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FDA discloses vaccine guidelines blocked by White House

SeattlePI.com Tuesday, 6 October 2020
WASHINGTON (AP) — The Food and Drug Administration laid out updated safety standards Tuesday for makers of COVID-19 vaccines after the White House blocked their formal release, the latest political tug-of-war between the Trump administration and the government’s public health scientists.

In briefing documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. That requirement would almost certainly preclude the introduction of a vaccine before Nov. 3.

President Donald Trump has repeatedly insisted a vaccine could be authorized before Election Day, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.

Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.

A senior administration official confirmed to the AP on Monday that the White House had blocked FDA's plans to formally publish the safety guidelines based on the 2-month data requirement, arguing there was “no clinical or medical reason" for it.

But the FDA tucked the information into a memo posted ahead of an Oct. 22 meeting of its outside vaccine advisory panel. The group of non-governmental experts is scheduled to discuss general standards for coronavirus vaccines, part of FDA's effort to publicize its process and rationale for vaccine reviews. While information prepared for such panels does not carry the weight of a formal FDA guidance document, the release of the information makes clear the FDA plans to impose the safety standards for any vaccine seeking an...
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Video Credit: KTNV Channel 13 Las Vegas - Published
News video: The White House blocks new FDA guidelines

The White House blocks new FDA guidelines 00:25

The White House has blocked new guidelines from the FDA that could have made COVID-19 vaccines safer. The agency wanted vaccine developers to follow trial participants for two months after they received the shot.

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