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

[webfact]

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

 

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)

 

-- © Copyright Reuters 2020-09-23

 

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[Tug]

Uh ho Donald won’t like that time to start wreaking careers and lives to get them to say what he wants 

[Mama Noodle]

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. 

[Tug]

10 minutes ago, Mama Noodle said:

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’s primary principals then threaten to ruin there careers if they don’t do what he says 

[Mama Noodle]

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? 

[Chomper Higgot]

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.

 

 

[Mama Noodle]

Just now, Chomper Higgot said:

Let’s see what his response is.

So no evidence then, but the article and the OP on the board was posted regardless. 

[Chomper Higgot]

9 minutes ago, Mama Noodle said:

So no evidence then, but the article and the OP on the board was posted regardless. 

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.

 

 

 

Edited September 23, 2020 by Chomper Higgot

[Mama Noodle]

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. 

[Chomper Higgot]

9 minutes ago, Mama Noodle said:

 

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. 

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 might be.

 

But once again you 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; I owe you nothing.

 

“Let’s see what his response is.”

 

 

Edited September 23, 2020 by Chomper Higgot

[Mama Noodle]

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.

[Chomper Higgot]

5 minutes ago, Mama Noodle said:

 

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

Which is why I said:

 

“Let’s see what his response is.“

 

 

[Credo]

48 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? 

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.   

 

[Mama Noodle]

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. 

[Scott]

Troll post removed.   Continue and face a suspension.  

 

[Morch]

1 hour 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? 

 

What does 'legitimately interfering' stand for, in your mind?

[Mama Noodle]

Just now, Morch said:

What does 'legitimately interfering' stand for, in your mind?

 

Some illegal or unethical physical action performed behind the scenes in an effort to circumvent the FDA and his own Operation Warp Speed. 

[Credo]

3 minutes ago, Mama Noodle said:

 

Some illegal or unethical physical action performed behind the scenes in an effort to circumvent the FDA and his own Operation Warp Speed. 

And the entire forum does not have to use your definition.   

 

[Mama Noodle]

3 minutes ago, Credo said:

And the entire forum does not have to use your definition.   

 

No you dont, nobody does, but any logical person can conclude that trump being publicly hopeful about an early vaccine does not equate to interfering with the FDA. 

[Morch]

12 minutes ago, Mama Noodle said:

 

Some illegal or unethical physical action performed behind the scenes in an effort to circumvent the FDA and his own Operation Warp Speed. 

 

So basically, nothing which actually happened, or is actually suspected to have happened, just another bunch of insinuations.

 

4 minutes ago, Mama Noodle said:

 

No you dont, nobody does, but any logical person can conclude that trump being publicly hopeful about an early vaccine does not equate to interfering with the FDA. 

 

Why would any logical person conclude that? Because Trump refrains from exerting pressure to push his views? Because he cares much for proper procedures and decorum?

 

 

[Mama Noodle]

1 minute ago, Morch said:

So basically, nothing which actually happened, or is actually suspected to have happened, just another bunch of insinuations.

 

Thats exactly what Ive been saying, thanks. 

[darksidedog]

4 minutes ago, Mama Noodle said:

 

No you dont, nobody does, but any logical person can conclude that trump being publicly hopeful about an early vaccine does not equate to interfering with the FDA. 

That is correct. However, the article says that the FDA are applying more stringent standards, "to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process."

No one has said that he is doing so, yet given his desire to see it out before the elections, it is a concern for some.

You have asked for evidence and been repeatedly told to wait and see what happens, as I repeat, no one is saying he is doing so.

The bickering on the issue will now stop please, as it is pulling the thread off topic.

[ehs818]

Having read some of these posting that are defending tRump, I must say that therse folks never fail to entertain us. You drank the Kook-Aid, that is clear. As for asking others to provide proof for their opinions, I guess they could flip that request back at you. Prove the man is the stable genius that he claims to be. Prove his wealth. Prove he's not a rapist. Prove he's not a pedophile. Go ahead. We dare you!

[charmonman]

6 hours ago, Mama Noodle said:

 

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. 

The point is that there is a perception that he might interfere for political reasons based on his previous actions in so many other areas of the government. Whether you agree or not, he is not trusted by a large portion of the American public. If you choose to trust him that’s your business.

[PattayaJames]

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.

 

So they changed the rules just to make sure. 

[Chomper Higgot]

1 minute ago, PattayaJames said:

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.

 

So they changed the rules just to make sure. 

I wonder when a vaccine for tin-foil-hat syndrome will become available?!

[Mama Noodle]

Be so delicious when the usual suspects go full anti-vax because the vaccine had a trump affiliation. 

[Catoni]

8 hours ago, 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 

Better Trump than the Democrats that can’t even run their own cities and states they’ve been in control of, in some cases for decades. 
   And you think they can run the country.... 

Harris + Biden = Venezuela North. 

[Rimmer]

Troll post and a mysterious medical condition post removed, do not troll on here please with that nonsense!!

[Eric Loh]

8 hours ago, Mama Noodle said:

 

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

Perhaps these words were more revealing that he exerting pressure on the FDA. 

 

" The deep state, or whoever over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics".