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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

#151

Post by nfw2 »

After hearing Fauci's recent comments on the matter, my understanding is that the phase III trials can be considered for approval once there are enough infections in the control group to do a comparative analysis.

Since the events now needed to confirm the vaccine are in the control group, not the experimental group, it seems that the blocker for approval now isn't SAFETY, as it has been continually suggested, but EFFICACY.

If that is indeed the case, what makes the most sense to me would be to allow an early approval of any vaccine that meets reasonable safety requirement (some x months in stage 3 trial), but the patient must sign a waiver saying that they understand there may be rare side effects and there is no guaranteed immunity.

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

#152

Post by ciarannolan »

blackflame7000 wrote: post #73
Tepix wrote: post #20

Earlier quoted context omitted.

Why do people care about what medical advice Trump has to offer? We don't really need a vaccine, we can just drink bleach!

I think Trump’s sarcasm is lost on some people and thats why they dislike him so passionately.

> He added: "I see the disinfectant that knocks it out in a minute, one minute. And is there a way we can do something like that by injection inside or almost a cleaning? As you see, it gets in the lungs, it does a tremendous number on the lungs, so it would be interesting to check that." [1]

There's video of this. He is 100% serious.

[1] https://www.nbcnews.com/politics/donald-trump/trump-suggests...

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

#153

Post by Vysero »

jaas wrote: post #21
Vysero wrote: 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.

"Because she's a U.S. Senator who may be the Vice President soon. That's why people care, even if you don't."

This is exactly my point. You are part of the problem the article was pointing out. I personally, don't care what her opinion is because she's not an expert. Just like I don't care what Trump's opinion is because he's not an expert. The fact that the article says I should shows that it's politically biased, and the hypocrisy of talking about how political motivations are causing problems while simultaneous politically charging your own article is disgusting.

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

#154

Post by ethanbond »

garmaine wrote: post #120
apocalyptic0n3 wrote: post #93

Earlier quoted context omitted.

The bigger issue is if they rush a drug that does long term harm to people, it could destroy the company. This is a drug that they will be giving out to 300+ million people in the US along. Screwing it up would result in a massive amounts of lawsuits that they may not recover from. They don't want to risk that just for some political capital with a person who may not be in power in a few months.

The fix for that is easy: have the FDA authorization grant them immunity from vaccine safety or efficacy liability.

Man that is a good solution. That way we get a vaccine immediately! Who cares if it’s saline. Or arsenic.

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

#155

Post by tux1968 »

ip26 wrote: post #51
treeman79 wrote: post #38

Earlier quoted context omitted.

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…

I think the common understanding of a decision 'driven by politics instead of science' is making the choice in the way that most advantages your own political career, instead of the way that saves lives or the economy.

Aren't those two things essentially the same thing? The best way to advance your career is to make choices that benefit the most people. You're not going to get ahead if your decision fails to save lives or the economy.

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

#156

Post by shajznnckfke »

DoreenMichele wrote: post #84
shajznnckfke wrote: post #37

Earlier quoted context omitted.

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…

with so many people out of work and struggling This concern can be addressed other ways. I run two subreddits aimed at helping people establish an online income (as part of the goal). In a post-covid world, I think we will do more good if we focus more on adapting to a new reality where increased germ control is a permanent expectation rather than expecting a vaccine to fix everything and allow us to return to "busin…

I do think there will be a permanent adjustment in society to deal with the risks created by this type of virus in the future. Tell everyone to start wearing masks as soon as the outbreak starts, instead of telling them that masks are only for idiots and healthcare workers. Isolate travelers from affected areas before it has a chance to spread, and so on. But I also expect that just about every occupation from industries that are shut down will continue to exist in this new world.

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

#157

Post by credit_guy »

maxerickson wrote: post #87
credit_guy wrote: post #56

The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA." I feel there's some weasel wording going on here. The…

'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'. The headline is inaccurate, but that's on Statnews. When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they…

Yes, but then the pledge is devoid of content. The act of seeking approval is a submission of evidence that demonstrate safety and efficacy.

The "pledge" is essentially just saying "we'll do everything as we always planned to do it".

Why make this pledge then? What's the value added?

There is value added indeed. In today's climate of general mistrust, simply stating that you will not cut corners (even if there was never any possibility of cutting corners) can allay some fears. But then, who is stoking these fears? Should they know better than doing that?

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

#158

Post by ethanbond »

BurningFrog wrote: post #136
spamizbad wrote: post #71

Earlier quoted context omitted.

The 1976 swine flu outbreak is one example of what can go wrong if you rush a vaccine: https://en.wikipedia.org/wiki/1976_swine_flu_outbreak It was rushed by the Ford administration for political reasons and got a lot of people very sick.

Let's quantify "a lot of people". Out of 45 million vaccinated, 450 got Guillain-Barré Syndrome. I couldn't find info on if any of them died. That would have been acceptable if it had stopped a disaster, but as it turned out the 1976 Swine Flu epidemic never really materialized as expected. With Covid killing 1000 Americans per day, I think we should happily accept those odds of side effects or worse.

Yeah, um, the point of trials is to find out what those odds are.

They can easily be much, much, much worse.

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

#159

Post by rsynnott »

dmarchand90 wrote: post #36
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

I wouldn't have thought the companies involved are primarily thinking of that. The risk to the companies is that Trump going on about skipping trials will hurt public confidence in any vaccine that is finally released, even if such skipping never happens. This announcement may serve to reassure some people that the manufacturers are going to behave themselves even if the government is negligent.

Also, probably, reassure some shareholders. The reputational risks involved in this trial-skipping stuff are horrific.

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

#160

Post by ethanbond »

kurthr wrote: post #142
gizmo686 wrote: post #57

Earlier quoted context omitted.

Covid isn't that bad when compared to the potential harm that a dangerous vaccine could cause when injected into billions of people. Particularly because deploying the vaccine would not immediately stop all the covid19 damage. Further, deploying a dangerous or innefective vaccine would also cause significant long term damage to public health by fueling doubt in healthcare; particuarly since antivaccers are already a…

This is quite simply false based on a worst case scenario of a 1976 Swine Flue vaccine level fallout, which had https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_sy... Your chance of getting COVID over the next year is certainly greater than 1% even if you live in a fairly unaffected area of the US (and are likely closer to 10% without extreme measures), while your chance of dying is almost 1% and severe effe…

The worst case vaccine to ever hit the market which is a significantly different thing than the worst case vaccine we’ve ever developed.

Do you know how many failed drugs go into a successful one? The success rate is absolutely abysmal.

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