Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot

Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot
Novavax’s two-dose dose COVID-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday. The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend authorization of the shot for use in the U.S. after an all-day public meeting in which they weighed safety and effectiveness data.… Read the rest

FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine

FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine
A vial of the Phase 3 Novavax coronavirus vaccine prepared for use in a trial at St. George’s University hospital in London, on Oct. 7, 2020. (Alastair Grant/AP Photo)   Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19.… Read the rest

Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts

Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts
Lauran Neergaard | June 03, 2022 Americans may soon get a new COVID-19 vaccine option — shots made with a more traditional technology than mRNA versions. The big question: Why should they care? After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax’s vaccine. It’s late in the pandemic for a new choice, with about three-quarters of U.S.… Read the rest

FDA panel gives nod to Novavax COVID-19 shot

FDA panel gives nod to Novavax COVID-19 shot
BY NATHANIEL WEIXEL – 06/07/22 An outside advisory panel voted overwhelmingly to recommend that the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, a move that could lead to the addition of a fourth vaccine to the U.S. arsenal. The FDA’s vaccine advisory panel voted 21-0, with one abstention. The FDA does not have to follow the panel’s recommendation, though it often does.… Read the rest