I see the 18-months timetable frequently quoted, but that’s taking into account all sorts of red tape and bureaucratic hoops to jump through.
Suppose all the red tape were done away with and the government essentially gave vaccine manufacturers a free hand and vast amounts of funding, and said “Who cares about vaccine quality or patient safety or all that usual stuff - just get us a Covid-19 vaccine that works” - what’s the absolute soonest it could be ready?
How do you get a vaccine that works without caring about vaccine quality?
On Joe Rogan, Michael Osterholm implied he could make one overnight, but it probably wouldn’t be safe.
12-18 months is pretty much the no-red tape timeline. It is red tape and other things, such as production, that drag the normal timeline out to many more years. Of course “red tape” also means “making sure it is safe and that the company/lab did everything they’re supposed to so we know it works,” it isn’t just bureaucratic interference for the sake of obstinance. There is a balance between regulatory restrictions and speed of development, and it is legitimate to argue it is too far to the regulatory side in normal times, but the proximate threat of SARS-2 changes the balance considerably.
It is NOT a Hollywood scenario of a hero scientist having the cure, and an evil pencil pusher standing in the way of releasing it. It takes time to see if a vaccine is safe and if it works. For example, it may take the immune system several weeks to produce enough antibodies to be immune. It could take several months after that to find out if people who got the vaccine get sick at a lower rate than a control group. Usually that testing would happen before production was ever considered, but for a SARS-2 vaccine, production problems will be addressed while the vaccine is being tested. That will greatly speed things up if it works.
Of course, 12-18 months assumes that something being tested and trialed now actually works. There is no guarantee of that. None of them may be effective.
And remember, we are going to give it to everyone. So a vaccine with a 1 in 100 chance of horrible side effects is much more destructive than a disease with a 1 in 100 chance of a horrible outcome.
I had no idea Antibody-dependent enhancement (ADE) was a thing, but the wikipedia article is worth a read if you’re interested.
I have wondered this myself. I saw the movie contagion the other day, and a researcher gave herself a vaccine then exposed herself to the virus. Sometime later they were doing lottery based distribution of the vaccine, though I don’t know exactly how long, or if that is even realistic. The disease was considerably worse than covid-19 though, so I imagine a lot of red tape got slashed that maybe would not happen with covid-19.
Obviously they are already doing human trials on covid-19 vaccines already, so no need for a dramatic researcher-infects-herself scenario.
That’s also not a controlled trial. And it has a test group of 1. You cannot generalize from a group of 1. There are all sorts of reasons for a person exposed to the virus not to get sick, besides the vaccine. Especially if she didn’t test herself for a titer first (I haven’t seen the movie); it’s just that with any infection, she needed to make sure she didn’t have a prior asymptomatic exposure that left her immune. And you can state a priori that this virus doesn’t have any asymptomatic people infected, but I can’t suspend my disbelief for that. There’s no way to know that without performing a titer test on EVERYONE.
Literally anything can be asymptomatic. Strep throat can be asymptomatic. It can also have nothing but but behavioral symptoms (PANDAS), or have no symptoms until a rash (scarlet fever) appears. Polio can be asymptomatic. Hell, cancer can have no manifestations that the person feels-- I had an aunt who had stage 4 breast cancer, and had absolutely no idea until she had an x-ray for a dislocated shoulder after a car accident, and they found out it had metastasized. She did self-exams, and got mammograms, and never found anything. I walked around on a broken ankle, and had no idea I’d broken it. I was 16. I didn’t find out I’d broken it until I was 41, and had an x-ray for a sprain, and they asked me why the old fracture had never been set. It must have been the “bad sprain” when I was 16, because there was no other old injury it could have been.
Anyway, they can slash a lot of red tape-- there was some legislation passed in the US called the “Orphan drug act,” IIRC, in the late 1980s. It allowed red tape to be cut for drugs that existed, but had not gone through testing to make them available, that were known to be effective for rare diseases, and were never going to be available for people with those diseases, because there was no way for a company to recoup the cost of testing in developing a drug for a rare disease.
Remember, though: the red tape is what kept the US from using thalidomide for nausea during pregnancy, as many European countries did.
The red tape has a reason.
So, in the case of an emergency, we maybe able to dispense with some things, on the model of the Orphan Drug Act, but we can’t call “killing people” red tape. There’s only so much that can be dispensed with. Especially when talking about a vaccine given to healthy people, as opposed to a drug given to people already ill.
