If you dose people with a new vaccine, you’ll need to monitor them 6 months at a minimum. 12 months would be better.
It takes 3 months to nail down the protocol and for all the sites to be ready. Then you start recruiting and for a vaccine, you’d want a large population (reflects usage). So assume 6 months to recruit 1000 people. They don’t all start at the same time, so if you’re tracking for 6 months, it will probably take 9 monthsfor the last person to finish the trial.
Then you need to analyze all the data you collected, so another 3 months. Then the FDA takes 3 months to review and approve.
There is a TON of work that goes into running a clinical trial.
> Then you need to analyze all the data you collected, so another 3 months.
Help me understand this. You vaccinate 1000 people. In 6 months, the number of them that get sick is 10% of the rate of the unvaccinated. 0.1% have a bad reaction. How much more analysis do you need?
> the FDA takes 3 months to review and approve
How much time if that is moved to the front of the queue and all hands work on it? Given how enormously disruptive the coronavirus is, we cannot afford to not have all hands working on it.
Then in terms of the trial, 6 months would be nice, but it wouldn't be ethical to actually expose them to the virus. You'd simply need to recruit a very large number of patients and see if the treatment groups has less disease than the non-treated group. With infection rates pretty low across the entire population, you'd need to recruit thousands, just to capture the handful that actually get exposed.
Then when it comes to analysis, you need to clean the data (yes, there will be errors), then you need to do a statistical analysis of not only efficacy but every possible side effect. You're probably measuring things like viral shedding, so that's another entire dataset. Oh, then you'll have missing data. Do you toss that patient's data out entirely? Or keep them? What impact does that have on your conclusion?
I could go on and on, but suffice to say it's a ton of work. And yes, you can speed up some parts, but other parts you just have to let them run their course.
I believe the magnitude of this pandemic will in time push us (rather violently) to think outside the box.
If you're testing a drug for a serious cancer, then there is a lot of tolerance for side effects - the alternative is death, so even if it causes things like nerve damage, it's an acceptable risk.
With vaccines, you're going to treat a huge percentage of the population and they'll be healthy when you give it to them. As such, the risk-benefit analysis is much different since there is a chance for serious harm.
And so on. The exact rate could be set according to the actual infection and death rates in the population. Given the current costs of curfew, we could create an entire government agency just to administer this, and still save trillions.
For inspiration, consider the Manhatten project.
How do you test the efficacy if you don't know who you're injecting? Maybe it works really well on a certain population, and reacts harmfully to people with some pre-existing genetic trait or condition. You wouldn't know, because you took a random set of volunteers.
If you're going to counter and say "we'd still do the pre-analysis on the volunteers"... Well, that's what takes time.
You could do that time-consuming screening after they get the trial vaccine, not before. After all, I suspect it is highly unlikely that a virus vaccine would give someone a bacterial disease or a genetic disorder.
Also, before the 6 month trial is up, you're still going to have data trickling in that will give a good indication whether it's working or not.
Source: I saw the movie "Contagion" and learned that a vaccine is considered safe and effective based on one monkey not getting sick. I believe everything celebrities tell me.
Ok. So let’s say you give the vaccine and run the tests later. This person’s white blood cell count is way above normal.
Is that caused by the vaccine? Was it something else? Was it always there? You have no idea because you didn’t capture a baseline.
The challenge of clinical trials is you don’t know what to expect, and you’re measuring effects on top all the stuff that’s happening in the background with completely healthy people.
The goal is to capture as much data as possible so you can actually draw conclusions from it. Otherwise you’re left thinking “it’s probably the drug, but I’m not sure”.
Normally, yes. But this isn't normally - here the goal is to get a vaccine as quickly as possible.
For example, white blood cell counts. Draw the blood, set it aside, inject the vaccine. Then get around to testing the blood. You save what, a week that way? That's a big deal.
Based on your descriptions, it seems that a lot of time can be saved by doing things concurrently rather than serially.
Other people may have a different risk/reward calculation.
I wonder if the downvoters fully understand that Covid-19 is a big deal. If we don't manage to eradicate it and it becomes as common as the (various strains of) cold, we will likely take a big hit to global life expectancy. It may also evolve to become more virulent and we may yet discover various unpleasant things about it. Even if it stays exactly as it is now and we just let it run it's course and get 70-80% of world population infected, before eradicating it in say two years time with a vaccine, we will eat a huge, multi-year dip in life expectancy in the developed world.
And clearly, we are not accelerating this yet in ways that are completely safe (e.g. would we have more and better volunteers faster and more regularly if we paid them more than $100 for each visit?).
There were news today that first subjects are getting the experimental vaccines already. I don't know if it's fast enough or not. But I doubt people will not try to speed things up, at all levels.
"Although far behind, the United States did work hard to get a jet into the air during the war. Lockheed was engaged to build a jet fighter, using the British De Havilland Goblin engine. Speed was called for, and Lockheed gave Clarence L. “Kelly” Johnson full authority for the project. He set up his special unit, the famous “Skunk Works,” with 23 engineers and 105 shop men, and he did 96 percent of his own fabrication and all inspection. Lockheed's normal development procedure of engineering conferences was by-passed; only 700 drawings were made; sometimes parts were made from a drawing, and sometimes the reverse was done: simplicity was Johnson's keynote. The XP-80 cost only 63 percent of the XP-38 prototype, which had been made by the customary system of development. It was accepted by the AAF only 143 days after the start of development, even though the engine had not been on hand until the 132nd day. After General Electric had designed an improved Whittle-type engine, the 1-40 or J33, the XP-80A was designed around it: the United States had a jet fighter and one of the best aeronautical designs in its history by the end of 1945."
"The most telling criticism of massed-manpower engineering practices is the record of the “Skunk Works.” Starting with the XF-80, this technique has been used periodically by Lockheed's Kelly Johnson to produce the U-2, the JetStar business jet, and the A-11 (F-12). The XF-80, it will be recalled, used 23 engineers and was designed in 143 days; the U-2 also used 23 engineers and took 80 days; the JetStar used 41 engineers and took 241 days; Johnson used 135 engineers to build the A-11, which was designed to go over Mach 3 at 20 miles high. This contrasts with the 3,500 engineers used to build North American's XB-70, which went Mach 3 at 15 miles high. Although it must be acknowledged that none of these aircraft are large, the XF-80, the U-2, and the A-11 all pushed beyond the state of the art, and the repeated success of the “Skunk Works” shows that effectiveness of the system is no fluke."
"The Jetmakers" by Charles Bright (yes, my dad)
Think about it - 23 engineers and 80 days for the U2. Kelly Johnson knew how to get things done.
Though, if 1% of your planes have issue that causes them to stop working midflight after 1 year, at worst you'll lose a few pilots and fix the issue by inspecting rest of the planes.
Backtracking and fixing issues after giving a vaccine to millions of people is a bit more problematic. Not just technically, but also in gaining the trust back, etc.
Is there a type of screening that requires you to do tests over a period of more than a week, because you need the results from some slow tests to order other slow tests? If you just exclude all the people that need unexpected additional tests, is that so many it will ruin the data?
A vaccine could compromise one's immune system and indirectly cause that bacterial disease or genetic disorder. That would be its side effect too.
Besides allergic reactions and contamination, the oral polio vaccine can cause polio:
3 days? That's really aggressive.
This is speculative but what process would you expect them to follow for these next steps of expanding the scope of testing volunteers?
Would they prioritize higher-risk people like medical? Older people? Healthy people? Some random combo? Volunteers?
There are going to be a lot of volunteers.