U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine - May 19, 2025
FDA Review of Novavax’s COVID-19 Vaccine
Biff #SARSisAirborne 🍉 (@Biff248824) on X
“Yesterday’s FDA VRBPAC meeting was a big success, we got everything that we were hoping for within the scope of the meeting agenda:
- Novavax is permitted to continue using a monovalent JN.1 target (1⬇️), which they showed is still inducing robust neutralizing antibody titers across JN.1 lineage strains, such as predominant LP.8.1 (2⬇️). The mRNA manufacturers are also permitted to target LP.8.1, if they wish…”
Novavax says its COVID-19 shot is on track for full FDA approval after delay
FDA chief says they're looking at whether to approve COVID shots for next winter
“Makary's remarks echo his justification for delaying Novavax's COVID-19 vaccine, which was expected to get full approval on April 1. Novavax said Monday that the FDA had asked the company to commit to another clinical trial of the shot.”