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Covid-19, Novavax and FDA

CNN on MSN · 1d

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.

Novavax COVID Vaccine Moves Closer to Full FDA Approval

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ends. (The World Health Organization declared an end to the COVID emergency in May 2023.)

The Wall Street Journal on MSN · 2d

FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say

41mon MSN

Novavax Stock Is Up Again on Speculation Over the Fate of Its Covid Shot

Novavax stock was climbing again on Monday after the company expressed new confidence in the eventual approval of its ...

U.S. health officials inject new uncertainty into approval process for Covid boosters

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

3h

Novavax: Grandiose Ambitions, Smart Strategy, But FDA Decision Adds To Challenges

Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

4d

Novavax's stock surges on 'good news' from Food and Drug Administration

Novavax’s protein-based vaccine is only available under a pandemic-era emergency-use authorization, and formal approval from ...

5d

RFK Jr. could pull Covid vax for kids

HHS Secretary Robert F. Kennedy Jr. is mulling removing the Covid-19 vaccine from the recommended childhood vaccine schedule.

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