LONDON- Leaders of the global scheme aiming to get COVID-19 vaccines to the world’s poorest are pushing manufacturers, including Pfizer and Moderna, to cut or slow deliveries of about half a billion shots so doses are not wasted.
COVAX, the World Health Organization-led scheme, wants between 400 and 600 million fewer vaccines doses than initially contracted from six pharmaceutical companies, according to internal documents seen by Reuters.… Read the rest
Tag: Novavax
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
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
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
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