC reports consultancy fees paid to his institution, unrelated to the present work, from the GSK group of companies. RS reports no conflict of interest.
  

Sources of support: GlaxoSmithKline Biologicals SA was the funding source and was involved in the preparation, review and approval of the manuscript.

December 20, 2016 – Vaccine safety evaluation: Practical aspects in assessing benefits and risks (full text) “Allegations that vaccines may cause an AEFI must be dealt with diligently and either confirmed or refuted based on scientific evidence. Misleading data can rapidly undermine confidence in an individual vaccine, or can lead to groundless suspension or withdrawal of the product from the market; ultimately having dramatic consequences for public health including decreased coverage and disease resurgence (Table 2). In some cases, it takes a long time after an AEFI is reported to generate sufficient scientific data to determine that the AEFI was not caused by the vaccine; such as the unfounded fears that measles-mumps-rubella vaccine (MMR) caused autism or that whole-cell pertussis vaccines caused encephalopathy.”…”The quality of information provided may be insufficient to either confirm the diagnosis or assess the likelihood of a causal association. Underreporting is a well-recognized limitation of passive surveillance systems. Comment: If the final phase study, phase 3, only involves thousands of children before being approved when it finally is out in public and millions of people are receiving them, the reactions are claimed to be occasional. Many doctors and clinics are NOT reporting adverse events when they hear about it from a patient. 9 out of 10 doctors and pediatricians are telling parents this is normal.

• Disclosures: ADP and FTDS are employees of the GSK group of companies and report ownership of stock/restricted shares/shares in the GSK group of companies.
• PB has received grants and personal fees from Pfizer, and personal fees from GSK, Novartis, and Sanofi Pasteur MSD, unrelated to the present work.
• NG was previously an employee of the GSK group of companies, declares stock ownership and is also inventor on patents owned by the GSK group of companies.
• LRS reports consulting fees from Vical, Genocea, and Janssen Pharmaceuticals, and is a member of the scientific advisory board of Abivax.
• MEl-H has received a speaking honorarium from the GSK group of companies, unrelated to the present work.

Sources of support: GlaxoSmithKline Biologicals SA was the funding source and was involved in the preparation, review and approval of the manuscript.

December 20, 2016 – Vaccination of special populations: Protecting the vulnerable (full text) “Among the estimated 2 million pregnant women immunised in the US during the 2000–2003 influenza seasons, only 20 adverse events were reported to the CDC Vaccine Adverse Event Reporting System, of which 17 were minor injection-site or systemic reactions. There are fewer data on Td or Tdap uptake, due to the recent introduction of the vaccine for use during pregnancy and the fact that most of the global elimination campaigns have been carried out with tetanus toxoid vaccine. Nonetheless, a US study of 26,229 women vaccinated with Tdap matched with 97,265 unvaccinated women found no evidence of an increased risk of adverse obstetric events apart from a small increased risk of chorioamnionitis. Comment: I don’t see minor reactions here do you? Found 11 cases where Vaccine is FLU3 or TDAP and Symptom is Foetal death and Serious

December 20, 2016 – Vaccine strategies: Optimising outcomes (full text) “There is however evidence that the most vulnerable groups are still not receiving the MMR vaccine in parts of the Americas. In a recent study of MMR immunisation of children younger than 5 years in low income areas of El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama, conducted for the Mesoamerican Health Initiative, vaccine coverage was 45–80% and the data indicated that families were bringing their children to health facilities but they were not receiving all appropriate vaccines during visits. This highlighted major problems that need to be addressed to prevent missed opportunities: a shortage of vaccines, failures to immunise at all well-child clinic visits, inadequate knowledge of current immunisation schedules and a lack of documentation of vaccinations by healthcare professionals.”
Disclosures:

• KH, SK and SP are employees of the GSK group of companies, and report ownership of stock/restricted shares/shares in the GSK group of companies.
• PB has received grants and personal fees from Pfizer, and personal fees from GSK, Novartis, and Sanofi Pasteur MSD, unrelated to the present work.
• JIS reports no conflict of interest.
• MEl-H has received a speaking honorarium from the GSK group of companies, unrelated to the present work.
• GDZ is an investigator on investigator-initiated research funded by Merck and Roche.

Sources of support: GlaxoSmithKline Biologicals SA was the funding source and was involved in the preparation, review and approval of the manuscript.

December 5, 2016 – The Social Value of Childhood Vaccination in the United States “We obtained data on vaccine manufacturers’ profit margins from annual reports and financial statements. When measuring manufacturers’ profits, we used the gross profit margin, which represents the sales volume minus production costs. Obtaining a company wide average across the top 5 vaccine manufacturers produced an average gross profit of 75%.This is a conservative approach, as gross profits do not subtract out manufacturer research and development (R&D) and marketing expenses. By using the gross profit margin, we can view vaccines’ social value as society’s benefit from vaccination, and society’s investment in R&D as the cost of inventing and developing the vaccines. (Subtracting R&D from profits would negate this framing.) This framing is useful because investments should be undertaken when the benefits (ie, the return on investment) exceeds the cost; social value is an important part of this equation. Moreover, R&D costs include the costs of many failures that the innovator encountered on the way to the given successful product; there is not an established method for measuring R&D costs for vaccines. Comment: Every vaccine is a failure when it causes death and disability.

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 28, 2016 – Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared with Term Infants.  “Background: Premature infants have lower short-term immune responses to vaccination than term infants, but patterns of antibody persistence in preterm infants over longer periods are not well established. This study assessed the persistence of antibody response to the 13-valent pneumococcal conjugate vaccine (PCV13) in formerly preterm versus term infants.”…”Conclusions: The routine (3+1) vaccination schedule is likely to offer long-term protection against invasive pneumococcal disease in preterm infants and should be initiated regardless of gestational age or weight at birth, without delay of the toddler dose. (ClinicalTrials.gov identifier: NCT01193335)
Sponsor: Pfizer

November 11, 2016 – Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. (pdf download) “There were 5 SAEs assessed as vaccine-related (all HV Group): 1 case of ileocolic intussusception, considered related to third dose of RV5; 3 cases of fever, considered related to all study vaccines; and 1 case of diarrhea, considered related to first dose of RV5. No participants discontinued due to a vaccine-related SAE. During the entire study duration, five participants (0.2%) of 2308 participants in the HV Group died: obstructive hydrocephalus [one participant] one day Post dose 2; death of unknown cause [one participant] 44 days Postdose 1, Group A streptococcal sepsis [one participant] 2 days Post dose 1, and sudden infant death syndrome [SIDS] [2 participants] 10 days Postdose 2 and 49 days Postdose 1, respectively). No death was assessed to be related to the study vaccinations. None of the participants in the Control Group (N=402) died.
Funding for this research was provided by Merck, Sharp, & Dohme Corp., a subsidiary of Merck & Co., Inc., and Sanofi Pasteur, Inc.
Conflicts of Interest 

• Stanley L. Block, Nicola P. Klein, Kwabena Sarpong, Stephen Russell, and John Fling were investigators for the sponsor supported by research grants.
• Stanley L. Block has served on a speakers bureau for Merck, as a consultant for Merck and Sanofi Pasteur, and given expert testimony for class action suit (Merck).
• Nicola P. Klein reports research support from Merck, Sanofi Pasteur, GlaxoSmithKline, Pfizer, Nuron Biotech, MedImmune and Protein Science.
• Maria Petrecz, Sheryl A. Flores, Angela L. Ngai, Jin Xu, Jon Stek, Ginamarie Foglia, and Andrew W. Lee are employees of the sponsors and may hold stock and/or stock options from the sponsors.

November 11, 2016 – A Phase III Randomized, Double-Blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at 2, 3, 4, and 12 Months (pdf download) “The endpoints for the non-inferiority and acceptability of MMRV concomitantly administered with DTaP5-HB-IPV-Hib were antibody response rates at one month after administration of MMRV at Toddler dose.”
Funding for this research was provided by Merck & Co., Inc., Sanofi Pasteur, Inc., and Sanofi Pasteur MSD.
Conflicts of Interest

• Timo Vesikari, Thomas Becker, Andre F. Vertruyen, and Katleen Poschet were investigators for the sponsor supported by research grants.
• Marco Pagnoni, Sheryl A. Flores, Jin Xu, G. Frank Liu, Jon Stek, and Andrew W. Lee are employees of Merck and may hold company stock and/or stock options.
• Florence Boisnard, Stephane Thomas, and Eddy Ziani are employees of Sanofi Pasteur MSD.

November 11, 2016 – Neisseria meningitidis Serogroup B Vaccine, Bivalent rLP2086, Induces Broad Serum Bactericidal Activity Against Diverse Invasive Disease Strains Including Outbreak Strains (pdf download)
Conflicts of Interest and Source of funding: 

• SLH, RD, JCH, CT, RO, LKM, JP, ASA, KUJ and TRJ are current employees of Pfizer and may hold stock options.
• This study and editorial/medical writing support was supported by Pfizer Inc.

October 15, 2016 – Is a discussion of dengue vaccination for the 2016 Olympics necessary?

• BG, AB, FN, and NJ are employees of Sanofi Pasteur;
• JLA-G and SRSH are investigators in the CYD15 and CYD14 trials, respectively.

September 2016 – Maternal influenza immunisation in resource-limited settings “The results of Tapia and colleagues’ large randomized trial are important because they show not only the efficacy but also the feasibility, of maternal seasonal influenza immunization on infant protection during the first months of life in Mali.”

• OL has been an investigator for Sanofi Pasteur MSD; reports personal fees from Sanofi Pasteur; and reports grants and non-financial support from GlaxoSmithKline Biologicals, Sanofi Pasteur, and Pfizer.

August 17, 2016 – Measuring indirect effects of rotavirus vaccine in low income countries (full text) “Horizontal transmission of RV5 to siblings of vaccinated infants was described in the US and transmission of RV1 occurred in 19% of 100 sets of twins during a randomised controlled trial in the Dominican Republic; approximately a quarter of whom developed anti-rotavirus IgA sero-conversion.” Comment:  Will there be cases of  Rotavirus vaccine strain cases just as there is for live virus Polio vaccines? 

Conflict of Interest

• NAC declares receipt of research grant support and honoraria for participation in rotavirus vaccine advisory board meetings from GlaxoSmithKline Biologicals.
• NBZ has received investigator initiated research grants from GlaxoSmithKline Biologicals and from Takeda Pharmaceuticals. AB declares no conflicts of interest.

August 17, 2016 –  The safety and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) booster vaccine in healthy Vietnamese children (full text)
The safety and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) booster vaccine in healthy Vietnamese children
Table 1. Percentage of children reporting unsolicited adverse events within the 31-day post-vaccination period (Total Vaccinated Cohort; N = 300).

Footnote: N, total number of participants; n, number of participants in a given category; CI, confidence interval.
Financial disclosure
GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and publication of this manuscript.
Conflict of interest

• HHH, SK and GJ are employees of GSK group of companies and HHH and GJ declare having GSK stocks.

Boostrix is a trademark of the GSK group of companies.

August 8, 2016 – Vaccine Coverage for United States Infants at Milestone Ages: Missed Opportunities for Vaccination “Coverage rates for RV, compared with DTaP and PCV, were slightly lower for the 1st dose, but the differences were smaller by the 7-month milestone. Vaccine coverage then diverged thereafter—DTaP and PCV coverage rates increased steadily after 7 months of age, whereas RV coverage remained flat. … Interventions, including taking advantage of all well-child visits as opportunities for vaccination, should target the first 6 months of life, specifically the first 3 months of age or the time of the first vaccination visit.”
Potential conflicts of interest.

