FDA Approves Prevnar 20 Vaccine for Use in Infants and Children

The Food and Drug Administration (FDA) has approved Prevnar 20® (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes in infants and children 6 through 17 years of age, and for the prevention of otitis media caused by 7 of the 20 Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in infants and children 6 weeks through 5 years of age.

Prevnar 20 consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13 (Pfizer), along with 7 additional serotypes that cause invasive pneumococcal disease. The approval was based on data from a clinical trial program that included approximately 3500 infants and 800 children of all ages.

In a pivotal phase 3 study (ClinicalTrials.gov Identifier: NCT04382326), the safety and immunogenicity of a 4-dose series of Prevnar 20 was compared with Prevnar 13 in healthy infants. Findings demonstrated that all 20 serotypes of Prevnar 20 met the coprimary objective achieving noninferiority of immunoglobulin G (IgG) geometric mean concentrations (GMCs) after dose 4.

Moreover, 14 of the 20 serotypes met the coprimary objective of noninferiority of the percentage of participants with predefined IgG levels after dose 3, and all serotypes met noninferiority for the key secondary objective of IgG GMCs after dose 3. Prevnar 20 elicited robust functional responses and increases in antibody responses for all 20 serotypes after dose 4.

The safety profile of Prevnar 20 was consistent with Prevnar 13. The most commonly reported pediatric adverse reactions included injection site pain/redness/swelling, drowsiness, decreased appetite, fatigue, and fever.

Prevnar 20 is also indicated for active immunization for the prevention caused by 20 Streptococcus pneumoniae serotypes in adults 18 years of age and older.

The product is supplied in single-dose prefilled syringes containing 0.5mL suspension for intramuscular injection. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet in June to discuss the addition of new vaccines to the recommended immunization schedules.


  1. US FDA approves Prevnar 20®, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children. News release. Pfizer Inc. Accessed April 27, 2023. https://www.businesswire.com/news/home/20230426006061/en/U.S.-FDA-Approves-PREVNAR-20%C2%AE-Pfizer%E2%80%99s-20-valent-Pneumococcal-Conjugate-Vaccine-for-Infants-and-Children.
  2. Prevnar 20. Package insert. Pfizer Inc.; 2023. Accessed April 27, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=15428.