Live data from Hacker News

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

statnews.com

41–50 of 344 posts

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

#41
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.

I care because she is my future vice president. It was clear what her intent was.

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

#42

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 pro…

Ah I gotcha yea, I just misread the article. That makes more sense and seems much more reasonable.

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

#43

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 n…

> 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 see -- yea totally agree, I thought they were committing to a rigid timetable or something but that's not what's happening here as you say.

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

#44
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.

It seems odd to write an impassioned comment about how little one cares about someone else’s opinion. Wouldn’t shrugging and then immediately forgetting what they think and moving on be more consistent with your claimed state of mind?

He’s pointing out that the article has political undertones. If it were purely about the virus, kamala harris, or any politician for that matter, wouldn't have even been mentioned

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

#45
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

Any increase in testing time will give some, albeit hard to measure, improvement in safety of the vaccine. Or am I missing something?

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

#46
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…

No point shipping a vaccine early if it doesn't actually work. That could do more damage, people thinking it's safe to be around others maskless, when in fact the world population instead received an ineffective vaccine.

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

#47
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.

>>I don’t feel reassured that those won’t be rushed.

actually I am. Vaccine makers don't gain much by doing something risky (considering the negatives) so they'll check the ones seeking election at all costs.

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

#48
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…

> The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine.

I think it’s difficult to quantify how successful the flu vaccine is. I’ve reviewed the numbers and it’s not clear the general flu vaccine does anything. That being said, targeting specific strains can help (problem with flu is the various strains and ability to mutate so easily).

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

#49
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.

It seems odd to write an impassioned comment about how little one cares about someone else’s opinion. Wouldn’t shrugging and then immediately forgetting what they think and moving on be more consistent with your claimed state of mind?

No it wouldn't be consistent with that. That would be consistent with not thinking critically. The hypocrisy of quoting a politician in order to reinforce your narrative whilst simultaneous talking about how the narrative your trying to reinforce is being driven by political motivations is... well it's sad really.

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

#50
post #21
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 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.

When did becoming a US senator give you expertise on determining the scientific merit of a vaccine?
Post reply on HN