• M. A. O., M. G. G., and D. Z. are employees of Merck & Co. Inc, a manufacturer of rotavirus vaccine.
  
• B. G. G. completed this work as part of a research fellowship with Merck & Co Inc. G. S. M. has served on advisory boards for Merck & Co Inc.

August 2016 – Schedules for Pneumococcal Vaccination of Preterm Infants: An RCT (full text)

• FUNDING: This work was supported by Pfizer Ltd as an investigator-led study. The funder had no input into the conduct of the trial, analysis of data, interpretation of results, or the preparation of this manuscript.

• POTENTIAL CONFLICT OF INTEREST: Dr Ladhani and Prof Heath have conducted studies on behalf of St George’s, University of London, funded by vaccine manufacturers but do not receive any personal payments or travel support.
• Prof Pollard has previously conducted clinical trials on behalf of Oxford University, funded by vaccine manufacturers, but did not receive any personal payments from them. Prof Pollard chairs the UK Department of Health’s Joint Committee on Vaccination and Immunization; the views expressed in this manuscript do not necessarily reflect the views of the Joint Committee on Vaccination and Immunization or the UK Department of Health.
• Dr Faust acts as chief or principal investigator for clinical trials and studies conducted on behalf of the University Hospital Southampton NHS Foundation Trust and the University of Southampton, sponsored by vaccine manufacturers, universities, or NHS trusts but receives no personal payments from them. Dr Faust has participated in advisory boards for vaccine manufacturers.
• Dr Goldblatt contributes to occasional GlaxoSmithKline advisory boards; he is supported by the National Institute for Health Research Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. The other authors have indicated they have no potential conflicts of interest to disclose.

July 19, 2016 – Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies “Pandemic planners will also need to consider the accumulated tolerability and safety experiences for each adjuvant. Although adjuvanted influenza vaccines are generally well tolerated, the safety profiles of these adjuvants used in combination with novel influenza antigens warrants continued monitoring.”

CONFLICT OF INTEREST

• M. Elizabeth Halloran and Ira Longini Jr. work together with Sanofi Pasteur on modeling their dengue vaccine and receive some funds for helping to establish a field site in Mexico to evaluate the vaccine. However, this is independent of this research and they had no influence over the analysis presented here.
• Dr. Brady and Cincinnati Children’s Hospital Medical Center receive research grant funding from Pfizer for quality improvement research about vaccines. This is independent of the research reported in this manuscript and had no influence over the analyses presented here.
• Dr. Frenck has received funds from Pfizer Inc, GSK and Takeda to conduct clinical trials. He did not receive any funding in relation to this manuscript.
• Dr. Walter has served as a consultant to Merck, as a DSMB member for Novartis, and has served as an investigator for clinical studies funded by bioCSL, GlaxoSmithKline, Merck, Novartis, Novavax, and Pfizer.
• Dr. Belshe has been a consultant and speaker for Medimmune and Sanofi Pasteur and a consultant for Novartis and GSK.
• Dr. Stapleton has received funds from GSK, Merck, and Bavarian-Nordic to conduct clinical trials. He did not receive any funding in relation to this manuscript.
•  Dr. Chen has consulted for MedImmune on non-influenza research and declares no other conflicts of interest.
• Dr. Edwards has received funding from Novartis to my institution of studies of group B strep vaccines in pregnant women and serve on a DSMB for an influenza trial funded by Novartis.

June 29, 2016 – Multicriteria decision analysis and core values for enhancing vaccine-related decision-making (full text) “Because disease burden and medical needs in a specific population can change during the decade it takes for a product to come to market, some vaccines have been developed that no longer align with public health priorities. Furthermore, the development of such priority lists has not followed a transparent and explicit process. Possible criteria for inclusion of a disease target on the NAM list could include the intrinsic morbidity and mortality of the disease, the disease incidence, and a manufacturer’s perspective on the feasibility and potential profitability of a vaccine that prevents the disease.”

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.

March 22/29, 2016 – Pregnancy in the Time of Zika – Addressing Barriers for Developing Vaccines and Other Measures for Pregnant Women (full text) “There are several current scientific and structural barriers to developing vaccines for pregnant women. These barriers challenge the ability to prepare and respond to epidemics and are particularly highlighted during a public health emergency that has pregnant women and their unborn fetuses as the primary affected population.”

• Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Beigi reported having received research funding from Novavax and Novartis Vaccines for maternal immunization research. No other disclosures were reported.
  

March 14, 2016 – A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults (full text) “Subjects in this phase 3, randomized, active-controlled, observer-blind study were randomized 2:1 to receive bivalent rLP2086 at months 0, 2, and 6, or hepatitis A virus vaccine (HAV, Havrix®) at months 0 and 6, and saline at months.  HAV was chosen because of the well-established safety profile of this vaccine.”…”The most commonly reported system organ class of SAEs was infections and infestations (bivalent rLP2086, n = 20 [0.5%]; HAV/saline, n = 13 [0.7%]). The most commonly reported SAEs were appendicitis (bivalent rLP2086, n = 3; HAV/saline, n = 4), spontaneous abortion (bivalent rLP2086, n = 2; HAV/saline, n = 3), gastroenteritis (HAV/saline: n = 3), suicidal ideation (bivalent rLP2086, n = 3; HAV/saline, n = 1), depression (HAV/saline, n = 3), and asthma (bivalent rLP2086, n = 3). No other single SAE was reported by >2 subjects in either vaccine group. Few subjects reported SAEs considered by the study investigator to be related to study vaccination throughout the study period (n = 2 in each group): neutropenia and an anaphylactic reaction in the bivalent rLP2086 group, and demyelination and spontaneous abortion in the HAV/saline group.”

• Conclusions: The results presented provide additional data demonstrating that bivalent rLP2086 has an acceptable safety and tolerability profile in healthy individuals ≥10–26 years of age. No new safety concerns were identified in this trial of a vaccine that is important for the prevention of a severe disease.

• Financial disclosure: This study was funded by Pfizer Inc., which also funded the development and publication costs for the present manuscript. All authors had full access to the data and the corresponding author had final responsibility for submission of the manuscript.

• Acknowledgments: Writing support was provided by Daniel E. McCallus, PhD, of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

March 8, 2016 – A first-in-human phase 1 trial to evaluate the safety and immunogenicity of the candidate tuberculosis vaccine MVA85A-IMX313, administered to BCG-vaccinated adults “Conflict of interest statement. ALV and FH are shareholders in Imaxio. FH and JDC are named as inventors on patents and patent applications concerning the IMX313 technology.

February 17. 2016 – The 5As: A practical taxonomy for the determinants of vaccine uptake (full text) “Consistent with a traditional psychological approach to the study of the determinants of health behaviour (e.g., the health belief model or the theory of planned behavior and, factors included judgments about one’s susceptibility to contracting an infectious disease, the perceived severity of a contamination as well as perceived benefits and judged efficacy of vaccination, concerns about side effects and the impact of social norms. Interestingly, using Acceptance as a coding category also highlighted additional possible determinants such as trust, cognitive biases and past behaviors. The fifth classification that we termed Activation (deliberately alliterative) emerged from this study in the form of interventions that made vaccination as easy as possible through the facilitation of access, made it a net positive, rather than negative, experience with small incentives, made vaccination the default rather than a choice, or provided reminders.

Conflict of interest statements: This study was partially funded through an unrestricted research grant from Sanofi Pasteur.

• G. Vallee-Tourangeau has received an unrestricted research grant for other research from Sanofi Pasteur.
• A. Thomson is an employee of Sanofi Pasteur.

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 – 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 lists of Conflicts of Interest I’ve have ever seen.

February 3, 2016 – Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults (full text) “Over the whole study period, reported SAEs were consistent with expectations for this population of adults aged 60 years or older at the time of vaccination, such as cardiovascular disorders and cancers. No SAEs were considered related to vaccination. Also, no safety concerns related to immune-mediated diseases were identified between month 36 and month 72.”

• Funding This work was supported by GlaxoSmithKline Biologicals SA, Belgium, which paid for all costs associated with the development and the publishing of the present manuscript. The sponsor was involved in all stages of the study conduct and analysis. Trademarks: Zostavax is a registered trademark of Merck & Co., Inc.

• Conflict of interest statement All study sites received a grant from GlaxoSmithKline Biologicals SA for carrying out this clinical trial. R.C. and T.S. report receiving grants from GSK outside the submitted work. G.C., H.L., and T.C.H. are GSK employees. No other potential conflicts of interest are reported.

February 2016 – Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial “Four subjects withdrew from the study prematurely because of AEs: 1 subject in the ACWY3 group (Krabbe disease on day 117 after the third vaccination), 1 in the routine group (bronchiolitis on day 14 after the first vaccination) and 2 subjects in the ACWY4 group (both experienced convulsions). Of the 2 infants experiencing convulsions, the first suffered a severe seizure on day 38 after the fourth study vaccination and the second subject suffered a potential mild seizure on day 2 after the third study vaccination (this subject also suffered 2 SAEs of severe bronchiolitis—on day 17 after the first vaccination and day 46 after the second vaccination—both of which required hospitalization and a third SAE of a severe asthma attack on day 95 after the third vaccination).”

• Peter M. Dull, MD is currently at the Bill and Melinda Gates Foundation, Seattle, Washington.
• Novartis Vaccines and Diagnostics, Inc. provided financial support for the conduct of the research, including study design as well as data collection, analysis and interpretation, and paid all costs associated with the manuscript development.
•  L.H. and I.S. were employees of Novartis group companies and held stock ownership from the sponsoring company at the time of the study but are now employees of GlaxoSmithKline group companies.
• F.X. was a contractor associate at Novartis Vaccines and Diagnostics, Inc. but is now a contractor associate at GlaxoSmithKline LLC, United States.
• P.M.D. was a permanent employee of Novartis Vaccines and Diagnostics, Inc. during study conduct and data analysis and interpretation.
• The institutions of S.L.B., J.S., and H.G. received funding from Novartis Vaccines and Diagnostics, Inc. for study conduct.
• S.L.B. has received speaker fees from Novartis Vaccines and Diagnostics, Inc. and research grants from Pfizer, outside the submitted work. The other authors have no conflicts of interest to disclose.

February 2016 – Maternal Immunization With an Investigational Trivalent Group B Streptococcal Vaccine: A Randomized Controlled Trial (full text)

• Financial Disclosures Dr. Donders received research fees for undertaking this trial.
• Dr. Halperin received research funding from Novartis Vaccines and Diagnostics, Inc. to undertake this clinical trial and has served on ad hoc scientific advisory boards for Novartis and other vaccine manufacturers.
• Dr. Devlieger is holder of a FWO (The Research Foundation–Flanders) Fundamental Clinical Investigatorship 1803311N.
• Mr. Forte, Dr. Wittke, Dr. Slobod, and Dr. Dull were permanent employees of Novartis group companies at the time the study was conducted.
• Mr. Forte and Dr. Slobod are now employed by the GlaxoSmithKline (GSK) group of companies. Dr. Baker is a consultant statistician on the GSK (formerly Novartis Vaccines) GBS project.

