Merck’s Vaxneuvance Receives FDA Priority Review for Use in Pediatric Populations to Prevent Invasive Pneumococcal Disease

December 14, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Vaxneuvance (15-valent pneumococcal conjugate vaccine, V114) and granted Priority Review:For use in children aged 6 weeks to 17 years, to prevent invasive pneumococcal disease (IPD) caused by 15 serotypes of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F).。FDAThe PDUFA target action date for this sBLA has been set for April 1, 2022.

In July 2021, Vaxneuvance was approved in the United States.FDAApproved for the prevention of IPD caused by the aforementioned 15 pneumococcal serotypes in adults aged 18 years and older. The adult indication for Vaxneuvance was also approved through the priority review process. Previously, the FDA had granted VaxneuvanceBreakthrough Therapy Designation (BTD), for use in pediatric populations aged 6 weeks to under 18 years and adult populations aged 18 years and above, to prevent IPD caused by vaccine serotypes.

Vaxneuvance is a 15-valent vaccine composed of pneumococcal polysaccharides from 15 serotypes conjugated with CRM197.VectorProtein binding, includingSerotypes 22F and 33F, which are commonly associated with IPD globally, are not included in the currently licensed pneumococcal conjugate vaccines (PCV) for pediatric populations.

This sBLA is based on the results of Phase 2 and Phase 3 clinical studies conducted in pediatric populations, including infants, children, and adolescents. The data supports the potential use of Vaxneuvance across various clinical settings, including vaccination for infants, toddlers, and special populations at increased risk of pneumococcal disease (such as children infected with HIV or those suffering from sickle cell disease [SCD]). The submission also includes data supporting the use of Vaxneuvance as part of a mixed vaccination regimen following the initiation of infant PCV13 vaccination programs, as well as data on the use of Vaxneuvance for catch-up vaccination in older children who are either unvaccinated against pneumococcal disease or have previously received partial or complete low-cost pediatric PCV (pneumococcal conjugate vaccine).

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae. Different strains of this bacterium are called serotypes. When Streptococcus pneumoniae invades parts of the body where it is not normally present,BacteriaWhen it occurs in certain parts of the body, invasive pneumococcal disease (IPD) happens. IPD can cause severe and potentially life-threatening infections in infants and children. Children under 2 years old are particularly susceptible to pneumococcal infections, and the incidence of IPD remains highest in the first year after birth.

There are 100 different types of pneumococcal bacteria, some of which continue to put children at risk, includingSerotypes 22F, 33F, and 3 account for more than a quarter of IPD cases in children under 5 years old.22F and 33F are not included in the currently licensed pneumococcal conjugate vaccines (PCV) for the pediatric population. Additionally, although serotype 3 is included in the currently available pneumococcal vaccines, it remains one of the leading causes of IPD in the pediatric population.

The Phase 3 clinical development program for Vaxneuvance consists of 16Clinical TrialComposition, the safety, tolerability, and immunogenicity of Vaxneuvance were studied in different populations (including healthy elderly individuals, healthy children, immunocompromised individuals, and those with certain chronic diseases).

Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at Merck Research Laboratories, stated: "Vaxneuvance has the potential to provide meaningful protection against IPD in children and infants by targeting pneumococcal strains or serotypes, including serotype 3, which represent a significant disease burden. This includes serotype 3, as well as serotypes 22F and 33F, the latter two of which are not included in the currently licensed pneumococcal conjugate vaccines (PCV) for this pediatric population. We look forward to working with the U.S.FDA"Collaboration Brings the First New Option in Pediatric Pneumonia Vaccination in Over a Decade." (Bioon.com)

Source of the original text:U.S. 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