Pneumococcal disease describes a group of infections caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus. There are more than 90 strains of pneumococcus. previous childhood vaccines focused on 7-strains that were thought to cause infection (Prevnar or Prevnar 7 and 13). Several more strains have emerged and now the vaccine has expanded to cover 20 strains (Prevnar 2o).
August 2, 2022 – Incidence of Acute Chest Syndrome in Children With Sickle Cell Disease Following Implementation of the 13-Valent Pneumococcal Conjugate Vaccine in France “Monthly incidence of ACS per 1000 children with SCD over time as analyzed by segmented linear regression with autoregressive error; monthly incidence of hospitalization for vaso-occlusive crisis, asthma crisis, and acute pyelonephritis per 1000 children with SCD over the same period as the control outcomes.
June 10, 2021 Approval Letter – PREVNAR 20 “Effective this date, we have also approved your BLA for Pneumococcal 20-valent Conjugate Vaccine, according to the regulations for accelerated approval, 21 CFR 601.41. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Pneumococcal 20-valent Conjugate Vaccine under your existing Department of Health and Human Services U.S. License No. 0003. Pneumococcal 20- valent Conjugate Vaccine is indicated for active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in adults 18 years of age and older.”
PREVNAR 13 Pneumococcal 13-valent Conjugate Vaccine Diphtheria CRM197 Protein Package Insert (pdf)
August 2, 2022 – Incidence of Acute Chest Syndrome in Children With Sickle Cell Disease Following Implementation of the 13-Valent Pneumococcal Conjugate Vaccine in France “Monthly incidence of ACS per 1000 children with SCD over time as analyzed by segmented linear regression with autoregressive error; monthly incidence of hospitalization for vaso-occlusive crisis, asthma crisis, and acute pyelonephritis per 1000 children with SCD over the same period as the control outcomes.
May 13, 2015 – Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Pneumococcal Meningitis in U.S. Children “Serotype 19A continued to be the most common serotype in 2011-2013. Antibiotic resistance decreased significantly. Morbidity and case-fatality rate due to PM remain substantial.”
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 21, 2015 – Five winters of pneumococcal serotype replacement in UK carriage following PCV introduction (full text) “On-going substantial serotype replacement further indicates that continuing surveillance of carriage in addition to IPD is required to inform the future of pneumococcal vaccination.”…”NHS Foundation Trust/University of Southampton that are sponsored by vaccine manufacturers but receives no personal payments from them. SNF, JMJ and SCC have participated in advisory boards for vaccine manufacturers but receive no personal payments for this work. SNF, SCC and JMJ have received financial assistance from vaccine manufacturers to attend conferences.”…”This study was made possible via investigator-initiated research grants from Pfizer to SCC, SNF and JMJ.”
April 2015 – Differential Impact of Pneumococcal Conjugate Vaccines on Bacteremic Pneumonia Versus Other Invasive Pneumococcal Disease “Non-13VT disease prevalence and incidence increased significantly during the study period, in both BP and non-BP IPD. The proportion of non-13VT serotypes causing BP and non-BP IPD increased from 5% and 13% in the pre-PCV period to 59% and 74% in the PCV13 period, respectively. The incidence of non-PCV13 BP and non-BP IPD increased in the respective periods by approximately 5-fold and 2-fold. The most common serotype among non-13VT serotypes was 12F. These trends were more pronounced in children <2 years old, probably reflecting lower vaccine uptake in older children, leading to a delayed effect.”
March 30, 2015 – Choosing between 7-, 10- and 13-valent pneumococcal conjugate vaccines in childhood: A review of economic evaluations (2006–2014) “A more thorough exploration of uncertainty should be made in future analyses on this subject, as we lack understanding to adequately model herd and serotype replacement effects to reliably predict the population impact of PCVs. The introduction of further improved PCVs in an environment of evolving antibiotic resistance and under the continuing influence of previous PCVs implies that the complexity and data requirements for relevant analyses will further increase. Decision makers using these analyses should not just rely on an analysis from a single manufacturer.”
