FDA approves Pfizer’s pneumococcal conjugate vaccine for infants and children
Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) in infants and children from six weeks to 17 years of age.
The vaccine protects against IPD caused by 20 Streptococcus pneumoniae (pneumococcal) serotypes and builds on Pfizer’s previous PREVNAR 13 vaccine, but includes an additional seven serotypes that have been shown to be linked to antibiotic resistance, heightened disease severity, invasive potential and prevalence in paediatric pneumococcal cases.
Annaliesa Anderson PhD, senior vice president and chief scientific officer, Vaccine Research and Development at Pfizer, commented: “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. 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.”
Dr Sheldon Kaplan, 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, both US, added: “With the approval of PREVNAR 20 for the paediatric 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. We are thrilled with this approval as it signifies a new chapter in paediatric 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.”
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