We’ve got a guy here in Australia who’s got a dozen vaccine candidates in his lab, with one lab worker feeding the mice. He’s talking to the press begging for money: if he had more money, he could hire more lab workers, run more mice, and cut back to 8 hour days.
Yeah there are a lot of different efforts. Media and stock-picking or short term market reaction attention tends to be on one at time, but it’s not a matter of deciding if one will succeed. If so the chances per history would be pretty low. But it’s a lot of efforts, the pharma research priority (along with COVID treatments) worldwide.
Moderna insider selling doesn’t tell you anything about that particular effort IMO. The medical benefit of a drug and profit potential for the company developing it are two pretty different things. This is a common dilemma in incentivizing expensive development of drugs for diseases with low revenue potential (rare or tend to hit eg very poor countries). In this case there’s an obvious shareholder interest in being the company which helped beat this disease, from a reputation POV, plus internal morale and sense of purpose of research staff. Doesn’t mean it will make a lot of money. Various investors including insiders could well be expressing opinions about the profit aspect, you own stock seeking profit, not because they think the medical news is wrong or overhyped,.
Anyway I personally believe it’s now pessimistic to call ‘12-18 months’ a super best case. Plus, time flies when you’re sitting around…well not actually but it’s close to 3 months ago that ‘12-18’ became the standard talking point in democratized mass punditry. An effective vaccine in enough quantity to make a difference by the end of 2020 is IMO now the realistic best case. 18 months from now has become a relatively pessimistic case, though later is possible and ‘never’ still can’t be ruled out.
The main part of the total timeline to wide availability of safe effective vaccine which can be compressed is manufacturing development (learning how to manufacture it in quantity) and then going ahead with mass production. Normally a profit making entity can’t risk going on to that step without knowing they have a winner. But govts in an emergency can contract for mass production of multiple reasonably likely candidates before knowing which if any work safely, and just throw away the mass quantities of the ones which don’t pan out. That part can be done in parallel at risk of losing $'s. The safety and efficacy testing itself can’t necessarily be compressed.
What do you base this on? Even given that the clock should start on the 12-18 months in March - or even February - that still doesn’t get us to end of 2020.
I don’t understand this to be the case - I understand having enough data on both the efficacy and safety from a large enough number of trial subjects to be the issue. Since we can’t just expose everyone in the trial to COVID-19 in a blinded way (ethically), you have to wait for enough trial subjects to encounter COVID-19 in the wild, which will take a certain amount of time (not a handful of weeks), and you also have to have enough time to rule out long-term side effects from the vaccine. I’d love some authoritative cites on the compressed timeline here, if you have a scientific basis for your beliefs.
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Actual progress in terms of the number of efforts generated worldwide and some positive results. 12 months was an estimate not knowing those things, not an absolute minimum written in stone (though it could still be longer than that, or longer than 18 months, and ‘never’ still can’t be ruled out). Reasonable best case is end of the year IMO, not expected case necessarily.
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I don’t understand that response. I said, the safety and efficacy testing, what you are describing, can’t necessarily be greatly compressed. What can be definitely be compressed, by doing it in parallel, is developing the mass production method (a separate development) and implementing it before you know the vaccine works. Normally you don’t have a widely available vaccine the day the safety/efficacy trials are declared a success, but some months later. Because you only begin to devote serious money to developing and implementing a mass production process once you know it’s going to be worth it. Doing safety/efficacy and mass production development/implementation in parallel is only financially practical if somebody is willing to contract to buy it in quantity whether it works or not (and have to throw it away and get nothing for the money if it doesn’t). Normally even the govt isn’t willing to do that, but will be here to some degree at least.
So is end-of-year just a gut feel, or can you show/cite your work here?
I get your point, thanks for clarifying.
I agree that if you’re willing to do the bulk manufacturing in parallel, knowing that you may throw away the entire product if the testing doesn’t pan out, that you can shave whatever is the manufacturing time off of the timeline. And I agree that we, as a society, should absolutely be willing to do that for any of the promising vaccines. What I don’t know is a) whether manufacturing time was actually included in the 12-18 month timeline or b) if so, how much of the 12-18 months it represented.