March 18, 2015 – Evaluating the implementation of the 13-valent pneumococcal vaccine supplementarydose programin Australian primaryhealth care settings (pdf) “Given the high proportion of eligible children vaccinated in the first six months of the program, consideration should be given to the duration of catch-up and supplementary dose programs, though this has to be weighed against cost-effectiveness and provision of ample opportunity for vaccination. Further evaluation of the effect of aligning supplementary (or catch up) vaccination programs with the NIP schedule is needed. This should include review of national data on timing of vaccine receipt as well as the effect on parents need to return for a separate appointment and prospects for opportunistic vaccination.”
March 16, 2015 – 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants “This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.”
February 25, 2015 – Early impact of PCV7/PCV13 sequential introduction to the national pediatric immunization plan, on adult invasive pneumococcal disease: A nationwide surveillance study “This was accompanied by a 52% increase in non-VT13 strains. These changes were most apparent in winter. PCV impact was most pronounced in younger adults (39% decrease in overall IPD with only a non-significant increase in non-VT13 cases) while in those >65 years a non-significant decrease in overall IPD was observed with a 64% increase in non-VT13 cases. Non-VT13 serotypes that increased significantly were 12F, 15A 10A and 6 C. A continuous reduction in isolates with penicillin MIC > 0.06 μg/ml was observed (26% to 11%, p < 0.001).”
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 postvaccination 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).
November 22, 2014 – Pneumococcal 13 valent CRM197 vaccine conjugate “A 33-year-old woman developed erythema nodosum after receiving pneumococcal 13 valent CRM197 vaccine conjugate [Prevenar]. Author comment: “Skin Erythema nodosum caused by pneumococcal vaccination has not previously been reported. It is important for clinicians to be aware of this rare, yet potential, adverse effect to pneumococcal vaccine.”
September 10, 2014 – Safety, Tolerability, and Immunogenicity of 15-Valent Pneumococcal Conjugate Vaccine in Toddlers Previously Vaccinated with 7-Valent Pneumococcal Conjugate Vaccine. “However, diseases caused by serotypes not included in PCV7 have increased. A 15-valent pneumococcal conjugate vaccine containing serotypes in PCV7 and 8 additional serotypes (1, 3, 5, 6A, 7F, 19A, 22F, 33F) was developed and evaluated in toddlers 12 to 15 months of age. Comment: This vaccine is a huge money maker for Pfizer. There is over 100 strains of pneumonia, we may well be seeing PCV 100 in the near future.
July 7, 2014 – Invasive Pneumococcal Disease After Implementation of 13-Valent Conjugate Vaccine “Initial data suggest that nonvaccine serotypes are more common in children with underlying conditions, who have greater morbidity from disease. In the post-PCV13 era, a larger proportion of patients are hospitalized, but mortality rates are unchanged. Routine vaccination with PCV13 may not be enough to reduce the risk in patients with comorbidity.”
July 1, 2014 – Vaccines: Can Transparency Increase Confidence and Reduce Hesitancy? (pdf) “The authors did report adverse events associated with vaccines, including high-quality evidence that the MMR vaccine is associated with febrile seizures and the varicella vaccine is associated with complications in immune-deficient people. There was moderate-quality evidence for purpura associated with the hepatitis A and MMR vaccines, febrile seizures with the pneumococcal conjugate 13 vaccine, and intussusception wit rotavirus vaccines.
May 23, 2014 – Serotype distribution and antimicrobial susceptibility of USA Streptococcus pneumoniae isolates collected prior to and post introduction of 13-valent pneumococcal conjugate vaccine “PCV13 serotypes represented 42.9% of isolates in 2008 and 30.1% in the second period, and this decrease was driven by 19A and 7 F. Non-PCV13 serogroups/serotypes 23A, 15B/15C, 7C, 8 and 31 increased. Penicillin-non-susceptibility rates were 9.6 – 10.0% and 38.9 – 42.7% when applying the parenteral (i.e. ≥4 μg/mL) and oral breakpoints (i.e. ≥0.12 μg/mL), respectively. Comment: We should all be looking forward to PCV50 soon, as in 50 pneumonia antigens.
February 2014 – 13-valent Pneumococcal Conjugate Vaccine in Older Children and Adolescents Either Previously Immunized With or Naïve to 7-valent Pneumococcal Conjugate Vaccine (full text) “Local reactions (redness, swelling and tenderness) at the PCV13 vaccination site, systemic events [fever, decreased appetite, irritability, increased or decreased sleep and hives (urticaria)], and the use of antipyretic medication to prevent or to treat symptoms were recorded by parents/legal guardians in an electronic diary for 7 days postvaccination.”
