Pfizer snags FDA approval for expanded pneumococcal vaccine

April 28, 2023

Pfizer announced this week that the FDA has approved its 20-valent pneumococcal conjugate vaccine for use in infants and children aged six weeks to 17 years.

The jab, Prevnar 20, protects patients from 20 Streptococcus pneumoniae serotypes, all of which can cause pneumococcal disease (IPD). 

Prevnar 20 is an upgraded version of Pfizer's Prevnar 13 vaccine, which was first approved in 2010. The updated vaccine now contains an additional seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) which are associated with antibiotic resistance, severe illness, and are commonly found in pediatric pneumococcal cases. According to a study, these seven serotypes alone are responsible for about 37% of IPD cases in children under five years of age in the U.S.

Pfizer shared promising preliminary findings from its phase 3 trial in August of last year, and in January of 2023, the FDA granted priority review to the jab’s supplemental Biologics License Application (sBLA).