Positive topline results were announced from a phase 1/2 study evaluating the immunogenicity, safety and tolerability of Pfizer-BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19.
The study (ClinicalTrials.gov Identifier: NCT05596734) included approximately 990 healthy adults 18 to 64 years of age. Study participants were randomly assigned to receive either the combination vaccine candidate or a licensed influenza vaccine and Pfizer-BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine administered intramuscularly at the same visit.
Results showed that the combination vaccine elicited robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. The safety profile of the vaccine candidate was consistent with that observed for Pfizer-BioNTech’s COVID-19 vaccine.
“We are encouraged by these early results in our phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of 2 respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and health care systems all over the world,” said Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head, Vaccine Research and Development at Pfizer.
A phase 3 trial evaluating the mRNA-based combination vaccine is expected to begin in the coming months. The vaccine candidate has received Fast Track designation from the Food and Drug Administration.
This article originally appeared on MPR
References:
Pfizer and BioNTech announce positive topline data for mRNA-based combination vaccine program against influenza and COVID-19. News release. Pfizer and BioNTech. October 26, 2023. www.businesswire.com/news/home/20231026448732/en/Pfizer-and-BioNTech-Announce-Positive-Topline-Data-for-mRNA-based-Combination-Vaccine-Program-Against-Influenza-and-COVID-19.
