[BurningFrog]

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.

[rrrrrrrrrrrryan]

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.

[Wowfunhappy]

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.

[emiliobumachar]

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

[BickNowstrom]

I think a lot of ammo for anti-vaxers comes from the government and media not being completely honest about vaccine side-effects. That's because it is difficult for an individualist or a socialist to separate public health from individual health. The CDC is not your personal physician. The CDC worries when newspapers publish facts about vaccines, such that some vaccines can cause severe and traumatic side effects, while being 52% effective, because they worry about obtaining herd immunity and need people to accept the vaccine for that. They want you to go through weird little side-effects, like not enjoying alcohol for months, so you don't infect a senior they count in the flu statistics. It's when "do no harm" means sacrificing the lives of a few to save the many.

Then there are political and funding concerns. If your own government funds your research to investigate if Agent Orange is harmful to the point of culpability costing billions, you are very careful and delicate with your conclusions. If your vaccination tests show that black Africans show more severe adverse effects, or that, maybe yes, the connection between vaccination and (worsening of) autism is both plausible and understudied, what do you do? For them its a single kid, maybe 2-3 in 100.000 which will start to suffer from autism years earlier, and a disease eradicated. For anti-vaxers, it is their kid.

Essential workers and at-risk people are first in line to receive the vaccine. The hope was availability in September, and public rollout in the beginning of 2021.

The anti-vax conspiracy mud has completely destroyed online information about this subject. There are more such subjects, where it is very difficult to find what the anti-activists are freaking out about. For instance, my gut tells me that physical and mental torture can be effective to obtain useful information. That that's why the mob, military, and police mainly use it for. But, online, nothing: torture is completely ineffective for the first 10 pages of Google. The Holocaust is another obvious one. 5G rollout ("completely safe, maybe, we don't know for sure. Improved Youtube streaming is important tho!"). Or try to find information on how the riots created a spike in infections. All news sites report on the same non-peer reviewed non-scientific institute paper, saying the riots caused spikes is a lie, yet the paper clearly postulates that riots increased infection for black participants and their families, but taken on the whole, they likely caused non-protestors to stay at home more for fear of violence and this reduced virus spread.

[ethanbond]

Yeah, um, the point of trials is to find out what those odds are.

They can easily be much, much, much worse.

[shajznnckfke]

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 possible that there’s some side-effect that doesn’t show up until t+1 months.

Further, we could build an expression of our estimate z of the total harm caused by the virus (including downstream harms like “deaths of despair” from economic damage). By minimizing y-z over t, we can find out the best time to release the vaccine (maybe to the most at-risk populations first).

I don’t think anyone at the FDA is doing this calculation. I think they are just trying to get y below some threshold, which is probably quite low compared to z. My goal in this conversation is to advocate for the people who will suffer and die because of that gap - and hope there is someone better qualified than me that fills that role in the government helping decide what to do. My fear is that the FDA is a highly conservative institution using processes that aren’t well-adapted to the current epidemic.

To add more color, I think if the vaccine comes out with unexpected side-effects, heads will roll at the FDA. But no heads will roll at the FDA over the many thousands who could have been saved by releasing a vaccine sooner.

[hilbertseries]

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.

[nfw2]

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.

[saalweachter]

Also, what the reduction is risk of catching the disease in question is.

[Robotbeat]

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.

[BurningFrog]

I completely agree.

[seanmcdirmid]

The death rate for the syndrome is 7.5% according to wiki, so maybe 40 deaths?

https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_sy...