FDA Expands Approval of Pfizer’s Pneumonia Vaccine to Infants and Children

The FDA has approved Pfizer’s Prevnar 20 (20-valent pneumococcal conjugate vaccine) to prevent invasive pneumococcal disease in infants and children from six weeks through 17 years of age.

The updated approval also includes use of the vaccine for prevention of otitis media (severe ear infection) in infants six weeks through five years of age.

Agency approval is based on results from phase 2 and phase 3 clinical trial programs.

The vaccine previously received Breakthrough Therapy in August 2020 and the sBLA received Priority Review in January.

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