On Vaccine Development and Testing

[Roboramma]

How is that ethical?

In one vial you have something you know to be a potentially life-saving drug.

In the other vial you have something you know to be completely useless.

How can you ethically withhold the first vial from half the residents in a nursing home where the disease is already spreading?

You're already withholding it from everyone else. Why withhold it in this case? Because there's more good to be done from determining it's efficacy than the potential saving of those few people who get the placebo in that case.

The ethical considerations seem pretty similar to any drug trail that is placebo controlled, though the stakes vary from drug to drug.

 

[EHocking]

You're already withholding it from everyone else. Why withhold it in this case? Because there's more good to be done from determining it's efficacy than the potential saving of those few people who get the placebo in that case.

The ethical considerations seem pretty similar to any drug trail that is placebo controlled, though the stakes vary from drug to drug.

As has probably been posted before.

The ethical way to test is to infect healthy, young individuals that have a higher chance of surviving the virus without a vaccine.
Here's an interesting article on challenge testing (which is what we're really talking about).
Speed coronavirus vaccine testing by deliberately infecting volunteers? Not so fast, some scientists warn

 

[rjh01]

As has probably been posted before.

The ethical way to test is to infect healthy, young individuals that have a higher chance of surviving the virus without a vaccine.
Here's an interesting article on challenge testing (which is what we're really talking about).
Speed coronavirus vaccine testing by deliberately infecting volunteers? Not so fast, some scientists warn

The trouble with that is this does not tell you what happens if you give the vaccine to older people. The vaccine might work on healthy people, but not on older people. Or the vaccine could be dangerous to older people. The only way to be sure is at sometime to give it to these older people.

 

[Roboramma]

As has probably been posted before.

The ethical way to test is to infect healthy, young individuals that have a higher chance of surviving the virus without a vaccine.
Here's an interesting article on challenge testing (which is what we're really talking about).
Speed coronavirus vaccine testing by deliberately infecting volunteers? Not so fast, some scientists warn

I agree. I was only commenting on the scenario put forth. If you were doing what rjh07 suggested, I don't think the problem would be the placebo controls.

 

[Roboramma]

The trouble with that is this does not tell you what happens if you give the vaccine to older people. The vaccine might work on healthy people, but not on older people. Or the vaccine could be dangerous to older people. The only way to be sure is at sometime to give it to these older people.

All knowledge is uncertain, and learning new things is about adjusting our baysean probability estimates. Sure, testing on young people doesn't necessarily mean that it will work on older people, but it should make us shift our estimate in the probability that it does. How much? I'll leave that to the experts to tell us, but there's no a priori argument that it will be to such a small degree that challenge testing in young, healthy people isn't useful.

 

[EHocking]

The trouble with that is this does not tell you what happens if you give the vaccine to older people. The vaccine might work on healthy people, but not on older people. Or the vaccine could be dangerous to older people. The only way to be sure is at sometime to give it to these older people.

You’re putting the cart before the horse. Current testing is for efficacy. Challenge testing is merely a method to fast-track testing of efficacy.

 

[casebro]

This morning's NYT feed said one of the big Pharmas has 60,000,000 doses in production. Darnnit, erased from my email, can't find it there.

 

[xjx388]

One of the questions I have is: How long is a Sars-CoV-2 vaccine good for? It's entirely possible that we can't vaccinate for more than a few months or so. What then?

 

[pipelineaudio]

Then we make sure we have 8 billion doses every few years

 

[Skeptic Ginger]

How is that ethical?

In one vial you have something you know to be a potentially life-saving drug.

In the other vial you have something you know to be completely useless.

How can you ethically withhold the first vial from half the residents in a nursing home where the disease is already spreading?

First, when you are doing said research you don't know the treatment is life-saving. The treatment arm might not be protected, or there might be side effects.

Second, when studies like this show early results of life saving success, the studies are stopped and everyone who got placebo gets the vaccine.

 

[dann]

Third, the participants volunteer to participate. They are told that they are part of a double-blinded study where they will receive either a drug/vaccine or a sugar pill/saline solution.

