White House nixes updated FDA guidelines on vaccine approval

White House has blocked new Food and Drug ministration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented ir introduction before v. 3 election.

At issue was FDA's planned instruction that vaccine developers follow patients enrolled in ir trials for at least two months to rule out safety issues before seeking emergency approval from ncy.

A senior ministration confirmed move Monday evening, saying White House believed re was “ clinical or medical reason” for ditional requirement.

White House action was first reported by New York Times.

intervention by Trump officials is latest example of ministration undercutting its own medical experts working to combat pandemic that has killed more than 210,000 Americans.

FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in FDA's vaccine review for weeks, vowing that career scientists, t politicians, will decide if shots are safe and effective for mass vaccination.

But President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, even though top government scientists working on ministration's vaccine effort have stated that that timeline is very unlikely.

Last week seven former FDA commissioners blasted ministration for “undermining credibility” of FDA in a Washington Post op-ed and called for release of pending vaccine guidelines."

former FDA chiefs warned that public fears that a vaccine was rushed out for political reasons could derail efforts to vaccinate millions of Americans.

senior ministration official, who spoke on condition of anymity to discuss action, said White House was intent on getting a safe vaccine to market and wanted to make sure “ditional loopholes” weren't ded that would slow down process.

Beyond damaging optics of overruling its own FDA, practical impact of White House move against guidelines could be relatively limited.

Only one drugmaker, Pfizer, has suggested it could have data on safety and effectiveness of its vaccine before Election Day. And a number of variables would still have to align for company to submit, and FDA to review and greenlight, a vaccine application before v. 3. Pfizer's competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.ditionally, FDA scientists have been discussing contents of guidelines publicly for weeks and have me clear that recommendations have alrey been shared with each of vaccine developers.

“re's re re to get all excited about this guidance,” said Dr. Peter Marks, he of FDA's vaccine division, in an online interview last week with nprofit Friends of Cancer Research.

companies kw what we're expecting,ded Marks. 

Inste, Marks said, releasing guidelines was “an attempt to help public see what we're requiring of COVID-19 vaccines.”

He ded that guidelines would explain that all upcoming vaccines would be reviewed by FDA's independent panel of outside vaccine visers, before ncy makes its own final decision.Marks explained Monday that two months of safety follow-up for vaccines is important because most serious side effects connected with shots often occur in first several weeks after vaccination.

“ safety profile of a vaccine that's going to be used in millions of people has to be incredibly clean,” Marks said in an online discussion with Journal of American Medical Association.

When asked about potential timing for a first vaccine, Marks said an emergency authorization could come “before end of year.”

guidelines blocked by White House are a of nbinding document that FDA routinely uses to vise companies on research and regulatory standards for medical products. FDA released its initial expectations for COVID-19 vaccines in June. Among or metrics, ncy said that any vaccine would have to be at least 50% protective against virus.

But guidelines didn't spell out conditions under which FDA would use its emergency authorization powers to speed up availability of a vaccine. Under emergency review, medical products face a lower standard than full that merely requires that ir expected benefits outweigh ir risks for use during a public health crisis. lack of specifics around using emergency authorization for a vaccine became a flashpoint for outside experts, physicians and even politicians. FDA officials n began drafting a second guidance document with ditional details.

Among or things, guidelines would have me clear that any vaccine approved through emergency pathway would still need to meet FDA's preset safety and effectiveness standards. Inste, expedited process would be used to bypass certain logistical and regulatory hurdles, such as thousands of ps of manufacturing documentation rmally required for a tritional vaccine application.

Emergency authorization for a vaccine would likely limit initial use to medical and or frontline workers, nursing homes and people most at risk of catching or becoming seriously ill from virus. 

(IM CREDITS:Twitter/@WhiteHouse)

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