The U.S. Food and Drug Administration (FDA) has approved Pfizer’s PREVNAR 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR.
“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, Ph.D., senior vice president and chief scientific officer, Vaccine Research and Development, Pfizer. “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.”
In the United States, there remains a considerable burden of disease attributed to serotypes not included in currently approved pneumococcal conjugate vaccines (PCVs). 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 IPD in countries, like the U.S., with existing pneumococcal vaccination programs. A study found that the seven additional serotypes alone accounted for an estimated 37% of IPD in U.S. children under five 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, 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 Dr. Sheldon Kaplan, 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. 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 U.S. 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 U.S. Phase 3 study. Further positive data from a Proof-of-Concept Phase 2 study that assessed the safety and immunogenicity of PREVNAR 20 also supported the FDA’s decision.