January 23, 2014 – Trends in Asymptomatic Nasopharyngeal Colonization with Streptococcus pneumoniae After Introduction of the 13-Valent Pneumococcal Conjugate Vaccine in Calgary, Canada ““Pneumococcal nasopharyngeal colonization has changed profoundly since the introduction of conjugate vaccines and overall colonization by pneumococcus has declined in recent years. By 2012, non-vaccine serotypes have nearly completely replaced vaccine serotypes. The impact on clinical disease remains to be seen.”
January 6, 2014 – Risk of Fever After Pediatric Trivalent Inactivated Influenza Vaccine and 13-Valent Pneumococcal Conjugate Vaccine “An observational study found an increased risk of febrile seizure on the day of or 1 day after vaccination (days 0-1) with trivalent inactivated influenza vaccine (TIV) in the 2010-2011 season; risk was highest with simultaneous vaccination with TIV and 13-valent pneumococcal vaccine (PCV13) in children who were 6 to 23 months old. Trial Registration clinicaltrials.gov Identifier: NCT01467934“
January 2014 – Parapneumonic Pleural Effusions Caused by Streptococcus pneumoniae Serotype 3 in Children Immunized with 13-Valent Conjugated Pneumococcal Vaccine “One-third of these children had been immunized with the 13-valent conjugated pneumococcal vaccine after the age of 12 months, according to the national immunization schedule.”
December 15, 2013 – Pneumococcal Serotype Diversity among Adults in Various Countries, Influenced by Pediatric Pneumococcal Vaccination Uptake “After pediatric PCV adoption, the median differential was 24.4% (p<0.003).The median differential in IPD incidence among adults was 5.6 cases/100,000 population before pediatric PCV use and 6.4 afterward (p=0.52). The differentials for the serotypes in alternate vaccines helps explain recent national recommendations for one or both vaccines in various populations. These differences may widen further, with more extensive pediatric uptake of higher-valence PCVs.”
December 14, 2013 – Serotype distribution and antimicrobial susceptibilities of nasopharyngeal isolates of Streptococcus pneumoniae from healthy children in the 13-valent pneumococcal conjugate vaccine era “The most common carriage isolates were 6C, 19A and 23A. The prevalence of the six additional PCV13 serotypes carriage in children appropriately vaccinated with PCV13 was lower than in children appropriately vaccinated with PCV7 (0 vs. 0.060); the greater reduction in prevalence of carriage was observed for serotype 19A (0 vs. 0.041). Serotype 6C was the most common drug-resistant serotype (17.2%). Further epidemiological studies are needed to assess changes in circulating SP serotypes following the large-scale introduction of PCV13.
November 2013 – Nonprotective Responses to Pediatric Vaccines Occur in Children Who Are Otitis Prone “We recently found that children who experience recurrent otitis media despite individualized care (stringently-defined otitis prone [sOP]) do not develop an antibody response to several vaccine candidate protein antigens expressed by Streptococcus pneumonia (Spn) and Haemophilus influenzae. Here we sought to determine if these same children also failed to develop antibody to routine pediatric vaccinations.”
September 24, 2013 – Effects of Immunocompromise and Comorbidities on Pneumococcal Serotypes Causing Invasive Respiratory Infection in Adults: Implications for Vaccine Strategies “Specific factors related to immunocompromise seem to determine the appearance of invasive infection by specific pneumococcal serotypes. Although the coverage of serotypes in the 13-valent conjugate pneumococcal vaccine (PCV13) was high, some non-PCV13-emergent serotypes are more prevalent in immunocompromised patients.”
September 24, 2013 – Serotype-Specific Changes in Invasive Pneumococcal Disease after Pneumococcal Conjugate Vaccine Introduction: A Pooled Analysis of Multiple Surveillance Sites “The small increases in IPD caused by non-vaccine serotypes that these findings reveal are likely to be the result of serotype replacement, but changes in antibiotic use and other factors may also be involved. These findings have several important limitations, however. For example, PCV7 is no longer made and extrapolation of these results to newer PCV10 and PCV13 formulations should be done cautiously.”
