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And Guidelines Blocked

The White House has moved to prevent the release of new, stricter guidelines developed by the US Food and Drug Administration for the emergency authorization of a coronavirus vaccine, according to the New York Times.

Last month, the FDA appeared set to reveal stricter guidelines for the emergency authorization of any SARS-CoV-2 vaccine, but, as CNN noted at the time, the new criteria would make it unlikely that any candidate vaccine could receive authorization by Election Day in early November. Politico then reported that President Donald Trump said the guidelines have to be approved by the White House and that they "may or may not approve it."

As the New York Times now reports, the White House has blocked the guidelines. It notes that the FDA submitted the guidelines to the Office of Management and Budget two weeks ago, but they have languished on the desk of the White House chief of staff, Mark Meadows and are unlikely to be given the OK.

According to the Times, a key point of contention in the new guidelines is the requirement of a median two months of follow up on clinical trial volunteers, which would make the authorization of a vaccine by the election unlikely. It notes FDA officials have said this follow-up time was necessary to identify possible side effects and make sure the protection offered isn't fleeting. 

The Times adds that the FDA is seeking other ways to make sure vaccines meet these standards and that some vaccine developers have said they would follow the agency's recommendations even if not approved by the White House.