While Pfizer won its competition with Merck to get its next-generation pneumococcal vaccine to the market, it lost its more critical battle in June when the FDA said its rival could administer its next-gen shot to young children and infants.
Two months later, in catch-up mode, Pfizer has responded with clinical data that could clear the way for its shot, Prevnar 20, to be blessed for babies.
Pfizer said it hopes to file its Biologics License Application with the FDA for Prevnar 20's approval by the end of the year, according to a press release.
In the pediatric population, Prevnar 20 is roughly a year behind Merck’s next-gen shot. Merck presented its phase 3 data for Vaxneuvance use in infants in August of last year.
An unexpected stumbling block came in March when the FDA delayed its decision on Vaxneuvance, which pushed the eventual approval back by three months.
Once its shot is approved, Pfizer may be able to claim an edge over Merck, as Vaxneuvance protects against 15 serotypes.
In the phase 3 trial, Prevnar 20 elicited immune responses, with all 20 of the serotypes covered by the shot meeting the study’s non-inferiority criteria. The trial also measured immune responses after a third dose of the four-dose series of Prevnar 20, with 14 of the 20 serotypes meeting the criteria. Of the six that didn’t, four missed by a narrow margin and two came up more significantly short, per the release.
Merck gained its initial green light for Vaxneuvance use in adults in July 2021. But children are the key demographic, as they make up 80% of the lucrative market. Sales of Prevnar 13 reached $5.3 billion last year.