September 3, 2013 – Parapneumonic Pleural Effusions Caused by Streptococcus pneumoniae Serotype 3 in Children Immunized with 13-Valent Conjugated Pneumococcal Vaccine ” One third of these children had been immunized with the 13-valent conjugated pneumococcal vaccine after the age of 12 months, according to the national immunization schedule” Comment: Serotype 3 is included in Prevnar 13
Sepetember 1, 2013 – Funding – Awarded Grants Modeling distinct neonatal purine metabolism to inform vaccine development “The proposed research tests the hypothesis that breast feeding accelerates B cell priming and immunoglobulin diversity following immunizations at 2 and 4 months of age by modulating the microbial colonization of the infant gut. Studies will focus on the response to the conjugated vaccines against Haemophilus influenza (HIb) and Streptococcus pneumonia [Prevnar 13(R)]. A major goal of this application is to determine mechanisms by which breast feeding impacts neonatal B cell development and antibody affinity maturation. To test our hypothesis, immune responses and gastrointestinal microbe colonization from birth to one year of age will be examined among infants who are exclusively breast fed for at least the first four months of life versus those who are exclusively formula fed.”
September 2013 – Long-term Immune Responses to Pneumococcal Conjugate Vaccines in Children Previously Vaccinated With 7-valent Pneumococcal Conjugate Vaccine (full text) “S.J., R.N., M.M., and P.C.M. were employees of Pfizer Inc at the time of the study. N.P.K. reports receipt of research support from Pfizer Inc, GlaxoSmithKline, Merck and Co., Sanofi Pasteur and Novartis. This study was sponsored by Wyeth, which was acquired by Pfizer Inc in October 2009.”…” Late immune responses to infant pneumococcal vaccination should continue to be monitored to improve our understanding of the long-term persistence of vaccine-related immune response. Additional information regarding the immunogenicity and safety of vaccinating high-risk adolescents, including those who are immunosuppressed, with PCV13 would be helpful.” Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (PILOT)
September 2013 – Changes in Infectious Disease Mortality in Children During the Past Three Decades “We estimated that pneumococcal conjugate vaccines would have prevented 2 deaths annually in our population, rotavirus vaccines 1 to 2 deaths, influenza vaccine 1 death and varicella vaccine 0.7 death. Conclusions: We found that even though mortality from infectious diseases in childhood decreased markedly during the period concerned, it could have been further reduced by means of existing vaccines. Even though the number of deaths prevented would have been small, the number of years of life saved would have been great because the life expectancy of children is long. Comment: The number of lives DESTROYED by these vaccines and the amount of money spent to “save” these few lives is what should be studied. The many billions of dollars could have been spent on clean water, housing, education, shoes. The last sentence here is simply stupid…unless the number of life LOST by the vaccines is also discussed.
July 12, 2013 – Geographic and temporal trends in antimicrobial nonsusceptibility in Streptococcus pneumoniae in the post-vaccine era in the United States “Recent trends suggest geographic differences in serotype distribution may be starting to affect the prevalence of nonsusceptibility, possibly due to the decrease in the number of nonsusceptible serotypes.
July 2013 – Pneumococcal Serotypes before and after Introduction of Conjugate Vaccines, United States, 1999–2011 (full text) “On the basis of this 2010–2011 surveillance data, PCV13 could provide coverage for 48% of PNSP and 39% of all isolates causing disease. Continued monitoring of pneumococcal serotypes causing invasive and noninvasive disease will be crucial for assessing the full effect of PCV13.”
June 17, 2013 – Pneumococcal Serotypes before and after Introduction of Conjugate Vaccines, United States, 1999–2011“The trend of a relative increase in serotype 35B strains observed in this study is likely to continue because it is not included in PCV13. Serotype 35B isolates were more commonly recovered from children <5 years of age and from noninvasive specimens. Most (83%) of the 35B isolates obtained in 2010–2011 were PNSP. CDC reported that 51% of serotype 35B strains causing invasive disease during 1995–2001 were from older patients (>60 years of age) and 69% were PNSP .”
