Author Topic: Vaccine  (Read 246 times)

downer

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Vaccine
« on: August 03, 2020, 07:08:33 AM »
The issue of the vaccine is big enough on its own for its own thread by now. When will one come, who will get vaccines first, how much will they cost, who will pay for them, who will take credit, who will get rich? Will an effective vaccine be the solution everyone wants? Will Big Pharma act with integrity?

I've already expressed some opinions on the vaccine, and got some pushback.

So I noticed this NYT headline with interest.
 
Scientists Worry About Political Influence Over Coronavirus Vaccine Project
https://www.nytimes.com/2020/08/02/us/politics/coronavirus-vaccine.html

As I said before, I will probably at least wait to see what medical authorities in European countries recommend, since American medicine and the FDA are subject to political pressure. The rush to be first with a vaccine may also lead to rushing the process and cutting corners.

I saw Eric Feigl-Ding on Twitter suggest that there is already an effective vaccine and we don't need to finish Phase IV of trials before making it available.
"Change takes courage." Alexandria Ocasio-Cortez

Treehugger

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Re: Vaccine
« Reply #1 on: August 03, 2020, 07:37:35 AM »
Thanks for posting this. Vaccines have been on my mind today (thanks to the NYTimes article).

I agree about waiting for European authorities to weigh in. But will they have access to the our vaccines? Or will we have access to theirs?

I’ve heard that they are pushing a vaccine in Russia. Apparently, whatever it is, it is just for Russians not for everyone. At least as far I have heard. I am not saying I want that particular vaccine. My point is that maybe the vaccines that are being pursued at “warp speed” here will only be available here just as the Russia vaccine is only available there. And maybe this will limit the European scientists’ ability to comment on our vaccine’s safety & efficacity.

pigou

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Re: Vaccine
« Reply #2 on: August 03, 2020, 08:14:08 AM »
The process of developing this vaccine is revealing flaws in the way we do medicine, but now also affect the lives of the non-poor. There's a whole rant to be written on this, but the idea of doing a medical trial with 50% control and 50% treatment group until you hit a pre-specified endpoint is nothing short of unethical malpractice (in general, not just with this vaccine). We should be running response-adaptive designs with multiple vaccine candidates in the same study. As data come in, we'd learn which vaccines work or do not work and could adjust how new patients are allocated to the various conditions. As new vaccines are ready for trial, they could be dynamically introduced and evaluated.

The old-school RCT is based on the assumption that there's no cost to delaying the best available care, which is obviously nonsense. It survives because MD/PhDs can barely figure out how to run ANOVAs and teaching Bayesian statistics is a non-starter: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1861033

Quote
Accordingly, we replicated the study by Casscells et al1 by asking a convenience sample of physicians, house officers, and students the same question: “If a test to detect a disease whose prevalence is 1/1000 has a false positive rate of 5%, what is the chance that a person found to have a positive result actually has the disease, assuming you know nothing about the person's symptoms or signs?” [...]

Approximately three-quarters of respondents answered the question incorrectly (95% CI, 65% to 87%). In our study, 14 of 61 respondents (23%) gave a correct response, not significantly different from the 11 of 60 correct responses (18%) in the Casscells study (difference, 5%; 95% CI, −11% to 21%). In both studies the most common answer was “95%,” given by 27 of 61 respondents (44%) in our study and 27 of 60 (45%) in the study by Casscells et al1 (Figure). We obtained a range of answers from “0.005%” to “96%,” with a median of 66%, which is 33 times larger than the true answer. In brief explanations of their answers, respondents often knew to compute PPV but accounted for prevalence incorrectly. For example, one attending cardiologist wrote that “PPV does not depend on prevalence,” and a resident wrote “better PPV when prevalence is low.”

This question required simple multiplication and if they can't figure that one out, I have zero faith that we can teach these people about multi-armed bandit problems. But I'm glad there's at least a political push to make the vaccine available more quickly, because wider availability is exactly what that implies given the data we have so far. At this point, I'd immediately take the Oxford vaccine if it were somehow available. (Yes, I've signed up to be a Phase 3 trial participant in the US. I think I'm too low risk of exposure to get invited, although I live in a city with multiple testing sites.)

On the logistics, a vaccine will become available globally for sure, because there's no reason for the company that develops it to enter any sort of exclusive manufacturing agreement (and no reason for any country to ask for that). They'll have partners in the US manufacturing it here, partners in Germany, the UK, etc. While vaccines manufactured in the US will almost surely be distributed within the US first, that's not the same as limiting availability to the US. This manufacturing capacity is already being built for the leading vaccine contenders, because Operation Warp Speed is surprisingly competently run, and the US alone will probably have on the order of 100 million doses before the end of the year.

In terms of pricing, the US paid I believe $25/dose. Who will get rich? I hope the companies that developed the vaccine. Because investments always go to where there are profits to be made, it'd be nice if you could actually make some money with public health for a change. The reason we don't have a vaccine for malaria is that it primarily kills poor people and so nobody is particularly motivated to invest in it. The vast majority of pharmaceutical R&D funding comes from the private sector, not the government.

