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

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

#21
post #8
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 U.S. Senator who may be the Vice President soon. That's why people care, even if you don't. You know that already so please spare us the personal commentary masked as a question.

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

#22
They did not actually commit to finishing the clinical trials.

> The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...

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

#23
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 doesn't even have to be a "bad" vaccine. The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine.

Combined with a high baseline infection rate, and an aggressive testing regime (at least compared to flu/other non-pandemic diseases), there will be a lot of people who get vaccinated and proceed to get sick and test positive.

The real evidence of the vaccine working would be by the herd immunity it creates. But that is a population level effect, and people are terrible at understanding population level effects.

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

#24
post #8

Earlier quoted context omitted.

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 the article is about is about political involvement tainting public trust in the vaccine development process, and she is a prominent politician who recently made remarks about the matter.

"Because the article is about is about political involvement tainting public trust" - and how does quoting a political candidates opinion on something she knows nothing about not doing exactly that to this article? .. you have to be kidding me.

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

#25
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'…

> the figures are similar in European countries.

Do you have a source ?

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

#26

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…

If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean no matter what the interim results say, the FDA may feel inclined to approve the vaccine. Considering that we need healthy people to willingly take these vaccines to end the pandemic, losing that trust in the process would be devastating. People need to believe that the FDA approved it because the evidence shows the vaccine is most likely effective without safety concerns. If they don't, then they won't take it, and if the vaccine then fails phase III, its not clear how you regain that trust as a regulatory agency.

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

#27
post #18

Earlier quoted context omitted.

She was asked by CNN, given that she's running on the Biden-Harris ticket. No one particularly cares whether you care or not, but she is clearly a rather important person right now and was asked this question given that public health has marched to political drums rather than safety drums lately.

Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...

Who better to ask about politics than a politician?

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

#28
post #18

Earlier quoted context omitted.

She was asked by CNN, given that she's running on the Biden-Harris ticket. No one particularly cares whether you care or not, but she is clearly a rather important person right now and was asked this question given that public health has marched to political drums rather than safety drums lately.

Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...

You seem to be trying to say something but trail off into weak points all the time. Why would you not talk to the opposition about a politically motivated issue made by the President?

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

#29
post #18

Earlier quoted context omitted.

She was asked by CNN, given that she's running on the Biden-Harris ticket. No one particularly cares whether you care or not, but she is clearly a rather important person right now and was asked this question given that public health has marched to political drums rather than safety drums lately.

Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...

Oh shut the fuck up you passive-aggressive autistic cunt.
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