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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

#181

Post by DoreenMichele »

shajznnckfke wrote: post #172
DoreenMichele wrote: post #169

Earlier quoted context omitted.

Well, I didn't say anything about eliminating jobs. Just that I, personally, see no reason to tie the idea of going back to work to a vaccine. I think we would do better to look for germ control solutions that are already proven and available currently. As one example, ordering online or calling ahead and picking up is a way to support local eateries while minimizing the spread of germs. I'm a big fan of Little Caesa…

I agree that we should try to adjust to the world we find ourselves in, but there’s only so much problem-solving effort to go around, and I think most people are already trying to do what they can. It’s tough to reshape society on a dime.

I, personally, think there is insufficient focus on doing what is doable in the here and now. Society is reshaped all the time, every day, by every choice ever person makes. If we aren't even trying to push it in X direction because we are spending our energy justifying not bothering to try that -- "because it's too tough" -- then that strikes me as self-fulfilling prophecy.

I get really tired of self-fulfilling prophecy. Given what is at stake, I think we can and should do better than simply justifying our failures to adequately rise to the occasion.

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

#182

Post by saalweachter »

ethanbond wrote: post #158
BurningFrog wrote: post #136

Earlier quoted context omitted.

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.

Also, what the reduction is risk of catching the disease in question is.

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

#183

Post by Vysero »

meheleventyone wrote: post #141
blackflame7000 wrote: post #68

Earlier quoted context omitted.

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 t…

I mean come on. Is anyone buying it’s just a coincidence? If you really do I’d take a critical look at what they want from you. Votes for Trump. I’d also be extremely wary of anecdotal chats as widespread evidence of anything.

Are you buying that it's just a coincidence that the author quoted the opinion of the vice president of the Democratic party in an article that's clearly in opposition of the view point of the leader of the Republican party? What's that you said about taking a critical look again?

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

#184

Post by nfw2 »

maxerickson wrote: post #163
nfw2 wrote: post #151

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 EF…

No, phase III is still examining safety. For example, they document how a larger number of vaccinated individuals react to infection. A phase II trial might not track any infections.

Phase III examines both the efficacy and safety of the vaccine. These are independent questions.

Just because a trial takes x years to determine efficacy, it doesn't necessarily take the same amount of time to determine safety.

Fauci said certain vaccines could be approved as soon as there were enough events in the control group. Any dangerous side effects would only be in the experimental group and not dependent on events in the control group. If the only blocking factor is number of events in the control group, that to me suggest that the question of safety has already be sufficiently resolved for some of the candidate vaccines.

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

#185

Post by refurb »

shajznnckfke wrote: post #140
timr wrote: post #123

Earlier quoted context omitted.

"Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19." This is a case where the media hysteria surrounding the risks of Covid isn't helping anyone. If polling is to be believed, the general public significantly overestimates their personal risk of mortality from the virus: https://us.beyondbullsandbears.com/2020/07/28/on-my-mind-the... As noted by the link above, the vast majority of that risk…

Maybe we should first distribute the vaccine to the elderly, then? It sounds like the trade-off benefits and risk would be different there.

Absolutely. Prioritize those at highest risk of Covid complications (elderly, comorbidities) or those at high risk of exposure (front line healthcare workers).

It will be interesting once vaccines become available. Vaccinating several billion people will have a lot of operational challenges and will likely take upwards of a year to complete.

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

#187

Post by maxerickson »

nfw2 wrote: post #184
maxerickson wrote: post #163

Earlier quoted context omitted.

No, phase III is still examining safety. For example, they document how a larger number of vaccinated individuals react to infection. A phase II trial might not track any infections.

Phase III examines both the efficacy and safety of the vaccine. These are independent questions. Just because a trial takes x years to determine efficacy, it doesn't necessarily take the same amount of time to determine safety. Fauci said certain vaccines could be approved as soon as there were enough events in the control group. Any dangerous side effects would only be in the experimental group and not dependent on…

Yes, I directly addressed that. A potential safety issue with vaccines is making the course of the infection worse. So you have to look at vaccinated people that get infected (an 'event') to check on that.

Phase II checks if the vaccines directly causes problems, but doesn't look at a lot of events.

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

#188

Post by ip26 »

tux1968 wrote: post #155
ip26 wrote: post #51

Earlier quoted context omitted.

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.

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.

Is this satire, or simply your first brush with politics?

The subject of the vaccine is a tidy hypothetical example. Approve vaccine (with no actual regard to efficacy or safety). Bolster confidence in the status quo, reopen economy. People feel hopeful, things look up, re-elect current administration. Whoops, turns out the vaccine is actually poison. But it's too late to elect the other guy now, and the administration retains power four more years.

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

#189

Post by pwinnski »

shajznnckfke wrote: post #110
FreakyT wrote: post #99

Earlier quoted context omitted.

We know that they trigger an immune response, but that alone doesn't necessarily mean much. For example, an early SARS vaccine candidate triggered an immune response in tests, but that immune response in practice actually made SARS infections worse .[1] [1]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/

Yeah, certainly we ought to see how animals and people with the vaccine react when exposed to the virus, but have we not already done that in the months these vaccine candidates have been tested? The current trials did things like give the vaccine to thousands of Brazilian health-care workers, which should have uncovered any issues like that (in the article you linked, the issue was uncovered by testing in a small sa…

We have a process with three stages of trials. No vaccine candidate has yet gone through all three stages, no.

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

#190

Post by hartator »

RangerScience wrote: post #174
mumblemumble wrote: post #130

Earlier quoted context omitted.

According to FDA, phase III trials typically take 1-4 years. It's worth noting that, if there are any adverse effects that take a while to become apparent, the trial will need at least that long to be able to detect them. To my knowledge, severe vaccine reactions usually happen fairly soon, but a year before onset isn't necessarily unheard of for some vaccines. Also, that's just for vaccines that got approved; there…

If the vaccine only confers a few months of immunity, like the yearly flu vaccine, how long does it take to develop, produce and distribute the update?

I think the yearly flu vaccine give you lifetime immunity against the strains you are vaccinated against. However flu strains change every year. (Hopefully that won’t be the case for covid!)
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