May 18, 2013 – Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults (full text) “Most of the AEs include diseases and conditions commonly observed among older adults, and infectious disorders were the most frequently occurring types of AEs in all groups. One (1) subject died but the event leading to death was not considered related to the study vaccine, and there were no vaccine related SAEs.”…”Disclosure statement: AG, KUJ, DJ, CD, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. LAJ, and MvC received funding from Pfizer to conduct this study. LAJ received support from Pfizer for attendance at a scientific meeting. The Group Health Research Institute has received grants from Pfizer, Novartis, Inviragen, Sanofi-Pasteur, the National Institutes for Health and the Centers for Disease Control and Prevention.”
May 18, 2013 – Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine “The only SAE considered by the investigator to be related to the study vaccine was idiopathic thrombocytopenic purpura (ITP) of a 81-year-old male 132 days after the second vaccination in the group that received PPSV23/PCV13. The ITP resolved after treatment. Nine (9) subjects died during the study. Eight (8) of the subjects (4 in the PCV13 group and 4 in the PPSV23 group) died after vaccination 1 (day 72 to day 309 after vaccination). One subject died on day 85 after vaccination 2. None of the events leading to death were considered related to study vaccine.“…”AG, TRJ, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. LAJ, KR, KP, and RNG receivedfunding from Pfizer to conduct this study. LAJ received support from Pfizer for attendance at a scientific meeting. The Group Health Research Institute has received grants from Pfizer, Novartis, Inviragen, Sanofi-Pasteur, the National Institutes for Health and the Centers for Disease Control and Prevention. The Minneapolis VA Medical Center was supported in part by the research service of the Minneapolis VA Health Care Service. Uppsala University has received research grants from Pfizer, GlaxoSmithKline, Eurocine and Sanofi-Pasteur.”
April 2013 – Modeling of Cost Effectiveness of Pneumococcal Conjugate Vaccination Strategies in U.S. Older Adults “The 13-valent pneumococcal conjugate vaccine (PCV13) is approved by the U.S. Food and Drug Administration for adults, but its role in older adults is unclear.”…”Results were sensitive to varying vaccine effectiveness and indirect effect estimates. In hyporesponsiveness scenarios, cost-effectiveness ratios increased by 37%–78% for single-dose strategies and 29%–35% for multiple-dose strategies.”
March 1, 2013 – Trends in serotype prevalence in invasive pneumococcal disease before and after infant pneumococcal vaccination in Belgium, 2002–2010 “PCV7 has an impact on SG distribution of invasive pneumococcal disease isolates of vaccinated and unvaccinated subjects. SG replacement forms a major threat to the success of PCV7. PCV13, including several additional replacement serotypes (STs 1, 7F, 19A), represents an attractive alternative.”
March 2013 – PCV13 Impact Evaluations: The Obvious and the Unpredicted (full text) “The unpredicted findings from this study complicate the inference that would logically be drawn, that is, that PCV13 use was the intervention that caused an absence of VT-IPD in the vaccinated children. On close evaluation of Figure 4, it is apparent that VT-IPD was declining in 2007 and 2008, before the PCV13 trial that was initiated in 2009.”
March 2013 – Changes in Molecular Epidemiology of Streptococcus pneumoniae Causing Meningitis following Introduction of Pneumococcal Conjugate Vaccination in England and Wales “A single instance of possible capsule switching was identified where one ST4327 clone expressed a serotype 14 capsule in 2005 and a serotype 28A capsule in 2009. In 2008 to 2009, ST191 (7F) became the most prevalent clone causing meningitis (10.3%). Case fatality (145 fatalities/1,030 cases; 14.1%) was high across all age groups and serotype groups. Thus, the introduction of PCV7 resulted in an increase in non-PCV7 serotypes, including some not covered by the 13-valent vaccine, such as serotypes 22F and 33F, emphasizing the importance of long-term epidemiological and molecular surveillance.”
November 26, 2012 – The cost-effectiveness of a 13-valent pneumococcal conjugate vaccination for infants in England “To our knowledge this is the first evaluation of a transition from PCV-7 to PCV-13 based on a dynamic model. The cost-effectiveness of such a policy change depends on a number of crucial assumptions for which evidence is limited, particularly the impact of PCV-13 on non-invasive disease.”
