Pfizer and its vaccine partner BioNTech announced on December 9 local time that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to their single-dose mRNA vaccine candidate for the treatment of COVID-19 and influenza.
FDA's Fast Track program aims to expedite the review of therapies for serious diseases or those with unmet medical needs. The two companies stated that a combined flu and COVID-19 vaccine could potentially streamline immunization practices for these two severe respiratory diseases.
Pfizer and BioNTech announced last month that they have initiated a Phase I trial for this candidate vaccine. The candidate vaccine is based on BioNTech's proprietary mRNA platform technology, containing mRNA strands encoding the SARS-CoV-2 wild-type spike protein and the Omicron subvariants BA.4/BA.5 spike protein, as well as mRNA strands encoding hemagglutinin from four different strains of influenza virus. The World Health Organization has recommended its use in the Northern Hemisphere for the 2022-2023 vaccination season.