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...
If possible, basic efficacy testing is done on non-human models, either in vitro or animal models. For species-specific viruses, this is difficult and may be impossible. I'm not sure what if any such testing was done with the SARS-COV-2 vaccine candidates.
A basic safety test with dosages thought to be low enough not to present any risks. The goal here is simply to see what if any side effects occur. Any comorbidities, no matter how unrelated, are reported. Note that these may occur in a control / nontreated population, so the key isn't "individual was treated, had condition", but "there is a statistically robust difference in rates of co-morbidities between treatment and control populations" In normal circumstances, such safety testing may take a year or more, and data reporting are ongoing through drug development and use.
Efficacy is determined, where groups treated are assessed for whether or not the drug provides any measureable effect. Note that this can range anywhere from "provides 100% immunity from infection" to "cancer patient dies a horrible painful death 2 weeks after control group". (If you're familiar with cancer research, it is rife with very marginal "positive responses" to therapy. Yes, with some spectacularly better instances.)
Finally, dosing is dialed in to find out how much and how often to deliver the drug. That's how we're ending up with single vs. double innoculation recommendations, and/or boosters, and wait times between dosing. Again, multiple groups followed over time.
All of this takes time. Since COVID-19 has a course of about 1--2 months from exposure to resolution (you get better or you die), and vaccinations have a lead time of about 2 weeks after second dose to full efficacy, that's about four momths just to get baseline measurements.
A typical drug study might have as few as 30--60 patients, though many have more. In the case of the SARS-COV-2 vaccines, trials were much larger as I understand (I don't have data or reports in front of me, so don't take my comments here as significant.)
If there's earlier research to build off of (e.g., mRNA base models of solutions and methods) then some of this process can be based on earlier research, which helps.
But you're still looking at 6--9 months before a vaccine can be recommended with strong assurances even under highly expedited conditions. Given circumstances, health authorities might be willing to operate more quickly and with less data, but those decisions would have to be considered preliminary and subject to revision. Revised understanding around COVID-19 has been highly problematic around the world, leading to trust issues and opportunists spreading disinformation.
And once you have a candidate treatment, you've still got to produce and supply that, with manufacturing and logistics considerations, all of which were evident in the rollout of existing SARS-COV-2 vaccines (e.g., production issues, patent licensing, quality control, storage and refrigeration, cold-chain management, patient contact, scheduling, and follow-up, etc.).
It's complicated.
Source: Some ancillary PHARMA related work in the past, eccelctic interests.
One of those manufacturing / logistics consideration was "we need to make a lot of high quality, sterile glass that can withstand the temperatures that the pharmaceutical companies are saying they're going to be using for transport."
Corning was part of Operation Warp Speed - https://youtu.be/asDKBi5Ungc - they had to build a glass plant to make 0.5B vials/year.