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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 ...
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 ...
As FDA Delays Novavax' COVID Vaccine Approval, Patients Fight Back
Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...
COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
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 ...
BioPharma Dive9d
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” ...
pharmaphorum9d
Does the Novavax delay augur a COVID vaccine policy change?
In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this ...
BioSpace12h
Is the New HHS Vaccine Requirement Anti-Vaccine Activism Disguised as Policy?
Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for ...
Newsday9d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON — 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 ...
CNN12d
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 ...