Edit: Linking an October goal to the election in November is journalistic malpractice that will fuel conspiracy theories. Even if a vaccine became available then, it'd take longer to vaccinate a sizable share of the population and hospitalizations and deaths wouldn't decline until weeks after, making it useless for electoral purposes. The October deadline is the result of a timeline that was proposed early in this year and that vaccine manufacturers are on track for: e.g. Moderna's Phase 3 trial in the US started in July and we should have results in early October. The Phase 3 trial of Oxford's vaccine in Brazil should have results before then.
« Last Edit: August 03, 2020, 08:19:12 AM by pigou »

apl68

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Re: Vaccine
« Reply #3 on: August 03, 2020, 08:31:46 AM »
I just learned that one of our staff members is afraid to take any vaccine that becomes available because she's heard that the government can inject tracers with the vaccine to track your movements.  I tried to tell her that that's not possible.

Liquidambar

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Re: Vaccine
« Reply #4 on: August 03, 2020, 08:59:59 AM »
I just learned that one of our staff members is afraid to take any vaccine that becomes available because she's heard that the government can inject tracers with the vaccine to track your movements.  I tried to tell her that that's not possible.

If trackers were that small, inexpensive, and effective, wildlife research would be so much easier...
Let us think the unthinkable, let us do the undoable, let us prepare to grapple with the ineffable itself, and see if we may not eff it after all. ~ Dirk Gently

Volhiker78

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Re: Vaccine
« Reply #5 on: August 03, 2020, 09:06:05 AM »
Whoever develops the regulatory package first (assuming at least one of the Moderna or Pfizer vaccines is effective) will undoubtedly file simultaneously for regulatory approval in Europe and the USA.  So both regulatory bodies will be reviewing at the same time.  There will be a lot of internal communication between FDA and EMEA. It will be highly unlikely that one group approves the vaccine and the other rejects the package.  The FDA is used to outside pressure so I’m not too worried about that aspect.  After the first vaccines are approved, future vaccines will have to be tested head to head against the approved ones; that will be a much higher hurdle than beating placebo.  I still think best case scenario is that a vaccine is available to non-high risk folks early in 2020. 

Anselm

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Re: Vaccine
« Reply #6 on: August 03, 2020, 09:17:32 AM »
At this point I do not care if someone gets rich from finding a vaccine.  Go take your money and buy more Wu Tang albums or whatever makes you happy.  I just want this to be over with.
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fleabite

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Re: Vaccine
« Reply #7 on: August 03, 2020, 09:24:56 AM »
Whoever develops the regulatory package first . . . will undoubtedly file simultaneously for regulatory approval in Europe and the USA.  So both regulatory bodies will be reviewing at the same time.  There will be a lot of internal communication between FDA and EMEA. It will be highly unlikely that one group approves the vaccine and the other rejects the package.

I agree. It is rare for the FDA to approve a drug that the European Medicines Agency does not. One I can think of offhand was a drug that provided very modest benefit. The FDA approved it; the EMA did not, considering that the benefit was not justified by the side effects. Unless a vaccine has only borderline efficacy, the two agencies are likely to agree on approval or non-approval.

RatGuy

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Re: Vaccine
« Reply #8 on: August 03, 2020, 09:31:18 AM »
I just learned that one of our staff members is afraid to take any vaccine that becomes available because she's heard that the government can inject tracers with the vaccine to track your movements.  I tried to tell her that that's not possible.

If trackers were that small, inexpensive, and effective, wildlife research would be so much easier...

If only we could get the wildlife to use iPhones

mamselle

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Re: Vaccine
« Reply #9 on: August 03, 2020, 10:16:58 AM »
Wherever it's developed, that company has to file country-by country patent submissions first.

That alone can take years (having reorganized one very messy patent filing office's files once upon a time), and takes up lots of legal and paralegal brainpower as well as translation costs and the need for compliance with local regulations for packaging, labeling, distribution, etc.

Somebodies gonna have fun...

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Wahoo Redux

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Re: Vaccine
« Reply #10 on: August 03, 2020, 10:21:32 AM »
I just learned that one of our staff members is afraid to take any vaccine that becomes available because she's heard that the government can inject tracers with the vaccine to track your movements.  I tried to tell her that that's not possible.

If trackers were that small, inexpensive, and effective, wildlife research would be so much easier...

If only we could get the wildlife to use iPhones

I can only imagine how bored an agent of Big Brother would be if I were injected with a tracer.

jimbogumbo

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Re: Vaccine
« Reply #11 on: August 03, 2020, 01:44:20 PM »
At this point I do not care if someone gets rich from finding a vaccine.  Go take your money and buy more Wu Tang albums or whatever makes you happy.  I just want this to be over with.

Ahem. re Wu Tang albums, from Wikipedia:

Shkreli made a request for compassionate release on April 22, 2020.[132] In his request he said he should be allowed to live at his new fiance's apartment, in New York City. Her name was redacted from the copies released to the press. In his request, Shkreli claimed his firm needed him to develop a remedy for COVID-19.[132] In denying the request, Judge Matsumoto characterized Shkreli's request an instance of "delusional self-aggrandizing behavior."[133]