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Novavax, FDA and Vaccine

MedPage Today · 16h

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 · 3d

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.

1don MSN

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 ...

1don MSN

FDA appears to be slow-walking vaccine approvals

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

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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