Pfizer: Positive Top-line Results of Pfizer’s Phase 3 Study Exploring Coadministration of Prevnar 20™ With Seasonal Flu Vaccine in Older Adults Released

Pfizer Inc. (NYSE:PFE) today announced positive top-line results from a Phase 3 study (B7471004) evaluating the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in adults 65 years of age or older when administered at the same time as the seasonal influenza vaccine (SIIV, Fluad Quadrivalent [adjuvanted], 2020/2021 strains). Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study’s primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. The safety profile of PREVNAR 20 was similar when the vaccines were coadministered as compared to when each vaccine was administered separately, one month apart.

“We are encouraged by these results showing that these two vaccines can be administered at the same time without affecting the immune protection provided by either vaccine or changing the safety profile,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “This study adds to the body of evidence further supporting that pneumococcal conjugate vaccines may be coadministered with influenza vaccines, this time studied with the adjuvanted influenza vaccine. We are committed to vaccine development to help address needs across many respiratory diseases.”

Across 66 investigator sites in the United States, a total of 1,796 participants were enrolled and randomized, with 1,727 of participants completing the study.

“Both PREVNAR 20 and the influenza vaccine are important for helping protect adults against pneumococcal pneumonia and the flu respectively; however, vaccination rates decline when someone needs to make multiple appointments to receive these vaccines,” said Luis Jodar, Ph.D., Senior Vice President and Chief Medical Officer, Pfizer Vaccines. “The results of this trial supports current CDC clinical guidance allowing coadministration during a single doctor or pharmacy appointment, so that more adults are able to help protect themselves against both of these respiratory diseases.”

Pfizer will seek to present and publish detailed outcomes from this clinical trial at a future date. Additionally, in May 2021, Pfizer announced the initiation of a Phase 3 clinical trial exploring coadministration of PREVNAR 20 and a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in adults ages 65 or older.

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