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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

#221

Post by hilbertseries »

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…

I don’t think your fear is well founded. The fact that these vaccines are already in phase 3 trials, despite being developed earlier this year, is a testament to how much the FDA understands the current situation. Look up how long it usually takes a vaccine to get from development to phase three trials, I can guarantee you it’s not six months. People in this thread are quite alarmist. Vaccine trials usually take a long time, because whatever is trying to be cured isn’t a pandemic. In a pandemic you can run trials and get results quickly in a large area. Any side effects of these vaccines are going to show up quickly, it runs through your bloodstream and then your immune system takes care of it. We’re running large phase three trials and we’ll have a sense of effectiveness and general safety in a few months.

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

#222

Post by ralph84 »

ISL wrote: post #213
jrochkind1 wrote: post #208

Sure, who even needs a regulator if pharmaceutical companies will just promise not to bring products to market unless they are "safe and effective".

Looming in the background are torts. If vaccine makers are forced to race ahead of safety in order to get to market and one turns out to be insufficiently safe, the manufacturer may get sued into the ground. By agreeing not to jump the safety protocol, they are continuing to both limit their liability directly (by ensuring a safer product) and adhere to best-practices (which might help in a future court case).

It's been decades since vaccine makers had any liability for their products in the US. That hasn't changed with COVID-19.

https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...

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

#223

Post by gamblor956 »

warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

EDIT: Downvoting someone for asking questions, even if based on a false premise, is completely shameful, especially when there's no claim to fact and it's clearly not made to be inflammatory.

A lot of inflammatory topics are raised by asking questions based on false premises.

If you assert that a vaccine is more likely to kill/injury you than the disease it prevents, it is more than reasonable for others to assume you that are trolling rather than satisfying your curiosity, especially since you could have asked it in a different manner: what is the risk of being injured/killed by the vaccine compared to the risk of being injured/killed by the disease itself?

And nobody knows the answer to that question, yet. That's why they're doing the Phase III trials right now.

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

#224

Post by DoreenMichele »

SpicyLemonZest wrote: post #212
DoreenMichele wrote: post #201

Earlier quoted context omitted.

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…

I guess I'm not sure how to respond. It's not about bars specifically; it's about returning to an environment where people are free to crowd about if they'd like. As long as there are top-down rules to micromanage where I can go and how many others I can go with, the problem isn't solved. "Maybe we should just get used to those rules" isn't a solution - in all but the hardest-hit areas, the rules are most of the prob…

top-down rules to micromanage

I don't operate that way. Generally speaking, that's antithetical to how I operate in life.

I think if we have more support for remote work for people who want/need it and more support for options like Little Caesar's pizza portal which allows for contactless take-out, that helps make life possible for the most vulnerable people. Given how long people are living and our success in keeping alive a lot of people with incurable conditions who need permanent accommodation, this doesn't impinge on the people who want to do a group activity.

If anything, it frees up space for them to have their group thing without so much exposure to random people so their group thing is safer to attend.

I had someone on HN say something to me once about wanting to "hug their mom" and how my comment on HN was somehow antithetical to that. I live with my two adult sons and I have a permanently compromised immune system. I feel strongly that being exposed to "your group" is generally less problematic than being exposed constantly to random stranger with god-knows-what other strains.

I'm not at all arguing for denying people the ability to go out. I've, in fact, been given hell for making statements about not liking mask mandates and not liking the lock down.

My Walmart is closed at night right now and before it closed I and my sons were managing germ control in part by doing a lot of our shopping at 2am when the Walmart was dead. And that's not possible now and going to Walmart is currently one of the most hazardous things we have to do.

So I'm not all interested in doing what you are seemingly arguing against. And I don't see how it has anything at all to do with what I am advocating for and stated above.

Edit:

I feel like you added this after I began typing and I didn't initially see it: "Maybe we should just get used to those rules" isn't a solution - in all but the hardest-hit areas, the rules are most of the problem!

I don't disagree with that. Reading into my statement that I am advocating for "just get used to the rules" is wildly misinterpreting my comment. I said nothing about accepting our current lock down rules at all.

