Pfizer with positive results from Phase 2 Study of its vaccine for the prevention of Invasive Disease and Otitis Media in Healthy Infants

Additionally, Pfizer Has Completed Enrollment of its Phase 3 Studies (NCT03828617, NCT03835975 and NCT03760146) for its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive preliminary results following administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

“The initial three doses of 20vPnC in this Phase 2 trial provide preliminary evidence that the vaccine candidate in infants has an overall safety profile that is similar to Prevnar 13. 20vPNC induced immune responses for all 20 serotypes in infants. These findings are encouraging and should support the program’s advancement to Phase 3,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “Once data with the fourth dose are available, we will discuss Phase 3 plans with regulators. If successful in Phase 3 and approved, 20vPnC may help protect infants against seven additional Streptococcus pneumoniae serotypes, which represent prevalent circulating global disease strains today, in addition to those contained within Prevnar 13.”