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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

#311

Post by HeadsUpHigh »

bglusman wrote: post #132

So, correct me if I'm wrong, but a) current hypothesis is people with prior exposure to common-cold non-COVID-19 coronaviruses are by and large either asymptomatic or have milder symptoms than those without such exposure b) presumably it should be possible to test people for these antibodies much as we can test people for COVID antibodies If people would volunteer for the b) anti-body test in reasonable numbers, and…

Coronaviruses are called so because they look a certain way under an electron microscope. They don't necessarily have common proteins. So you point a does not stand. As for point b,due to the fact that antibodies are specialized and there are tons of viruses that cause the common cold, I wouldn't expect them to match or even exist at any given time in the bloodstream since they only last ~6m and after that memory takes the role of rapid production of new antibodies in case of a new infection.

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

#312

Post by timr »

CydeWeys wrote: post #268
timr wrote: post #259

Earlier quoted context omitted.

In what age group? The 1976 vaccine actually killed people and gave Guillain Barré to many more, so that's your worst-case outcome. So far, under 20 years of age, the fatality rate for Covid is measured in low-single-digit thousandths of a percent (i.e. under a thousand in the US). https://www.medrxiv.org/content/10.1101/2020.08.24.20180851v...

Yeah, the worst vaccine mortality rate ever was still not remotely as bad as that, and you're not considering that a vaccine given to a 20 year old is helping to protect all the other people said 20 year old comes into contact with, who will have substantially higher mortality rates from COVID.

"Yeah, the worst vaccine mortality rate ever was still not remotely as bad as that"

Citation required.

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

#313

Post by [deleted] »

CydeWeys wrote: post #262
timr wrote: post #251

Earlier quoted context omitted.

"I've had vaccine side effects and I've had COVID and I'd take ten more vaccine side effects over one COVID, please." I don't know what side-effects you've had from vaccines, but when I talk about risks, I'm not talking about headaches...people actually died from from the 1976 H1N1 vaccine.

... yeah, and way more people are dying from COVID than have ever died from all vaccines put together.

[deleted]

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

#314

Post by kurthr »

xnyan wrote: post #300
kurthr wrote: post #280

Earlier quoted context omitted.

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.

If the virus was 10x more deadly (if it was 10x more contagious we'd almost all have it by now), I'd probably advocate for even more accelerated testing and deployment (we're close to the edge for full deployment over the next 9 months even in developed countries as it is). It's a trade-off between deaths from the virus and from a vaccine... once the vaccine is 100x lower risk than the virus you start rolling out to high risk profiles (front line medical and essential workers along with 60+ / pre-existing) since they have disproportionate >10x risk of transmission & death... then as production and deployment catch up roll out to medium (30s-50s especially with kids) after another 3-6 months and eventually low risk profiles (those 20s and under without kids or pre-existing conditions). That extra 6 month delay balances some of the risk between virus and vaccine. Since we'll have several different vaccines to choose from we can also pick the most effective ones that have the lowest side effects for later inoculation, while higher risk groups just need some protection today.

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

#315

Post by mumblemumble »

nfw2 wrote: post #206
mumblemumble wrote: post #195

Earlier quoted context omitted.

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.

Yes, but figuring out whether something is safe is different than figuring out whether is something is effective. To answer the efficacy question you would look at the infection and mortality rate of the experimental group and compare it to the rates of the control group. There is a minimum number of infection events needed in the control group for the comparison to be statistically significant, hence the long trial…

Establishing safety also involves a comparison with the control group. Otherwise you can't tell if the outcome in question is significantly more or less likely in the treatment population than in control.

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

#316

Post by s1artibartfast »

kurthr wrote: post #289
s1artibartfast wrote: post #238

Earlier quoted context omitted.

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.

Who considers it horrific and in what context?

Here are some common causes of death for ages 20-29 in the USA[1]:

Poisoning kills 460 ppm

suicide kills 336 ppm

Motor vehicles kill 331 ppm

Homicide kills 245 ppm

Heart disease kills 80 ppm

[1] https://webappa.cdc.gov/sasweb/ncipc/leadcause.html

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

#317

Post by CydeWeys »

timr wrote: post #312
CydeWeys wrote: post #268

Earlier quoted context omitted.

