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FDA Again Scrutinizes Novavax Covid-19 Vaccine

MedPage Today · 43m

FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional protein-based option for the coronavirus -- is sowing uncertainty about updates to other vaccines too.

CNN on MSN · 2d

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 says vaccine application still ‘approvable,’ despite FDA delay

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” requiring additional clinical study.

18hon MSN

FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...

1d

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 ...

FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...

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 ...

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