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Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Strong Positive Phase 2 Results
Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Strong Positive Phase 2
About this update from Pfizer, Inc.
[{"type":"text","content":"\nPfizer Inc. (NYSE: PFE) today announced data from its Phase 2 study (NCT06524414) evaluating the safety, tolerability and immunogenicity of a four-dose series of its investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) in infants compared to four doses of PREVNAR 20 at months 2, 4, 6 and 12-15. Based on the strong immune responses observed for all 25vPnC serotypes from Phase 2, compared to PREVNAR 20, Pfizer is confident that the required non-inferiority thresholds may be achieved for the 25vPnG pediatric Phase 3 program.\n\n\nKey preliminary data from the broader Phase 2 study were presented today in an oral presentation at the 14th meeting of the International Society of Pneumonia & Pneumococcal Diseases in Copenhagen, Denmark (ISPPD). Results found:\n\nOne month after Dose 3, geometric mean titers for serotype 3 were 8.8-fold higher with 25vPnC than with PREVNAR 20 (4.22 vs. 0.48).\n\nOne month after Dose 4, geometric mean titers for serotype 3 were approximately 15-fold higher with 25vPnC than with Prevnar 20 (13.85 vs. 0.92).\n\n\n\nThis vaccine candidate is expected to cover up to 90% of disease-causing serotypes in children under 5 years of age, which includes approximately 15% from serotype 3.\n\n\n“For more than 25 years, our vaccines have helped protect children from pneumococcal disease, yet significant disease burden remains,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “These Phase 2 results reinforce our confidence in a next-generation vaccine designed to expand protection across serotypes while improving responses to key residual disease drivers such as serotype 3. We are advancing our Phase 3 program with the goal of delivering broader and more durable protection for children.”\n\n\nThe Phase 2 study is a randomized trial in healthy infants, with initial enrolment beginning in July 2024, evaluating 25vPnC compared with PREVNAR 20. Participants were randomized to receive 25vPnC or PREVNAR 20 at months 2, 4, 6 and 12–15 assessing the safety and tolerability, including local and systemic reactogenicity within seven days after each vaccination, as well as adverse events and serious adverse events in participants who receive at least one dose. The trial also assessed immunogenicity one month after Dose 3 and one month after Dose 4, ...