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Calista241

(5,585 posts)
Wed Sep 2, 2020, 10:21 AM Sep 2020

Overwhelmingly strong results could end COVID-19 vaccine trials early, Fauci says

Source: LA Times

A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, Dr. Anthony Fauci, the nation’s top infectious disease official, said this week.

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “The data is so good right now that you can say it’s safe and effective,” Fauci said Tuesday. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, he said, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the COVID-19 pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear that President Trump is pushing for an early vaccine approval to help win reelection.

Read more: https://www.latimes.com/science/story/2020-09-02/covid-19-vaccine-trials-could-end-early-if-results-are-overwhelming



I suspected the conflict between Fauci and Trump could have been orchestrated with a result like this in mind.
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genxlib

(5,518 posts)
1. That is going to get misinterpreted badly
Wed Sep 2, 2020, 10:27 AM
Sep 2020

Is seems to me that he was saying that the Safety Monitoring Board has that option if they see something exceptionally positive.

He is not saying something like that is being seen.

It is a hypothetical situation. Not a developing one.

Either way, it certainly provides scientific cover for the claims to be made whether they are valid or not.

Sapient Donkey

(1,568 posts)
10. That was the first thought I had when reading it
Wed Sep 2, 2020, 02:56 PM
Sep 2020

People will not interpret what he's saying correctly. I personally would prefer he keep that sort of analysis to smaller groups of people, because sadly there are too many people who are not be able to parse his words correctly.

 

Steelrolled

(2,022 posts)
12. I agree it will be misinterpreted.
Wed Sep 2, 2020, 04:02 PM
Sep 2020

But in the end, only the FDA/CDC/etc people count.

But it is a good fact to point out. If after a couple months, nearly no-one with the real vaccine got COVID-19, and the expected number of people with the placebo did get COVID-19, and no new safety issues have arisen, it would be a good argument to start using it in some cases. It would be the beginning of the end.

I registered for the trial a month or so ago, but haven't yet been called. The number of volunteers needed is small (500 for medium sized cities). And I could be in a demographic for which they have plenty to choose from (sniff sniff).

Iliyah

(25,111 posts)
2. I do not trust this admininstration . ..
Wed Sep 2, 2020, 10:29 AM
Sep 2020

They lie. Write lies. And since they will not work with WHO, I will not be taking USA's vaccine.

When Biden/Harris wins - that is another story.

brewens

(13,536 posts)
3. I'm pretty sure that in this situation, any president would have done everything possible
Wed Sep 2, 2020, 10:43 AM
Sep 2020

to expedite the process. Of course Trump is more than willing to risk lives to be able to say he got it done before election day. I think we can count on hearing it has been accomplished and on the way by then. It won't matter to Trump and his followers when it does not materialize any time soon after, if he is elected. There will be excuses and someone to blame.

PoindexterOglethorpe

(25,811 posts)
4. IF ongoing clinical trials produce overwhelmingly positive results.
Wed Sep 2, 2020, 10:51 AM
Sep 2020

If and only if. Overwhelmingly.

A couple of really important words.

Fauci is being irresponsible for speaking like this.

zipplewrath

(16,646 posts)
8. What he said was absolutely correct
Wed Sep 2, 2020, 11:57 AM
Sep 2020

Unfortunately, there is a residual implication that in fact current results are as overwhelming as they will need to be. He didn't say that and unless they were, he either should have clarified that currently that wasn't the case, or openly stated that they were very encouraged by early results. The fact that we really haven't heard any such thing does make one wonder what's up.

still_one

(92,060 posts)
5. If Fauci and peer review outside of the administration endorse the vaccine(s), I am
Wed Sep 2, 2020, 11:01 AM
Sep 2020

inclined to believe them

jeffreyi

(1,938 posts)
7. I read a blog about vaccine development
Wed Sep 2, 2020, 11:35 AM
Sep 2020

It's called In the Pipeline, by Derek Lowe. I think he's a biochemist. Apparently a couple of the strong contenders right now have delivery and storage issues...they have to be kept really, really cold. Like below zero cold. That's a big logistical issue, this is not an easy thing on a large scale. Interesting reading.

DeminPennswoods

(15,265 posts)
11. This is what happened with Remdisivir
Wed Sep 2, 2020, 03:25 PM
Sep 2020

The results were so good, the trial was stopped and all participants got the drug. While only a theraputic, it does appear that it's safe and effective in mitigating SARS2 symptoms.

genxlib

(5,518 posts)
13. I think it helped that Remdisivir has been developed earlier for something else
Wed Sep 2, 2020, 04:37 PM
Sep 2020

Originally developed in 2009, as an existing drug so they had some data on it already.

So the efficacy was the major question since they already had some data on safety.

 

not_the_one

(2,227 posts)
15. An INDEPENDENT board?
Wed Sep 2, 2020, 08:58 PM
Sep 2020

Any board approved by the turd will be lying for the benefit of the turd. The CDC and the FDA have already thrown their credibility out the window. I even find that Fauci has used pretzel logic too many times to try to stay on the good side of the turd, to be trusted.

I will have nothing to do with any vaccine that comes out while the turd is still in power.

Once President Biden's selected experts gives it clearance, I'm in.

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