FDA Approves Pfizer’s Prevnar 20 for Infants

FDA has approved Pfizer’s Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine for use in infants and children aged six weeks through 17 years. It is also approved for preventing otitis media in infants aged six weeks through five years.

Approval was based on data from the company’s Phase 2 and Phase 3 clinical trial programs. “Three core Phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of PREVNAR 20, including previously announced positive, top-line results of the pivotal U.S. Phase 3 study (NCT04382326),” Pfizer says. “Further positive data from a proof-of-concept Phase 2 study (NCT03512288) that assessed the safety and immunogenicity of PREVNAR 20 also supported the FDA’s decision.