January 20, 2016 – Development of a more efficient hepatitis B virus vaccine by targeting hepatitis B virus preS to dendritic cells “Conventional hepatitis B virus (HBV) vaccines fail to induce protective antibody titers in 5–10% of immune-competent vaccinees. Therefore, there remains an urgent need to develop a safe and effective HBV vaccine. Methods: In this study, we developed an effective and economical method for producing the HBV vaccine by using the high binding capacity of biotin-streptavidin.”    Comment: Patent owner free to license for a fee is NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH

January 12, 2016 – Completion and compliance of childhood vaccinations in the United States (full text) “The Advisory Committee on Immunization Practices recommends routine childhood vaccination by age 2 years, yet evidence suggests that only 2% to 26% of children receive vaccine doses at age-appropriate times (compliance). The objective of this study was to estimate vaccine completion and compliance rates between birth and age 2 years using recent, nationally representative data.

• GK is an employee of the GSK group of companies and has ownership of stocks in the GSK group of companies.
• SKK and KLD are employees of RTI Health Solutions, a contract research organization that received funding from the GSK group of companies to conduct the analysis described in this manuscript. Although RTI Health Solutions was contracted to complete the research study described herein, neither
• SKK nor KLD were compensated for their contributions as authors on this manuscript. SKK has also received funding from Merck & Co., Inc., Otsuka America Pharmaceutical, Inc., Novartis Pharmaceuticals, Pfizer, Bristol-Myers Squibb, and Eli Lilly for contract research.
• KLD has also received funding from AstraZeneca, Eli Lilly, Millennium Pharmaceuticals, Inc., Novartis Pharmaceuticals, Pfizer and Shire Pharmaceuticals for contract research.

Acknowledgments

• The authors are grateful to Ning Wu (former employee of GSK Vaccines) for her contribution to development of the study design, analytic plan, and interpretation of the results.
• Mayank Ajmera (RTI Health Solutions) drafted the manuscript based on the study report.
• Editorial support was provided by Jenny Andersson (CROMSOURCE Ltd on behalf of GSK Vaccines),
• Marie Cloes (Business & Decision Life Sciences on behalf of GSK Vaccines),
• Heather Santiago (GSK Vaccines), and
• Mayank Ajmera, Sean Candrilli and Daniel Siepert (RTI Health Solutions).

January 4, 2016 – An approach to death as an adverse event following immunization “Events that are inconsistent with immunizations are due to co-incidental conditions that may account for infant and childhood mortality. In countries with a high infant mortality rate the coincidental occurrence of death and immunization may occur not infrequently and a robust mechanism to obtain information from autopsy and perform an AEFI investigation and causality assessment is essential. Communication with the community and all stakeholders to maintain confidence in the immunization programme is critical.”

January 2, 2016 – A novel lipid nanoparticle adjuvant significantly enhances B cell and T cell responses to sub-unit vaccine antigens “Sub-unit vaccines are primarily designed to include antigens required to elicit protective immune responses and to be safer than whole-inactivated or live-attenuated vaccines. But their purity and inability to self-adjuvant often result in weaker immunogenicity. Emerging evidence suggests that bio-engineered nanoparticles can be used as immunomodulatory adjuvants. Therefore, in this study we explored the potential of novel Merck-proprietary lipid nanoparticle (LNP) formulations to enhance immune responses to sub-unit viral antigens.”

January 2, 2016 – Assessment of influenza vaccine effectiveness in a sentinel surveillance network 2010–13, United States (full text) “Moderate VE emphasizes the importance of developing more immunogenic vaccines to provide higher protection in all ages, and the declining VE in older adults supports the particular importance of more immunogenic vaccines in this group. Influenza vaccination provides the best protection against influenza virus infection.”…”Conflicts of interest: BJC has received research funding from MedImmune Inc. and Sanofi Pasteur, and consults for Crucell NV.

Volume 5, 2016 – Immunogenicity and safety of a quadrivalent influenza vaccine in children and adolescents in Taiwan: A phase III open-label trial (full text)

• Role of the funding source This project and medical writing was funded by Sanofi-Pasteur. The sponsor participated in drafting of the final manuscript and in the decision to submit the article for publication.
• Conflicts of interest N.L. and C.-H.H. are employees of Sanofi Pasteur. C.F. was an employee of Sanofi Pasteur during the conduct of the study but declares no current conflicts of interest. All other authors declare no conflicts of interest.
• Acknowledgments Medical writing was provided by Dr. Phillip Leventhal (4 Clinics, Paris, France). The study and medical writing were funded by Sanofi Pasteur.

December 16, 2015 – Safety and immunogenicity of high-dose trivalent inactivated influenza vaccine in adults 50–64 years of age (full text) “Acknowledgments Medical writing was provided by Dr. Phillip Leventhal Clinics, Paris, France) and funded by Sanofi Pasteur. Role of the funding source. This study was funded by Sanofi Pasteur. Sanofi Pasteur participated in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

• Conflict of interest statement C.A.D., E.J. and V.L. are full-time employees of Sanofi Pasteur. M.D. and E.Y. were full-time employees of Sanofi Pasteur at the time the study was conducted.
  

December 8, 2015 – Building a new communication paradigm: Can we influence influenza perception? (full text) “There is also something unequal about the playing field in vaccination communication; people who are anti-vaccines tell real stories, first-hand accounts, or ‘my best friend’ sort of accounts, about individual experiences. The pro-vaccine side doesn’t benefit from that until we have news stories, the awful stories about someone losing a loved one or a child. Using personal stories is a very powerful approach that entirely changes how people relate to the information.”…” Engaging in social media Telling stories also means listening to stories. And if you want to engage with stakeholders, you can’t ignore social media, said Stéphane Suisse, Social Engineer at Sanofi Pasteur. Suisse started off with some figures: 40% of Europeans are active users of social media and 66% access these social media through a mobile device. And while we are just beginning to understand how social media work, people are making greater use of them to discuss topics such as vaccination, or just to spread their own opinions, whether we like it or not. Therefore, if science doesn’t engage in these social conversations, others will fill the gaps.

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.

September 9, 2015 – The FDA Guidance on therapeutic cancer vaccines: the need for revision to include preventive cancer vaccines or for a new guidance dedicated to them “Many therapeutic vaccine trials, either investigator-initiated or led by pharmaceutical companies, have been completed and many are currently ongoing, following the FDA Guidance on Therapeutic Cancer Vaccines published in 2011.”…”Here we discuss a set of recommendations for revising the current Guidance to also cover preventive vaccines or to include in a new Guidance dedicated specifically to vaccines for cancer prevention.”

September 8, 2015 – Enhanced immune responses by skin vaccination with influenza subunit vaccine in young hosts (full text) “In addition to immunological advantages, microneedle skin vaccination offers logistical advantages, such as ease of administration, rapid transport and delivery, lack of a requirement for highly trained personnel to administer the vaccine as needed for intramuscular injection, and little or no bio-hazardous waste.”

• Conflict of interest: MRP is an inventor of patents that have been licensed to companies developing microneedle-based products, is a paid advisor to companies developing microneedle-based products and is a founder/shareholder of companies developing microneedle-based products. This potential conflict of interest has been disclosed and is managed by Georgia Tech and Emory University. The other authors have no known conflicts of interest to declare.

September 8, 2015 – Cost-effectiveness of high-dose versus standard-dose inactivated influenza vaccine in adults aged 65 years and older: an economic evaluation of data from a randomised controlled trial “Interpretation High-dose trivalent inactivated influenza vaccine is a less costly and more effective alternative to the standard-dose vaccine, driven by a reduction in the number of hospital admissions. These findings are relevant to US health-care beneficiaries, providers, payers, and recommending bodies, especially those seeking to improve outcomes while containing costs. Funding Sanofi Pasteur

August 27, 2015 – Ebola in the United States — Public Reactions and Implications “Although there had been only two cases of Ebola transmission inside the United States and both patients had survived, a November 2014 opinion poll revealed that the U.S. public ranked Ebola as the third-most-urgent health problem facing the country — just below cost and access and higher than any other disease, including cancer or heart disease, which together account for nearly half of all U.S. deaths each year“…”The media most likely played a role in increasing public concern, primarily by running many stories about Ebola. Nightly news shows on three major networks — CNN, NBC, and CBS — aired nearly 1000 segments about Ebola between mid-October and early November 2014, when the majority of the U.S. public (76 to 81%) said they were following news on Ebola “very closely” or “fairly closely.”…”During an election period, public health leaders can expect politicians from the nonincumbent party to be critical of their actions. It may therefore be useful to reach out to political leaders and gain the support of nonpartisan groups that can help reduce any polarization of the issue.“

June 9, 2015 – The Potential for Reducing the Number of Pneumococcal Conjugate Vaccine Doses While Sustaining Herd Immunity in High-Income Countries (full text) “Currently, the conditions for regimen simplification, and therefore the potential benefits, are limited to high-income countries. The additional epidemiologic and programmatic considerations around a two-dose PCV schedule in low-income countries are complex and beyond the scope of this commentary.”

• Competing interests: KLOB has research funding related to pneumococcal vaccine from National Institutes of Health, Glaxosmithkline, Pfizer, the Bill & Melinda Gates Foundation, and Gavi, The Vaccine Alliance.
• DG’s laboratory is in receipt of collaborative and/or contract funding from vaccine manufacturers including Merck, Sanofi Pasteur, GSK, and Novartis, and DG has received honoraria or consulting fees in the past from Merck, GSK, Sanofi Pasteur, Novartis, and Pfizer.
• WJE’s partner works for GSK. JAGS is a member of the Joint Committee of Vaccination and Immunisation, has received financial support for research on pneumococcal vaccines from the Wellcome Trust, the National Institute for Health Research (UK), GAVI—the Vaccine Alliance, and PATH Vaccine Solutions, has done consultancy work on pneumococcal vaccines for PATH Vaccine Solutions, and received financial support for research by GSK in 2009/10. SF, AJVH and EM declare no conflict of interest.

June 8, 2015 – Vaccines: From valuation to resource allocation (full text) “Prospects are strong for developing a compelling and comprehensive framework for assessing the value of vaccines and for devising related evidence-based tools as an aid to decision-making. We are at the dawn of a new and perhaps golden era of vaccines in which scientific discovery, political commitment, and economic muscle are coming together to offer the promise of transformational gains in children’s health.”

• Conflict of interest: DEB’s recent research on vaccines has received support through grants from the WHO, Sanofi Pasteur, and Merck.

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 – Evidence of Herd Immunity and Sustained Impact of Rotavirus Vaccination on the Reduction of Rotavirus-Related Medical Encounters Among Infants from 2006 through 2011 in the United States

• Merck & Co., Inc. provided Optum Epidemiology with the funding for this analysis.
• F.T.W. and J.D.S. are employees of Optum Epidemiology;
• S.S. was an employee of Optum Epidemiology at the time the analysis was completed.
• T.C.M. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. The authors have no other funding of conflicts of interest to disclose.

May 21, 2015 – Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria–tetanus–acellular pertussis and inactivated poliovirus booster vaccine (dTpa–IPV) in healthy adults (full text)”Pain was the most frequent solicited local adverse event (AE; ≥62.7% subjects) and fatigue the most frequent solicited general AE (≥18.5%). No serious AEs were reported during the study.”…”This study was sponsored and funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study conduct and analysis; and also took charge of all costs associated with developing and publishing the manuscript.”

• Conflict of interest statement SK, KH and MK are employees of GSK
• and KH and MK declare having GSK stocks.
• NR was previously employed by GSK group of Companies.
• TFS has received honoraria from GSK as consultant, lecturer, member of advisory boards and for conducting clinical trials on behalf of his institution.

