White House reverses course, endorses FDA's COVID-19 vaccine authorization guidelines

In a reversal of course, the White House has endorsed the FDA's new guidance for authorizing emergency use of a COVID-19 vaccine, The Wall Street Journal reported. 

The guidance comes with a requirement for a two-month observation period after clinical trial participants are given the final dose of the vaccine to see if there are any negative side effects, meaning a vaccine almost certainly won't come until after Election Day on Nov. 3. 

The FDA published the updated guidance Oct. 6, and the new standards for an emergency use authorization are close to the standards for a full approval, according to The Washington Post

The FDA said it hopes the release of the guidance "helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved," according to the Journal

The White House has previously opposed the plan, and it was reported Oct. 5 that the guidance had been sitting in the White House's Office of Management and Budget since mid-September. The White House cited drug industry concerns over the guidance as a reason to not sign off on it. 

The White House doesn't have to approve the guidance, because they're not official regulations, but the FDA typically seeks the White House's approval so companies and the public will know what standards drugs are held to in order to be approved.


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