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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

#191

Post by seanmcdirmid »

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.

The death rate for the syndrome is 7.5% according to wiki, so maybe 40 deaths?

https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_sy...

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

#192

Post by nfw2 »

maxerickson wrote: post #187
nfw2 wrote: post #184

Earlier quoted context omitted.

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.

I see, thanks for the clarification

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

#193

Post by shajznnckfke »

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.

There’s no hard line where we need to test for t months, and then we will find out if the vaccine is safe. There is no magic threshold where suddenly we know the answer for sure. It’s more like: the size of the error bars on our estimate of the harm y in quality-adjusted-life-years (QALY) is constrained by some function on the time t, where there is diminishing returns as t increases. It’s always going to be possible that there’s some side-effect that doesn’t show up until t+1 months.

Further, we could build an expression of our estimate z of the total harm caused by the virus (including downstream harms like “deaths of despair” from economic damage). By minimizing y-z over t, we can find out the best time to release the vaccine (maybe to the most at-risk populations first).

I don’t think anyone at the FDA is doing this calculation. I think they are just trying to get y below some threshold, which is probably quite low compared to z. My goal in this conversation is to advocate for the people who will suffer and die because of that gap - and hope there is someone better qualified than me that fills that role in the government helping decide what to do. My fear is that the FDA is a highly conservative institution using processes that aren’t well-adapted to the current epidemic.

To add more color, I think if the vaccine comes out with unexpected side-effects, heads will roll at the FDA. But no heads will roll at the FDA over the many thousands who could have been saved by releasing a vaccine sooner.

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

#194

Post by [deleted] »

garmaine wrote: post #109

WTF. This is going to kill people. A lot of people. Look, the usual situation with vaccines is that we are weighing (1) the danger posed to the few people who get sick while the trials are going on; vs. (2) the risks taken on by everybody who gets the vaccine. The vaccine might have a small likelihood of triggering reactions or otherwise having adverse effects, and spread over the entire population these edge cases c…

[deleted]

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

#195

Post by mumblemumble »

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…

It's both. The purpose of phase II trials is merely to demonstrate that the new drug is safe enough to proceed to phase III trials. That's typically a much lower bar to clear than demonstrating that it's safe enough to release onto the market.

With (typically) no more than a few hundred participants, phase II trials don't really have the statistical power to detect anything but the most serious of safety problems.

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

#196

Post by shajznnckfke »

pwinnski wrote: post #189
shajznnckfke wrote: post #110

Earlier quoted context omitted.

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.

What I’m arguing is that we don’t need complete phase 3 trials to establish efficacy - we can establish that based on early data from those (and earlier) trials, while accepting larger error bars on the risk of side effects.

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

#197

Post by SpicyLemonZest »

talentedcoin wrote: post #170
DoreenMichele wrote: post #84

Earlier quoted context omitted.

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 think this comment is correct and is something that is being missed in the present conversation. For those who disagree -- isn't it better to take realistic steps to help people instead of just crossing our fingers and waiting for a vaccine?

It just seems terribly dismissive of all the people who want and demand a return to business as usual. A plan for handling the coronavirus that doesn't include "here's when we'll open the bars" is missing a huge piece of the problem.

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

#198

Post by mumblemumble »

hartator wrote: post #190
RangerScience wrote: post #174

Earlier quoted context omitted.

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!)

Officially, it gives you at least 6 months' worth of immunity, but, beyond that, there are no guarantees, and it generally fades over time.

That's why the recommendation is to wait until shortly before the onset of flu season to get vaccinated: If you get vaccinated in July, there's no guarantee that the vaccination will carry you through the worst of a (northern hemisphere) flu season.

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

#199

Post by trhway »

mumblemumble wrote: post #186

Meta observation: The sheer volume of downvoting of reasonable comments in here really speaks volumes about the extent to which the SARS-CoV-2 pandemic is at least as much a political subject as it is a scientific one.

"El sueño de la razón produce monstruos" (The Sleep of Reason Produces Monsters).

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

#200

Post by snowwrestler »

blackflame7000 wrote: post #77
snowwrestler wrote: post #63

Earlier quoted context omitted.

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.

And what basis do you have to believe such treasonous claims? CNN told you so? What motivation could they possibly have? Oh yeah, to get you to vote democrat. Don’t be naive.

> In a recent STAT-Harris survey, 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.

That's from this article, but it is broadly in line with other recent polls. Most Democrats and most Republicans are concerned about this administration rushing a vaccine.

The president has not helped matters by stating that he thinks a vaccine could be ready before the election, and by publicly attacking the FDA for supposedly trying to prevent that.

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