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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

#281

Post by 2bitencryption »

Animats wrote: post #211

The New York Times has a chart, updated daily, of all the vaccines in development.[1] This is worldwide, not US. Phase I: 24 Phase 2: 14 Phase 3: 9 Limited approval: 3 (CanSinoBio, Gamaleya Research Institute (Russia), Sinovac) Full approval: 0 That's not even including the hundred or so still in lab or animal testing. It's encouraging; something is likely to work. The real question is, how effective are the ones tha…

Of all the different vaccine "types" mentioned in the article (proteins, whole virus, mRNA, etc), which of those general types of vaccines are the most traditional, the most widely used, the most experimental, the most novel, etc?

I'm genuinely curious if "tried and true old vaccine tech" will come out on top in this case, or if "fancy new vaccine tech" will lead the way.

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

#282

Post by jmull »

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…

The phase 3 trial is where the safety and efficacy of a vaccine is determined for various groups. The risk/benefit decision you suggest can’t be made until it has been done.

It’s like the trolley problem but you don’t know whether more people will be killed if you throw the switch or not.

Also, if people are encouraged to take a vaccine that later turns out to have significant, previously unknown negative side effects, they will be less likely to take vaccines in the future. Squandered trust is very, very costly to regain so needs to be accounted for in a risk analysis.

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

#283

Post by takeda »

shajznnckfke wrote: post #148
takeda wrote: post #121

Earlier quoted context omitted.

That's why they want to absolutely make sure it won't cause a damage. The vaccine in 1976 was rushed for political reasons and that didn't end up well besides hurting many people it is also still used as an argument why you should not vaccinate.

I feel we are overweighting the importance of the political meta-game here and underweighting the real ongoing suffering caused by the virus (in terms of health, but also in economic deprivation). But if we’re going to talk about the meta-game, I think a swift return to normalcy after the vaccine is distributed could do a lot for the public’s opinion of the importance of vaccination. It could marginalize the antivax…

Vaccine won't restore normalcy at least not immediately.

> I think a swift return to normalcy after the vaccine is distributed could do a lot for the public’s opinion of the importance of vaccination. It could marginalize the antivax movement for decades to come.

A bad vaccine could absolutely cause havoc. And do the exact opposite, that's why they are being careful. If our president wouldn't politicize it, they wouldn't even have to say it.

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

#284

Post by HeadsUpHigh »

2bitencryption wrote: post #281
Animats wrote: post #211

The New York Times has a chart, updated daily, of all the vaccines in development.[1] This is worldwide, not US. Phase I: 24 Phase 2: 14 Phase 3: 9 Limited approval: 3 (CanSinoBio, Gamaleya Research Institute (Russia), Sinovac) Full approval: 0 That's not even including the hundred or so still in lab or animal testing. It's encouraging; something is likely to work. The real question is, how effective are the ones tha…

Of all the different vaccine "types" mentioned in the article (proteins, whole virus, mRNA, etc), which of those general types of vaccines are the most traditional, the most widely used, the most experimental, the most novel, etc? I'm genuinely curious if "tried and true old vaccine tech" will come out on top in this case, or if "fancy new vaccine tech" will lead the way.

Proteins and whole virus are the most common. mRna is new and I think at least some companies are taking advantage of the epidemic to push the technology forward.

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

#285

Post by kurthr »

ethanbond wrote: post #160
kurthr wrote: post #142

Earlier quoted context omitted.

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.

Do you read Derek Lowe?

https://blogs.sciencemag.org/pipeline/archives/2020/09/03/co...

If you don't, you should... and yes, I do. The swine flu vaccine was accelerated. Many drugs for cancer will literally kill you (slower than the cancer), so the safety of a drug needs to be measured against placebo and demonstrate significant improvement. First, do no harm.

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

#286

Post by lowdanie »

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…

Phase III tests for both safety and efficacy. The efficacy portion is the bottleneck because the experimenters do not a priori know the rate of infection. So rather than waiting for a fixed amount of time, we must wait for a target number of infections.

In contrast, since we know when each person in the treatment group got the vaccine, safety can be measured after a predetermined amount of time.

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

#287

Post by takeda »

adrianb wrote: post #175
loeg wrote: post #94

Earlier quoted context omitted.

> 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? No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing. Here's the protocol: 1. Volunte…

> This process can take years if the background rate of infection is low enough. This is why the phase 3 trials tend to be organised in countries with high rates of infection, such as Brazil, South Africa or India. In locations with low rates of infection it's too likely that the people in the experimental group don't get infected simply because they don't get exposed to the virus.

> This is why the phase 3 trials tend to be organised in countries with high rates of infection, such as Brazil, South Africa or India.

Or US (we are still higher than Brazil in cases per million). South Africa or India are actually much lower than us.

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

#288

Post by brian_cloutier »

School-Cotton wrote: post #228
Animats wrote: post #211

The New York Times has a chart, updated daily, of all the vaccines in development.[1] This is worldwide, not US. Phase I: 24 Phase 2: 14 Phase 3: 9 Limited approval: 3 (CanSinoBio, Gamaleya Research Institute (Russia), Sinovac) Full approval: 0 That's not even including the hundred or so still in lab or animal testing. It's encouraging; something is likely to work. The real question is, how effective are the ones tha…

> That's the "herd immunity" fraction for a disease with a growth rate of 3. Only if you assume (1) perfectly homogeneous mixing and (2) nobody is naturally immune (either due to cross-reactivity with immune responses to other coronaviruses or for any other reason).

To add to this, the effective reproduction number (what I think the GP is referring to?) varies not just with the prevalence of immunity, but also with the contact network of the population in question.

Currently the effective reproduction number is not 3, in most places, because we're avoiding large gatherings and, depending on the region, wearing masks and avoiding indoor gatherings.

If many more people were immune, even if we hadn't reached herd immunity, we could safely relax restrictions on gatherings without causing another wave. Concerts would still be out of the question, but dinner parties and hair salons would no longer be so concerning.

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

#289

Post by kurthr »

s1artibartfast wrote: post #238
kurthr wrote: post #142

Earlier quoted context omitted.

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…

For what it's worth, The infection fatality rate 20-29 I have seen is about 7/100,000. I have seen many drugs with higher death rates form side-effects.

The death rate for GBS from the swine flu vaccine was considered horrific at ~5ppm. I don't wish that on anyone, but I'd note that its still 10x better than the COVID death rate for the cohort you've found (average 25), and I certainly hope they don't asymptomatically spread that disease to parents (50) or grandparents (75), which are orders of magnitude worse off.

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

#290

Post by nfw2 »

jmull wrote: post #282
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…

The phase 3 trial is where the safety and efficacy of a vaccine is determined for various groups. The risk/benefit decision you suggest can’t be made until it has been done. It’s like the trolley problem but you don’t know whether more people will be killed if you throw the switch or not. Also, if people are encouraged to take a vaccine that later turns out to have significant, previously unknown negative side effect…

The data we have gives some information about the risks, although it not a completely clear picture. There is uncertainty, but any sort of risk/benefit analysis has to deal with uncertainty.

I don't think OP is arguing that people be encouraged to take the vaccine, just that the option be made available to them if they want it. I don't think it would squander trust if it is explicitly repeated that the vaccine is not known to be effective yet and that there are still potential side effects, and the recipient acknowledges they understand.

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