FDA Approves Prevnar 20 Vaccine to Prevent Invasive Pneumococcal Disease in Children 6 Weeks Through 17 Years

The FDA has approved Pfizer’s 20-valent Pneumococcal Conjugate Vaccine (Prevnar 20) to prevent invasive pneumococcal disease (IPD) caused by 20 Streptococcus pneumoniae serotypes among infants and children 6 weeks through 17 years of age, as well as for the prevention of otitis media in infants 6 weeks through 5 years of age caused by the original 7 serotypes contained in the vaccine.

Prevnar 20 is a next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13, as well as 7 additional serotypes that cause invasive pneumococcal disease. These additional serotypes are associated with high case-fatality rates, antibiotic resistance, and meningitis.

Prevnar 20 helps protect against more strains of pneumococcal pneumonia-causing bacteria than any other conjugate vaccine available, according to Pfizer. The approval was based on findings from the phase 2 and 3 clinical trial programs for the pediatric indication of Prevnar 20.

A trio of phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of the vaccine, including previously announced positive, top-line data from NCT04382326.

“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 U.S. infants and children," said Annaliesa Anderson, PhD, senior vice president and chief scientific officer, Vaccine Research and Development, Pfizer, in a press release “This important Prevnar 20 approval builds on more than 20 years of real-world impact with Prevnar and Prevnar 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine.”

The FDA approved Prevnar 20 for the prevention of invasive disease and pneumonia in adults 18 years of age and older on June 8, 2021. Pfizer recently submitted a supplemental Biologics License Application to the FDA to include data in the vaccine’s prescribing information for adults 18 years of age or older regarding coadministration of the vaccine with a seasonal inactivated influenza vaccine.

The 7 serotypes that were not included in the currently approved pneumococcal conjugate vaccines have led to a considerable disease burden in the United States. The newly approved vaccine builds on the previously approved Prevnar 13 vaccine, with 7 additional serotypes—8, 10A, 11A, 12F, 15B, 22F and 33F—linked to antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. Further, data show that these 7 serotypes included in Prevnar 20 are among the most common that cause pediatric IPD.

A recent study found that these 7 serotypes accounted for an estimated 37% of IPD in US children under 5 years of age. The US Center for Disease Control and Prevention Advisory Committee on Immunization Practices is expected to take action as soon as possible on new vaccines after FDA approval, with the next regularly scheduled ACIP meeting set for June 21-22, 2023, according to Pfizer.

“With the approval of Prevnar 20 for the pediatric indication, 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 5,” said Dr. Sheldon Kaplan, chief, Division of Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Chief, Infectious Disease Service, Texas Children's Hospital, in a press release. "We are thrilled with this approval as it signifies a new chapter in pediatric pneumococcal conjugate vaccination. Based on the real-world results we’ve observed with Prevnar 13, Prevnar 20 has the potential to greatly reduce the substantial remaining burden of pneumococcal disease among US infants and children and help protect them against this potentially serious disease.”

Reference

U.S. FDA Approves PREVNAR 20®, Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children. News release. Pfizer. April 27, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20r-pfizers-20-valent-pneumococcal