Prevnar 20 FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2023.
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 used for the prevention of invasive pneumococcal disease and otitis media.
- Prevnar 20 is a vaccine indicated for:
- active immunization for the prevention of invasive pneumococcal 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 individuals 6 weeks of age and older.
- active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age.
- active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.
The indication for the prevention of pneumonia caused by S.pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Prevnar 20 includes capsular polysaccharide conjugates for the 13 S. pneumoniae 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 by intramuscular injection.
In children, Prevnar 20 is administered as a 4-dose immunization series at 2, 4, 6, and 12 through 15 months of age.
In adults 18 years of age and older, Prevnar 20 is administered as a single dose. - Common adverse reactions in infants vaccinated with a 4-dose schedule include irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.
Common adverse reactions in infants and children 15 months through 17 years of age vaccinated with a single dose include irritability, pain at the injection site, drowsiness, fatigue, muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever.
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
| Date | Article |
|---|---|
| Apr 27, 2023 | Approval U.S. FDA Approves Prevnar 20, Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for Infants and Children |
| Jun 8, 2021 | Approval FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
