mRNA Vaccine Candidate Against COVID-19 and Influenza Fast-Tracked

Pfizer Inc. and BioNTech SE today announced the companies had received U.S. Food and Drug Administration (FDA) Fast Track Designation for their mRNA-based combination vaccine candidate for influenza and COVID-19.

A combined vaccine for influenza and COVID-19 has the potential to simplify immunization practices.

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 influenza strains, recommended for the Northern Hemisphere 2022/23 by the World Health Organization.

Pfizer and BioNTech previously announced the start of a Phase 1 trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults.

Fast Track is a process designed to facilitate the development of vaccines intended to address unmet medical needs.

Additional flu shot news is posted at PrecisionVaccinations.com/Inflienza.