October 5, 2012 – Acute exercise enhancement of pneumococcal vaccination response: A randomised controlled trial of weaker and stronger immune response “This data indicates the effectiveness of exercise as a vaccine adjuvant, particularly in weaker responses. Thus, given the potential public health benefits of no-cost behavioural intervention to enhance response to vaccination, testing in at-risk populations should be pursued.”
October 2012 – Evolving Picture of Invasive Pneumococcal Disease in Massachusetts Children: A Comparison of Disease in 2007–2009 With Earlier Periods “The reduction in IPD after introduction of PCV7 persists in Massachusetts children; however, serotypes causing IPD have changed significantly in the last decade. Continued surveillance is necessary to determine the impact of 13-valent pneumococcal conjugate vaccine, as well as track potential changes in disease incidence and character due to non–13-valent pneumococcal conjugate vaccine serotypes.”
September 7, 2012 – Prevention of pneumococcal diseases in the post-seven valent vaccine era: A European perspective (pdf) “Higher frequencies of serotype 3, and 19A isolates resulted in slightly increased coverage, compared to IPD, of the 13-valent vaccine relative to the 7- or 10-valent vaccines. Thus not all serotypes were represented in similar proportions in different types of pneumococcal disease.”
August 29, 2012 – Completeness of Reporting in Randomized Controlled Trials of 3 Vaccines: A Review of Adherence to the CONSORT Checklist “The reporting of RCTs of vaccines is incomplete, with important methodological details missing from most reports. Journals could play a leading role in implementing changes. Improved reporting would make publications of vaccine trials easier to find, the findings easier to interpret, and aid the incorporation of findings into policy.”
August 21, 2012 – Antigenic protein fragments of Streptococcus pneumoniae (patent) “Owing to the limited serotype coverage, risks of serotype replacement and the high cost of pneumococcal glycoconjugated vaccines, great interest in the development of formulations based on pneumococcal protein antigens has emerged in the last decade (Bogaert et al., 2004b).”
June 2, 2012 – A Century of Pneumococcal Vaccination Research in Humans “Author Information 1 Merck Vaccines, 770 Sumneytown Pike, WP97-B364, West Point, PA 19426 USA2 Rollins School of Public Health and Division of Infectious Diseases, School of Medicine, Emory University, Atlanta, GA, USA; Medical Research Council, University of the Witwatersrand, National Institute for Communicable Diseases Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa”. Comment: More conflicts of interest in developing a pneumonia shot for children in South Africa.
May 15, 2012 – The Impact of the Heptavalent Pneumococcal Conjugate Vaccine on Risk Factors for Streptococcus pneumoniae Carriage in Children “In vaccinated group, breast-feeding was associated with increased nonvaccine type pneumococcal carriage, mainly in children with URI.”
April 24, 2012 – Cost-effectiveness of 2 + 1 dosing of 13-valent and 10-valent pneumococcal conjugate vaccines in Canada (pdf) “This study was sponsored by Pfizer Canada, Inc. Giovanni Zanotti is an employee of Pfizer Canada, Inc., and Raymond A. Farkouh is an employee of Pfizer Inc., which manufacturers 7-valent and 13-valent pneumococcal polysaccharide-protein conjugate vaccines. Stephanie R. Earnshaw and Cheryl L. McDade are employees of RTI Health Solutions, an independent contract research organization that has received research funding from Pfizer Canada, Inc. for this and other research studies, as well as funding from other pharmaceutical companies that market vaccines and drugs for other medical conditions.”
March 3, 2012 – Can vaccination against pneumococci prevent otitis media with effusion? “Meta-analysis of results showed no significant preventive advantage for antipneumococcal vaccination. Based on the results it was confirmed that neither primary nor secondary prevention by antipneumococcal vaccination has a beneficial impact on OME.” [OME is otitis media with effusion, simply stated, an ear infection with fluid behind the eardrum that often thickens and decreases hearing. Anti-pneumococcal vaccines are most commonly known as Prevnar or Prevnar-13. This study shows that neither of these vaccines prevent or decreases the incidence of OME. Side note: When Prevnar was first released in 2001, the vaccine only reduced the incidence of ear infections by 7%. Through a massive marketing campaign, the billion-dollar, block buster vaccine was pushed into general use.]