Yeah, the worst vaccine mortality rate ever was still not remotely as bad as that, and you're not considering that a vaccine given to a 20 year old is helping to protect all the other people said 20 year old comes into contact with, who will have substantially higher mortality rates from COVID.

"Yeah, the worst vaccine mortality rate ever was still not remotely as bad as that" Citation required.

40 million people got it, only 25 died: https://www.latimes.com/archives/la-xpm-2009-apr-27-sci-swin...

I'll leave the math as an exercise for the reader, but that's a really low mortality rate, orders of magnitude less than even young healthy people who've gotten COVID-19.

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

#318

Post by blackflame7000 »

takeda wrote: post #277
blackflame7000 wrote: post #73

Earlier quoted context omitted.

I think Trump’s sarcasm is lost on some people and thats why they dislike him so passionately.

It's quite amazing how people twist to pretzels to explain some ridiculous statements by the president, because no way person that I support would be this stupid. Then you have people posting pictures of "UV infusions" and others saying it was sarcasm. Like if sarcasm in that context makes that statement any better. Besides, no matter how you slice this, that wasn't a sarcasm[1]. There is a reason why his daily brief…

The twisting of logic is by you, a person incapable of recognizing absurdity as a joke instead of real. You are Poes law incarnate because it serves a political purpose. If I put a gun to your head and asked you to guess whether Trump meant it or not you would say he didnt. You know it. I know it. The only people who dont know it are the people who are uninformed who you hope to sway with your pearl-clutching rhetoric. Anyone with a third grade education those bleachers bad for you. Duhhh

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

#319

Post by takeda »

blackflame7000 wrote: post #318
takeda wrote: post #277

Earlier quoted context omitted.

It's quite amazing how people twist to pretzels to explain some ridiculous statements by the president, because no way person that I support would be this stupid. Then you have people posting pictures of "UV infusions" and others saying it was sarcasm. Like if sarcasm in that context makes that statement any better. Besides, no matter how you slice this, that wasn't a sarcasm[1]. There is a reason why his daily brief…

The twisting of logic is by you, a person incapable of recognizing absurdity as a joke instead of real. You are Poes law incarnate because it serves a political purpose. If I put a gun to your head and asked you to guess whether Trump meant it or not you would say he didnt. You know it. I know it. The only people who dont know it are the people who are uninformed who you hope to sway with your pearl-clutching rhetori…

You're absolutely right, he sarcastically spoke for 3 and half minutes, during a press conference about deadly pandemic, to the clear shock of Dr. Brix (and I'm sure other medical staff, but we only have her on video) and then he stopped doing press conferences, because joke was so great.

But who was the audience?

Dude you voted for a person who managed to bankrupt a casino!

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

#320

Post by blackflame7000 »

takeda wrote: post #319
blackflame7000 wrote: post #318

Earlier quoted context omitted.

The twisting of logic is by you, a person incapable of recognizing absurdity as a joke instead of real. You are Poes law incarnate because it serves a political purpose. If I put a gun to your head and asked you to guess whether Trump meant it or not you would say he didnt. You know it. I know it. The only people who dont know it are the people who are uninformed who you hope to sway with your pearl-clutching rhetori…

You're absolutely right, he sarcastically spoke for 3 and half minutes, during a press conference about deadly pandemic, to the clear shock of Dr. Brix (and I'm sure other medical staff, but we only have her on video) and then he stopped doing press conferences, because joke was so great. But who was the audience? Dude you voted for a person who managed to bankrupt a casino!

Trump has created over 500 business with about 4 of them going bankrupt. Last I checked 2/3 businesses fail. Atlantic City has a lot more problems than bankrupt casinos. The entire state is democrat run (Corey Booker Anyone?) and it's not like Trump's casino is the only one to fail in AC. Conversely the Trump hotel in Vegas is doing just fine even without a casino. That kind of ruins your whole Trump is inept argument on the casino front or else that one would be bankrupt too regardless of location.
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