NEW YORK CITY (dpa-AFX) - Drug major Pfizer Inc. (PFE) announced Wednesday positive top-line results from a Phase 3 study (B7471004) exploring coadministration of Prevnar 20 with seasonal flu vaccine in older adults.
The trial evaluated 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.
The company noted that 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.
A total of 1,796 participants were enrolled and randomized in the trial across 66 investigator sites in the United States, with 1,727 of participants completing the study.
Luis Jodar, Senior Vice President and Chief Medical Officer, Pfizer Vaccines, said, '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. 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 said it will seek to present and publish detailed outcomes from this clinical trial at a future date.
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.
The U.S. Food and Drug Administration approved PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older in June.
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