Replies to post #254931 on Biotech Values

[DewDiligence]

PFE advances 25-valent pediatric pneumococcal vaccine to phase-3—plans 2026 phase-1 start of 35-valent adult vaccine:

https://www.businesswire.com/news/home/20260520512448/en/Pfizer-Advances-Pivotal-Pediatric-Pneumococcal-Vaccine-Program-Following-Strong-Positive-Phase-2-Results

Despite significant reduction in pneumococcal disease burden by the currently available 20-valent standard-of-care-vaccine, serotype 3 remains a notable cause of invasive pneumococcal disease and complicated pneumonia in children. Therefore, based on this Phase 2 data [elsewhere in this PR] and discussions with regulatory authorities, Pfizer began a pivotal pediatric Phase 3 program in May 2026. The studies evaluate safety, tolerability and immunogenicity of 25vPnC in healthy children where participants receive either 25vPnC or PCV20 at 2, 4, 6 and 12 to 15 months of age. Participants will receive the same vaccine for all four vaccinations for up to 2,400 individuals comparing 25vPnC to the currently licensed 20-valent standard-of-care vaccine [Prevnar 20]. The vaccine candidate covers 25 serotypes including serotype 3, adding five new serotypes to the established vaccine coverage for infants. If successful, this has the potential to broaden protection to about 90% of disease-causing serotypes in US children.

Meanwhile… [for adults] Pfizer has decided to move directly to a fifth-generation vaccine candidate covering 35 serotypes. This fifth-generation adult candidate has the potential to increase serotype coverage while also improving immunogenicity for critical serotypes including serotype 3 with Pfizer’s proprietary next generation technology. The adult vaccine candidate is expected to enter clinical development by the end of 2026, pending alignment with regulatory authorities.