Edward Jenner’s experiment had some serious ethical problems to say the least. He gave his gardener’s son cowpox and a few weeks later administered smallpox variolous material, multiple times.
(After he came of age, Jenner gave the lad a cottage to live in. Nice I guess).
NOW I AM NOT ADVOCATING WE DO SOMETHING LIKE THIS**.
The question is, if someone did something similar, injected many different [del]undesirables[/del] vounteers with all the candidate vaccines and then exposed them to SARS-COV-2 multiple times (here lad, breath this aerosol i**n) wouldn’t it cut down the estimated timetable considerably?
And if so, isn’t there a chance that some unscrupulous type might do so anyway?
We have the medical skills to test directly for antigens, so we could bypass the “here lad, breath this aerosol” step and endanger them less without losing efficacy of testing.
We could shortcut the prelim safety testing and start injecting volunteers with every candidate vaccine, I guess, and just hope that none of the formulations end up provoking lethal systemic allergic responses or actually give them COVID or whatever.
No matter how many corners you cut, you still need to test for wide ranging safety and efficacy, and that simply takes time. It’s not sufficient to know that there are no side effects after 30 days. 9 women can’t have a baby in 1 month.
We have vaccines now. They’ve been developed. We need to know if they’re safe and effective.
There are some discussions being held surrounding the ethics of doing Phase III challenge trials for vaccine candidates. If you assume the hypothetical, that you will completely disregard ethical considerations, then such a trial has the potential to determine short-term efficacy in a couple of months instead of the 12-18 (or whatever) months the Phase III studies intend.
This still does nothing to speed up safety testing, though. So even if you have evidence of efficacy, your death rate would have to be pretty severe for you to pull the trigger and roll the dice on any unknown medium-to-long-term effects.
Part of the issue is that, even if you compress the testing phase, there’s no guarantee this one, or the next one, or the next one, will work. So it seems we’re looking at a minimum of 4 months from the time they actually hit upon the winning formula.
But it sounds like the ethical issues with human challenge trials might not absolutely prelude them from happening. I wonder if anyone here would volunteer.
There are a lot of people who might volunteer, and in particular, people who are likely to be exposed in the course of their jobs anyway, e.g. medical workers, first responders, and people who are working in grocery stores and essential businesses in a customer-facing role. The problem with a rapid challenge trial without initial safety trials is that a bad vaccine can actually make things worse, and by worse I mean take people who might just suffer a mild case of COVID-19 and put them into an uncontrollable cytokine release storm on top of the ethically dubious action of deliberately exposing people to a live virus when we really cannot tell who will have a critical reaction to it.
While what Edward Jenner did would not be considered remotely ethical today, we do need to put it in the context that there were no effective treatments for smallpox once the disease was contracted, smallpox outbreaks routinely killed in excess of 10% of the population, and Jenner was testing the thesis that cowpox inoculation could protect against acquiring smallpox which had already been demonstrated as both generally safe and demonstrably efficacious (even when the vaccination didn’t fully protect the patient the symptoms of the illness were much less pronounced and rarely fatal), so in a sense, he already had the information that we would get out of vaccine trials, albeit not as quantitatively demonstrated as we would demand for a modern trial. Jenner was neither operating in a blind rush to a cure, nor did he take a risk of doing even greater harm than smallpox epidemics were already doing; he observed the phenomenon that milkmaids did not appear to contract smallpox in any significant quantity, formed the hypothesis that exposure to cowpox provided prophylactic protection, and then tested his hypothesis.
One thing that should be borne in mind is that a challenge trial would likely be restricted to people who have a minimal risk of contracting a serious case of COVID-19, e.g. young adults in their 20s or 30s with no underlying health issues or co-morbidities, and thus, the vaccine would only be approved for those same groups or a modest expansion thereof, and not for the most vulnerable populations. Later, more thorough non-challenge trials (where people are inoculated and then allowed to contract the virus through normal interactions) could expand that use but it isn’t as if a single challenge trial is going to make the virus approved for the entire public, and especially if the vaccine trial results in more fatalities or persistent detrimental effects (e.g. the 1954 polio vaccine Cutter incident or the 1976 ‘swine flu’ vaccine that was more damaging that the influenza epidemic it was intended to stop) and causes people to resist vaccination even for a proven vaccine. We have all of this so-called ‘red tape’ for a reason, and that reason is so that people have good reason to trust medical science instead of Dr. Oz’s Miracle Quack Potions and porcelain vagina eggs promoted by an actress-cum-wellness guru, and we’re having enough problem with that mind of alternative (non)medicine already without feeding the fear with legitimate harms.
