Document Type

Article

Publication Date

1-2024

Identifier

DOI: 10.1080/14760584.2023.2294153

Abstract

INTRODUCTION:

Streptococcus pneumoniae is a causative agent of pneumonia and acute otitis media (AOM), as well as invasive diseases such as meningitis and bacteremia. PCV15 (V114) is a new 15-valent pneumococcal conjugate vaccine (PCV) approved for use in individuals ≥6 weeks of age for the prevention of pneumonia, AOM, and invasive pneumococcal disease.

AREAS COVERED: This review summarizes the V114 Phase 3 development program leading to approval in infants and children, including pivotal studies, interchangeability and catch-up vaccination studies, and studies in at-risk populations. An integrated safety summary is presented in addition to immunogenicity and concomitant use of V114 with other routine pediatric vaccines.

EXPERT OPINION: Across the development program, V114 demonstrated a safety profile that is comparable to PCV13 in infants and children. Immunogenicity of V114 is comparable to PCV13 for all shared serotypes except serotype 3, where V114 demonstrated superior immunogenicity. Higher immune responses were demonstrated for V114 serotypes 22F and 33F. Results of the ongoing study to evaluate V114 efficacy against vaccine-type pneumococcal AOM and anticipated real-world evidence studies will support assessment of vaccine effectiveness and impact, with an additional question of whether higher serotype 3 immunogenicity translates to better protection against serotype 3 pneumococcal disease.

Journal Title

Expert review of vaccines

Volume

23

Issue

1

First Page

137

Last Page

147

MeSH Keywords

Infant; Humans; Child; Vaccines, Conjugate; Pneumococcal Infections; Streptococcus pneumoniae; Pneumococcal Vaccines; Otitis Media; Serogroup; Pneumonia; Antibodies, Bacterial

Keywords

Immunogenicity; PCV15; VAXNEUVANCE; pediatric; phase 3; pneumococcal conjugate vaccine; pneumonia; safety

Comments

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Publisher's Link: https://www.tandfonline.com/doi/full/10.1080/14760584.2023.2294153

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