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Fauci says rushing out a vaccine could jeopardize testing of others

JacksinPA

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Exclusive: Fauci says rushing out a vaccine could jeopardize testing of others - Reuters

CHICAGO/NEW YORK (Reuters) - The top U.S. infectious diseases expert is warning that distributing a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines.

Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the U.S. Food and Drug Administration to deliver a vaccine before November to boost his chances of re-election.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declined to comment on the president, but said there are risks in rushing out a vaccine despite the urgent need.

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters in a phone interview.

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci said.

Large-scale clinical trials of the leading vaccine candidates from Moderna Inc (MRNA.O), Pfizer Inc (PFE.N) andAstraZeneca Plc (AZN.L), which aim to enroll tens of thousands of volunteers, were launched in recent weeks. Johnson & Johnson (JNJ.N) last week said it hopes to include 60,000 subjects in its Phase III vaccine trial.

Trump stoked concerns of politicizing the regulatory approval process with an announcement on Sunday of an emergency use authorization for plasma from recovered COVID-19 patients to treat current patients before its benefits have been assessed in randomized, placebo-controlled clinical trials.

Trump had tweeted on Saturday that “deep state” elements at the FDA were delaying progress on drugs and vaccines until after the Nov. 3 election in order to hurt his reelection bid.

Safe and effective vaccines are seen as essential to ending the pandemic that has claimed the lives of more than 800,000 people worldwide, over 177,000 of them in the United States.

But vaccine experts worry that the White House may apply pressure on the FDA to push out a vaccine via an EUA before it has been fully tested - a pathway that has never been used to approve a vaccine intended for widespread use.

“I would be very worried about using an EUA mechanism for something like a vaccine. It’s very different from plasma therapy,” said Dr. Peter Hotez, an infectious disease expert and vaccine researcher at Baylor College of Medicine.

Fauci said the FDA’s guidance on vaccines - both for full approval and for an EUA - explicitly requires a demonstration that it is both safe and effective.
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Fauci makes a lot of sense by hitting the prematurely rushing candidate vaccines into large groups of the public before they are proven safe & effective. It's politics vs common sense public health.
 

Mr Person

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Trump doesn't care. He just wants enough people to think that something is out or about to come out and that he is personally responsible. He doesn't care if it works, if it turns out to be harmful, or if it not only doesn't work but discourages volunteers in other vaccines under development thus causing even more overall harm. He just needs enough people thinking he 'fixed' it in time for the election.
 

Jetboogieman

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Mark my words.

Trump is going to try to push a vaccine in order to salvage his election chances.

It's gonna be quite the clown show.

Stay tuned.
 

Threegoofs

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Trump doesn't care. He just wants enough people to think that something is out or about to come out and that he is personally responsible. He doesn't care if it works, if it turns out to be harmful, or if it not only doesn't work but discourages volunteers in other vaccines under development thus causing even more overall harm. He just needs enough people thinking he 'fixed' it in time for the election.

Because...he knows he and his family are going to prison if he doesnt eke out another four years of presidential immunity.
 

Rexedgar

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Mark my words.

Trump is going to try to push a vaccine in order to salvage his election chances.

It's gonna be quite the clown show.

Stay tuned.

That campaign has begun, a while back!

Ultra-violet light, disinfectant, Hydroxychloroquine and a few others.

Friday the FDA was deep-state and on Sunday the FDA was the best ever.........

Clutching anything he thinks will stave off the ‘wolves,’ at this point, imo!
 

Common Sense 1

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What vaccine is been distributed before before they are proven safe & effective? Oh that's right it has not happened.......

Or is this more of what if....... TRUMP? :doh
 

CaughtInThe

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Trump just needs for the rubes to think a vaccine is imminent to win an election for himself.
 

grip

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The danger in approving an emergency vaccine before it can be really tested is that if people either get serious side effects or not much protection that the public will be hesitant about trying one of the other vaccines.

On the other hand, if we don't get something available soon, the COVID effect on economics, business growth, and unemployment may become catastrophic.
 

JacksinPA

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The danger in approving an emergency vaccine before it can be really tested is that if people either get serious side effects or not much protection that the public will be hesitant about trying one of the other vaccines.

On the other hand, if we don't get something available soon, the COVID effect on economics, business growth, and unemployment may become catastrophic.

Introducing mass doses of a new & virtually untested covid vaccine in less than a year is ridiculous & potentially life threatening. Of all the untried vaccines being developed, how will we be able to segregate the different recipients from the randomized controls?

No vaccine has ever been developed for a coronavirus. It evolved with a big of tricks that make that a real problem.
 

grip

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Introducing mass doses of a new & virtually untested covid vaccine in less than a year is ridiculous & potentially life threatening. Of all the untried vaccines being developed, how will we be able to segregate the different recipients from the randomized controls?

No vaccine has ever been developed for a coronavirus. It evolved with a big of tricks that make that a real problem.

I imagine, with 30 different vaccines being developed, they'll have to allow only enough product to cover certain areas. If too many vaccines are made universally available, it will be an impossible mess to keep track of which ones are doing what and where?

Yeah, upper respiratory viruses from this class are notoriously adaptive and changing. It may become a seasonal problem, every year, that no vaccine can permanently immunize against.
 

JacksinPA

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The danger in approving an emergency vaccine before it can be really tested is that if people either get serious side effects or not much protection that the public will be hesitant about trying one of the other vaccines.

On the other hand, if we don't get something available soon, the COVID effect on economics, business growth, and unemployment may become catastrophic.

At the rate this pandemic is going, it will be catastrophic. Schools & businesses closed, the economy in shambles & Trump declaring victory.
 

grip

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At the rate this pandemic is going, it will be catastrophic. Schools & businesses closed, the economy in shambles & Trump declaring victory.

You'd have to be kind of an idiot to believe this is any kind of victory or winning.
 
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