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They could not even test themselves to see whether they developed immunity against SARS-Cov2. All we know is that someone sprayed something up their nose and ho

They could not even test themselves to see whether they developed immunity against SARS-Cov2. All we know is that someone sprayed something up their nose and hoped that it actually had the effect that they wanted. This is the catch.

dcolkitt 6y ago
But the point is, even if there's a 1% chance that this plausibly works, the government should be throwing money at bio-hackers like this. Or at the very least exempting them from the regulations that stand in their way. Very likely these moonshots won't work. But they're still dirt cheap relative to the economic impact of Covid. If there's a way to disrupt the current slow approach to vaccine production, we should be exploring it. Find a few thousand smart, maybe insane, biohackers. Give them each a $100k grant. Give them total immunity from FDA regulation. Free them from all the bureaucratic and ethical shackles that slow down establishment science. At a cost of $300 million, even a 1% chance that one of them figures out a way to double the rate of vaccination, constitutes a 1000%+ return on investment.
- jiofih 6y ago
  If they have total immunity from FDA regulations, how are you going to be confident it actually works and is safe at scale? The regulations are there for good reasons. I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials.
  - dcolkitt 6y ago
    > I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials. The vaccine trials were drastically slowed down by the regulations against human challenge trials.
    - namesbc 6y ago
      Not true, HCT would not have speed up the deployment of the vaccine by even one day.
      - will4274 6y ago
        Err.. why not? Not sure how asserting this without explaining why helps. From my understanding, Moderna made their vaccine in a day in early 2020 (https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...) and HCT basically means deliberately infecting people. One day to make the vaccine, four weeks for it to take effect, infect everybody, four weeks to see who gets sick - that's 2 months to make and test a vaccine with HCT. It took us 11 months without HCT.
        tzs 6y ago
        You still need the phase I trial to determine that it is somewhat safe, the phase II trial to determine that it is somewhat effective for some people, and the phase III trial to see if it is safe and effective on a large diverse population and to characterize side effects. If you were dealing with a disease that is rare so that it might take a long time for enough people in phase II or III to get exposed to it naturally, an HCT might be able to cut the amount of time you need for phase II and maybe phase III. With COVID, there should be enough people getting exposed naturally to make that unnecessary in phase III and probably in phase II. What an HCT might do for a COVID vaccine is let you figure out early that your vaccine does not work. That might let you abandon an ineffective vaccine during phase II instead of not finding out it doesn't work until after you have spent a lot of time and money on phase III.
- _Microft 6y ago
  Everyone loves an underdog but I can not imagine that this could possibly work. Why do you think bio-hackers could come up with something that thousands of smart people in the industry could not? The money would almost certainly be better spent on upgrading production facilities in advance and starting vaccine production long before approval. This has the risk that they might need to trash everything if the trial is not successful but in the case it is, production has a headstart.
  - monkeypizza 6y ago
    Your argument may be too strong - you're suggesting that big companies or the professional class of responsible people always does things better. But HN is founded on many examples of that not being true. i.e. if your argument applies word for word against Semmelweis (who advocated hand-washing) or doubters against other earlier amateur vaccines, it it will fall victim to what we now know about those older cases, when the at-the-time experts were wrong. In this case I wouldn't say that the reason this kind of research is valuable is anything related to medicine per se - but more that it can show the value of the much lower liability level he operates in, and how it means that amateurs can make massive cuts in preparing and defending from lawsuits. Example: if a company realized that only food-quality ingredients were required, not lab-quality, would it be worth it for them to justify that to the FDA and spend millions on it? probably not. My hypothesis for what's going on in general in medicine is this effect times a thousand, at every stage of development.
- Avshalom 6y ago
  1% is not the lowest percent.
- namesbc 6y ago
  Or, this has a 0.0001% of working, and a 20% chance of developing an autoimmune reaction that kills him.
- CJefferson 6y ago
  We don't need more vaccine candidates. We had high-quality vaccine candidates at least 9 months ago. What we need are: (a) The ability to produce hundreds of millions of doses. (b) Tests that prove (as convincingly as we can) that the vaccine are safe. I don't see any evidence that anyone has any idea how to do better at either (a) or (b).

