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U.S. FDA to tighten coronavirus vaccine authorization standards ahead of election - paper


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U.S. FDA to tighten coronavirus vaccine authorization standards ahead of election - paper

 

2020-09-22T201730Z_2_LYNXNPEG8L1VH_RTROPTP_4_HEALTH-CORONAVIRUS-VACCINE-DEVELOPERS-PLEDGE.JPG

FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic/Illustration

 

(Reuters) - The U.S. Food and Drug Administration is expected to soon announce new, more stringent standards for an emergency authorization of a COVID-19 vaccine, lowering the chances that one might be cleared for use before the Nov. 3 election, the Washington Post reported on Tuesday.

 

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process, the newspaper said.

 

According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of severe cases of COVID-19 in patients who received a placebo in the trials.

 

Few vaccine developers were expected to have definitive trial results before the presidential election. Pfizer Inc had been the exception, although its timetable could slip with the new guidance.

 

Moderna Inc has said it is unlikely to have data in October. AstraZeneca Plc's trial in the United States is halted while investigators try to determine whether a serious neurological problem suffered by one participant in the company's U.K. trial was caused by the vaccine.

 

Moderna and Pfizer began their late-stage trials on July 27, and took about a month to enroll 15,000 people, the halfway point for their initial planned enrollment.

 

The trials are designed for people to receive their second shot either three or four weeks after the first. Two months of follow-up would make it unlikely the companies would have enough data before mid-November.

 

Pfizer said on Tuesday that based on current infection rates it still expects to know whether or not their vaccine works as early as the end of October.

 

Pfizer's trial protocol calls for an early look at the data after just 32 participants become infected.

 

"We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis to help inform FDA’s ultimate determination of authorization or approval," the drugmaker said in an emailed statement.

 

(Reporting By Deena Beasley and Michael Erman; Editing by Jonathan Oatis and Bill Berkrot)

 

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-- © Copyright Reuters 2020-09-23
 
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They say, without providing any evidence whatsoever. 

Huh..........guess those trump glasses filter pretty good trump is known for strong arming others to spout his bs all of us aren’t rubes we know what’s coming first he will discredit the agency and it

His various promises of a vaccine before the election and/or before the end of the year are interference, since it is not possible to adequately test the vaccine in that time.     

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36 minutes ago, webfact said:

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process


They say, without providing any evidence whatsoever. 

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Just now, Tug said:

Huh..........guess those trump glasses filter pretty good trump is known for strong arming others to spout his bs all of us aren’t rubes we know what’s coming first he will discredit the agency and it’s primary principals then threaten to ruin there careers if they don’t do what he says 

 

I would genuinely like to know if Trump is legitimately interfering with the FDA's vaccine approval process, outside of the actions his office has publicly taken (Operation Warp Speed)

 

So your little rant aside, do you have any? 

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5 minutes ago, Mama Noodle said:

 

I would genuinely like to know if Trump is legitimately interfering with the FDA's vaccine approval process, outside of the actions his office has publicly taken (Operation Warp Speed)

 

So your little rant aside, do you have any? 

Let’s see what his response is.

 

 

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3 minutes ago, Chomper Higgot said:

I didn’t even suggest  this ‘evidence you believe others owe you’, I certainly owe you no evidence at all.

 

Rather, where you have expressed your ‘genuine’ desire to ‘know’, I advise you watch Trump’s actions.

 

If you have a problem with article being posted in this forum, please take that up with TVF management.

 

So consistently smug, all the time. 

 

What actions, that you seem to know so much about, should I be looking at as a legitimate reason consider the president is interfering with the FDA's vaccine approval process? 

 

Youtube, news media, anything. Feel free to back up your claims. 

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1 minute ago, Chomper Higgot said:

Simple and straightforward as it was, I’ll repeat what I said for your benefit:

 

Let’s see what his response is.”

 

It is a very clear statement and makes absolutely no claim to have any knowledge of what those action should might be.

 

But once again yo attempt to assert I owe you an explanation of what Trump’s response will be. I do not, I don’t owe you any explanation, no evidence, nothing.

 

Let’s see what his response is.

 

Duly noted, no evidence forthcoming, because it doesn't exist.

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Just now, Credo said:

His various promises of a vaccine before the election and/or before the end of the year are interference, since it is not possible to adequately test the vaccine in that time.   

 

How are those words interfering with the FDA's vaccine approval procedures in any way. 

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