May 15, 2015 – Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial “In all groups, pain was the most common solicited injection-site reaction, whereas headache, malaise, and myalgia were the most common solicited systemic reactions. Almost all injection-site (99.1%) and systemic reactions (96.2%) were mild or moderate in severity and most (88.2%) resolved within 3 days. Although 19 (1.2%) adult IIV4 recipients reported grade 3 headache and 16 (1.0%) reported grade 3 malaise, all other types of grade 3 reactions were reported by less than 1% of the IIV4 recipients in either age group. Less than 2% the IIV3 recipients reported a grade 3 injection-site reaction and none reported a grade 3 systemic reaction.”

• Conflict of interest statement: Professor Nolan’s institution (Murdoch Children’s Research Institute) received research grants from Sanofi Pasteur to conduct this study and has received research grants from other companies as well.
• Yanee Hutagalung is a full-time employee of Sanofi Pasteur and owns stock options in Sanofi Pasteur.
• Martin Dupuy, Stéphanie Pépin, and Melanie Saville are full-time employees of Sanofi Pasteur.

May 2015 – Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study (full text) (full text) “8 years of PCV use in England and Wales has reduced the overall incidence of invasive pneumococcal disease by more than 50%. The herd protection induced by PCV7 is continuing, and similar indirect protection is occurring from the additional serotypes covered by PCV13. There is, however, evidence of increasing invasive pneumococcal disease due to non-PCV13 serotypes, particularly in children younger than 5 years in 2014. If this increase continues, the maximum benefit of the PCV13 programme in children might already have been achieved.”

• MPES has served on ad-hoc advisory boards for Pfizer and GlaxoSmithKline.
• CLS is and MPES has been an employee of the Public Health England Respiratory and Vaccine Preventable Bacteria Reference Unit (Colindale, London, UK), which has received research funding from Pfizer and GlaxoSmithKline.
• SNL has worked on clinical trials for vaccine manufacturers including GlaxoSmithKline and Pfizer on behalf of St George’s University of London (London, UK), but has received no personal remuneration.

April 27, 2015 – Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years (full text) “A total of 38 subjects (48.7%) reported at least one unsolicited AE up to Day 21 after either dose, including 5 subjects (6.4%) with a Grade 3 event. The most frequently report AEs were cough (6.4%; n = 5) and oropharyngeal pain (5.1%; n = 4). A total of 7 subjects (9.0%) reported 8 AEs which were considered by the investigator to be related to vaccination, including injection site dryness (n = 1), injection site hematoma (n = 2), injection site pruritus (n = 2), dysgeusia (n = 1), pruritus (n = 1), and pruritic rash (n = 1). From Day 0 to 84, 46 subjects (59.0%) reported at least 1 AE, including 7 (9.0%) who reported a Grade 3 event. The most frequent AEs reported up to Day 84 were nasopharyngitis (12.8%; n = 10), cough (6.4%; n = 5), and neck and oropharyngeal pain (5.1%; n = 4).”…”SAEs from Day 0 to 385, 49 subjects (62.8%) reported at least one MAE, which were most frequently upper respiratory tract infection (6.4%; n = 5) and sinusitis (7.7%; n = 6). From Day 0 to 385, three subjects (3.8%) reported at least one SAE, which were obstructive hernia, pneumonia, and small cell lung cancer.”

• Conflicts of Interest: OG, PI, PL, and DV are employees of GSK group of companies and own restricted shares in GSK.
• MD is an employee of GSK. MM was an employee of GSK at the time of the study.

April 23, 2015 – Factors associated with maintenance of antibody responses to influenza vaccine in older, community-dwelling adults (full text) “The study clearly demonstrated that antibody response to trivalent inactivated influenza vaccine, and maintenance of this response, are associated with pre-vaccination antibody titers. Hence, older adults with low pre-vaccination HAI antibody titers are less likely to respond to influenza vaccination. It is unclear if these older adults are at higher risk for influenza and complications to influenza or if they may be vaccine failures.”

Competing interests

• H. Keipp Talbot has received research funding from Sanofi Pasteur, MedImmune/Aztrazeneca and Giliead and is an advisor for Teva pharmaceuticals.
• Laura A. Coleman PhD, RD, currently works for Abbott Nutrition. At the time the study was conducted, she was at the Marshfield Clinic Research Foundation.
• Maria E. Sundaram, Edward A Belongia, and Marie Griffin have received research funding from MedImmune.

April 16, 2015 – Pre-existing immunity, more than aging, influences influenza vaccine responses (pdf) “Pre-existing immunity in this study had a significant effect on the ensuing immune response to vaccination. The constant evolution of the influenza virus makes yearly vaccine strains difficult to predict. Yet, despite the change in all 3 influenza vaccine strains for the 2008-2009 season, we found cross-reactivity to these strains in our study population.”…”This exemplifies the impact that prior immunity may have in providing protection from influenza and the potential longitude of this impact. The history of a person’s influenza vaccination/infection likely influences their current responses, and the immune system of older adults may have an extensive lifetime of exposure to draw from.”

Acknowledgments

• We sincerely thank Dr. Michael Decker of Sanofi Pasteur, Swiftwater, PA for providing TIV and monovalent influenza vaccines to assess CMI responses.
• Footnotes
  • HKT has received research funding from Sanofi Pasteur and MedImmune.
  • MRG and MS have received research funding from MedImmune.
  • JMK has received research funding from GlaxoSmithKline and Juvaris, Inc. (now Colby Pharmaceuticals).

April 9, 2015 – The diversity of meningococcal carriage across the African meningitis belt and the impact of vaccination with a group A meningococcal conjugate vaccine (pdf) “Carriage was more prevalent in males than females, perhaps because of more frequent social mixing among young adult males than females in Muslim societies, more prevalent in rural than in urban areas and in those exposed to smoke, either from cigarettes or from cooking. Development of less polluting methods of cooking is a priority for many parts of the developing world and could contribute to a reduction in the incidence of meningococcal infection as well as of pneumonia. The absence of an association between carriage and recent respiratory symptoms contrasts with findings from studies in Burkina Faso. The lack of any association with attendance at social gatherings was inconsistent with findings from the UK, where social behaviour was closely linked to risk of carriage.”

• Competing interests Helen Findlow reports performing contract research on behalf of Public Health England for Novartis Vaccines and Diagnostics, Baxter Biosciences and GlaxoSmithKline.
• Ray Borrow reports performing contract research on behalf of Public Health England for Novartis Vaccines and Diagnostics, Pfizer, Baxter Biosciences, Sanofi Pasteur, Serum institute of India and GlaxoSmithKline.
• Caroline Trotter reports receiving a consulting payment from GSK. None of the other authors declare a conflict of interest.
• Funding The work of the MenAfriCar Consortium is supported by grants from the Bill & Melinda Gates Foundation and from the Wellcome Trust. Nicole Basta is supported by NIH grant DP5OD009162.

April 8, 2015 – Antibody to Influenza Virus Neuraminidase: An Independent Correlate of Protection (full text) “Although it has been recognized for years that antibody to viral NA plays a role in the protection against influenza, little attention has been paid to the NA component in discussions of improved influenza vaccines. In fact, the viral NA has recently been termed “the forgotten antigen”. Part of the problem has been the availability of little comparative data on the distinct role of antibody to NA in protection, given the major role of antibody to HA. In addition, the vaccine-induced antibody response to NA may be variable, owing to the lack of standardization of antigen content in current vaccines. Financial support.

• This work was supported by Sanofi-Pasteur (unrestricted grant).
• Potential conflicts of interest. J. G. P., R. T. C., E. J., and S. E. O. have received grant support from Sanofi-Pasteur.
• A. S. M. has received grant support from Sanofi-Pasteur and consultancy fees from Sanofi, GSK, and Novavax.
• J. M. K. has received grant support from Juvaris Bio-Therapeutics and GSK. All other authors report no potential conflicts.

April 1, 2015 – Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial (full text) “In the absence of any infant MenC vaccine priming doses, the protection provided by just one MenC vaccine dose administered at 12 months of age would strongly rely on the persistence of herd protection, induced by a previous catch up MenC immunisation campaign, which could then be maintained by a booster in adolescence.”
Competing interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare:

• ALK, AmK, and DP have received travel grants from vaccine manufacturers to attend scientific meetings.
• AJP has previously conducted studies on behalf of Oxford University funded by vaccine manufacturers but does not receive any personal payments or travel support.
• AJP chairs the UK Department of Health’s (DH) Joint Committee on Vaccination and Immunisation (JCVI); the views expressed in this manuscript do not necessarily reflect the views of JCVI or DH. MDS, AF, SNF, and PH act as investigators for clinical trials conducted on behalf of their respective Universities and NHS Hospital Trusts sponsored by vaccine manufacturers and have participated in advisory boards but receive no personal payments from these activities.
• MDS and SNF have had travel and accommodation expenses paid by vaccine manufacturers to attend international conferences related to paediatric infectious disease.
• RB performs contract research on behalf of Public Health England for Baxter Bioscience, GlaxoSmithKline, Pfizer, Sanofi Pasteur, Sanofi Pasteur MSD, and Novartis Vaccines.
• PTH has conducted studies on behalf of St George’s University of London, funded by vaccine manufacturers but does not receive any personal payments or travel support.
• AmK and JM have received grants from the NIHR Oxford Biomedical Research Centre UK, GlaxoSmithKline Biologicals, and the European Society of Paediatric Infectious Diseases.

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 GSK Biologicals

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 28, 2015 – What are affordable vaccines? (full text) “Vaccine affordability is a complex problem and directing the focus only on price could lead to wrong, restricted, and non-sustainable solutions. In my view, very low vaccine prices are not sustainable for an industry that has the mission to invent, develop, and deliver vaccines with high quality standards. The risk of having unsustainable prices is that the vaccine industry would probably not be there any longer to develop and deliver vaccines.”…”I am a full-time employee of Novartis Vaccines. This letter is based on my personal opinion and does not necessarily reflect that of the company.”

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.

March 2015 – Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination (full text) “To date, this is the first study of AS03-adjuvanted H5N1 vaccine in children to assess safety up to 24 months after vaccination, and our results suggest that the long-term safety profile of the vaccine is clinically acceptable. Notably, the child with autoimmune hepatitis had increased concentrations of serum transaminases at baseline, and the child with uveitis also experienced tonsillitis, gingivostomatitis, and fever one day after the second dose of vaccine and seven days before the development of uveitis, raising the possibility of a viral infection as the cause of the subject’s symptoms. Although there are no other long-term studies of AS03-H5N1 vaccines in children, mass vaccination during the 2009 swine-origin pandemic outbreak provided important safety data regarding AS03-adjuvanted A/H1N1pdm09 vaccine. Recent reports have suggested a link between an A/H1N1pdm09 vaccine (a strain distinct from the one we used) or natural infection with subsequent onset of narcolepsy. Further research will help to elucidate the chain of events that resulted in narcolepsy and the potential roles of genetic and environmental factors in triggering this disease.”

• JD-D declares that he received payment from GSK for lectures and board membership.
• MG-S declares that she received payment from GSK, Pfizer, and Sanofi Pasteur for grants, travel support, and past board membership, and from GSK for expert testimony.
• JM declares that he received payment from Pfizer, Sanofi Pasteur MSD, and GSK for board membership and lectures, a grant from Pfizer and that he and his institution received investigator fees from GSK to support this study and others.
• MT declares that his institution received money from 4clinics and GSK for consultancy.
• PG, PM, PG-C, and CVA declare that they are employees of GlaxoSmithKline group of companies.
• PM, PG-C, and PG report ownership of stock/stock options. IU, AJR, J-MB, and MVP-C have no conflict of interests to declare.

