FDA Publishes Vaccine Rules Opposed by White House

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The FDA released new safety standards for COVID-19 vaccines that require vaccine makers to follow clinical trial participants for at least two months, pushing against the White House’s move on Monday to block the formal release of new guidelines.

for COVID-19 vaccines on Tuesday, pushing against the White House’s move on Monday to block the formal release of new guidelines.

“I want to assure them, and you, that the FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness,” he said “There really is no margin for error here,” Stephen Ostroff, MD, a former FDA acting commissioner, told the AP. “Even when you’re talking about limited use of a vaccine, there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”

 

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