White House reportedly blocked FDA’s new coronavirus vaccine guidelines

[Chris Smith]

• Reports say the White House disagrees with new coronavirus vaccine approval guidelines from the FDA which would make it impossible for a vaccine candidate to seek emergency use authorization before the presidential election.
• The FDA wants volunteers to be followed for at least two months after receiving the shots to identify potential side effects. This would prevent frontrunners from seeking approval before the election.
• Trump administration and FDA officials said that the new guidelines are already known to pharmaceutical companies, which plan to adhere to the requests.

The White House and the Food and Drug Administration (FDA) are at odds over new vaccine guidelines for the novel coronavirus. President Trump has politicized vaccine research, with recent reports saying that the administration is looking to fast-track the emergency use authorization of at least one COVID-19 vaccine to have the drug approved in time for the November 3rd presidential election. Public health officials, including Dr. Anthony Fauci and FDA scientists, have insisted that vaccines' safety will not be compromised to speed up approvals.

COVID-19 vaccine development has moved at tremendous speeds, and at least one vaccine candidate might be approved for emergency use by the end of the year. Fauci confirmed as much in recent interviews. China and Russia have already started using Phase 3 vaccines on the general public, with the latter drawing intense scrutiny for the decision to advance the vaccine without proving that it’s safe and effective first.

The FDA has established new guidelines for emergency approval that would make it impossible for a vaccine to roll out publicly before the elections. There has been pushback from the White Hous, but it might not produce any results, as the FDA already shared the guidelines with the companies making vaccines.

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White House reportedly blocked FDA’s new coronavirus vaccine guidelines originally appeared on BGR.com on Tue, 6 Oct 2020 at 17:30:13 EDT. Please see our terms for use of feeds.

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