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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 ...
Moderna Shares Fall on Vaccine Sales Miss, Delay in FDA Review
Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...
Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters
The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...
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 ...
Fierce Pharma4h
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
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 ...
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 ...
Fierce Pharma2h
Moderna targets more cost cuts amid broader vaccine market uncertainty under HHS secretary RFK Jr.
On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...
BioSpace2h
HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past
The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...
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 ...
BioPharma Dive3d
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” ...
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.