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Stricter Criteria Adopted

The White House has approved the new, stricter guidelines for seeking emergency authorization for a coronavirus vaccine, the Washington Post reports. It notes that this approval comes after the US Food and Drug Administration published the guidelines on its website.

The FDA last month appeared to be on the verge last month of releasing stricter standards for the emergency authorization of any SARS-CoV-2 vaccine. These guidelines, the Post noted at the time, aimed in part to reassure the public that the vaccine development process is not being rushed or swayed by political factors. However, President Donald Trump said, according to Politico, that the guidelines have to be approved by the White House and that they "may or may not approve" them.

Earlier this week, the New York Times reported that the White House was blocking the approval of the new criteria and that a source of friction was the requirement that vaccine developers have at least a median two months of follow up on clinical trial volunteers — a requirement that would make the authorization of a vaccine by the US election unlikely.

The Post now reports that the FDA published the stricter guidelines to its website as part of briefing materials for an upcoming vaccine advisory committee meeting. Following this, it says, the White House then approved the vaccine guidance, making it official.