By Colin Kellaher

 

Vaccine partners Pfizer Inc. and BioNTech SE on Friday said the U.S. Food and Drug Administration has granted fast-track designation to their single-dose vaccine candidate for Covid-19 and influenza.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Pfizer and BioNTech, which last month said they had initiated a Phase 1 study of the vaccine candidate, said a combined Covid-19/flu vaccine has the potential to simplify immunization practices against two severe respiratory diseases caused by evolving viruses that require vaccine adaptation.

The companies said the vaccine candidate is based on BioNTech's proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, as well as mRNA strands encoding the hemagglutinin of four different flu strains, recommended for the Northern Hemisphere 2022/23 by the World Health Organization.

New York drugmaker Pfizer and Mainz, Germany, immunotherapy company BioNTech first launched an influenza vaccine collaboration in 2018 and began work on their Covid-19 vaccine in 2020.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

December 09, 2022 07:17 ET (12:17 GMT)

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