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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

#61

Post by takeda »

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.

I heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company.

I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

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

#62

Post by ssully »

gizmo686 wrote: post #23
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 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…

My understanding is that while prevent infection using the vaccine is a big goal, the other more important goal is that it triggers a better response in people when they do get sick. Specifically, if you get the vaccine and then go on to catch the virus, your body will fight it better and you will have minor symptoms (and hopefully don't go to the ICU).

I will say that everything I've said is just from what I read. If someone with an actual medical background knows more, I would love to hear it.

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

#63

Post by snowwrestler »

blackflame7000 wrote: post #44
landryraccoon wrote: post #13

Earlier quoted context omitted.

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

Of course it has political undertones; the only reason these companies felt compelled to issue this statement was to counter the widely-spread fear that the sitting president of the U.S. would attempt to corrupt the standard vaccine process to his political benefit.

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

#64

Post by remy_0 »

warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

What are your sources?

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

#65

Post by calvinmorrison »

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

How about "rushing" the vaccine to you know... end the pandemic? Or would you rather more people die "from covid" to hurt Trumps chances of winning?

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

#66

Post by evilsnoopi3 »

warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

This is simply not the case except when talking about a totally untested vaccine. The whole point of phase III trials is to confirm "safety and efficacy" in a wide population. Moderna, for instance, aims to enroll 30k people in it's (currently ongoing) phase III trial. After that, it's just a matter of data analysis. The FDA would certainly not approve a vaccine that had comorbidity higher than the disease it is trying to treat.

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

#67

Post by darkerside »

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…

I agree. They are only saying they will demonstrate safety and efficacy through the trials, not that the trials will be technically completed.

And, I think that's fine. I'm not taking a politician's word for whether that has been achieved, but I agree with it in concept.

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

#68

Post by blackflame7000 »

meheleventyone wrote: post #28
Vysero wrote: post #18

Earlier quoted context omitted.

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?

How is an expedited vaccine political? It’s the author that’s asserting political motivation with assumptive logic at best and borderline anti-vaxer at worst. People are smarter than you think and they can pick up on subtle cues of bias. I know i’ll get downvoted for this because that’s how people on this website are, but the democrats have completely botched the covid/blm crisis as of late and their credibility is tanking. Just talk to people but pretend you’re a trump supporter and I think you might be shocked what you hear

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

#69

Post by darkerside »

takeda wrote: post #61
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.

I heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company. I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

Not to mention people's health...

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

#70

Post by SpicyLemonZest »

JMTQp8lwXL wrote: post #46
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…

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.

I think you're misunderstanding the problem space here. We don't expect a coronavirus vaccine to prevent close to 100% of infections, so it's not a binary question of working vs. not working. The question is, how strong of an effect at what level of confidence is required to conclude that it's working well enough?
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