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Comment by dcolkitt | Hacker News Reader

Hypothetical question. Imagine if for some reason everyone in the trial received the vaccine on a rainy day (maybe it occured in Seattle during a bad patch of weather). The vaccine shows immunity, but we can only be sure for a population that got it on a rainy day.

Now we're distributing the vaccine, but the bottleneck is that we have to keep waiting for rainy days. It's especially bad in Arizona and Nevada. Is your contention that we keep the rainy day requirement? Even when all are scientific and empirical priors tell us that the effect is de minims.

The example is kind of silly, but it makes my point. There's literally countless number of factors that go into any trial. There's no possible way that the way treatment is deployed in the field will exactly match the way it was tested. Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements.

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> Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements.

They certainly do. And the FDA, a collection of the leading doctors, scientists, and public health experts, just told you that two doses is the regimen. Is there something that you know that these experts don't?

Considering that the FDA let thousands of Americans needlessly die because they delayed the approval hearing to enjoy a relaxing Thanksgiving weekend... Yes, I don’t trust their judgement.

As for more general critiques, there’s mountains of evidence that the FDA is too risk averse, even before Covid.

https://www.hoover.org/research/fdas-risky-risk-aversion

Setting aside my deep visceral reaction to what you're suggesting, how is it safe or productive to conduct a review on a Friday evening at the end of a long week and not sleep or eat until it is done? Do you have any reason to believe they would make more or fewer mistakes doing so? And what's your personal policy on making really important decisions while sleep deprived? Would you, for example, get some sleep before signing a contract on a house?

If anyone only ever made decisions while they were perfectly fed and rested, this would be a sad, slow, boring world, because nothing would ever get done or decided. There is such a thing as urgency, and people do work beyond a 35 hour work week with evenly spaced meals, and especially during a global pandemic.

Specific to this instance, this FDA meeting was a formality -- they had already had the data for two weeks to review. The efficacy was well-known. They chose to take a 4-day holiday (Thursday, Friday, Saturday, Sunday).

People don't all of a sudden sign house contracts. They've germinated the idea, spent weeks or months working through the pros and cons, talking to their life partners and family and agent and mortgage broker. The decision is made well in advance of the actual contract signing, and all the red lines are done before you get to the actual meeting to sign on the line. Similarly with the FDA regulators, they weren't meeting to review the data for the first time and come up with a decision on the spot. This was one final step in a very long process.

The application was submitted on November 22 and the review meeting was not scheduled until December 10. The UK, not exactly a country known for taking reckless medical risks, approved the Pfizer vaccine eight days earlier than the US despite receiving the application at the same time.

While nearly ten thousand Americans died, I guess the FDA was “catching up on its sleep”. Eight long days of glorious sleep!

And yet, regardless of your own personal feelings and beliefs, here we sit, locked in our little worlds which have been shrunk down to the space inside the walls of our homes, with a government mandated two dose regimen as you scream helplessly into the wind like an obese turtle on its back screeching for help. Because we're going to Follow the Science that the government and experts have decided is Correct. So stop complaining, stay the fuck inside, and quit questioning the science because you half-dosers are really starting to sound like antivaxxers and antimaskers all of a sudden.

A lot of ad hominem and hysterics, for someone who continuously dances around the very simple question. What is your prediction for the effectiveness of a single dose regime?

Because if it's over 50%, then the math is very simple. First doses must go first. Here's my simple proposal: I bet you $500 that the first peer-reviewed study to specifically test one-dose mRNA Covid-19 vaccines finds at least 50% effectiveness.

Talk is cheap, and I'm sure you get a lot of upvotes on Reddit and Twitter by sprouting some "Follow the Science" hashtag. But actual people's lives are on the line, so if you won't even risk a little bit of money on your beliefs, stop risking people's lives.

Your proposal is highly unspecified. I suggest that you should add a durability term or the 50% effectiveness is meaningless. That is, for how long do you suspect there to be at least 50% effectiveness?

Are you trolling? This is a comically slavish attitude towards "science," but sadly one that all too many people have.

Now replace "FDA" with "FAA" and "two doses is the regimen" with "the 737 MAX is safe."

737 MAX is a debacle all right, but FAA actually has a stellar track record as far as government agencies go, and is respected worldwide. Or replace FAA with NTSB.

There is nothing special with these two dose regimens. It's just what was decided to try for the first studies.

3-4 weeks are quite short intervals for booster shots, picked because of the urgency of getting results, not because it's optimal from a medical standpoint.

> FDA, a collection of the leading doctors, scientists, and public health experts

FDA is primarily a regulatory bureaucracy, tasked with enforcing federal law in this area. The incentives it is under do not always align with optimizing public health.

Are they "leading" because they lead in expertise or because they control the reigns of regulation?

I'm not sure I would describe the FDA as optimistically as you do - they are a collection of federal employees, leaning heavily on private industry expertise to navigate the demands of politicians, the expectations of the public, and needs of businesses.

I think the analogy to your example is to have conducted a larger trial where the dose was given under different weather conditions, or in the case of the real vaccine vary the timing of the 2nd dose. I agree, if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low, we should do what will save the most lives. This is an emergency.

" if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low"

Experts do not agree.

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