30 Apr 2023 • Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved its 20-valent pneumococcal conjugate vaccine, PREVNAR 20, for the prevention of invasive pneumococcal disease (IPD) caused by 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children aged six weeks through 17 years.

Additionally, the vaccine is approved for the prevention of otitis media in infants aged six weeks through five years of age caused by the original seven serotypes contained in PREVNAR. The vaccine includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases.

The FDA's decision is based on results from the Phase 2 and Phase 3 clinical trial programs for the pediatric indication for PREVNAR 20.

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