Exactly. You can call anything a vaccine if you don’t care if it works or is safe.
Wait, wait, I suddenly see a market opportunity!
- Fill vials with pretty much anything
- ???
- Profit!
Design process analysis suggests eliminating your Step 2.
I believe the traditional nostrum for such purposes is Extract of Ophidia.
I’m sure some regimes could produce a crowd of “volunteers” for rigorous testing. Some pharma firms might conduct tests in a convenient locale without telling [del]victims[/del] volunteers the details. Oh no, that can’t happen now! :smack:
There is a commercial outfit that does trials like that in London. Volunteers in the sense that they aren’t drafted… they get paid to go into quarantine, get exposed, see if they get sick.
Getting paid for taking part in drug trials has for many years been a way of making money. Popular with students.
However, sometimes it goes horribly wrong.
Here is a documentary about one that nearly killed off the participants in London a few years ago.
and these were fit young men.I guess if you pay enough, you will always get participants willing to take a risk.
I saw this! What a story. I had actually heard about it at the time that it happened, and it was a case where everything that could go wrong, did.
In 2014-15, there were reports of significant numbers of people being quarantined for 3 weeks in this or that hospital because of “Ebola exposure”, and it turned out they were volunteers who took the then-experimental vaccine. One of them was the husband of an American missionary who herself got Ebola, and he said the vaccine made him very sick for a few days (other people said the same thing) but it was nothing compared to what his wife went through, and it was a small price to pay to ensure that other people didn’t have to get it in the future.
Rushing a vaccine out could also lead to something like this, where a superpotent polio virus strain that wasn’t sufficiently weakened GAVE people polio.
I think the least dangerous fast track would be to skip the human trials. Do animal trials. Compare the results to previous results at that stage, that matched vaccines that went on to prove to be effective and not dangerous to humans.
Still very risky. But not totally blind.
Here is a detailed article from Science Translational Medicine explaining the ~6 different approaches currently underway toward a CV vaccine, a bit about their progress, and the pitfalls/advantages of each. It’s a long read, but the author also covers the problems with testing and applying the results to large, varied populations.
His take is that a usable vaccine will be available *at scale *in 18 months or so. And that it will probably only work short term (1 or 2 years) but give us time to learn and develop a longer lasting one to be distributed later.
It’s a long article, but well worth the read, imo.
There will be no “red tape” delaying this vaccine. You will know the instant that Gilead (or whoever) patents a vaccine that immunizes people without killing them, because they will media-blitz this fact across cable news and social media 24x7 until they get it approved.
I swear to god, there is no limit of cranks who have zero knowledge of a product or process, but are fully ready to blame “gummint red tape” if it isn’t progressing quickly enough.
Vaccination is not just a medical effort, it is a social effort. There is no such thing as “a vaccine that works” and “a vaccine that has skipped quality or safety trials”. This is like asking how long it takes to produce a zero that is also a one. The question doesn’t even make sense.
To elaborate… let’s say we release a vaccine to 100,000 healthy people, and it turns out to kill 0.1% of them. When that news hits the wire, what do you think happens? Not only do people refuse to take that vaccine, they refuse to take the successor vaccine that actually works and doesn’t kill anyone.
I’ve gotta say it’s amusing to remember Sarah Palin’s inane musings about imaginary death panels in 2008, and put that side by side with conservatives in 2020 gaming out what percentage of ordinary healthy Americans should be put at risk of dying just to get the economy limping again in time for the 2020 election.
A complicating factor is that the people most susceptible to the Coronavirus are the elderly, those with weakened immune systems and those already suffering from existing chronic conditions for which they are being treated.
There is already a problem accurately assessing which deaths are due exclusively to Coronavirus and what part other conditions play.
So how do you eliminate these variables when testing a vaccine?
I guess it would need a very large test to eliminate all the variables.
Better to start with fit young volunteers. Give the vaccine to half of them and a placebo to the rest. Then deliberately infect all of them with Coronvirus and compare how many vaccinated and unvaccinated show signs of infection and any other reaction attributable to the vaccine.
This kind of virus seems to be challenging to investigate because there are some people who are be infected but not show any symptoms. Was it the vaccine that protected them or their own immune system? Testing a vaccine on vulnerable groups and then deliberately infecting them would, I expect, suffer from a distinct lack of volunteers.
How are they going to do these tests?
I seem to remember that in the UK they had for many years a ‘common cold research unit’ that offered free holidays in the countryside for a few weeks as long as you were willing to be infected with a cold virus - another kind of Coronavirus.
There are typically at least two phases of human tests, safety and efficacy. I don’t know how they will test safety – who can you ethically test it on?
If they can find medical personnel who are still antibody negative for coronavirus, they would be an obvious group for the efficacy tests.
When they have a vaccine that’s known to work without killing people, it will be approved. That’s what the approval process is for. They probably will still media blitz it, because advertising, but it won’t be necessary.
I had done it for about 9 years [stopped when I was diagnosed with cancer, now I can’t do anything except provide an autopsy subject unless there is a very specific study my oncologist wants me to participate in]
I did various aspects of the flu vaccination every fall [ranging from which type I got to how it was given - those damned airguns STILL hurt!] I did one on guaifenesin in combination with something else [pill options were both placebo, guai+placebo, mystery component + placebo or gia + mystery drug - I can’t remember what they combined it with. I was able to tell them by taste which ever pill I got, it definitely had guaifenesin in it by taste ] I have done other odds and ends, though my roomie got a serious big bucks one - Ebola - 18 months, $1800 plus the normal medical visits - in general it will always be beginning, middle and wrap up, but she also got one visit a month. Anything vaccinationwise starts and ends with a titre.
I did an audio guinea pigging for the Navy’s study on something or another for sonar, I have exceptionally excellent high and low end hearing - it was wonderful spending most of a summer sitting in an air conditioned sound booth at $18 an hour =)
Red tape is not an evil entity. It’s there for a reason. You do want it in place, especially in a situation like this.
Without “red tape” I can concoct a vaccine in my home biochem lab in a matter of hours. It will kill you but that’s a minor side-effect - your COVID will die too. Unless scavenger squirrels carry it to others. Damn squirrels…