Novavax scores narrower Covid vaccine approval
Digest more
Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating their protein-based vaccine technology. The approval positions Novavax as the only non-mRNA COVID-19 vaccine with full FDA approval, offering a differentiated alternative amid growing mRNA fatigue.
The Food and Drug Administration (FDA) vaccine advisory group today recommended sticking with a monovalent JN.1 lineage vaccine for COVID vaccines for the upcoming US respiratory virus season, though the experts didn't recommend a specific sublineage.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.