[1]: https://www.theguardian.com/world/2020/nov/23/coronavirus-sc...
Unfortunately, rules in fields like medicine and aviation are written with blood. Someone gets too greedy or too comfortable and you have large numbers of people death or incapacitated.
We already have large numbers of charlatans preying on the hopes of desperate people, must be very careful not to lower the barrier too much or these might jump too. Even worse, people might be targeted by slick psychopaths and coerced into extremely dangerous things, destroying communities when anything goes wrong.
Hopefully though, some mountains might have been moved and some things might have gotten faster from now on.
There are people out there that won't hesitate to kill any number of people for the hard cash or fame, some did it before and that's how the rules were born. I am sure that some of rules could be revisited thanks to the new tech but portraying it as "rules kill people" is intellectually dishonest or naive.
Look what happened with Boeing 737-MAX. Some businessmen, scientists and engineers will cut corners to get their job "done" and every now and then it will be catastrophic.
It’s just that using the vaccine is an active choice so you run into trouble with ethics.
If exposing a few people on purpose is a moral wrong, then surely allowing millions of them to contract it by accident so that a few people in your RCT can become infected by chance is a moral abomination.
FWIW, ethicists were split, but mostly on board with HCTs. It was mostly the government that was opposed.
Essentially, no one signing up for the trial would have been properly able to give consent, because no one knew the real consequences.
https://www.statnews.com/2020/06/23/challenge-trials-live-co...
Our current testing protocol requires letting the virus rampage through the population before the trials will achieve statistical significance, which is surely more unethical than deliberately exposing a small number of people.
Suppose we replace Covid with "car crashes" and vaccine with "seatbelts". This is a good analogy because crashes are rare and we can't cure trauma (like on Star Trek). It would be absurd to deliberately cause car crashes in order to study the effect of seatbelts. For the experimental group, there will still be some minor injuries. For the control group, many will die.
Phase III trials for each of these new vaccines end long after the efficacy is determined. Estimated primary completion dates are in June 2021 (BioNTech/Pfizer) and November 2021 (Moderna).
Even after the drug is accepted, monitoring for safety continues.
Limiting factor is safety and testing for safety.
They started trials with two people, one gets vaccine one gets placebo. They look for side effects then add more and more people while constantly observing those vaccinated for side effects.
Vaccines are not inherently safe, they are safe because they have gone trough huge amount of volunteer testing. If there are unwanted side-effects, vaccine is withdrawn. Since vaccines work with the immune system, you must look for autoimmune reactions, neurological symptoms etc. Some of them can emerge weeks or months later. With new mRNA vaccines there are even more unknowns.
Emergency authorization they seek means taking calculated risk. With covid-19 epidemic taking that risk is acceptable.
I cannot think of a valid utilitarian argument allowing willing people from getting a vaccine.
First, vaccines have an extremely high success rate, 33% of vaccines make it through all trials to approval. 50% after phase 1 is complete.
The worst vaccine side effect ever is widely considered to be the swine flu vaccine from 60 years ago, where 1 in 100,000 got GBS (a bad disease).
If we knew with 100% confidence that this vaccine was tied for the worst, then if you are over 65 it would be about 1,000x better for you to take this "bad vaccine" versus not.
Each successive trial lost us a lot of time, and very little confidence gain.
The reality is we had many groups all independently find a vaccine that worked in Q12020. It's only the government ban on their use that allowed the pandemic to proceed like it has.
Right now in the US, the FDA has said it is not even planning to MEET on the Pfizer candidate's approval for 3 weeks. Just insane. Then, the CDC says it needs 24-48 hours after FDA approval to authorize it's release. Why can't the meet right now? Why can't the CDC pre approve release? Or be in the meeting and give simultaneous approval? Or be on a phone alert to give approval within 1 hour?
The most likely answer is that in a nationally declared pandemic, any vaccine produced by someone who has gotten a vaccine approved in the last 10 years can sell and distribute (cash only no insurance) vaccines without approval. Require them to collect data on its usage and efficacy. Wait until normal process to require people to be vaccinated.
I think you should check your math. Because covid-19 infection fatality rate is "relatively low", only 10 times seasonal influenza (3X for people in their 30's 15X for people in their 70s) the limit where utility turns negative is quite low.
One purpose of approval is to move responsibility from drug companies to the government. They can just pay small fee for National Vaccine Injury Compensation Program or something similar. If you allow volunteers but they have to pay the insurance from free markets, vaccines become too expensive. Drug companies are not willing to give them.
Biopharma leaders unite to stand with science http://www.news.sanofi.us/2020-09-08-Biopharma-leaders-unite...
>The worst vaccine side effect ever is widely considered to be the swine flu vaccine from 60 years ago, where 1 in 100,000 got GBS (a bad disease).
During the 2009 A(H1N1) influenza pandemic Finnish health system used vaccine called Pandemrix, It was almost exactly the same as Focetria used elsewhere in the Europe but it was manufactured using slightly different method. It caused Narcolepsy for 200 kids in Finland and 100 in Sweden before withdrawn.
First, regarding "worst case side effects", I am willing to accept your premise that elevated rates of narcolepsy was in the 2009 A(H1N1) vaccine was worse, and do some math based on that.
Looking solely at deaths (let alone potential long term health risks of contracting covid). The IFR for those over 75 is about 4.6% now https://www.medrxiv.org/content/10.1101/2020.07.23.20160895v....
If you assume that people had a 10% chance of contracting the disease, you can say that those over 75 would have approximately a 0.46% chance of dying (4.6 in 1,000 dead) if they don't get the vaccine.
If they do get a vaccine, that turns out to be as bad as Pandemrix (I believe your example of the worst case side effects), then you would expect 1 in 18400 to get narcolepsy. (source: https://en.wikipedia.org/wiki/Pandemrix).
So if you are a regulator looking at the elderly population, and you assume this is tied for Pandemrix, then for every 18,400 people you would assume 1 case of narcolepsy if you give the vaccine, and 84.64 dead. (85x by volume).
I don't know your opinion of "how much worse is death versus narcolepsy?". If you believe death is 10x worse than narcolepsy, then by severity and volume, taking a vaccine with the worst side effects ever would seem about 850x better than not taking it (in elderly populations). Earlier in the pandemic, when IFRs were over 2x as bad, this was well over 1,000x better.
If you are getting different math, please let me know, because even using Pendemrix, I cannot seem to justify banning vaccines on utilitarian grounds.
Now I do agree that moving responsibility from drug companies to the government is fine, but I think that can be addressed directly if that is a concern. If the argument is "without government assuming responsibility they would be too expensive", I don't think we have any proof of that, not enough for a ban.
It is the classic "make a baby in 9 months with 9 women" dilemma. There is no way around conducting a trial and waiting long enough until you see what happens to the participants.
A little time could maybe be shaved off by speeding up production. The mRNA vaccines have an advantage here, you can basically use an RNA printer to churn out whatever RNA sequence you need.