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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 ...
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 appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...
FDA to tighten vaccine approval requirements: reports
The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.
Fierce Pharma2d
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 ...
STAT4d
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
Dermatology Advisor1d
Novavax COVID Vaccine Moves Closer to Full FDA Approval
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
Chicago Tribune5d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded ...
Mercury News5d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
“I don’t think because there’s a strain change that this is a new product,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that’s the new ...