The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application for Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age.
Vaxneuvance consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease. The application is supported by data from phase 2 and phase 3 clinical studies that assessed the efficacy and safety of Vaxneuvance in infants, children, and adolescents, including those at increased risk for pneumococcal disease (eg, HIV infection or sickle cell disease).
The application also includes data supporting the potential use of Vaxneuvance as a part of a mixed dosing regimen following initiation of an infant vaccination schedule with PCV13 (Prevnar 13), along with use in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a lower-valency pediatric pneumococcal conjugate vaccine.
In the multicenter, randomized, double-blind, active-comparator-controlled phase 3 PNEU-PED study (ClinicalTrials.gov Identifier: NCT03893448), the safety, tolerability, and immunogenicity of Vaxneuvance were compared with PCV13 in 1720 healthy infants enrolled at 42 to 90 days of age. Results from the trial showed that Vaxneuvance met the primary and key secondary endpoints demonstrating noninferiority to PCV13 for all 13 shared serotypes at 30 days post vaccination, and superiority to PCV13 for shared serotype 3 and serotypes 22F and 33F.
Additionally, the multicenter, randomized, double-blind, active comparator-controlled phase 3 PNEU-DIRECTION interchangeability (ClinicalTrials.gov: NCT03620162) and PNEU-PLAN catch-up (ClinicalTrials.gov: NCT03885934) studies compared the safety, tolerability, and immunogenicity of Vaxneuvance to PCV13 in 900 healthy infants 42 to 90 days of age and 606 participants 7 months to 17 years of age, respectively. Findings from both studies showed that Vaxneuvance met the primary immunogenicity endpoint with comparable immune response to PCV13 for all 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post vaccination.
“Vaxneuvance has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine currently available for this population,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
In July 2021, the FDA approved Vaxneuvance for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
The FDA has set a target action date of April 1, 2022 for announcing its decision on the sBLA for pediatric patients.
US FDA accepts for Priority Review the supplemental Biologics License Application for Merck’s Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for use in infants and children. News release. Merck. Accessed December 1, 2021. https://www.businesswire.com/news/home/20211201005091/en/U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Merck%E2%80%99s-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-Use-in-Infants-and-Children.