White House raises issues with FDA's vaccine approval process

The White House doesn't seem likely to sign off on new emergency use authorization standards for COVID-19 vaccines proposed by the FDA, as top officials have raised objections to the guidance, people familiar with the matter told The Wall Street Journal.

In talks with the FDA in recent days, White House officials have expressed a number of concerts about the guidelines, including a proposal that would require researchers to monitor clinical trial participants for side effects for two months after being injected with an experimental vaccine. 

Administration officials haven't indicated they'd approve the FDA's proposal or seek to resolve their concerns with the guidance, the Journal reported. A White House spokesperson declined to comment. 

The White House doesn't have to approve the guidelines, 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, according to the Journal

In the case of the proposed guidelines for an emergency use authorization for a COVID-19 vaccine, the FDA wanted the White House's blessing to reassure Americans that any vaccine they would be offered would meet high standards, the Journal reported. 

It was reported in September that the FDA is expected to announce new standards for the emergency use approvals for a COVID-19 vaccine to make it more difficult for any vaccine to be approved before Election Day. 

Drugmakers have indicated they will follow strict FDA guidelines for approval, with several CEOs pledging that science will come first in the race to develop a vaccine. 

Read the full article here.


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