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The New Head Of the FDA On COVID-19 Tests And Vaccines

MARY LOUISE KELLY, HOST:

One year and one month ago, the Food and Drug Administration launched its first attempt to fight COVID-19. The agency granted emergency use authorization to a test, a genetic test, for the coronavirus. Well, in the year since, the agency has greenlit a bunch of other measures aimed at saving lives - hundreds of varieties of surgical and respirator masks, more than 300 types of tests, nearly a dozen therapeutic drugs and most recently, of course, a trio of vaccines.

In the past year, the FDA has also faltered at times, buckling to political pressure and misrepresenting basic science. Now, under a new administration, the FDA has a new interim leader, Dr. Janet Woodcock. She's acting commissioner of the FDA, and she's here now. Welcome.

JANET WOODCOCK: Thank you.

KELLY: I have to start with the vaccines, which have been made available at truly stunning speed. All three seem to have sailed through the FDA's authorization process, which, of course, is not the same. Being authorized for emergency use is not the same as having been approved by the FDA. People who've gotten their shot already know that the pharmacist will tell you this, that this has not been approved by the FDA. From the standpoint of the American public, does it matter? When do you expect that they will be formally approved?

WOODCOCK: Well, to get approved, the companies have to send in a very big application with many, many details on manufacturing, validation and a lot of things probably the public isn't that interested in. However, I can assure the public that the clinical testing for safety and effectiveness that was needed to do this emergency authorizations that were done was very robust and very similar to any vaccine and even more testing, really, than most vaccines that we would normally approve.

KELLY: People should have confidence that even though it doesn't have an official stamp of approval, these vaccines are safe.

WOODCOCK: Yes, they're safe, and they work. Very large numbers of people have already received them and been followed very carefully in the clinical trial.

KELLY: How likely is it that we will have to update our vaccines every year, that it'll be kind of like - that we all get an annual flu shot and we just expect that it's not going to last forever?

WOODCOCK: Well, that's going to depend on the virus and how fast it changes. As you know, right now, variants are spreading in the United States. So far, it looks like those different versions of the same virus are still going to be susceptible to the immune response that the vaccine stimulates. But it is possible that we could get variants that were more resistant to that immune response, and so we would have to give a booster. And that would depend on how fast that variant would spread in the United States and how prevalent it would become. And a concern scientists have right now is because the whole world is like a petri dish with the vaccine replicating everywhere, that every time it replicates in a person gives it a chance to mutate and change. And so right now, variants are arising in the United States and all over the world.

KELLY: Let me turn you to testing and specifically to rapid tests. Three at-home rapid antigen tests have been authorized for emergency use by you, by the FDA. One is over-the-counter. Two require a prescription. How good are they? Do they work?

WOODCOCK: Yes, they do work. How well a test works depends on the situation that it's in. For example, if a test would have 1 in 100 false positives, if you test those very large number of people who didn't have the virus, you would have more false positives - right? - than true positives. But if you tested a whole lot of people who have the virus, then you'd have a lot more true positives.

KELLY: Yeah.

WOODCOCK: So it's very confusing to the general public. But in general, they work for what they're intended for, which is for home use, for people that they don't have to go to the doctor's or go outside or whatever and have a test.

KELLY: Which prompts the question of why the FDA has not authorized more of them. They are cheap. You're saying they work. These rapid tests are rapid, and they're widely available in other countries. Why not here?

WOODCOCK: Well, we, again, respond to applications that are given to us. There are standards that have to be met, and it can be tricky to do these tests. They're also going to be more vulnerable, many of them, to variants. And so we're going to have to keep surveillance over them because they may become less accurate, in fact, if variants become prevalent.

KELLY: Your agency has acknowledged early missteps with antibody tests, a different test, but many of them were allowed to be used without review. And I do wonder, is that weighing on your decision? Is that holding back more rapid authorization of antigen tests now?

WOODCOCK: I don't think so. I think there are a number - quite a number of applications in before us that they need to satisfy our standards and conditions before we would authorize them. You know, the American public deserves tests that are reliable and will do what they say they're going to do on their label.

KELLY: I do want to ask - I said as I was introducing you that the FDA has made some missteps, has buckled to political pressure, misrepresented basic science. I was referring to incidents last year, including when scientists, a bunch of scientists, came out and said the FDA had grossly misrepresented data on blood plasma and how effective that could be in treating COVID patients, for example. You are in charge now - on an interim basis for now. Have you made changes that should cause Americans to be more confident that the FDA is going to accurately represent science and data?

WOODCOCK: Well, I believe that right now we are really free of political pressure, that we are making science and data-based decisions and that will continue. With the convalescent plasma, I believe it was more of a error in description rather than a deliberate misrepresentation.

KELLY: But again, when you came in and took over, were there any changes where you looked around and thought, we need to do this differently?

WOODCOCK: Well, I'm doing a lot of things differently, but that's because I'm very well familiar with the agency. But I believe the agency processes are very robust. And we have great assurance that our scientific processes will go on independently.

KELLY: That is Dr. Janet Woodcock. She is acting commissioner of the Food and Drug Administration. Dr. Woodcock, thank you very much for your time and for joining us. We appreciate it.

WOODCOCK: Thanks for the opportunity. Transcript provided by NPR, Copyright NPR.