March 2, 2012 – Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010–2011 “Risk difference estimates varied by age due to the varying baseline risk for seizures in young children, with the highest estimates occurring at 16 months (12.5 per 100,000 doses for TIV without concomitant PCV13, 13.7 per 100,000 doses for PCV13 without concomitant TIV, and 44.9 per 100,000 doses for concomitant TIV and PCV13) and the lowest estimates occurring at 59 months (1.1 per 100,000 doses for TIV without concomitant PCV13, 1.2 per 100,000 doses for PCV13 without concomitant TIV, and 4.0 per 100,000 doses for concomitant TIV and PCV13). Incidence rate ratio and risk difference estimates were lower for children receiving TIV without concomitant PCV13 or PCV13 without concomitant TIV. Because of the importance of preventing influenza and pneumococcal infections and associated complications, our findings should be placed in a benefit–risk framework to ensure that population health benefits are maximized.”
February 22, 2012 – Pneumonia Vaccine “The approval of Prevnar 13 was based on data from clinical trials involving surrogate endpoints that suggest but don’t prove that the vaccine would improve clinical outcomes. So far the safety of the vaccine has been tested in clinical trials involving about 6000 older …”
February 24, 2011 – Preliminary Data: Febrile Seizures Increased With Fluzone Plus Prevnar 13 “Concern about Fluzone – the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age – arose from a data mining signal from the passive Vaccine Adverse Events Reporting System. Prior to that, a report from Australia suggested a statistically increased risk for febrile seizures within a day of receipt of another brand of flu vaccine that has since been pulled from the market worldwide.”
February 23, 2011 – Effect of Pneumococcal Conjugate Vaccination on Serotype-Specific Carriage and Invasive Disease in England: A Cross-Sectional Study (full text) “Although the recent introduction of PCV13 into UK vaccination schedules is likely to have an incremental benefitemerging serotypes should be considered for inclusion in future vaccines on the reduction of IPD compared to PCV7, this benefit might be offset by increases in the carriage of some high invasiveness serotypes. These .”
January 29, 2012 – Pneumococcal genome sequencing tracks a vaccine escape variant formed through a multi-fragment recombination event “Here, we use array-based sequencing of 62 isolates from a US national monitoring program to study five independent instances of vaccine escape recombination, showing the simultaneous transfer of multiple and often large (up to at least 44 kb) DNA fragments”
2012 – An infant with meningitis caused by resistant pneumococcus: infection despite vaccination. “We present the case of multidrug resistant non-vaccine serotype 19A pneumococcal meningitis in a 5-month-old boy. He was admitted to our Paediatric Intensive Care Unit (PICU) with seizures and septic shock. A barbiturate-induced coma was eventually required to control the seizures; shock was combated with intravenous fluids and inotropes. He received a 6-week course of ceftriaxone and vancomycin. At follow-up, one year after discharge, he had unilateral deafness and minor developmental delay.”
April 2010 – ARCHIVED – Canada Communicable Disease Report “Following critical appraisal of individual studies, summary tables with ratings of the quality of the evidence using NACI‘s methodological hierarchy (Tables 6 and 7) were prepared, and proposed recommendations for vaccine use developed. ”
December 30, 2011 – FDA expands use of Prevnar 13 vaccine for people ages 50 and older “The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.”
August 2008 – A new serotype 14 variant of the pneumococcal Spain9V-3 international clone detected in the central region of Argentina (full text) “We suggest that the results of this study will provide a reference for monitoring the evolution of the variants of Spain9V-3, the emergence of new clones and the impact of pneumococcal vaccination programmes in Argentina.”
December 16, 2004 – Emergence of Penicillin-Nonsusceptible Streptococcus pneumoniae Clones Expressing Serotypes Not Present in the Antipneumococcal Conjugate Vaccine (full text) “Multivalent pneumococcal conjugate vaccines containing 7–11 serotypes have been developed to protect infants from pneumococcal disease caused by the common childhood strains. Several studies have reported that administration of pneumococcal conjugate vaccines reduced nasopharyngeal carriage of pneumococcal serotypes included in the vaccine (vaccine type [VT] serotypes) [7–9]. However, replacement of VT serotypes and, sometimes, serotypes antigenically related to VT serotypes (VT related) by non-VT serotypes, in the nasopharynx and middle ear fluid (MEF), has been reported.”
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.”