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 will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.

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 U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.

Key Takeaways Novavax received Food and Drug Administration approval for its new, protein-based COVID-19 vaccine.The shot, Nuvaxovid, is designed for older adults and those between the ages of 12 and 64 who have underlying conditions that puts them at higher risk from the disease.

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.