The bivalent vaccine is likely to get regulatory support, along with government contracts, but competitors, notably Moderna, will also step into the ring.
Pfizer Inc. and BioNTech SE have more data under their belts as they prepare to head into the US Food and Drug Administration Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting on 28 June, which will include discussion of a monovalent and bivalent updates to the FDA-approved Comirnaty vaccine targeted to the Omicron variant.
The companies announced data on 25 June from 1,234 participants in a Phase II/III trial showing that monovalent and bivalent...
Pfizer/BioNTech and Moderna rapidly adapted Comirnaty and Spikevax for the 2024-2025 season to address the KP.2 variant after the US FDA had advised them to target JN.1 in June.
The companies said their combination mRNA vaccine showed protection against SARS-CoV-2 and influenza A, but not influenza B.
The UK giant’s COVID-19 prophylactic sipavibart could soon reach Europe and competition is sparse.
When life hands a biotech company the equivalent of good grapes, the expectations are for its products to be the equivalent of fine wine. Before that Moderna looks likely to make lemonade.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