March 2015 – Immunogenicity, Safety, and Antibody Persistence at 3, 5, and 10 Years Postvaccination in Adolescents Randomized to Booster Immunization with a Combined Tetanus, Diphtheria, 5-Component Acellular Pertussis, and Inactivated Poliomyelitis Vaccine Administered with a Hepatitis B Virus Vaccine Concurrently or 1 Month Apart (pdf) “The study was powered to evaluate immunogenicity, and so rare AEs or SAEs may not have been detected. Safety was assessed for 14 days after each vaccination (except for SAEs, which were collected at any time through 30 days after the last vaccination) but this information was not collected throughout the 10-year follow-up. Only 62.8% of the participants could be assessed at the 10-year follow-up, and not all participants could be assessed at all time points. The determination of prior exposure to pertussis disease or pertussis vaccination was based on participant recall only and was not verified from medical records.”

• This study was funded by Sanofi Pasteur, which also contributed to the study design, data collection, analysis and interpretation, review and editing of the manuscript (by Robert Lersch), and the decision to publish.
• J. Embree and B. Law have no conflicts of interest to declare. T. Voloshen and A. Tomovici are employees of Sanofi Pasteur

February 2015 – Immunological effect of administration of sequential doses of Haemophilus influenzae type b and pneumococcal conjugate vaccines in the same versus alternating limbs in the routine infant immunisation schedule: an open-label randomised controlled trial “In this open-label, randomised, controlled study, eligible healthy infants 6–12 weeks of age recruited through five clinical trials units (four in the UK and one in Malta) were randomly assigned in a 1:1 ratio to two vaccination groups: consistent limb or alternating limb.”…”Use of different (alternating) limbs for sequential doses of routine infant vaccines does not reduce, and might enhance, immunogenicity. The underlying mechanism for this finding warrants further research.”

• Funding NIHR Oxford Biomedical Research Centre and GlaxoSmithKline Biologicals.

February 2015 – Safety, Tolerability and Immunogenicity of 15-valent Pneumococcal Conjugate Vaccine in Toddlers Previously Vaccinated With 7-valent Pneumococcal Conjugate Vaccine (full text) “Funding for this research was provided by Merck & Co., Inc. A.S.M., M.J.D. and W.J.W. were employed by Merck at the time of this research. Other than employees of Merck & Co., Inc. (as indicated on the title page), all authors have been investigators for the sponsor. Employees may hold stock and/or stock options in the company. The authors have no funding or conflicts of interest to disclose.”…

“The most common systemic AEs were fatigue, myalgia, pyrexia and irritability. These AEs were solicited during the study and recipients of either formulation of PCV15 tended to have higher frequencies of these AEs than recipients of PCV7. A higher observed percentage of recipients of adjuvanted PCV15 reported myalgia, irritability or pyrexia versus those who received either nonadjuvanted PCV15 or PCV7. In addition, 1 recipient of adjuvanted PCV15 reported an AE of febrile convulsion (day 10 postvaccination, lasting 2 minutes) that was deemed not related to the study vaccine by the investigator.“

January 19, 2015 – Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium (full text) “At each time point anti-diphtheria GMCs appeared to be negatively associated with aluminium content, although the small sample size precludes firm conclusions and this is likely of little clinical importance in view of the high levels of seroprotection to diphtheria in all groups over time.”

• Financial disclosure This study was sponsored and funded by GlaxoSmithKline Biologicals S.A. GlaxoSmithKline Biologicals S.A. was involved in all stages of the study, conduct and analysis and also took charge of all costs associated with the development and the publishing of the manuscript.
• Conflicting interests CV: acts as sub- and principal- investigator for clinical trials for which the university obtained a research grant from GlaxoSmithKline Biologicals SA for this study, and research grants from other companies including Merck, SanofiJanssen Research and Development, Amgen, UCB and Genticel outside the submitted work.
• HT: acts as sub-investigator for vaccine trials conducted on behalf of the University of Antwerp, for which the University obtains research grants from GlaxoSmithKline Biologicals SA and other companies including Merck &Co., Novartis Vaccines, Genticel, SP-MSD, Pfizer. The University also received reimbursement for travel costs and meeting expenses from these companies.
• NR: Was an employee of GlaxoSmithKline Biologicals SA during conduct of the study.
• SK and HHH: are employees of GlaxoSmithKline Biologicals SA.
• KH: acts as sub- and principal investigator for clinical trials for which the university obtained a research grant from GlaxoSmithKline Biologicals SA for this study, and research grants from other companies including Merck, Sanofi Pasteur MSD outside the submitted work.
• ES reports no conflict of interest
• PVD: 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 GlaxoSmithKline Biologicals SA and other companies including Merck &Co., Novartis Vaccines, Genticel, SP-MSD, Pfizer. The University also received reimbursement for travel costs and meeting expenses from these companies.

January 15, 2015 – Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial (full text) “Adverse reactions are directly observed during post-vaccination period of 15 min. The iDSMB is informed about population trends in hospitalised cases of the disease potentially related to interventions or the probable-related adverse events.”…”Competing interests: In the past 5 years,

• AJL has received research funds for surveillance of otitis media and OM pathogen nasopharyngeal carriage from GlaxoSmithKline (manufacturers of Synflorix) and Pfizer (manufacturers of Prevenar13).
•  AJL has had costs of conference attendance reimbursed by GSK and Pfizer. AJL has no paid consultancies with either company.
• KM has served on Advisory Boards for GSK and Pfizer. GSK is providing in kind support for the Vietnam Pneumococcal trial, of which he is the PI.
• HSV, RMA and PSM have received research funds for surveillance of otitis media and OM pathogen nasopharyngeal carriage from GlaxoSmithKline (manufacturers of Synflorix).

January 15, 2015 – Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: Randomised, controlled trials (full text) “These studies showed that vaccination with the pneumococcal protein PhtD elicits both CD4 T cell and memory B cell responses in adults and that the reduced immune response in older persons compared to young adults can be partially restored with AS02V adjuvant system. The anti-PhtD antibodies elicited post-vaccination were shown to be functional. No safety concerns were raised and AS02V-adjuvanted PhtD had an acceptable reactogenicity profile. An AS02V-adjuvanted PhtD vaccine may therefore be beneficial in efforts to reduce the burden of pneumonia in the adult population, including older persons.”…

• Conflict of interest: The study was supported by GlaxoSmithKline (GSK) Biologicals
  

January 5, 2015 – Safety of Measles-Containing Vaccines in 1-Year-Old Children “CONCLUSIONS: This study did not identify any new safety concerns comparing MMRV with MMR + V or after either the MMRV or the MMR + V vaccine. This study provides reassurance that these outcomes are unlikely after either vaccine.”

• FINANCIAL DISCLOSURE: Drs Klein and Baxter report research support from Merck & Co, GlaxoSmithKline, Sanofi-Pasteur, Pfizer, Novartis, MedImmune, and Nuron Biotech; Dr Naleway reports research support from GlaxoSmithKline; and Dr Belongia reports research support from MedImmune. The other authors have indicated they have no financial relationships relevant to this article to disclose.

• FUNDING: Supported by a subcontract with America’s Health Insurance Plans under contract 200-2002-00732 from the Centers for Disease Control and Prevention.

• POTENTIAL CONFLICT OF INTEREST: Drs Klein, Naleway, and Baxter have received research support from Merck and GlaxoSmithKline. The other authors have indicated they have no potential conflicts of interest to disclose.

December 30, 2014 – Efficacy of Neonatal HBV Vaccination on Liver Cancer and Other Liver Diseases over 30-Year Follow-up of the Qidong Hepatitis B Intervention Study: A Cluster Randomized Controlled Trial (full text) “We sincerely thank all participants and their families in the QHBIS and all staff who were involved in the initial intervention study and subsequent follow-up studies; we greatly appreciate Merck for vaccine donation through WHO, the support from the Ministry of Health, China, and the support and statistical consultation in the original intervention study from WHO and from University of Oxford, England. Comment: So donations from Merck are going through WHO?! Merck is profiting from their own vaccine with the results of this study.

November 18, 2014 – Influenza Vaccine Effectiveness in the United States During 2012‐13: Variable Protection by Age and Virus Type (pdf) “Cross‐ lineage protection was also observed in Canada during 2012‐13 and in the United States during 2011‐12. In contrast, data from Canada during 2011‐12 showed little or no cross‐ lineage protection, and previous studies have assumed little or no cross‐lineage protection when estimating the value of quadrivalent influenza vaccines. However, our 2012‐13 season results taken together with similar findings in 2011‐12, suggest that licensed quadrivalent vaccines may provide little or no additional protection compared to trivalent vaccines.” Comment: The quadrivalent influenza vaccine has 15ug more antigen, and could be more reactive. (See here) This study is saying there is no difference between the three or four virus influenza vaccine.

• Potential conflict of interest: H. Q. M., M. E. S., J. K. M., and E. A. B. reports research grant support from Medimmune.
• M. G. reports research support from Medimmune and Novartis. P.A.P. reports service on Speakers Bureau for MedImmune.
• R. K. Z. and M.P.N. reports research grant support from Medimmune, Sanofi Pasteur, Pfizer Inc, and Merck & Co and consulting fees from Medimmune. J.M.R. reports research grant support from Pfizer, Inc. S. E. O. reports research grant support from Sanofi Pasteur.
• A. S. M. reports research grant support from Sanofi Pasteur and consulting fees from Novartis, Novavax, and GSK.

November 2014 – A Half-Century of Prevention — The Advisory Committee on Immunization Practices (full text) “Recently, more attention has been paid to financial relationships between committee members and vaccine manufacturers. The adequacy of the procedures for monitoring and addressing conflicts of interest for federal advisory groups has been questioned frequently by Congress, consumer groups, and even the Office of Inspector General of the Department of Health and Human Services, and the ACIP has been a specific focus of several inquiries. Ongoing efforts to identify and eliminate meaningful threats to the committee’s independence, whatever their source, remain essential to preserving the value of the ACIP’s recommendations and public confidence in government vaccination activities.”

August 14, 2014 – Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults “At least one serious adverse event during the safety surveillance period was reported by 1323 (8.3%) of the participants in the IIV3-HD group, as compared with 1442 (9.0%) of the participants in the IIV3-SD group (relative risk, 0.92; 95% CI, 0.85 to 0.99).

• Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01427309.
  

August 8, 2014 – Vaccine effectiveness of the pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against clinically suspected invasive pneumococcal disease: a cluster-randomised trial “The vaccine effectiveness was 50% (95% CI 32—63) in the 30 527 infants with three plus one and two plus one schedules combined and the absolute incidence rate reduction was 207 episodes per 100 000 person-years (95% CI 127—286). The vaccine effectiveness against the patient-file verified non-laboratory-confirmed invasive pneumococcal disease was 71% (95% CI 52—83) in infant three plus one and two plus one schedule combined.”

• Funding: GlaxoSmithKline Biologicals SA and National Institute for Health and Welfare (THL), Finland.
  

July 15, 2014 – Cost-effectiveness of programs to eliminate disparities in elderly vaccination rates in the United States (pdf) Comment: The word “assume” was used 15 times in this study.

• Competing interests CIM has no conflicts to report. RKZ has received grant support from Merck, Sanofi and MedImmune and received consulting fees from MedImmune.
• MPN has received grant support from Merck and MedImmune and received consulting fees from MedImmune.
• KJS has received grant support from the St. Margaret’s Foundation via grant support from Merck to study the cost-effectiveness of the pneumococcal polysaccharide vaccine.”

