The US Food and Drug Administration (FDA) has approved Pzifer’s Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age and for the prevention of otitis media in infants 6 weeks through 5 years of age caused by the original seven serotypes contained in Prevnar.

The vaccine previously was approved for adults ages 18 years and older.

“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,” says Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, in a 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.”

Prevnar 20 builds on Pfizer’s approved Prevnar 13 vaccine and includes seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 

Moreover, data show that the additional seven serotypes included in Prevnar 20 are among some of the most common serotypes causing pediatric invasive pneumococcal disease in countries, like the US, with existing pneumococcal vaccination programs. A study found that the seven additional serotypes alone accounted for an estimated 37% of invasive pneumococcal disease in US children under 5 years of age.

“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 (pneumococcal conjugate vaccine), 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 of the division of infectious diseases, department of pediatrics at Baylor College of Medicine and chief of infectious disease service at Texas Children’s Hospital, in a 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.”

The FDA’s decision is based on results from the phase 2 and phase 3 clinical trial programs for the pediatric indication for Prevnar 20. Three core phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of Prevnar 20, including previously announced positive, top-line results of the pivotal US phase 3 study (NCT04382326). Further positive data from a proof-of-concept phase 2 study (NCT03512288) that assessed the safety and immunogenicity of Prevnar 20 also supported the FDA’s decision.