UK moves towards ethically controversial coronavirus vaccine trialsExBulletin

Ali Shapiro, Host:

The UK Government has submitted what many consider to be an ethically controversial entry into the competition to find the COVID-19 vaccine. The UK will spend $ 43 million on plans to vaccinate volunteers and intentionally expose them to the coronavirus to see if the vaccine works. Joining us now to discuss the value of these so-called challenge studies is Joe Parka of NPR.

Hello, Joe.

JOE PALCA, byline: Hello, Ali.

Shapiro: Why does Britain go this route?

Parka: Well, think about these big studies underway. You give a vaccine to some people. You give others an inert placebo. And I would like to see if the vaccine group is more protected. But you can’t tell people to go out and get infected, so you have to wait and wait for some of them to get enough cases to make a comparison. And you wait, you wait, you wait, and you wait. In a challenge study, someone is vaccinated and then deliberately exposed. And if they don’t get infected or get sick, the vaccine seems to work and there is no speculation as to whether anyone has been exposed.

Shapiro: But if they get sick, someone has deliberately infected them with a potentially deadly illness. It doesn’t seem like a great plan.

Parka: No. Well, well, in some cases, there are treatments to prevent the exposed people from getting sick. Of course, there is still no good cure for COVID-19. But what they are doing-the project works in two stages. First, they find the absolute minimum dose of virus that makes them sick, but hopefully it’s not big enough to make them sick. Anyway, that’s hope. And once you know the dose, you have to vaccinate someone and wait a few weeks. And you challenge them. But that’s how they work.

Shapiro: Well, the risk to volunteers seems to be considerable, but is there any other reason why people don’t do such challenging studies often?

Parka: Yes, that’s right. So, first of all, you have a limited theme pool. Usually it is a dozen or maybe dozens. And they are usually healthy and young volunteers. But even if the vaccine works for them, you want-you are making the vaccine you want to work for everyone. So there are no elderly people. No woman is pregnant. You have no small children. Therefore, it is not always easy to extend the results to other populations. Second, if there are very rare side effects that the vaccine actually causes, it is probably not seen in a small group of subjects.

Shapiro: Well, the UK has decided to move forward with this plan. So when are you planning to start?

Parka: Early next year with approval. They need to get-there is a special ethics committee convened by the Medicines and Healthcare Products Regulatory Agency, which is equivalent to the UK Food and Drug Administration. And they must give their blessings before this can move forward.

Shapiro: Is the United States thinking about this?

Parka: Well, that’s true. The National Institute of Allergy and Infectious Diseases has contracted with the Institute to create virus strains that can be used in challenging studies as needed. Now, one of the reasons why such research is needed is when few people are infected. If there aren’t many viruses around, the only way to test a vaccine is to actually vaccinate people. And that way, you know they are exposed. Unfortunately, that doesn’t matter. Currently, there are many viruses.

Shapiro: Yeah. All right. Joe Parka from NPR.

Thank you very much.

Parka: You are welcome.

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