This is the Trumpian way of thinking: "How can you ethically withhold the first vial from half the residents in a nursing home where the disease is already spreading?"
“What do you have to lose?” (Daily Beast, April 4, 2020)
Even when the drugs "have not been shown to be safe and effective for treating or preventing Covid-19." (The Guardian, May 1, 2020)

 

[EHocking]

This morning's NYT feed said one of the big Pharmas has 60,000,000 doses in production. Darnnit, erased from my email, can't find it there.

This?
As yet untested, but the pharma company is taking a punt on it anyway.

 

[dann]

Another great Last Week Tonight with John Oliver on the virus, this time about testing, testing, testing:


And why America still isn't there.

 

[lomiller]

One of the questions I have is: How long is a Sars-CoV-2 vaccine good for? It's entirely possible that we can't vaccinate for more than a few months or so. What then?

Using the vaccine yearly should be suffice to deal with the possibility that the resistance is short lived.

A bigger concern I have is that betacorona viruses are prone to antibody-dependant enhancement, which can cause the virus to be more deadly in people who have been immunized. Several SARS vaccine candidates were abandoned due to this. This makes rushing a vaccine though testing a dangerous prospect IMO.

 

[Lplus]

Using the vaccine yearly should be suffice to deal with the possibility that the resistance is short lived.

A bigger concern I have is that betacorona viruses are prone to antibody-dependant enhancement, which can cause the virus to be more deadly in people who have been immunized. Several SARS vaccine candidates were abandoned due to this. This makes rushing a vaccine though testing a dangerous prospect IMO.

Presumably you mean that those who are vaccinated are less likely to get the virus, but if they do get it, they get it worse? How does that work with those who have antibodies from having had the virus instead of from vaccination?

 

[lomiller]

How does that work with those who have antibodies from having had the virus instead of from vaccination?

There seem to be a few papers now that suggest the adaptive immune response plays a roll in turning relatively mild COVID infections into the serious variety that kills people. eg:

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3546070
https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.25866

 

[dann]

Presumably you mean that those who are vaccinated are less likely to get the virus, but if they do get it, they get it worse? How does that work with those who have antibodies from having had the virus instead of from vaccination?

That is much too speculative at this point. An awful lot af things can go wrong if vaccines aren't properly tested - and testing them properly takes time.
Let's wait until we hear abou the first tests being made and the outcome.

 

[Roboramma]

https://www.nytimes.com/2020/05/04/opinion/coronavirus-vaccine.html

Today, the U.S. government could go big and create a Covid-19 vaccine A.M.C., guaranteeing to spend about $70 billion on new vaccines — enough to make direct investments to support capacity installation or to repurpose capacity and to pay, say, $100 per person for the first 300 million people vaccinated.
An investment of that size can anticipate and overcome several challenges typical of vaccine development. If we want to achieve a 90 percent probability of success, we must take into account historical rates of success from publicly available data; doing that suggests that we need to actively pursue not two or three vaccine candidates, but 15 to 20.

 

[Segnosaur]

One way to test vaccines ethically is if the virus gets into a nursing home they give the vaccine to half the people there. The other half get a fake vaccine as a control. Then compare the two results. Of course blood tests would need to be taken before and after. For example the test will be no good if most of the people have already had the virus.

I would say a better group of people to test with... people in the meat-processing industry.

They tend to be younger (working age), so can better handle any complications. And they work in a relatively high-risk environment where the disease has been known to spread fairly easily. (So we will have an idea fairly quickly if the vaccine is effective).

 

[EHocking]

I would say a better group of people to test with... people in the meat-processing industry.

They tend to be younger (working age), so can better handle any complications. And they work in a relatively high-risk environment where the disease has been known to spread fairly easily. (So we will have an idea fairly quickly if the vaccine is effective).

You don't want your subjects in a high-risk environment, you want your subjects in a highly-controlled environment in order to remove as many complicating variables as you can from your test model.
Here is a useful article on vaccine development and testing.