Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

The BioNTech-sponsored, randomized Phase 1 study is designed to evaluate the safety, immunogenicity, and optimal dose level of a combined vaccine candidate against COVID-19 and influenza and is being conducted in the United States, aiming to enroll 180 healthy volunteers 18 through 64 years of age. The follow-up period for each participant will be a total of six months.
“The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. Pfizer is deeply proud of our continued work to explore its potential to protect against influenza and COVID-19 in one combination vaccine, which we think could simplify immunization practices against these two respiratory pathogens, potentially leading to better vaccine uptake for both diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Even with existing seasonal influenza vaccines, the burden of this virus is severe across the world causing thousands of deaths and hospitalizations every year. This is an exciting step in our ongoing journey with BioNTech as we collectively look to transform the prevention of infectious diseases around the world.”
EMERGENCY USE AUTHORIZATION
Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Source Pfizer