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Novavax, COVID-19 and FDA

The Associated Press on MSN · 13h

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

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from Novavax

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.

3don MSN

US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...

3d

Novavax COVID vaccine moves closer to full FDA approval

Novavax's COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company ...

16h

Seasonal COVID shots may no longer be possible under Trump admin

Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the ...

5don MSN

FDA asks Novavax for post-approval data on COVID vaccine, raising hopes for green light

Novavax said on Wednesday the U.S. Food and Drug Administration had asked the company to produce more data on its COVID-19 ...

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 ...

23h

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 ...

5d

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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