It is possible we will simply fail to develop a useful vaccine at all, you realize? Why are you acting like it’s inevitable and the “pessimistic case” is in 18 months? I wouldn’t trust glowing news reports based on enthusiastic researchers overly much. Lots of stuff looks great on the chalk board or even in the lab testing that never works in the field.
Who is this in reply to? I think both Corry El and I have stated in this thread that we see ‘never’ as a possibility.
I don’t understand for the life of me what any of this is based on. Eighteen months is really, really fast to produce a working vaccine from scratch for a type of virus for which no vaccine has ever been created. It’s incredibly optimistic.
I understand that a lot of the research is built on what was done for SARS 15 years ago, so they’ve had a bit of a head start.
Vaccine candidates became available almost as soon as the virus was described. Within a week or two. Then testing in glass, then getting enough quantity to test in mice, then inoculating mice, waiting for immunity to develop, exposing to infection, waiting for infection to develop … most if the candidates haven’t yet got to the stage of testing in humans to see if they all get sick and die from the vaccine, and even if they get funding for that, are still a long way off from testing to see if they give immunity in humans. Most of the candidates will never get funding.
Knowing a lot more about the development of vaccines got people through the first week in only a week – that’s why it’s only taking a year or two to develop a vaccine. I don’t know how fast they’ll be able to rush the next stages, it will be interesting to watch.
The problem is that the 12-18 month estimate is made presuming that the Government and industry will have set up production lines and infrastructure for multiple candidates, essentially eating the cost of the failed candidates.
Some of the candidates are using an amplification technology, which means they can go from start to full availability in a couple of weeks if they happened to get approval.
It was in response to Corry El. Yes, he gives lip servce to “never” as a possibility - “it can’t be ruled out”. Meanwhile inside of 6 months is a realistic best case.
Well, if it all works out I will happily admit to being overly pessimistic. They are still at the “does it work/kill people” stage, though. We had a little miracle story up here in Canada. A company had a rapid test for the virus that would gives results in <45 min. Got rushed approval and was going to be a key part of reopening plans. Flunked out in the field.
For example, “Fauci says vaccine possible by end of 2020”, May 27 interview, ‘Nov-Dec if everything goes right’ IOW realistic best case, not necessarily expected case and certainly not worst case which is that it no effort pans out in the near term.
They’ll be made. And tossed if they don’t get approved. Or sit waiting for approval. Company gets paid either way I guess. Taxpayers buy it approved or not.
If passes phase 2 then phase 3. Phase 3 30,000. All over 18. No kids. Not really enough to break down much by demographic cohorts. Seems small to look for uncommon adverse outcomes in lower risk groups. Hope they weight to the vulnerable so they can at least prove safety and efficacy for them.
Yeah, this is my reading, too. I haven’t been able to find an actual transcript, but it appears Fauci is saying that they’ll have “a couple hundred million doses” manufactured, but he wasn’t commenting on the testing timeline.
DSeid, you say 30k is low for a phase-3 trial. What would you expect to see here? How long does a phase 3 trial normally last?
He said:
“We’re going to start manufacturing doses of the vaccines way before we even know that the vaccine works, so that by the end of the year the prediction of the statistical analysis and the projection of cases indicate that we may know whether its effective, efficacious or not by maybe November, December, which means that by that time we hopefully would have close to a 100 million doses,”
May have the doses, may also know by then whether they are effective. He didn’t specifically say ‘safe’ but that’s generally established earlier. He’s saying realistic best case is vaccine available for use in meaningful quantity late this year, I believe.
At risk of repetition that doesn’t mean it couldn’t end up with the doses available but not cleared for use yet, or ever. It’s also possible the doses aren’t available even if that’s the plan.
Proving safety is where the big n is needed. Vaccine efficacy doesn’t need as many.
Kid vaccine phase 3 trials can have 30 to 70K kids to demonstrate safety before approval. Harder yet for a germ in which rare delayed adverse impacts are concerns.
How big is big enough depends on frequency of the infection and of adverse outcomes in the group. Less frequent infections and less frequent adverse outcomes needs more enrolled. Testing as rates are dropping means bigger n needed. Younger adults with less frequent death or serious disease from the germ need bigger n to prove safety.
Time also varies. Several months is pushing it. Years not unheard of.