Pfizer, BioNTech Get FDA Fast-Track for Covid-19/Flu Combo Vaccine
December 09 2022 - 7:32AM
Dow Jones News
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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