Question · Q3 2025
Alex Hammond sought more details on the delay in initiating the pivotal trial for the adult 25-valent pneumococcal program, specifically asking if the dialogue with the FDA had changed and if surrogate endpoints might no longer be approvable.
Answer
Chris Boshoff, Chief Scientific Officer and President of Research and Development, explained that Pfizer is working closely with the FDA and other regulators on study designs and endpoints. He stated that the adult and pediatric 25-valent programs are planned to start next year, pending positive data and FDA feedback, to align and coordinate the studies. He highlighted the vaccine's enhanced immunogenicity against serotype 3 and mentioned ongoing work on a fifth-generation vaccine.