The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by 7 of the 20 Streptococcus pneumoniae serotypes.
The 20vPnC vaccine consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13® (Pfizer), along with 7 additional serotypes that cause invasive pneumococcal disease.
The sBLA is supported by data from a clinical trial program that included approximately 3500 infants and 800 children of all ages. In a pivotal phase 3 study (ClinicalTrials.gov Identifier: NCT04382326), the safety and immunogenicity of a 4-dose series of 20vPnC was compared with Prevnar 13 in healthy infants.
Findings demonstrated that all 20 serotypes of 20vPnC met the coprimary objective achieving noninferiority of immunoglobulin G (IgG) geometric mean concentrations (GMCs) after dose 4. Moreover, 14 of the 20 serotypes met the coprimary objective of noninferiority of the percentage of participants with predefined IgG levels after dose 3, and all serotypes met noninferiority for the key secondary objective of IgG GMCs after dose 3. The vaccine candidate elicited robust functional responses and increases in antibody responses for all 20 serotypes after dose 4. The safety profile of the 20vPnC vaccine was consistent with Prevnar 13.
A Prescription Drug User Fee Act target date of April 2023 has been set for the application.
The 20vPnC vaccine is currently available under the brand name Prevnar 20 for active immunization against pneumonia and invasive disease caused by Streptococcus pneumoniae due to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults.
This article originally appeared on MPR
- US FDA accepts for Priority Review the supplemental Biologics License Application for Pfizer’s 20-valent pneumococcal conjugate vaccine in infants and children. News release. Pfizer Inc. Accessed January 6, 2023. https://www.businesswire.com/news/home/20230106005038/en/U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Pfizer%E2%80%99s-20-Valent-Pneumococcal-Conjugate-Vaccine-in-Infants-and-Children.
- Pfizer announces positive top-line results from phase 3 study of 20-valent pneumococcal conjugate vaccine in infants. News release. Pfizer Inc. August 12, 2022. Accessed January 6, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-study-20.