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

#225

Post by CydeWeys »

timr wrote: post #123
shajznnckfke wrote: post #92

Earlier quoted context omitted.

Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19. My concern is that there’s an agency whose job is to minimize the risk of harm from a covid-19 vaccine, but not an agency whose job is to balance the risk of harm from a vaccine with the ongoing harm from not having a vaccine.

"Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19." This is a case where the media hysteria surrounding the risks of Covid isn't helping anyone. If polling is to be believed, the general public significantly overestimates their personal risk of mortality from the virus: https://us.beyondbullsandbears.com/2020/07/28/on-my-mind-the... As noted by the link above, the vast majority of that risk…

> It would be tragic, for example, to see any serious side-effects from a vaccine in people under the age of 20, who have essentially no risk from infection.

They have little risk of death if they have no comorbidities, but even for a 20 year old, just getting COVID-19 is likely gonna be worse than the side effects from almost any vaccine imaginable. I've had vaccine side effects and I've had COVID and I'd take ten more vaccine side effects over one COVID, please.

There's also the fact that vaccines are never 100% effective and that herd immunity is important, so the 20 year old still needs the vaccine to protect the older people they may run across. So even if the 20 year old is personally somehow guaranteed an asymptomatic, no-damage infection from COVID, they still need the vaccine. Vaccines don't just protect you, they protect everyone else, and a large part of their efficacy in reducing total population mortality is through these herd immunity effects, not just from protecting the individual people who've been vaccinated.

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

#226

Post by Robotbeat »

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.

They can’t easily be “much, much, much” worse for a vaccine that has already been through orders of magnitude more screening than the Swine Flu vaccine.

The Precautionary Principle cuts both ways, and I think this breaks peoples’ brains.

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

#227

Post by refurb »

nfw2 wrote: post #216
refurb wrote: post #204

Earlier quoted context omitted.

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…

Sure, that makes sense. My comment was based on Fauci's recent comments saying approval could happen as soon as next month if there are enough infections in the control group. It seems to me that what he is implying is that the risk of long-term side effects would not be worth blocking approval of a vaccine if the vaccine proved to be effective in preventing the virus.

Gotcha. Yeah, that timeline seemed really aggressive, but I would hope that the FDA uses it's standard set of evaluating criteria for any new vaccine. Even though the phase 3 might only have a few months of data, you can pool phase 1 + 2 data as well, which would give you a bit more confidence as to potential long term side effects.

It would also depend on what they approve it for. You could see them restricting it to high-risk patients. In that case the risk-benefit is much better, so you'd be willing to take a chance on some hidden adverse event popping up since you'd be looking at avoiding a significant risk of death from Covid).

At least in my experience, there isn't a set formula for evaluating new drugs. The FDA really does look at every piece of data it can find. I've also found the FDA to be pretty conservative - if they are unsure, they lean towards not approving, or approving with significant restrictions.

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

#228

Post by School-Cotton »

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).

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

#229

Post by SpicyLemonZest »

talentedcoin wrote: post #209
SpicyLemonZest wrote: post #197

Earlier quoted context omitted.

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…

You're not entirely wrong, but the flip side of the coin is that people won't comply with a rule just because we as a society would like them to. People will lock down for immediate severe outbreaks, as they used to for polio, but the longer lockdowns continue the more people will just say "no" and ignore them.

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

#230

Post by ISL »

ralph84 wrote: post #222
ISL wrote: post #213

Earlier quoted context omitted.

Looming in the background are torts. If vaccine makers are forced to race ahead of safety in order to get to market and one turns out to be insufficiently safe, the manufacturer may get sued into the ground. By agreeing not to jump the safety protocol, they are continuing to both limit their liability directly (by ensuring a safer product) and adhere to best-practices (which might help in a future court case).

It's been decades since vaccine makers had any liability for their products in the US. That hasn't changed with COVID-19. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...

I signed a waiver for a non-approved yellow-fever vaccine in the US recently (supply of the approved vaccine is either non-existent or very limited); there must be some level of testing/certification required before reaching that threshold?
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