Pneumococcal conjugate vaccines in children

Sanjay Jayasinghe

doi:10.1071/MA24050

RESEARCH ARTICLE (Open Access)

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Pneumococcal conjugate vaccines in children

Sanjay Jayasinghe ^A ^B ^*

+ Author Affiliations

- Author Affiliations

^A National Centre for Immunisation Research and Surveillance, Kids Research, Sydney Children’s Hospitals Network, Locked Bag 4001, Westmead, NSW 2145, Australia.

^B Children’s Hospital at Westmead Clinical School, Faculty of Medicine, The University of Sydney, Westmead, NSW 2145, Australia.

Dr Sanjay Jayasinghe is a medical epidemiologist with extensive experience in research on pneumococcal disease and vaccines. He is a senior research fellow at the National Centre for Immunisation Research and Surveillance (NCIRS) and a senior lecturer (conjoint) in the Children’s Hospital at Westmead Clinical School of the Faculty of Medicine, The University of Sydney. He is also a National Health and Medical Research Council (NHMRC) emerging leadership fellow. He currently chairs the Enhanced Invasive Pneumococcal Disease (IPD) Surveillance (EIPDSWG) working group that oversees national IPD surveillance.

^* Correspondence to: sanjay.jayasinghe@health.nsw.gov.au

Microbiology Australia https://doi.org/10.1071/MA24050

Submitted: 25 August 2024 Accepted: 8 October 2024 Published: 31 October 2024

© 2024 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of the ASM. This is an open access article distributed under the Creative Commons Attribution 4.0 International License (CC BY).

Abstract

Pneumococcal conjugate vaccines (PCVs), which have been in population-wide use in children for over two decades now, are highly efficacious in preventing life threatening pneumococcal infections. The strong herd effect of PCVs through reduction in pneumococcal nasopharyngeal carriage in vaccinated children prevents disease in adults as well. Since 7vPCV, which was the first PCV used widely, several new PCVs with each adding more serotypes have been developed. These new PCVs have been approved using immune-bridging criteria based on an aggregate correlate of protection (Cp) derived from vaccine efficacy and antibody responses data from early PCV trials. This Cp that the World Health Organization (WHO) accepts for assessing new PCVs for which it is impracticable to undertake placebo-controlled trials with clinical outcomes is 0.35 μg mL^–1 of enzyme-linked immunosorbent assay (ELISA) immunoglobulin G (IgG). Effectiveness and antibody response data more recently of 13vPCV has led to developing Cp for each individual vaccine serotype, that, for some, varies considerably to 0.35 μg mL^–1. In trials of newest PCVs, such as 15vPCV and 20vPCV, the comparator used is 13vPCV that has, in turn, been licensed using immune bridging, which leads to potential ‘downward-drift’ risk of protection from the new PCVs. This and the data that have emerged on serotype replacement disease and dosing schedules makes it important to review and rethink how new PCVs are assessed, their clinical benefits are inferred and vaccination programs are designed.

Keywords: Australia, children, correlate of protection, invasive pneumococcal disease, PCV schedule, pneumococcal conjugate vaccine, pneumococcal disease, pneumococcal serotypes, vaccine efficacy, vaccine impact.

Biographies

Dr Sanjay Jayasinghe is a medical epidemiologist with extensive experience in research on pneumococcal disease and vaccines. He is a senior research fellow at the National Centre for Immunisation Research and Surveillance (NCIRS) and a senior lecturer (conjoint) in the Children’s Hospital at Westmead Clinical School of the Faculty of Medicine, The University of Sydney. He is also a National Health and Medical Research Council (NHMRC) emerging leadership fellow. He currently chairs the Enhanced Invasive Pneumococcal Disease (IPD) Surveillance (EIPDSWG) working group that oversees national IPD surveillance.

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