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Covid vaccine makers commit to not seek approval until complete Phase III trials

statnews.com

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Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#31

Post by vikramkr »

Vysero wrote: post #8
anamexis wrote: post #4

Earlier quoted context omitted.

It sounds like her opinion is that she will defer to trained virologists.

That's completely beside the point. What I asked is, why should I care what her opinion on the mater is? Why was this quote included in this article? Also it doesn't "sound like" that at all. You could not possibly make that judgment based on the two sentences included in the quote.

because she's a public leader and vaccines dont work if people don't take them, and if people see people in positions of power avoiding the vaccine, they're going to be inclined to do the same. The science of getting the vaccine to work is only a part of the process of ending this pandemic. The enfire endeavor is useless if people don't take the vaccine because they don't trust it. And the everyday person is not a virologist.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#32

Post by deelowe »

wearhere wrote: post #5

What’s the timeline for Phase III trials? The article doesn’t seem to say. I don’t feel reassured that those won’t be rushed.

It's a moving target, so it's hard to say. Phase 3 trials depend entirely on the number of infected in the control group. Current estimates seem to indicate we may start seeing preliminary results in early Q4 with vaccines on target for an early 2021 date for implementation. These are the most aggressive schedules of course. Few are giving conservatives estimates right now, but I've seen June floated for more reasonable timelines.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#33

Post by snowwrestler »

astrophysician wrote: post #9

Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do? I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to…

The statement does not actually commit these companies to completing the entire Phase III trials regardless of outcome. The relevant paragraph from this article (with quote) is:

> In a statement, the companies pledged to “make the safety and well-being of vaccinated individuals our top priority.” The vaccine developers said they would continue to impose high ethical and scientific standards on the vaccine-testing process, and apply for government authorizations only “after demonstrating safety and efficacy through a Phase 3 clinical study.”

"Through" in that last quote is being taken to mean "at the completion of". But it can also mean "through the use of."

I disagree with the headline that Stat put on their article. To me it seems clear that the commitment from these companies is to the quality of the process, not a particular rigid timetable.

Edit - here is the full statement for those who want to read it.

https://investors.modernatx.com/news-releases/news-release-d...

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#34

Post by mikeyouse »

chundicus wrote: post #19
astrophysician wrote: post #9

Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do? I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to…

My understanding is that the data has to be overwhelmingly good to stop the trial early. I suspect the Trump administration's ability to actually fabricate trial data would be pretty limited without collateral damage (i.e. whistleblowing). Their ability to push it out of Phase III prematurely however is more debatable.

I don't think they typically stop the trial as much as they go to the FDA for emergency authorization with data from their midpoints showing overwhelmingly positive effects to get approval to proceed to Phase 4, while still finishing Phase 3. It's meant to compress the timeline, not to skip steps.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#35

Post by samatman »

jwieczorek wrote: post #15

Meanwhile, Russia just today announced it is starting the release of the first batch of its own vaccine to the public. https://www.aljazeera.com/news/2020/08/sputnik-russia-corona...

Correct, and this announcement is, among other things, a response to that.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#36

Post by dmarchand90 »

wearhere wrote: post #5

What’s the timeline for Phase III trials? The article doesn’t seem to say. I don’t feel reassured that those won’t be rushed.

My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#37

Post by shajznnckfke »

wearhere wrote: post #5

What’s the timeline for Phase III trials? The article doesn’t seem to say. I don’t feel reassured that those won’t be rushed.

The virus is pretty bad, right? Ought we be making a cost-benefit analysis where we compare the risks of side effects from the vaccine to the risks of the spread of the virus? In comparison to a vaccine like Gardisil, which surely prevents far fewer deaths than a covid-19 vaccine will, wouldn’t such an analysis actually indicate that the trials be rushed to some extent?

I’m feeling anxious that the current political milieu has a few factors pushing against deployment of a vaccine:

1. Republicans have been downplaying the virus the whole time, so they don’t take the need for a vaccine seriously.

2. Democrats are justifiably afraid of Trump pushing out a vaccine to get a pre-election “win”.

What I’m worried about:

1. Huge numbers of people dying every day from covid-19, with so many people out of work and struggling, with no end in sight other than a vaccine.

What’s the worst-case scenario for undiscovered side-effects on a treatment that has already been tested on thousands of people for months, and how probable is that risk?

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#38

Post by treeman79 »

ars wrote: post #2

"82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science. More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly." Wow. And lest you think this is a Trump thing, the figures are similar in European countries. A bad COVID vaccine (one that doesn'…

It is a political decision. The kind leaders are supposed to make, the kind they don’t like making.

A leader has to decide on either pushing early and either saving/condemning hundreds of thousand of lives.

Or playing it safe and condemning/saving hundreds of thousands to death while we complete years worth of trials.

Oh because that’s not enough pressure the economy is burning, which will cost many lives as well.

It’s a horrible decision to make anyway you slice it.

Politician is going to be hated no matter what.

If it works, they are bad for taking so long, taking risk. If it goes south...

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#39

Post by blackflame7000 »

ars wrote: post #2

"82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science. More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly." Wow. And lest you think this is a Trump thing, the figures are similar in European countries. A bad COVID vaccine (one that doesn'…

Do you really believe polls like this are accurate?
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