dcolkitt 6y ago

But the point is, even if there's a 1% chance that this plausibly works, the government should be throwing money at bio-hackers like this. Or at the very least exempting them from the regulations that stand in their way. Very likely these moonshots won't work. But they're still dirt cheap relative to the economic impact of Covid. If there's a way to disrupt the current slow approach to vaccine production, we should be exploring it. Find a few thousand smart, maybe insane, biohackers. Give them each a $100k grant. Give them total immunity from FDA regulation. Free them from all the bureaucratic and ethical shackles that slow down establishment science. At a cost of $300 million, even a 1% chance that one of them figures out a way to double the rate of vaccination, constitutes a 1000%+ return on investment.

jiofih 6y ago
If they have total immunity from FDA regulations, how are you going to be confident it actually works and is safe at scale? The regulations are there for good reasons. I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials.
- dcolkitt 6y ago
  > I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials. The vaccine trials were drastically slowed down by the regulations against human challenge trials.
  - namesbc 6y ago
    Not true, HCT would not have speed up the deployment of the vaccine by even one day.
    - will4274 6y ago
      Err.. why not? Not sure how asserting this without explaining why helps. From my understanding, Moderna made their vaccine in a day in early 2020 (https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...) and HCT basically means deliberately infecting people. One day to make the vaccine, four weeks for it to take effect, infect everybody, four weeks to see who gets sick - that's 2 months to make and test a vaccine with HCT. It took us 11 months without HCT.
      - tzs 6y ago
        You still need the phase I trial to determine that it is somewhat safe, the phase II trial to determine that it is somewhat effective for some people, and the phase III trial to see if it is safe and effective on a large diverse population and to characterize side effects. If you were dealing with a disease that is rare so that it might take a long time for enough people in phase II or III to get exposed to it naturally, an HCT might be able to cut the amount of time you need for phase II and maybe phase III. With COVID, there should be enough people getting exposed naturally to make that unnecessary in phase III and probably in phase II. What an HCT might do for a COVID vaccine is let you figure out early that your vaccine does not work. That might let you abandon an ineffective vaccine during phase II instead of not finding out it doesn't work until after you have spent a lot of time and money on phase III.
_Microft 6y ago
Everyone loves an underdog but I can not imagine that this could possibly work. Why do you think bio-hackers could come up with something that thousands of smart people in the industry could not? The money would almost certainly be better spent on upgrading production facilities in advance and starting vaccine production long before approval. This has the risk that they might need to trash everything if the trial is not successful but in the case it is, production has a headstart.
- monkeypizza 6y ago
  Your argument may be too strong - you're suggesting that big companies or the professional class of responsible people always does things better. But HN is founded on many examples of that not being true. i.e. if your argument applies word for word against Semmelweis (who advocated hand-washing) or doubters against other earlier amateur vaccines, it it will fall victim to what we now know about those older cases, when the at-the-time experts were wrong. In this case I wouldn't say that the reason this kind of research is valuable is anything related to medicine per se - but more that it can show the value of the much lower liability level he operates in, and how it means that amateurs can make massive cuts in preparing and defending from lawsuits. Example: if a company realized that only food-quality ingredients were required, not lab-quality, would it be worth it for them to justify that to the FDA and spend millions on it? probably not. My hypothesis for what's going on in general in medicine is this effect times a thousand, at every stage of development.
Avshalom 6y ago
1% is not the lowest percent.
namesbc 6y ago
Or, this has a 0.0001% of working, and a 20% chance of developing an autoimmune reaction that kills him.
CJefferson 6y ago
We don't need more vaccine candidates. We had high-quality vaccine candidates at least 9 months ago. What we need are: (a) The ability to produce hundreds of millions of doses. (b) Tests that prove (as convincingly as we can) that the vaccine are safe. I don't see any evidence that anyone has any idea how to do better at either (a) or (b).