May 16, 2014 – Non-publication and delayed publication of randomized trials on vaccines: survey (full text) “Results We analysed 384 trials (85% sponsored by industry). Of 355 trials (404 758 participants) that were completed, 176 (n=151 379) had been published in peer reviewed journals. Another 42 trials (total sample 62 765) remained unpublished but reported results in ClinicalTrials.gov. The proportion of trials published 12, 24, 36, and 48 months after completion was 12%, 29%, 53%, and 73%, respectively. Including results posted in ClinicalTrials.gov, 48 months after study completion results were available for 82% of the trials and 90% of the participants. Delay to publication between non-industry and industry sponsored trials did not differ, but non-industry sponsored trials were 4.42-fold (P=0.008) more likely to report negative or mixed findings. Negative results were reported by only 2% of the published trials.”

April 13, 2014 – Antibody avidity measurements in recipients of Cervarix® vaccine following a two-dose schedule or the licensed three-dose schedule “Even if the clinical relevance of the avidity measurements remains to be determined, this study indicates that AIs from Month 7 to 48 appeared similar for the two-dose in 9–14 year olds and three-dose HPV-16/18 vaccine schedules in 15–25 year olds. These findings therefore complement the conclusion made in the primary analysis of the clinical trial that the two-dose schedule was immunologically non-inferior to the three-dose schedule. This study also supports the use of this simple modified ELISA approach to monitor avidities for vaccine and non-vaccine specific antibodies in future HPV vaccine studies.” Comment: Cervarix is doing poorly in sales compared to Gardasil, GSK is finding an alternative way to compete with Gardasil.

• Funding source This work was funded by GlaxoSmithKline Biologicals SA. The costs associated with the development and publishing of the manuscript, including scientific writing assistance and statistical advice were also covered by GlaxoSmithKline Biologicals SA.” 
  

January 3, 3014 – Guillain-Barré Syndrome and Adjuvanted Pandemic Influenza A (H1N1) 2009 Vaccines: A Multinational Self-Controlled Case Series in Europe (full text) “Overall, 99 cases (33%) received influenza A(H1N1)pdm09 vaccination, mostly adjuvanted with AS03, before symptom onset (Table 3). Of these, 36 (37%) cases developed GBS within 42 days after a first dose of influenza A(H1N1)pdm09 vaccination whereas 7 cases occurred within the exposure risk window but after a second dose of influenza A(H1N1)pdm09 vaccination.”

• Jeanne P Dieleman has been involved in studies for pharmaceutical companies (i.e., GSK, Sanofi, Astra-Zeneca, Pfizer). None of these had any conflict with the present study.
• The affiliation (i.e. University of Bath) of Corinne S de Vries and Cormac Sammon has research and consulting contracts in place with Novartis vaccines and with GSK pharmaceuticals. The authors do not personally benefit from these contracts; all financial compensation is to the University of Bath and not to the authors
• Terhi Kilpi is a principal investigator of a nationwide Finish effectiveness study of the 10-valent pneumococcal conjugate vaccine, a collaborative study, for which her institute has received funding from GSK.
• Par Sparen received a grant from Glaxo Smith Kline in 2010 to for a retrospective, observational register based cohort study to evaluate the safety of GSK Biological’s H1N1 pandemic vaccine administered in Sweden according to local vaccination policy.
• Miriam CJM Sturkenboom: is head of a research group that occasionally conducts research for pharmaceutical companies including Pfizer, EliLilly, Boehringer, AstraZeneca and Novartis. None was related to this topic.This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

January 2, 2014 – A Study to Evaluate the Efficacy of GSK Biologicals’ Influenza Vaccine in Children – Total, other (not including serious) adverse events – Total, serious adverse events
Locations: Bangladesh and Thailand

• Sponsors and Collaborators GlaxoSmithKline – Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
  

January 2014 – Safety and Immunogenicity of a Toddler Dose Following an Infant Series of a Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b, Hepatitis B Vaccine Administered Concurrently or at Separate Visits With a Heptavalent Pneumococcal Conjugate Vaccine “Out of the 460 infants initially enrolled in the infant primary series study, 10 participants did not complete the primary series and 12 participants discontinued from the study between the infant series and the toddler dose (2 due to other adverse events“).

• Decreased appetite (26.1–31.7%), drowsiness (19.7–25.5%) and crying (26.1–30.2%) were all commonly reported; severe systemic adverse events were all reported by <3.5% of participants in all vaccine groups. Fever (temperature ≥38°C) postvaccination was reported with similar frequency by participants in all groups ranging from 28.2–38.5% and severe fever (temperature >39.5°C) was reported by 0–4.1% of participants of the 3 vaccine groups.

• Only 3 serious adverse events were reported: 2 cases in Group A, gastroenteritis 19 days postvaccination and bronchospasm 15 days postvaccination, and 1 case in Group C, febrile seizure 4 days postvaccination (concomitant diagnosis of roseola). None of the serious adverse events were deemed by the investigator to be related to vaccination.”

• This study was funded by Sanofi Pasteur and Merck.

Comment: This vaccine trial – a vaccine combining DTaP, polio, HiB AND Hepatitis B –used 460 children as experiments. Investigators always try to hide the serious reactions. For example, the abstract states, “severe systemic adverse events were all reported by <3.5% of participants in all vaccine groups.” That is 16 children….but investigators go on to say only 3 had severe adverse events. What happened to the other 13?  In addition, it is the standard phrase  — “None of the serious adverse events were deemed by the investigator to be related to vaccination.” – is extremely common in vaccine research. It is as though every reaction – from a sore arm to a death  – is the fault of the defective child…never that the fault of the poison coming through the needle. 

December 5, 2013 – Infectious disease research investments: Systematic analysis of immunology and vaccine research funding in the UK (full text) “Our data does not include contribution from the pharmaceutical industry, which is especially important in vaccine research, as these data are not publically available. “We urge pharmaceutical companies and industry partners to share their detail with the wider scientific community. We have established RESIN: Research Investments in Global Health (www.researchinvestments.org), a public good to document and disseminate research investment data in an online open-access database to benefit academic institutions and pharmaceutical and biotech companies. It is unlikely that divulging past and current research investments would jeopardise current and future research, where commercially sensitive data can be redacted and may help avoid duplication of research investments in global health.”

December 5, 2013 – A next-generation, serum-free, highly purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab® when administered according to a post-exposure regimen in healthy children and adults in China (full text) “Solicited systemic reaction Verorab 45/274” “Role of the funding source Sanofi Pasteur was involved in all stages of the trial, including study design, data collection, analysis and interpretation, preparation of this article, and decision to submit the article for publication. Contributors All authors contributed to the conception, design or conduct of the trial, or the analysis and interpretation of data and they have all approved the final version of this manuscript.

• Conflicts of interest RL, LH, JL, ZM, BH, YW, XW declare they have no conflicts of interest. MM, FGM, SP are Sanofi Pasteur employees.”
  

December 2013 – Standard Trivalent Influenza Virus Protein Vaccination Does Not Prime Antibody-Dependent Cellular Cytotoxicity in Macaques (pdf) “The H1N1 challenge elicited robust ADCC to both homologous and heterologous H1 HA proteins, but not influenza virus HA proteins from different subtypes (H2 to H7). There was no anamnestic influenza virus-specific ADCC or CTL response in vaccinated animals.”…”There was a marked difference in the ability of infection compared to that of vaccination to induce cross-reactive ADCC and CTL responses. Improved vaccination strategies are needed to induce broad-based ADCC immunity to influenza.”

Conflict of interests:

• Dr. Poland is the chair of a Safety Evaluation Committee for novel investigational vaccine trials being conducted by Merck Research Laboratories. Dr. Poland offers consultative advice on vaccine development to Merck & Co. Inc., CSL Biotherapies, Avianax, Sanofi Pasteur, Dynavax, Novartis Vaccines and Therapeutics, PAXVAX Inc, and Emergent Biosolutions.
• Dr. Jacobson serves as a member on a safety review committee and on a data monitoring committee concerning several non-influenza vaccines in studies funded by Merck Research Laboratories.

September 30, 2013 – The Effectiveness of Varicella Vaccination in Children in Germany: A Case-control Study (full text) “

• GlaxoSmithKline Biologicals SA (GSK) was the funding source and was involved in all stages of the study conduct and analysis. The investigators are independent from GSK. GSK also took responsibility for all costs associated with the development and publishing of the present article. The scientific writer was paid by GSK.
• C.C. and M.B. are employees of GlaxoSmithKline group of companies, M.G. was employed by GlaxoSmithKline group of companies at the time the study was performed, C.C. and M.G. own stock options in GSK,
• J.G.L. and A.S. received a research grant for the submitted study from GSK and unconditional research grants for various epidemiological studies, J.G.L. received honoraria as consultant from GSK and Astra Zeneca, as well as for lectures from GSK, Astra Zeneca, Abbott and Wyeth, and received financial support from GSK Vaccines, Sanofi Pasteur and Wyeth for participation on congresses
• A.S. received an honorary as consultant from Sanofi Pasteur MSD and financial support from GSK for participation on congresses

September 7, 2013 – Immunisation against meningococcus B – by Stanley A Plotkin “There is another aspect that should concern us. Considering that the development of a new vaccine costs at least half a billion US dollars, vaccine manufacturers must make choices. Bodies like the JCVI and ACIP should give prospective advice to manufacturers about which vaccines are of interest and will be recommended. This is not a question of protecting profits by manufacturers, but rather the reality that only a limited number of vaccines can be developed, and it is in the interests of all of us that development leads to widespread use and control of a disease.

• Plotkin: “I have received honoraria and consultancies from major vaccines manufacturers, including Novartis, Sanofi, and GSK.”
  

August 16, 2013 – Clinical Trial to Evaluate the Safety and Immunogenicity of a Trivalent Surface Antigen Seasonal Influenza Vaccine Produced in Mammalian Cell Culture and Administered to Young and Elderly Adults with and without A(H1N1) Pre-Vaccination (full text) In contrast to other influenza vaccines, this trivalent vaccine was produced in a mammalian cell line (Madin-Darby canine kidney (MDCK) cells). Solicited local (ecchymosis, erythema, induration, swelling, pain) and systemic (chills/shivering, malaise, myalgia, arthralgia, headache, sweating, fatigue, fever) reactions that occurred within 3 days of the day of vaccination were used as indicators of reactogenicity. As such, they were judged to be at least possibly related to the administration of the study vaccine. If a local or systemic reaction continued beyond day 4, it was additionally recorded as an AE.

• Competing interests: This study was funded by Novartis Vaccines, the employer of SM and DB.

July 13, 2013 – Doctors and pharma in China “Doctor-patient relationships in China are in crisis. Doctors have been injured or even killed by patients at work. One of the major drivers might be the unhealthy and unethical relations between many doctors and some drug companies.”

July 12, 2013 – Reasons for and against receiving influenza vaccination in a working age population in Japan: a national cross-sectional study (pdf) “The most frequent reason for not being vaccinated was lack of time to visit a medical institution in women aged 20–29, not being able to afford vaccination in those aged 30-49, concerns about adverse reactions in those aged 50–59, and doubts about vaccine efficacy in those aged 60–69. The avoidance of influenza vaccination among women aged 50–69 may be attributable to unfavorable views related to changes in influenza vaccination policy as a result of severe side effects and lawsuit judgments for compensation at the time their children were vaccinated. If these women retain negative impressions of influenza vaccination after reaching the age of 65 when vaccination is recommended, it may be difficult to increase the influenza vaccination rate in this age group.”

