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.
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,...).
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.
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.
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.
https://en.wikipedia.org/wiki/Human_challenge_study#Vaccines...
Yes, we do[1][2].
[1] https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm
8 months is incorrect. Here's[1] an article from 17 months ago about results from Moderna's covid-19 trials for vaccinations dating back to mar16 2020. So it's been 21 months, not 8 (and that's ignoring trials of mRNA vaccines years earlier as they weren't for this specific virus)
[1] https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-...
This is the answer for why not all annual flu vaccines need clinical trials.
Which one?
Here is a pretty good summary of the history of vaccine development.
https://www.medscape.com/viewarticle/812621_1
While nearly all influenza vaccines generate similar antibodies, Covid and influenza vaccines generate significantly different antibodies
Influenza vaccines generate antibodies against influenza Hemagglutinin proteins targeting sialic acid receptors
Covid vaccines generate antibodies for (S) glycoproteins targeting ACE-2 receptors.
In short, we have 80+ years of experience generating antibodies for hemagglutinin, and much less for (S) glycoproteins.
Going forward, the FDA has already said that a reformulation of the mRNA Covid vaccine would face a similarly shortened approval process.
>FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval
https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots...