FDA Grants Priority Review to Pfizer’s Pneumococcal Vaccine

The FDA will give Pfizer’s biologics license application (BLA) submitted for its vaccine targeting a form of streptococcus that can lead to fatal infections a priority review.

The agency gave the vaccine a Breakthrough Therapy designation in September 2018. The vaccine is 20-valent, meaning it protects against 20 strains of streptococcus, including all of those included in Pfizer’s Prevnar 13 vaccine. The new vaccine is intended to prevent pneumonia and invasive disease, either of which can be fatal, in adults age 18 and up. The FDA has given Pfizer a target of June 2021 to complete its review of the BLA.

The three phase 3 trials for the vaccine candidate enrolled more than 6,000 subjects age 18 and up, including some over age 65, as well as adults who had received pneumococcal vaccinations before and those who had never gotten such shots.