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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 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 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 ...
HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...
STAT2d
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 ...
Shreveport Times on MSN17h
Louisiana surgeon general backs bill to make ivermectin available over the counter to treat COVID
Louisiana Surgeon General Ralph Abraham backs bill to deregulate the drug ivermectin and recommends it to his own patients.
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 ...
BioPharma Dive2d
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” ...
CIDRAP2d
More FDA uncertainty roils full approval for Novavax COVID vaccine
Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...
FDA chief says they're 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 COVID-19 vaccines for next winter, citing a lack of data on booster shots.
Sun Sentinel2d
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.