FDA approves Prevnar 20 for pneumococcal disease
Pfizer Inc. announced that the FDA has approved Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar
The FDA’s decision is based on results from the Phase II and Phase III clinical trial programs for the pediatric indication for Prevnar 20. Three core Phase III 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 III study (NCT04382326). Further positive data from a Proof-of-Concept Phase II study (NCT03512288) that assessed the safety and immunogenicity of Prevnar 20 also supported the FDA’s decision.
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