Ten year public health impact of 13-valent pneumococcal conjugate vaccination in infants: A modelling analysis.

Pneumococcal disease is a substantial contributor to illness and death in young children globally. The introduction of 7-valent pneumococcal conjugate vaccine (PCV7) in 2000 had a significant impact in preventing pneumococcal disease in both vaccinated children and unvaccinated individuals (through herd effect). A higher valent PCV13 replaced PCV7 in late 2009. This analysis was undertaken to assess how many cases and deaths have been averted over the last decade since PCV13 introduction. A model estimated the number of infants vaccinated annually with PCV13, as well as the number of cases and deaths of invasive pneumococcal disease, pneumococcal pneumonia, and acute otitis media cases averted. PCV13 vaccination was estimated to have prevented 175.2 million cases of all pneumococcal diseases and 624,904 deaths globally between 2010 and 2019. These results demonstrate the substantial public health impact of PCV13 and highlight the importance of increasing the global reach of PCV programs.

The impact of pneumococcal conjugate vaccines on serotype 19A nasopharyngeal carriage.

Introduction: By preventing nasopharyngeal carriage acquisition among vaccinated persons, and thus reducing transmission, pneumococcal conjugate vaccines (PCVs) provide protection against pneumococcal vaccine serotypes among unvaccinated individuals. This systematic review assessed PCVs containing serotype 19A or cross-reactive 19F for 19A carriage effects.Areas covered: Peer-reviewed literature was searched for manuscripts published between 1/1/2000 and 06/18/2018 assessing the impact of PCV on 19A carriage.Expert opinion: Fifty-five, 12, and 32 articles were identified for PCV7, PCV10, and PCV13, respectively. In two of four PCV7 randomized controlled trials (RCTs), 19A carriage was significantly higher in PCV7-vaccinated vs control subjects; in two of two PCV10 RCTs, there was no significant difference in 19A carriage and acquisition between PCV10-vaccinated (2 + 1 schedule) vs control subjects, apart from one timepoint (3 + 1 schedule); and one of one RCTs of PCV13 showed significant decreases in 19A carriage and acquisition in PCV13- vs PCV7-vaccinated (3 + 1 schedule) children. These findings were consistent with observational studies in which an increase or no change in 19A carriage was observed in 91% and 67% of PCV7 and PCV10 studies, respectively, whereas 87% of PCV13 studies documented a decrease. Countries in which serotype 19A transmission is substantial should consider the use of vaccines containing serotype 19A.

Estimating the cost-effectiveness of an infant 13-valent pneumococcal conjugate vaccine national immunization program in China.

BACKGROUND: The burden of pneumococcal disease in China is high, and a 13-valent pneumococcal conjugate vaccine (PCV13) recently received regulatory approval and is available to Chinese infants. PCV13 protects against the most prevalent serotypes causing invasive pneumococcal disease (IPD) in China, but will not provide full societal benefits until made broadly available through a national immunization program (NIP). OBJECTIVE: To estimate clinical and economic benefits of introducing PCV13 into a NIP in China using local cost estimates and accounting for variability in vaccine uptake and indirect (herd protection) effects. METHODS: We developed a population model to estimate the effect of PCV13 introduction in China. Modeled health states included meningitis, bacteremia, pneumonia (PNE), acute otitis media, death and sequelae, and no disease. Direct healthcare costs and disease incidence data for IPD and PNE were derived from the China Health Insurance and Research Association database; all other parameters were derived from published literature. We estimated total disease cases and associated costs, quality-adjusted life years (QALYs), and deaths for three scenarios from a Chinese Payer Perspective: (1) direct effects only, (2) direct+indirect effects for IPD only, and (3) direct+indirect effects for IPD and inpatient PNE. RESULTS: Scenario (1) resulted in 370.3 thousand QALYs gained and 12.8 thousand deaths avoided versus no vaccination. In scenarios (2) and (3), the PCV13 NIP gained 383.2 thousand and 3,580 thousand QALYs, and avoided 13.1 thousand and 147.5 thousand deaths versus no vaccination, respectively. In all three scenarios, the vaccination cost was offset by cost reductions from prevented disease yielding net costs of ¥29,362.32 million, ¥29,334.29 million, and ¥13,524.72 million, respectively. All resulting incremental cost-effectiveness ratios fell below a 2x China GDP cost-effectiveness threshold across a range of potential vaccine prices. DISCUSSION: Initiation of a PCV13 NIP in China incurs large upfront costs but is good value for money, and is likely to prevent substantial cases of disease among children and non-vaccinated individuals.

Streptococcus pneumoniae serotype 19A: worldwide epidemiology.

INTRODUCTION: Streptococcus pneumoniae causes mucosal and invasive diseases with high morbidity and mortality. Introduction of the 7-valent pneumococcal conjugate vaccine (PCV7) into routine infant immunization programs worldwide resulted in serotype 19A becoming a leading cause of the remaining pneumococcal disease burden in vaccinated and nonvaccinated individuals. This article reviews the impact of the latest generation PCVs (10-valent PCV, PCV10, and 13-valent PCV, PCV13) on serotype 19A. Areas covered: This article covers immune responses elicited by PCV7, PCV10 and PCV13 against serotype 19A and their impact on nasopharyngeal (NP) carriage and disease in vaccinated and unvaccinated populations using data from surveillance systems, randomized controlled trials, and observational studies. Expert commentary: As expected from a PCV containing serotype 19A, PCV13 elicits significantly higher functional immune responses against serotype 19A than PCV7 and PCV10. Higher responses are likely to be linked to both direct impact in vaccinated populations and reductions in 19A NP carriage in children, thus inducing herd protection and reducing 19A invasive pneumococcal disease (IPD) in nonvaccinated children and adults. In contrast, PCV7 and PCV10 have shown mixed evidence of direct short-lived cross-protection and little to no impact on 19A carriage, resulting in continued transmission and disease.

Lack of association of Kawasaki disease after immunization in a cohort of infants followed for multiple autoimmune diagnoses in a large, phase-4 observational database safety study of 7-valent pneumococcal conjugate vaccine: lack of association between Kawasaki disease and seven-valent pneumococcal conjugate vaccine.

A large-scale, postmarketing observational database safety study was conducted following 7-valent pneumococcal conjugate vaccine (PCV7) licensure. A secondary outcome was the occurrence of predefined diagnoses among PCV7 vaccinees versus historic controls. Forty-two PCV7 recipients and 17 controls were hospitalized for Kawasaki disease (P = 0.012). After adjusting for potential confounding variables, this difference was not significant (P = 0.083). No association between Kawasaki disease and PCV7 was found.