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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

#201

Post by DoreenMichele »

SpicyLemonZest wrote: post #197
talentedcoin wrote: post #170

Earlier quoted context omitted.

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.

I honestly fail to see a connection between your statement and mine.

I don't generally drink alcohol and I have a permanently compromised immune system, so hanging out at bars isn't some normal part of my life. So I don't understand what you feel is so essential to "here's when we'll open the bars."

Also, a bar up the street from me has already re-opened and (when they were just doing take-out beer) I posted a photo of their take-out beer sign to the local subreddit I run at some point, even though I don't personally drink. So please don't take this as me being a tea-totaller who is dismissing alcohol when I say "I don't get it. I honestly don't get it. Can you please clarify?"

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

#202

Post by refurb »

onetimemanytime wrote: post #105
takeda wrote: post #76

Earlier quoted context omitted.

especially right now, a failure when so many are paying attention (and large part of population is now anti-vaxers) could actually ruin the company.

should have added that that the vaccine has very limited $$ potential (can't charge a gazillion for it due to bad PR and competition) and most makers have hundred billion brands that can be ruined by this. So they aren't going to risk their company for this. Lastly, suppose Acme Pharma released it against all common sense, all over the media scientists would talk against it, so lose-lose.

This! I have some experience with the big pharma companies and they are risk adverse, even when it comes to PR. They often have billions of dollars coming in from approved products, and they are often more worried about that existing revenue than any potential future revenue.

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

#203

Post by junipertea »

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.

You are, if you manage to blame the other party for sabotaging you.

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

#204

Post by refurb »

nfw2 wrote: post #179
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…

I can see why it may take years to determine if the infection rate has been significantly lowered. But what is the timeline for determining if there are serious deleterious symptoms? If we get to the point where we know a bunch of vaccines are safe, but not necessarily effective, could these be approved for anyone who understands the risks?

Adverse events are monitored continuously as long as the patient is still a part of the trial (which often extends past approval).

Once the product is approved, the FDA has an adverse event monitoring system that collects reports and analyzes them for signals that might imply a previously-unknown adverse event.

Of course it take more than just one case to for a new signal to be identified (unless it's really obvious like the patient dies right after getting the vaccine), so sometimes it may be a year or more until there is enough data to say "yes, we know nearly all the risks associated with this vaccine".

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

#205

Post by refurb »

blumomo wrote: post #139
eCa wrote: post #122

Earlier quoted context omitted.

It should be in everyone's (and certainly the manufacturers') interest that the vaccines actually are safe.

Past has shown that it wasn’t. See swine flu vaccinations.

No vaccine is 100% safe. That doesn't exist.

The real question is the risk/benefit profile. Does the benefit of the vaccine outweigh the risks. That was a "no" for the swine flu vaccine since the outbreak fizzled out quickly.

If tens of thousands were dying every month from the swine flu, then the vaccine may have still be worth it even with the GBS side effect.

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

#206

Post by nfw2 »

mumblemumble wrote: post #195
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.

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 periods.

To answer the safety question I assumed you would wait some X period of time and evaluate the incidence of severe side effects that may have been caused by the vaccine. This analysis wouldn't be dependent on results to the control group. I assume this analysis can be sufficiently done with the current phase 3 trial data we have based on Fauci saying the only thing we are waiting for is events in the control group.

I didn't consider the potential safety issue that the vaccine could potentially make the vaccine worse. This safety analysis would also be dependent on control group events.

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

#207

Post by BurningFrog »

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.

I completely agree.

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

#209

Post by talentedcoin »

SpicyLemonZest wrote: post #197
talentedcoin wrote: post #170

Earlier quoted context omitted.

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.

Idk. I think framing the problem in this way is missing a huge piece of the problem. Just because people want or demand a thing doesn’t mean that we as a society are going to be able to deliver it.

I think we need to think seriously about the fact that, even if COVID goes away, lockdowns like this could become part of the “new normal” (?) anyways. And by the time that happens a lot of affected businesses will already be gone or have to change.

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

#210

Post by takeda »

Vysero wrote: post #8
anamexis wrote: post #4

Earlier quoted context omitted.

It sounds like her opinion is that she will defer to trained virologists.

That's completely beside the point. What I asked is, why should I care what her opinion on the mater is? Why was this quote included in this article? Also it doesn't "sound like" that at all. You could not possibly make that judgment based on the two sentences included in the quote.

The 1976 swine flu vaccine was similarly rushed and look how it turned out.

I trust scientist to provide something that is safe, but if their decisions are overridden by a politician (doesn't matter whether Republican or Democrat) that is something that seriously dissolves that trust.

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