[legutierr]

It would have been much faster if regulators and ethicists hadn’t been so squeamish about challenge trials.

In order to save dozens of lives that might have been lost in challenge trials, we sacrificed hundreds of thousands of lives so that we could wait for more ethically-sound vaccine trials to complete.

[ajsnigrutin]

The problem are the vaccine mandates.

If you (soft or hard) mandate a vaccine, and you kill someone with it, that's a lot of responsibility to take, if the vaccine didn't go through a full trial.

If the vaccines were as optional as eg. flu vaccines are, then a simple waiver would solve most of the issues.

(a 20yo girl died in slovenia due to jannsen vaccine not that long ago, and she got vaccinated, becase she was soft-forced by the government mandates (48 hour testing, far away from home, but unable to use the bus without a test, to go to the testing site, 12eur/test,...).

[ericb]

Your reply is totally off-topic for the parent you replied to.

[dfabulich]

I see why you're saying that, but I think you missed their point. Challenge trials might well allow us to make a safe vaccine available sooner to those who want it, but if we mandate a vaccine that has only undergone challenge trials and then that vaccine kills someone, it would certainly be politically disastrous for challenge trials.

[Wowfunhappy]

Challenge trials are dangerous for the people who participate in the trials, but they aren’t any less rigorous.

[dfabulich]

I agree! But it would still be a political disaster if something does go wrong.

[Wowfunhappy]

This isn’t about opinions!

In a normal trial, you give half of participants a vaccine, and half of participants a placebo. Then, you wait around and see how many people in each group catch COVID naturally and get sick. Your vaccine works if fewer people who received a vaccine get sick compared to the placebo.

In a challenge trial, you give half of participants a vaccine and half of participants a placebo, and then purposefully expose them all to COVID so you don’t have to wait around for them to catch the virus naturally. As before, your vaccine works if fewer people who received a vaccine get sick.

A challenge trial gives you data which is more, not less, robust, because you’re controlling for more variables between groups. And we’ve used challenge trials to test vaccines in the past—just, never with a disease that’s nearly as deadly as COVID.

Any firestorm would result from a trial participant dying from the COVID they were purposefully given (which could absolutely happen), not from the vaccine. This has nothing to do with vaccine mandates.

[sjg007]

Challenge trials have nothing to do with adverse side effects in the original clinical safety trial. We also have good proxies for challenge trials for COVID.

[mrtnmcc]

You just make vaccine optional and only mandate once enough data is available.

[ericb]

I think there were some edits after I replied.

[daveguy]

Pointing to one person's death and claiming a specific cause... I assume you have very specific autopsy evidence to prove it?

[ajsnigrutin]

Yes, I do.

Well, not me personally but a "five-member commission, namely, three doctors (neurologist, infectologist and vascular specialist), a pharmacologist and Zoran Simonovič, a representative of the epidemiological profession" has.

https://www.gov.si/en/news/2021-11-30-expert-commission-conf...

> Minister of Health, Janez Poklukar, the head of the regional unit of the Maribor National Institute of Public Health, Zoran Simonovič, professor Borut Štrukelj from the Faculty of Pharmacy, Ljubljana and Maja Bratuša held a press briefing on the current situation regarding Covid-19 disease.

...

> “The commission unanimously assessed that there was a direct link between the vaccination with Janssen Johnson & Johnson and the tragic complication, i.e. the onset of the syndrome”, said Simonovič.

...

> Moreover, he said that he is to propose to the vaccine advisory group to stop vaccinating with Janssen in Slovenia, or to enable vaccination with Janssen only at the explicit request of an individual, who must confirm this with signature. “This means that the currently valid provisional vaccination protocol with Janssen will become permanent”, said Minister Poklukar.

[sjg007]

I think the clinical guidance for younger women (<50) is that they get a two dose mRNA vaccine and not Janssen or AZ for this very reason.

[ajsnigrutin]

Back when I was vaccinated, all four vaccines (pfeizer, moderna, jannsen and astrazeneca) were safe and good for everyone, but there were availability issues with pfeizer on one side, and on the other, jannsen needed only one dose, and you'd get your covid certificate faster (so one month sooner than with pfeizer, and that also means one month less of paying for tests and waiting in long lines every two days when these measures were implemented).

Soon after, astrazeneca was slowly pulled out due to a few deaths elsewhere (not in slovenia), then a wife of our diplomat died in belgium (jannsenn), and the media talked a lot about the hospital procedures, and how she could be saved... then this 20yo girl (from the report) died from jannsen, and we stopped using jannsen too, then scandinavian countries stoped using moderna due to heart issues in younger people, and we're down from 4 to 1 vaccine, with huge mandates that indirectly force you to get vaccinated. ...and the antivaxxers are just waiting for something bad to happen with pfeizer, to show they were right about safety issues.

[sjg007]

It’s more nuanced than that in terms of safety.

[ipaddr]

Were 100,000 of lives lost because of a delayed vaccine? Considering the third world hasn't had access to the vaccine and death rates are lower with delta I'm not sure skipping trials would have done much good.

[legutierr]

Vaccine challenge trials are faster not because they are any less rigorous. They are faster because you are actively infecting people, instead of just waiting for participants to be randomly infected as they go about their lives. You can have a much higher level of reliability with a trial that is orders-of-magnitude smaller, and you can have definitive results within weeks compared to months.

[betwixthewires]

Throwing ethical standards in the bin "for the greater good" is never a good idea.

[legutierr]

Challenge trials can be ethically designed, and they have been used to test vaccines for malaria, influenza, and other potentially-fatal diseases.

https://en.wikipedia.org/wiki/Human_challenge_study#Vaccines...

[maxerickson]

It is a good idea when the ethical standards are bad and get replaced by better ones.