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New COVID-19 Vaccine on Track for FDA Approval

CNN International 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.)

Bloomberg on MSN · 2d

Novavax Falls on Report That FDA Wants New Covid Vaccine Trial

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another clinical trial of its Covid vaccine.The company’s shares dropped as much as 13% on the news Friday.

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 ...

1h

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 ...

4don 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 ...

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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