White House nixes updated FDA guidelines on coronavirus vaccine approval
4 years, 2 months ago

White House nixes updated FDA guidelines on coronavirus vaccine approval

Live Mint  

The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented their introduction before the Nov. 3 election. “The companies know what we’re expecting.” Instead, Marks said, releasing the guidelines was “an attempt to help the public see what we're requiring of COVID-19 vaccines.” He added that the guidelines would explain that all upcoming vaccines would be reviewed by FDA's independent panel of outside vaccine advisers, before the agency makes its own final decision. When asked about the potential timing for a first vaccine, Marks said an emergency authorization could come “before the end of the year.” The guidelines blocked by the White House are a type of nonbinding document that the FDA routinely uses to advise companies on research and regulatory standards for medical products. Among other things, the guidelines would have made clear that any vaccine approved through the emergency pathway would still need to meet FDA’s preset safety and effectiveness standards. The vaccine would have to undergo review for full FDA approval, a monthslong process, before being approved for the general population The FDA has faced criticism for allowing emergency use of some COVID-19 treatments backed by little evidence, including the the malaria drug hydroxychloroquine, but FDA officials have made clear that vaccines would face additional standards.

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