July 11, 2013 – Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: A Phase III Randomized Controlled Trial in Children (full text) “Among children age 6–35 months in the QIV-only arm, 7 children (2.3%) reported a total of 10 SAEs. Four SAEs in 3 children were considered by the investigator to be related to the study vaccines: 2 SAEs (angioedema and acute conjunctivitis), which resolved within 7 days, were reported for a 12-year-old boy given TIV-Yam. A 1-year-old girl had a generalized seizure on the day after QIV receipt, and a 2-year-old boy had a febrile seizure 18 days after QIV receipt; both recovered within 1 day.”

• Financial support. This work was supported by GlaxoSmithKline Biologicals SA; GlaxoSmithKline SA was involved in all stages of the study conduct and analysis. GlaxoSmithKline SA also bore the costs associated with the development and the publishing of the present manuscript.
  

July 2013 – A Randomized, Controlled Trial to Assess the Immunogenicity and Safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Hib and Meningococcal Serogroup C Combination Vaccine Administered at 2, 3, 4 and 12-18 Months of Age (full text) “In addition, children for whom the following adverse events (AEs) would have been reported after the previous administration of the combination vaccines would be excluded from the booster phase of the study: fever with temperature ≥40.5°C, collapse, shock-like state or persistent inconsolable crying occurring within 48 hours of vaccination; seizures with or without fever within 3 days of vaccination; or encephalopathy within 7 days after vaccination with failure to recover within 24 hours.”

• M.C., L.U. and M.L. are employees of the GlaxoSmithKline group of companies. GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present article.
• The corresponding author had full access to the data and was responsible for the submission of the publication. All authors contributed to the study and were involved in writing and reviewing the article. The authors have no other funding or conflicts of interest to disclose.

July 2013 – Seroprevalence and Placental Transmission of Maternal Antibodies Specific for Neisseria meningitidis Serogroups A, C, Y and W135 and Influence of Maternal Antibodies on the Immune Response to a Primary Course of MenACWY-CRM Vaccine in the United Kingdom (full text) “A.J.P. has conducted clinical trials on behalf of Oxford University, sponsored by Wyeth/Pfizer Vaccines, GlaxoSmithKline Vaccines, Sanofi Pasteur, Sanofi Pasteur MSD and Novartis Vaccines and organized educational meetings at Oxford University with unrestricted grants from these manufacturers, but does not accept any personal payments from vaccine manufacturers. M.D.S. has received assistance to attend scientific meetings from Wyeth Vaccines, Novartis Vaccines and GlaxoSmithKline Vaccines and has had travel and accommodation expenses paid by Novartis Vaccines while working in collaboration with Novartis Vaccines, Siena, Italy. M.D.S. has also conducted clinical trials on behalf of Oxford University, sponsored by Pfizer, Sanofi Pasteur and GlaxoSmithKline. D.F.K. has received assistance from GSK and Wyeth to attend scientific meetings and funding for research from GSK. P.M.D. is an employee of Novartis Vaccines.”…”Conclusions: The levels of serogroup-specific meningococcal antibodies were low in mothers and 2-month-old infants. Immunizing mothers before or during pregnancy with meningococcal conjugate vaccines might increase antibody levels in early infancy and provide protection against infection due to N. meningitidis.”

July, 2013 – One or Two Doses of Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine Is Immunogenic in 9- to 12-Month-Old Children (full text) GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present article. All authors had full access to the data, and the corresponding author was responsible for submission of the publication.”…”Adverse events leading to an ER visit were reported by 10.6% and 16.9% of subjects in the ACWY-1 and ACWY-2 group, respectively. Seventeen subjects (10.6%) in the ACWY-1 group had at least 1 ER visit during the study. The most common diagnoses associated with the ER visits were infections (upper respiratory tract infection, viral infection, croup) as well as dehydration, pyrexia,  febrile convulsion and injuries. An ER visit was reported by 32 subjects (16.9%) in the ACWY-2 group. The most common diagnoses were diarrhea, vomiting and pyrexia, as well as infections (gastroenteritis, pneumonia, upper respiratory tract infection and viral infection) and injuries. No deaths occurred during the study. In order to identify whether the longer follow-up period contributed to the greater number of adverse event reports after vaccination in the ACWY-2 group, we conducted a post hoc analysis considering only adverse events reported after the second dose of ACWY-TT to study end (ie, 6 months extended safety follow-up) on subjects who received 2 vaccine doses (N = 172). The following adverse events were reported during the 6-month period from 12 to 18 months of age: any SAEs (0.6%), new onset of chronic disease (18.0%), rash (23.3%) and ER visits (11.0%) (Table 3).”

April 12, 2013 – What the World’s religions teach, applied to vaccines and immune globulins “Merck Vaccines, 770 Sumneytown Pike, WP97-B364, West Point, PA 19426, USA”…”Health professionals who counsel hesitant patients or parents can ask about the basis for concern and how the individual applies religious understanding to decision-making about medical products, explain facts about content and processes, and suggest further dialog with informed religious leaders. Key considerations for observant believers for each populous religion are described.”

April 2013 – Approaching the Vaccine‐Hesitant Parent using C‐A‐S‐E (pdf) – Potential conflict – Principal Investigator • Adult PCV13 Prevnar 13 vaccine (Pfizer) • Menveo MCV4 vaccine (Novartis)

March 2013 – Effectiveness of an Incomplete RotaTeq (RV5) Vaccination Regimen in Preventing Rotavirus Gastroenteritis in the United States (full text) “The contract grants OptumInsight Epidemiology oversight of the study conduct, reporting and interpretation, as well as final wording of any resulting articles. T.C.M. is an employee of Merck & Co., Inc.”

December 13, 2012 – A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants

• Supported by GlaxoSmithKline Biologicals (GSK) and the PATH Malaria Vaccine Initiative, which received a grant from the Bill and Melinda Gates Foundation.
• Drs. Aide, Greenwood, and Woods report receiving grant support from GlaxoSmithKline through their institutions.
• Drs. Aponte and Sacarlal report receiving consulting fees from GlaxoSmithKline through their institutions.
• Drs. Jongert and Olivier report being employees of GlaxoSmithKline, and
• Drs. Ballou, Guerra, Lapierre, Leach, Ofori-Anyinam, and Vekemans and Mr. Lievens report being employees of and holding stock in GlaxoSmithKline.
• Dr. Rettig reports receiving travel support from the PATH Malaria Vaccine Initiative, and Mr. Bawa reports receiving travel support from the PATH Malaria Vaccine Initiative through his institution. Drs. Bejon, Mwambingu, and Olotu report receiving grant support from the PATH Malaria Vaccine Initiative through their institutions.
• Dr. Cohen reports receiving consulting fees from and holding stock in GlaxoSmithKline, being a former employee of GlaxoSmithKline, and being a named inventor on several patents and patent applications related to malaria-vaccine development, the rights to which have been assigned to GlaxoSmithKline.
• Dr. D’Alessandro reports receiving consulting fees and lecture fees from Sigma-Tau Pharmaceuticals through his institution and lecture fees from Novartis through his institution.
• Dr. Kaslow reports holding stock and stock options in Merck.
• Dr. Loucq reports holding stock in GlaxoSmithKline.
• Dr. Lusingu reports receiving grant support, payment for the development of education presentations, and travel support from the PATH Malaria Vaccine Initiative through his institution and grant support from GlaxoSmithKline through his institution.
• Dr. Marsh reports receiving travel support and payment for board membership from Novartis.
• Dr. Njuguna reports receiving consulting fees from GlaxoSmithKline and grant support from the PATH Malaria Vaccine Initiative through her institution. Dr. Schellenberg reports receiving consulting fees from the PATH Malaria Vaccine Initiative.
• Dr. Tanner reports receiving payment for board membership from the UBS Optimus Foundation, payment for board membership from Novartis through his institution, grant support and travel support from the PATH Malaria Vaccine Initiative through his institution, and travel support from Sanaria through his institution.

December 3, 2012 – The JAMA Network and Merck Announce Strategic Collaboration “Through this collaboration, selected abstracts, articles and author videos from JAMA and the nine specialty journals available on The JAMA Network will also be available through Merck Medicus and Univadis. Starting this year, these materials will be available in English, Mandarin, French, Italian and Spanish. Brazilian, German, Portuguese and Japanese language translations will be added in 2013.”

November 26, 2012 – Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) “108 AEFIs were identified in the selected 100 VAERS reports. After initial review majority agreement was achieved for 83% of the AEFI and 17% required further discussion. In the end, only 3 (3%) of the AEFI were classified as definitely causally related to vaccine received. Of the remaining AEFI 22 (20%) were classified as probably and 22 (20%) were classified as possibly related to vaccine received; a majority (53%) were classified as either unlikely or unrelated to a vaccine received.“

• Research beyond this article on two of the authors conflicts of interest is as follows;
• Colin Marchant, MD – Adjunct Associate Professor of Pediatrics, Boston University School of Medicine, Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center, Boston, MA. This faculty member receives grant/research support from MedImmune, Merck, Wyeth-Lederle, GlaxoSmithKline; is a consultant for GlaxoSmithKline, Aventis, Abott, Johnson and Johnson; and is on the Speakers Bureau for GlaxoSmithKline and Abott.
• Dr. Marchant does not discuss investigational use of commercial products. – CDC, our planners, and our presenters wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters with the exception of: Dr. Elizabeth Barnett wishes to disclose receiving grant support from Sanofi Pasteur.

November 1, 2012 – Alternative Vaccination Schedule Preferences Among Parents of Young Children (full text) “H1N1 and seasonal influenza vaccine were the vaccines most commonly refused altogether (86% and 76%, respectively). The vaccines most commonly delayed to an age older than that recommended were the measles-mumps-rubella (26%) and varicella (46%) vaccines. The vaccines most commonly provided over an extended dosing period were the measles-mumps-rubella (45%) and diphtheria-tetanus-acellular pertussis (43%) vaccines.”…”One of 5 parents who followed the recommended schedule agreed that delaying vaccine doses was safer than the recommended schedule, and nearly 1 of 4 of these parents disagreed that the best vaccination schedule to follow was the one recommended by vaccination experts.“…

• FINANCIAL DISCLOSURE: Dr Dempsey receives compensation for service on an advisory board for Merck related to male human papillomavirus vaccination; the company had no input into the design, implementation, analysis, or presentation of the results of this study, and Dr Dempsey receives no research support from Merck. The other authors have indicated they have no financial relationships relevant to this article to disclose.”

October 1, 2012 – Effectiveness of Seasonal Influenza Vaccines in the United States During a Season With Circulation of All Three Vaccine Strains (full text) “Potential conflicts of interest. J. T. reports grant or clinical trial support from Sanofi, GlaxoSmithKline (GSK), Protein Sciences, and Vaxinnate, and is on the scientific advisory boards of Novartis and Immune Targeting Systems. H. K. T. has clinical trial support from Sanofi Pasteur. S. E. O. has clinical trial support and royalty income from Sanofi. J. V. W. is on the scientific advisory boards of MedImmune and Quidel. C. B. H. has performed consulting work for Medimmune and GSK. A. S. M. has grant support from Sanofi and is a consultant for GSK and Novartis. E. B. has grant support from Medimmune.”