Jenner skipped over the rigorous testing phase, no double-blind assignations of test subjects.
As Stranger said above, the relative safety and efficacy of his vaccination was already determined by the milk maids.
Jenner also got a head start in that the “vaccine” itself was already available. Jenner did not have to isolate particles of the virus and coax them to grow on various media, then find a method to kill or disable the virus. He got to skip all that tedious work, and merely had to scrape goop from a juicy cowpox lesion and transfer the stuff to a waiting patient.
Opportunity doesn’t always arrive in a 24-carat gold carriage.
We should also remember that in Jenners day, there was an established practice of trying to prevent smallpox by innoculation using a lancet dipped in a pustule from a current smallpox sufferer. On a healthy subject, the reaction to exposure was found to leave the patient with long term immunity. This procedure was established back in 1715 after it was introduced to the court by the wife of the ambassador to the Ottoman empire, where it was common practice. It did however have a 3% failure rate and patients could suffer from smallpox and other nasty diseases that donors may be suffering from.
Jenner’s vaccination was therefore a refinement of an existing practice and intended to avoid some of these side effects. In his day inoculating a young patient with smallpox would not have been regarded as ethically dubious. It was long since done on members of the royal family. Though the accounts of how the aristocrats, the great and good, were convinced that the procedure was safe enough back in 1718 involved experiments on prisoners and orphans. I guess the context is the hideous toll that endemic smallpox took on all levels of society at the time, it really was a horrific scourge.
I guess it is a case of assessing which is the lesser risk. With smallpox it was fairly clear cut. Covid-19? Much less so.
Jenner started with a single, relatively strong natural candidate with known safety/efficacy which he had to “simply” (not that it’s ever simple) verify.
Not several dozen untested candidates with unknown efficacy or side effects. And he wasn’t experimenting willy-nilly with just any treatment that came into his mind on anybody and everybody.
Forget [del]undesirables[/del] volunteers, if we came across a golden egg like that, people really would be jumping at the chance to test it on themselves. People are jumping at the chance to test the candidates we already have.
Do a Google Images search on smallpox. (only for those with iron stomachs)
That will help you understand the desperation of the people to avoid the disease. We have no grasp of the reality then: the body is completely covered, no space between the lesions. Add fever and pain, residual scarring, possible death.
Along with “variolation,” (using the matter inside the lesions), people also had “Smallpox Parties,” where a snuff container was passed around. It held scabs from a smallpox patient.
Nonetheless, despite the threat of smallpox, Jenners’ cow pox vaccine was too novel for some.
I have no doubt that testing a vaccine sufficiently to detect any problems in order to ensure public confidence in its safety will weigh heavily on the minds of the developers. It is highly regulated by the FDA, EMA and other medical authorities around the world. Many potential vaccines fail to make the grade in terms of safety or effectiveness.
Given the race for a vaccine, I wonder if these high standards will apply everywhere. Some country may decide that it is in their interest to accept a lower standard of safety testing in order to win the race. Governments are very mindful that they cannot sustain the level of economic support during a lockdown for more than a few months. They will simply run out of money and a vaccine is the key to restarting the economy.
Thank you. Twenty years here and there is still stuff for me to learn, or mentally retrieve from a lifetime of accumulated information. F’rinstance, I learned that the OP was talking about EDWARD Jenner, not Bruce, and I thought there were some steps I’m not willing to take to be healthy. Of course, the difference is that he hasn’t taken that step, either, and l’ve been Corvidized.
Yeah, that isn’t remotely ethical, and any challenge of Constitutional protection against “cruel and unusual punishment” would shut that down promptly. I know the typical view is that people who are in prison deserve whatever happens to them, and there are certainly some people who would beat serve this world by leaving it, but our current “prison industrial complex” has taken to incarcerating people with long sentences for literally victimless crimes such as marijuana possession or effectively institutionalizing people from disadvantaged backgrounds for youthful crimes that people from more privileged backgrounds could buy their way out.
Let’s not descend into the kind of dystopia where we experiment on prisoners because we can, please.