Without “red tape” it would take far longer and produce worse results. More people will die. Not just due to the delay but also due to taking an unsafe vaccine.
You either do it exactly right and things go very wrong.
“Making” the vaccine is easy and quick. There are numerous vaccines for COVID19 already made. I’m not a vaccine guy and even my lab could make one in a month or so.
The “Red Tape” that you refer to is also known as “Testing the Vaccine for Safety and Efficacy”. There is no way to speed this up sooner than 12-18 months. You want you know: Will it kill someone? Will it protect them? Will it make the disease worse? Will it have unforeseen latent effects? How long is it protective for if it works? Etc etc etc.
You can’t speed that up. You’ll kill people (potentially more than the pathogen on its own). 18 months is f*cking fast, to be honest.
With regard to the question In the OP, I’m trying to wrap my head around the idea of a vaccine that «works» when we don’t know anything about the «vaccine quality» or «patient safety»?
I’m not having any luck with that mental gymnastic.
Be brave. Take that experimental vaccine. Sign the waivers first. And order some memorial. My dad’s name is on a brass plate on a wood bench in his favorite botanic garden. Brave vaccine volunteers should at least get a plaque.
Several people have clarified that testing and certifying a vaccine does indeed take 12-18 months. I don’t know if that timeline includes the actual production of large quantities of vaccines. A friend of mine works for one of the major vaccine companies. They start work on next year’s flu vaccine a year or more out from when they need to have the vaccines ready to go. Part of that is predicting and modeling next year’s strain, because they can’t know yet what will hit. (This is why some years the flu vaccine is better than others.) A lot of time is needed to actually manufacture the vaccine as well, and not just in terms of producing the liquid in bottles for distribution. The steps in actually putting the pieces together into the vaccine are not as simple as mixing cake ingredients.
Kudos to Bill Gates to funding 7 different teams and production facilities so that we can get parallel development. I’m sure there are many, many other teams working on the problem as well.
We had a thread recently about whether each of us would get the vaccine as soon as it became available (presumably meaning it was approved, not that it was in trials, though some addressed that as well.) And I keep thinking about this question and this idea of “red tape,” as though clinical trials are just a waste of time. That attitude really scares me, and would scare me a lot more if I had reason to believe anyone actually in charge of developing and testing these vaccines held that attitude. I don’t have the background to understand precisely, in detail, how we know that vaccines are safe and effective. I’m no dummy, but I’m a lawyer, not a doctor. We can’t all be experts in everything. But I understand enough to feel confident that there are grown-ups in charge, and so I get all the recommended shots and boosters, including an annual flu shot and, hopefully someday, a coronavirus shot. If given the chance, I’d even consider participating in a clinical trial. But if I got the impression that someone like the OP was in charge of development, I might become an anti-vaxxer overnight. Good luck determining whether your vaccine works once you’ve lost the public’s trust.
How long we been working on an AIDs vaccine?
Time needed to create a vaccine varies fairly unpredictably.
It’s research, not a rote recipe.
The people who insist on ‘red tape’ are the same ones who put seat belts in cars, warnings on cigarette packets and do stress testing before building bridges…
What are the chances that we will never get a vaccine that works? I assume that since we think that 12-18 months is the expected value of the time from now that we will have one, there must be some probability of “never”.
There was a time when the Hollywood versions of Dr. Jekyll & Mr. Hyde seemed silly. In them (they have pretty much identical scripts, all based on the stage play, not on the book), Dr. Jekyll takes a potion that splits the good and bad impulses in his mind (which seems less implausible now than it once did, but nevermind), making him “all bad.” He was going for “all good,” initially, but got a rush off the bad experience, and indulged in it a few more times, then the transformations started happening without further doses of the potion.
It’s seeming less ridiculous now than it was 40 years ago.
Anyway, don’t uses yourself to experiment on. At best, it’s an article in The Journal of Irreproducible Results.
I’d volunteer to be one of the test subjects in a proper study. Just how often do you think people in supervised clinical studies DIE from the drug?
Well, there was the example of Spock with a goatee, and Uhuru! They certainly made a good case for plausibility in semi-modern times.
“RED TAPE” eventually got around to saving us all from COX inhibitors.