October 2012 – The Use of Live Attenuated Influenza Vaccine (LAIV) in Healthcare Personnel (HCP): Guidance from the Society for Healthcare Epidemiology of America (SHEA) (full text) “On the basis of a theoretical concern for transmission and despite the absence of evidence of an increased risk of secondary transmission of infection by LAIV recipients, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and Healthcare Infection Control Practices Advisory Committee have recommended that LAIV not be administered to HCP who interact with patients who at the time of contact require a protective environment (defined as a “specialized patient-care area with a positive airflow relative to the corridor, high-efficiency particulate air filtration, and frequent air changes,” as found in myelosuppression or stem cell transplantation units).” Also see: Acknowledgments Potential conflicts of interest

August 21, 2012 – Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study (full text) “One hundred and five Cochrane reviews did not report trial funding sources (70%, 62% to 76%), including (based on data extraction protocols) 11 reviews (7%) that recorded, but did not report, trial funding sources, 16 (11%) that provided a data extraction protocol that did not list trial funding source information, and 78 (52%) for which it could not be determined whether or not data on trial funding sources had been collected.”

August 2012 – Acute disseminated encephalomyelitis following 2009 H1N1 influenza vaccine “We describe a previously healthy 2-year-old boy with ADEM, who exhibited high fever, lethargy, and recurrent seizures at 25 days after H1N1 influenza vaccination. To our knowledge, there has been only one report of ADEM following the 2009 H1N1 influenza vaccine, although such vaccination is accompanied with optic neuritis apart from this case.”

July 2012 – Immunogenicity and Safety of a Quadrivalent Live Attenuated Influenza Vaccine in Children (full text) Comment: Four live viruses in LAIV, (Live Attenuated Influenza Vaccine) will add one more virus to shed. See Person-to-Person Transmission of Vaccine Viruses here;Using Live, Attenuated Influenza Vaccine for Prevention and Control of Influenza

• This study was sponsored by MedImmune, LLC. S.B., L.K., and R.B. have been members of a speaker’s bureau for MedImmune, LLC, and have received research grants and consulting fees from MedImmune.
• J.H. has received a research grant from MedImmune. J.F., F.D., and T.Y are employees of MedImmune.
• The authors have no other funding or conflicts of interest to disclose.”

July 2012 – Dose-range Study of MF59-adjuvanted Versus Nonadjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in Six- to Less Than Thirty-Six-month-old Children (full text)

• Supported by a research grant provided by Novartis Vaccines and Diagnostics (to S.L.B.).
• This project has been funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract Number HHSO100200700030C.
•  J.B, V.S and S.J.H are permanent employees of Novartis Vaccines and Diagnostics.
• The authors have no other funding or conflicts of interest to disclose.”

April 24, 2012 – Does Conflict of Interest Disclosure Worsen Bias? (full text) “Disclosure has severe limits as a strategy for mitigating bias. Cosgrove and Krimsky mention three reasons: that disclosure alone merely shifts “secret bias” to “open bias”; that it sometimes involves so much information about ties to the industry, for example, that the reader is blinded by the sheer “signal to noise ratio”; and that disclosure may be perceived as absolving a person from their responsibility for managing their conflict. Even more compelling is evidence emerging from the social sciences that suggests disclosure to be not only ineffective but also regressive. Comment: Clear admission of research and reporting bias!

March 27, 2012 – Assessing the Potential of a Candidate Dengue Vaccine with Mathematical Modeling “Competing interests: Laurent Coudeville, Jean Lang, and Remy Teyssou are employees of Sanofi-Pasteur (France). Adrienne Guignard, Gerhart Knerer, and Baudoin Standaert are employees of GSK Biologicals (Belgium). Joachim Hombach and Pem Namgyal are staff members of the World Health Organization.” More conflicts of interest

March 23, 2012 – The putative link between the MMR vaccine and autism and refusal to vaccinate. “This episode invites to think about the credibility and trust in the authorities and professionals to the population, as well as the suspicions that may arise when there are potential conflicts of interest among professionals, industry magazines and the population. A special area of interest is on the distorted expectations of health interventions, including vaccination, particularly with regard to both individual and collective prevention.”

February 12, 2012 – Conflicts of Interest in Vaccine Safety Research “Using the vaccine-autism debate as an illustration, this article details the conflicts of interest each of these groups faces, outlines the current state of vaccine safety research, and suggests remedies to address COIs. Minimizing COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program.”

January 9, 2012 – Meryl Nass on Vaccines (video)

October 13, 2011 – Oil-in-Water Emulsion Adjuvant with Influenza Vaccine in Young Children “Supported by Novartis Vaccines and Diagnostics.”

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.”

September 6, 2011 – Merck Bankrolled Anti-Parent Bill  “The bill’s fiscal analysis is unclear. The bill says parents are not financially liable, so taxpayers will have to pay for it,” Paulo Sibaja, director of legislation at the Capitol Resource Institute, told me. “We’re still trying to calculate the cost. But the cost will be 50 percent from the state, 50 percent from the federal government.” He said there be other consequences, such as “who will be legally liable for medical liability, the state or the parents? The bill undermines the parents, who are totally out of the decision affecting their child.” Comment: Merck lobbyists are behind state laws that create vaccine mandates, but taxpayers foot the bill for state purchases and administration of vaccines. Merck wins on all counts — more utilization, more vaccine purchases, and more sale of drugs for vaccine side effects.

August 30, 2011 – NIH launches Medical Research Scholars Program “Pfizer has a long tradition of supporting medical education and is proud to support the NIH Clinical Center, one of the most important teaching and research hospitals in the world,” said Freda Lewis-Hall, M.D., executive vice president and chief medical officer of Pfizer Inc. “Those who benefit from the Medical Research Scholars Program will gain special insight into many conditions where further research and greater medical understanding are urgently needed.”..”Support for students selected for the program includes a stipend and resources for education enrichment, such as travel to scientific meetings. There will be a curriculum in clinical protocol development and the conduct of human subjects research, along with seminars focusing on basic and laboratory studies and their translation into clinical protocols.”

August 20, 2011 – Ghostwriting Revisited: New Perspectives but Few Solutions in Sight (full text) “These documents [regarding ghostwritten articles on PrePro] amount to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.”

August 10, 2011 – Who watches the watchmen? Some commercial firms that oversee the ethics and scrutiny of clinical trials have been found wanting. Human volunteers in research deserve better.

August 9, 2011 – Being the Ghost in the Machine: A Medical Ghostwriter’s Personal View (full text)

August 9, 2011 – How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised (full text) Scientists and clinicians need to know the authorship, author interests, and origination of the articles they read to judge them appropriately. Since 1985, the International Committee of Medical Journal Editors (ICMJE). This voluntary, self-funded, closed-membership group of select general medical journal editors. The ICMJE has worked to provide guidance on how authorship should be managed in the complex setting of modern biomedical science to the benefit of the published literature. Issues such as accountability, fraud, conflicts of interest, trial registration, and access to data have been considered. However, certain industry practices, including publications planning, ghostwriting, and guest authorship, have yet to be adequately addressed. On the basis of industry publications and documents…this article shows how pharma has succeeded not merely in outmaneuvering the ICMJE guidelines, but is able to use them as the basis for inappropriate attributions of authorship. Comment: This is an excellent review of how corrupt medical research and publications have become.

August 2, 2011 – Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles (full text) Summary of article:

• Ghostwriting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.
• Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.
• The practice of ghostwriting could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghostwritten articles.
• We argue that a guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).
• The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system.

August 1, 2011 – Conflict disclosure plan dropped  The NIH will not require universities to create websites detailing researchers’ financial ties.

July 16, 2011 – Parents have good reason to distrust childhood vaccines “Most vaccine safety studies are funded by vaccine manufacturers. The CDC, National Institutes of Health and the vaccine manufacturers maintain a revolving-door relationship. Dr. Julie Gerberding, while head of NIH, approved three doses of Merck’s Rotateq for the immunization schedule; one year after leaving NIH (the statutory minimum) she was hired to head Merck’s vaccine division.”

May 12, 2011 – Cost effectiveness of pediatric pneumococcal conjugate vaccines: a comparative assessment of decision-making tools (pdf) Johnathon Edmund’s partner is currently employed for GlaxoSmithKline, manufacturer of a pediatric pneumococcal vaccine. Anne Marie Henao and Raymond Hutubessy are staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the World Health Organization. All the other authors declare that they have no competing interests

March 1, 2011 – Medical journals with advertising are more likely than subscription journals to recommend drugs “Free medical journals with drug advertising were significantly more likely to recommend specific drugs that were advertised on their pages than were journals that relied upon subscription fees to cover their operating costs. “Free journals almost exclusively endorse the use of the selected drugs, whereas journals that rely exclusively on subscription fees for their revenue are more likely to recommend against the use of the same drugs,” said lead author Annette Becker, MD, from the University of Marburg, Germany.”

February 3, 2011 – Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males (full text)  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.

• 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.”

February 2011 – Employee designation and health care worker support of an influenza vaccine mandate at a large pediatric tertiary care hospital. Authors: Feemster KA,Prasad P, Smith MJ, Feudtner C, Caplan A, Offit P, Coffin SE.  “Attitudes and beliefs regarding influenza and the mandate may transcend professional role. Targeted outreach activities can capitalize on beliefs regarding patient protection and ethical responsibility.”

January 2011 – Second National Immunization Congress 2010: Addressing vaccine financing for the future in the US

July 2010 – A New Era in Adolescent Immunization (free registration) “Funding has been provided by Novartis Vaccines. Stan Block, MD Professor of Clinical Pediatrics, University of Louisville, Louisville, Kentucky; Professor of Clinical Pediatrics, University of Kentucky College of Medicine, Lexington, Kentucky. Disclosure: Dr. Block receives speaker and research grants for sanofi and Novartis and research grants for GSK.

November 9, 2009 – NEJM editor: “No longer possible to believe much of clinical research published” “No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top 9 U.S.-based drug companies that it comes to tens of billions of dollars a year in North America alone. By such means, the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease.”

October 1, 2009 – A Cell Culture (Vero)–Derived H5N1 Whole-Virus Vaccine Induces Cross-Reactive Memory Responses (full text) Potential conflicts of interest

July 1, 2009 – Phase III Comparison of an Investigational Quadrivalent Meningococcal Conjugate Vaccine with the Licensed Meningococcal ACWY Conjugate Vaccine in Adolescents (full text) Comment: Every person in this study is employed by or funded by the very drug companies that make the vaccine.

• Financial support. Novartis Vaccines.
• Potential conflicts of interest:
• L.A.J. has received research funding from Novartis and Sanofi Pasteur and travel support from Novartis.
• R.B. has received research funding from Novartis and Sanofi Pasteur.
• K.R. has received grants and/or research funding from Novartis, Merck, Sanofi Pasteur, GlaxoSmithKline, Wyeth, and MedImmune and is a scientific advisor for Novartis and Merck.
• A.K., J.S., L.B., and P.M.D. are employees of Novartis Vaccines.” 

February 8, 2001 – Efficacy of a Pneumococcal Conjugate Vaccine against Acute Otitis Media (full text) “The efficacy of the vaccine against acute otitis media from any cause was thus 6 percent (95 percent confidence interval, –4 to 16 percent; the negative value indicates a possible increase in episodes of otitis media).

• Supported by Merck, Pasteur Mérieux Connaught, and Wyeth Lederle Vaccines and Pediatrics.

August 21, 2000 – Conflicts of Interest in Vaccine Policy Making Majority Staff Report Committee on Government Reform U.S. House of Representatives (pdf) “ACIP Members Do Not Fully Disclose Conflicts of Interest: Examination of ACIP members’ financial disclosure forms reveals that many members do not fill them out completely. CDC ethics officials conceded to Committee staff that they have been lax  in compelling ACIP members to provide complete and thorough information.”