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Prevnar 20 FDA Approval History

Last updated by Judith Stewart, BPharm on June 16, 2021.

FDA Approved: Yes (First approved June 8, 2021)
Brand name: Prevnar 20
Generic name: pneumococcal 20-valent conjugate vaccine
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 20 (pneumococcal 20-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.

  • Prevnar 20 includes capsular polysaccharide conjugates for the 13 serotypes contained in Prevnar 13, with seven additional serotypes that cause invasive pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
  • Prevnar 20 is administered as a single dose via intramuscular injection.
  • Common adverse reactions in adults 18-59 years include pain at the injection site, muscle pain, fatigue, headache, and arthralgia and injection site swelling. Common adverse reactions in adults 60 years and older include pain at the injection site, muscle pain and fatigue, headache, and arthralgia.

Development timeline for Prevnar 20

DateArticle
Jun  8, 2021Approval FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older

Further information

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