FDA approves 20-valent pneumococcal conjugate vaccine for infants 6 weeks and older

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Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV), Prevnar 20, has been approved by the FDA for the prevention of invasive pneumococcal disease (IPD) in infants aged 6 weeks to 17 years and for the prevention of otitis media in infants aged 6 weeks to 5 years, according to a press release from Pfizer.

Prevnar 20 contains streptococcus pneumoniae (pneumococcal) serotypes to protect against IPD. The original 7 serotypes contained in the vaccine protect against otitis media. Disease attributed to serotypes not included in currently approved PCVs remainsa burden in the United States. Prevnar 20 builds on the approved Prevnar 13 vaccine, including 7 additional serotypes (8, 10A, 12F, 15B, 22F, and 33F). These serotypes have been associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases, according to Pfizer. The additional 7 serotypes found in the vaccine are some of the most common causing pediatric IPD in countries with existing pneumococcal vaccination programs, like the United States. The 7 additional serotypes found in Prevnar 20 accounted for an estimated 37% of PID in US children under 5 years of age, according to the press release.

“We now have an expanded vaccine to help provide infants and children with the broadest serotype protection in a PCV, helping to protect against the 20 serotypes in the vaccine, which includes the specific serotypes responsible for significant burden of disease in children under five,” said Sheldon Kaplan, MD, chief, Division of Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and chief, Infectious Disease Service, Texas Children's Hospital. "We are thrilled with this approval as it signifies a new chapter in pediatric pneumococcal conjugate vaccination.”

The recent FDA approval is based on results demonstrated phase 2 and phase 3 clinical trials, including 3 core phase 3 pediatric studies that contributed to data on the safety, tolerability, and immunogenicity of Prevnar 20, according to Pfizer.

The CDC’s Advisory Committee on Immunization Practices is committed to taking action for new vaccines following FDA-approval as soon as possible, according to the press release. The next regularly scheduled Advisory Committee on Immunization Practices is set for June 21 and June 22, 2023.

Reference:

US FDA approves Prevnar 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children. Pfizer. April 27, 2023. Accessed April 28, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20r-pfizers-20-valent-pneumococcal