FDA Approves 20-Valent Pneumococcal Vaccine
The US Food and Drug Administration has approved Prevnar20 (Pneumococcal 20-valent Conjugate Vaccine), the first conjugate vaccine that protects against 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults aged 18 years or older.
The new vaccine includes conjugates for the 13 serotypes included in the Prevnar13 vaccine, as well as for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
The approval is based on data from 3 phase 3 trials involving more than 6000 adults, including those aged 65 years or older, vaccine-naïve individuals, and individuals with prior pneumococcal vaccination.
The most common adverse effects were injection site pain, muscle pain, fatigue, headache, and joint pain.
U.S. FDA approves PREVNAR 20™, Pfizer’s pneumococcal 20-valent conjugate vaccine for adults ages 18 years or older. News release. Pfizer; June 8, 2021. Accessed June 10, 2021. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20tm-pfizers-pneumococcal-20-valent