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Comment by bsimpson | Hacker News Reader

These vaccines were invented a year ago. Especially given the emergency this virus has created, I can't help but wonder how life would have been different if the trials were open to anyone who wanted one.

"This vaccine probably works. We won't know for sure until December. If you want to try it anyway, come get one. Otherwise, we'll let you know when the trials are completed."

It's heartbreaking to think about all of the irreplaceable experiences people missed this year, especially for those who didn't live to see the end of this pandemic. Of course I'm glad for all the people who didn't catch the virus, but the costs are too infrequently considered. Our regulatory bureaucracy was insanely expensive this year in terms of our most valuable resource: quality time. Nobody even questions it; we just accept that this is how it's supposed to work, because it's all we've ever experienced.

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There are real safety risks to testing unknown drugs and the public literally isn’t smart enough to assess the risk to themselves. Everyone would sign up for the test vaccine to get a chance at escaping quarantine without understanding the risk. And if we offered this on a regular basis it is inevitable that a candidate drug would have adverse effects on a large group and people would be out for blood because nobody actually read the fine print.

Here’s a list of examples that shows why the FDA must be deliberate in their testing. People can die or be permanently crippled when we screw it up. Just imagine if we rushed a coronavirus vaccine with a similar safety concern and ended up hurting millions of people before we realized it: https://www.cdc.gov/vaccinesafety/concerns/concerns-history....

The FDA already does have compassionate use exemptions for people that are on death’s door and there are no downsides to taking an experimental drug- they’re dying anyway if it doesn’t work out. I think that’s about the right level threshold for deciding whether to give people unproven drugs and we should not have rushed the vaccines any faster- hindsight may show us that the vaccines are safe but we couldn’t have known that a few months ago. We have to do the testing.

a chance at escaping quarantine without understanding the risk.

Yet it appears that the FDA makes no attempt to understand the downside risk associated with NOT taking the vaccine. I don't see them talking to economists trying to understand what damage will be done to our businesses, and how people will suffer as a result of that; or even of what lockdowns are doing to our mental health. The ONLY risks they're considering are on the side of taking the vaccination.

And this is always how it works for them, both in normal times and during the pandemic. Consider last March, when the CDC's covid-19 test was defective. Despite the fact that the assay is a simple matter that any decent hospital can do in their own lab, the FDA would not allow anyone to do it. That set America's pandemic fight back by a couple of weeks. If we could shift the spread backwards by two weeks, how many thousands of lives would we be saving? The FDA's hidebound refusal to look at both sides is responsible for this.

This probably isn't a situation you want to take a purely economic outlook towards the problem. When the largest at-risk group is the elderly you're not going to see a lot of financial disruption in sectors that keep the wheels moving.

I'm not looking for a purely economic outlook. I'm complaining that the FDA is at the far extreme, with a purely medical outlook, giving no consideration for other factors.

(I should amend that a bit. They've clearly done a lot to streamline their processes for this. But as far as I can tell, they haven't done anything to balance different kinds of risk in their standards.)

The bottleneck is/was manufacturing capacity.

Back in the summer, supplies were much smaller than the current shortage. So it wouldn't have made much difference.

That said, I support drug legalization of all kinds.

mRNA vaccines should become very fast to ramp up production of, since it's an industrial process, not a biological one, but this is the very first time it's done.

> These vaccines were invented a year ago

A single scientist at Pfizer created 10 vaccine candidates in a day. Most worked, but some were less 'tolerated' than others. It's ok to do that in a lab setting, with health care standing by. There are limited resources for trials, you can't easily scale to millions.

Huh? Anyone could sign up for the trial, even after I participated in one I still got calls from countless trial recruiters from other manufacturers. It was quite easy to participate

I'm thinking more broadly than a binary choice in the spring for someone who happens to live near a research lab and have clicked the right Facebook ad.

What if, at any time, you could walk into your doctor's office and say "I'm ready for that experimental vaccine?" You could contribute your data to the pool that increases our confidence in its efficacy. As confidence gets stronger, more people volunteer. Eventually, third party labs (maybe regulators like the FDA - maybe NGOs like the UL) certify that they believe a vaccine is safe and effective, which makes even more people comfortable getting it.

If we had done that, how would life be different now? Could we have closed fewer things? Would more people have led a more normal/less stressful lives? Would we be closer to being done with this mess? How many fewer long-term ramifications (health, financial, social, developmental, psychological, mortal) would people have to deal with?

We reconsidered, reenvisioned, and reinvented so many things this year. Why can't we apply that same mindset here too?

But if you just do the trial you don't know if you actually got the vaccine or placebo.

It’s pretty obvious if you got it or not. Also .... why would you want the trial to not be double blind??

How is it obvious in a trial?

I mean, take the flu shot. The times I've gotten it I've not had any reaction or one so mild I don't remember. Maybe a sore arm? Slightly tired, though that could have been work. I wouldn't personally know until they do blood tests.

Even if you have side effects - outside of a possible sore arm, you wouldn't know it was the vaccine or just unfortunate timing for a virus or something.

You want the trial to be double blind because it means there is less bias: https://www.verywellmind.com/what-is-a-double-blind-study-27....

A friend of mine did the Pfizer trial, and he strongly suspected he had the real thing because he had some pretty strong reactions to it, with flu-like symptoms making him feel awful for a day. He later got an antibody test, and it was confirmed.

I don't know what the poster above was talking about, getting calls to participate in a study. Nobody contacted my wife or I with such offers. I suspect that the poster was lucky to live right in a city where the test was being conducted; those outside of major cities are probably not included in his claim that anyone could participate in the trials.

I know some folks have reactions to vaccines: not everyone does, though. And weirdly, when folks don't know, sometimes the placebo gives them reaction. Pretty much, side effects have to happen more often in the real thing than they do a placebo.

Sometimes it just doesn't work to have double blind: LSD trials, for example, make things pretty obvious. It isn't the case for the flue, though.

You are correct on the trials: most folks don't get called. That said, living outside the city doesn't exclude you from trials in general because they generally need participants with x and/or y. Often, they will pay for expenses to travel, especially if your disease is uncommon or they have trouble finding participants.

that's interesting i didn't think about that! would taking an antibody test be banned for participants? because those who confirm that they received the real shot could change their behavior?

You can get a serology test to see if you have covid antibodies. It really defeats the purpose of the double-blind.

Oh, give me a break. The issue here were the fact that people were willing to break the lockdown, and not wear masks and social distance. All the countries that followed the protocol (larger countries and denser countries) were able to deal with the problem with minimal casualty. That was the real issue. Not this BS “taking too long to approve a vaccine”

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