FDA Approves Pfizer’s Pneumococcal Conjugate Vaccine, Prevnar 20, for Infants and Children

This afternoon, Pfizer announced the US Food and Drug Administration (FDA) approved Prevnar 20, the 20-valent Pneumococcal Conjugate Vaccine. The vaccine contains 20 of the Streptococcus pneumoniae (pneumococcal) serotypes that cause invasive pneumococcal disease (IPD) and is indicated to prevent IPD in children 6 weeks-17 years of age.

 “Today's FDA approval of our vaccine, Prevnar 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in US infants and children," Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said in a statement.

Containing 20 serotypes, Prevnar 20 grants the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine.

Prevnar 20 is approved to prevent invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in children 6 weeks and older. The vaccine is also indicated to prevent otitis media (middle ear infection) caused by 7 of the 20 strains in children 6 weeks-5 years of age.

IPD is caused by the Streptococcus pneumoniae bacterium. IPD is most severe in infants, young children, older adults, and others with immune deficiencies or chronic health conditions. IPD can potentially cause meningitis, bacteremia, pneumonia, otitis media, and sinusitis.

There is a substantial burden of IPD in the US, largely due to serotypes that are not included in the approved pneumococcal conjugate vaccines. Prevnar 20 builds on Pfizer’s already approved Prevnar 13 vaccine, with 7 additional serotypes that are associated with antimicrobial resistance, heightened disease severity, and high prevalence in pediatric pneumococcal infections.

“Data show that the additional seven serotypes included in Prevnar 20 are among some of the most common serotypes causing pediatric IPD in countries, like the US, with existing pneumococcal vaccination programs,” Pfizer stated. “A study found that the 7 additional serotypes alone accounted for an estimated 37% of IPD in US children under 5 years of age.”

The FDA’s decision comes after the agency reviewed phase 2 and 3 clinical trials of Prevnar 20 for pediatric IPD prevention. The studies evaluated the safety, tolerability, and immunogenicity of Prevnar 20.

The next step is for the US Center for Disease Control and Prevention’s (CDC) Advisory Committee of Immunization Practices (ACIP) to act on the FDA approval. ACIP is scheduled to meet June 21-22, 2023.