Pfizer’s sBLA for 20-Serotype Vaccine Gets Priority Review

Pfizer has gained a priority review from the FDA for a supplemental biologics license application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate 20vPnC for preventing bacterial infection by 20 pneumococcus serotypes in children between 6 weeks and 17 years old.

The multivalent vaccine candidate is an update of the company’s Prevnar 13 vaccine, which targeted 13 serotypes.

The 20-serotype vaccine was approved as Prevnar 20 in June 2021 for prevention of invasive disease and pneumonia in adults 18 years and older.

The FDA is expected to issue a decision on the application in April.