News

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 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 ...
What's holding up new COVID booster guidance from the FDA
The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...
FDA Commissioner says they're looking at whether to approve COVID vaccine for next winter
The FDA may be making changes to how it handles COVID-19 booster shots. The agency’s top official says they’re taking a ...
FDA chief looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...
MedPage Today1d
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 ...
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 ...
Pulmonology Advisor15h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.
Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline
The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...
ABC News3d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.
STAT4d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Like all Covid vaccine manufacturers, Novavax updates the strain its vaccine targets annually — on instructions from the FDA. The regulatory agency has not viewed such tweaks — needed because ...