The U.S. FDA has approved Moderna and Pfizer's updated mRNA COVID vaccines, designed specifically to target the Omicron variant KP.2 strain.
The vaccines — Moderna's Spikevax and Pfizer and BioNTech's Comirnaty — have been updated with a formula to more closely target currently circulating variants, which the FDA has stated is the preferred target for the 2024-2025 fall and winter season.
Pfizer-BioNTech’s Comirnaty received full FDA approval back in August 2021, followed by Moderna's full approval in February 2022.
Pfizer recently unveiled less than ideal topline results from a phase 3 trial testing its single dose combination mRNA vaccine candidate against influenza and COVID-19. While the vaccine elicited a robust influenza A immune response compared to a standard flu vaccine, it showed weaker results against the influenza B strain, failing to meet the trial's immunogenicity objective. The formulation demonstrated comparable responses against SARS-CoV-2 versus the companies’ licensed COVID-19 vaccine.
Back in June, Moderna revealed that the phase 3 trial of its combo vaccine met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial. According to Moderna, the vaccine produced statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.
