The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20, to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years.
PREVNAR 20 has been designed to avert IPD caused by 20 streptococcus pneumoniae (pneumococcal) serotypes.
It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR.
The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.
Three core Phase III paediatric trials also provided data on the safety, tolerability and immunogenicity of PREVNAR 20, including the earlier positive top-line findings of the Phase III trial in the US.
Additional positive results from a proof-of-concept Phase II trial that evaluated the safety and immunogenicity of PREVNAR 20 also supported the FDA’s approval.
PREVNAR 20 has been developed on the basis of Pfizer’s approved PREVNAR 13 vaccine.
It features seven additional serotypes, 8, 10A, 11A, 12F, 15B, 22F and 33F, which are related to antibiotic resistance, increased disease severity, invasive potential and prevalence in paediatric pneumococcal cases.
Pfizer vaccine research and development senior vice-president and chief scientific officer Annaliesa Anderson stated: “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.”