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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

#291

Post by Gibbon1 »

CydeWeys wrote: post #219
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?

Good news is that COVID (and coronaviruses in general) don't seem to have the same kind of mutation potential to bypass immune system responses like influenza does. So our best guess is that a COVID vaccine will be like Tdap or MMR, i.e. after the initial course you maybe only need occasional booster shots (if even that), vs influenza where it mutates enough that a new vaccine must be developed and administered every…

Not widely enough understood. Influenza is a segmented virus and generates new strains by reassorment. Where two different strains of influenza infecting a cell shuffle their RNA segments to produce a third strain.

Best to think of influenza as an ever shifting and recombining family of viruses.

Covid19 has a single strand of RNA and doesn't do that.

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

#292

Post by crx07 »

mchusma wrote: post #233

I hope that the benchmark for approval is "for a given group, the risk of the vaccine is lower than the risk of COVID". This has some good commentary: https://marginalrevolution.com/marginalrevolution/2020/09/on... some thoughtful commentary. I believe that for at risk populations it is very likely that taking a phase III vaccine candidate is the safer option right now, let alone after another month of data. I think…

Absolutely this.

I'm in an at-risk population, as are the two others in my household, and this pattern of perpetually delaying is driving me insane.

I'll gladly take a 0.1% chance of an unspecified SAE over a 50% chance of death. I'm about to the point where I'd consider outright bribing someone at a research lab to slip me a dose of any of them, even if I had to administer it myself.

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

#293

Post by Wowfunhappy »

rrrrrrrrrrrryan wrote: post #261
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.

If a few hundred people get a brutal side-effect, that's enough ammo for anti-vaxers to severely cripple the general public's trust in our public health systems. Somewhat frustratingly, this vaccine needs to be held to the same standards of safety & efficacy as any other vaccine, but I do wish they'd let immunocompromised people get access to the thing a notch earlier than they would otherwise.

Well, I don’t know what to do about that, but it seems to me that not releasing a vaccine which:

- Lowers the public’s chance of contracting COVID by 50%

- Causes 0.001% of the public to get seriously ill.

...then withholding that vaccine from everyone because some people who don’t understand probability may have a temper-tantrum would be deeply immoral.

None of this contradicts your point per se, but I don’t know what to do about it.

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

#294

Post by crx07 »

avaika wrote: post #275
jwieczorek wrote: post #15

Meanwhile, Russia just today announced it is starting the release of the first batch of its own vaccine to the public. https://www.aljazeera.com/news/2020/08/sputnik-russia-corona...

Well. As of now the Russian vaccine doesn't look like a trustworthy solution. Recently Russians published article in The lancet [1], but scientists who read this have a lot of questions. Especially on data consistency. They even published open letter to head of vaccine research Denis Logunov with open questions [2]. According to first reaction by Denis Logunov (don't have a link on this) the open letter doesn't worth…

This is nonsense -- I'm at high risk, and I'd take a flight to Russia right now to get a dose of Sputnik V if I knew I wouldn't catch COVID-19 on the trip.

Those grandstanding against these vaccines in the name of safety should know that they're directly responsible for deaths, and what's about to happen is we will just end up with a candidate from the least scrupulous manufacturer, because data are easy to manipulate and there's a lot of money on the line. I'd almost guarantee that this announcement means we've just traded a stable delivery platform for one of the mRNA candidates with risks that may be unknowable potentially for decades.

I'm a progressive and I get it that everything Trump does is necessarily frustrating, but whoever politicized this in response to his November 1st deadline should be ashamed, including whoever started the pledge that some of these companies signed today.

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

#295

Post by emiliobumachar »

rrrrrrrrrrrryan wrote: post #261
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.

If a few hundred people get a brutal side-effect, that's enough ammo for anti-vaxers to severely cripple the general public's trust in our public health systems. Somewhat frustratingly, this vaccine needs to be held to the same standards of safety & efficacy as any other vaccine, but I do wish they'd let immunocompromised people get access to the thing a notch earlier than they would otherwise.

AFAIK immunocompromised people are legitimately excluded from vaccination and have to rely on herd immunity.

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

#296

Post by andrekandre »

spamizbad wrote: post #71
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…

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.

slight aside, but from that link, was surpised to see "jet injectors" were used in 1970s.... i just toally assumed this stuff was sci-fi...

https://en.wikipedia.org/wiki/File:8365_loresOLDSCHOOL.jpg

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

#297

Post by cameldrv »

crx07 wrote: post #292
mchusma wrote: post #233

I hope that the benchmark for approval is "for a given group, the risk of the vaccine is lower than the risk of COVID". This has some good commentary: https://marginalrevolution.com/marginalrevolution/2020/09/on... some thoughtful commentary. I believe that for at risk populations it is very likely that taking a phase III vaccine candidate is the safer option right now, let alone after another month of data. I think…

Absolutely this. I'm in an at-risk population, as are the two others in my household, and this pattern of perpetually delaying is driving me insane. I'll gladly take a 0.1% chance of an unspecified SAE over a 50% chance of death. I'm about to the point where I'd consider outright bribing someone at a research lab to slip me a dose of any of them, even if I had to administer it myself.

The Moderna trial is enrolling, I know someone who is in it. You only have a 50% chance of getting the vaccine, but given your preferences, why not sign up for the trial?

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

#299

Post by nfw2 »

shajznnckfke wrote: post #193
ethanbond wrote: post #158

Earlier quoted context omitted.

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 possibl…

Fauci spoke on this matter recently. He said that phase 3 completion is not dependent on time, but rather dependent on the number of events (infections) in the control group.

This to me suggests the main blocker for approval now is proving efficacy, and that we already have enough data to conduct the time-based safety analysis you described with reasonable confidence.

There is another potential safety concern that the vaccine could exacerbate COVID infections. I don't know how critical this concern is, but it would also be constrained by number of infection events, not time.

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

#300

Post by xnyan »

kurthr wrote: post #280
xnyan wrote: post #278

Earlier quoted context omitted.

Are you arguing that the 1976 Swine Flue vaccine incident is the worst possible case or the worst possible case on record? If the former, then what is your evidence or reasoning for that? If the latter, how do we know that this is the worst case we can expect?

Well, the worst case is that the vaccine is actually a highly contagious world ending bioweapon that causes the extinction of humanity, so the latter. How do you know that the current death rate for COVID19 won't eventually be much higher for those who have "recovered"? Maybe all those asymptomatic youngsters are actually going to develop horrible debilitating lung and blood disorders? We work with the data we have,…

It sounds like in judgment of which is worse: over or underestimating the risks of the virus versus taking additional time for more testing.

How many other nations are doing this besides Russia? Why not? If you’re asking me to make a bet, I’m going to side with the vast majority of nation-states. not a guarantee by any means, but the best choice unless I decide to go back to school to study viral infections.

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