A Look At Why Johnson & Johnson Paused Coronavirus Vaccine Trial
ARI SHAPIRO, HOST:
This week has already brought two setbacks in the search for coronavirus vaccines and treatments. Eli Lilly has confirmed that its clinical trial for an antibody treatment is now on pause because of a potential safety concern. Johnson & Johnson announced a pause yesterday in its trial of a coronavirus vaccine. Here to bring us up to speed is NPR pharmaceutical correspondent Sydney Lupkin.
SYDNEY LUPKIN, BYLINE: Hi, Ari.
SHAPIRO: Let's start with Johnson & Johnson. What are the details with the pause there on the vaccine trial?
LUPKIN: Sure. Johnson & Johnson put all its coronavirus vaccine clinical trials on pause after one of the patients enrolled came down with an unexplained illness. The pause is temporary while they figure out what happened. For instance, they don't know whether the patient got the vaccine or a placebo, says Johnson & Johnson's head of R&D Mathai Mammen.
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MATHAI MAMMEN: We know very little at this point, and it'll be a few days at minimum for the right set of information to be gathered and evaluated.
LUPKIN: Dr. Naor Bar-Zeev at Johns Hopkins Bloomberg School of Public Health tells me a pause is pretty normal for a clinical trial.
NAOR BAR-ZEEV: So what we want is to have safety outcomes occurring so that we can measure them and quantify them and tell the public what the risks are.
LUPKIN: With so much attention surrounding a coronavirus vaccine, we're just hearing more about them now.
SHAPIRO: So that's Johnson & Johnson, but that's not the only company that's putting things on pause in the search for coronavirus vaccines and treatments.
LUPKIN: That's right. Last month, AstraZeneca put its coronavirus vaccine studies on hold when a British patient developed a neurological condition. Although trials started back up in the United Kingdom and elsewhere just a few days later, they remain on hold in the United States. We don't know why, but the company says it's working with the Food and Drug Administration to facilitate a review that could eventually restart the trial. And today we learned about the pause in the study of Lilly's COVID-19 antibody treatment because of a potential safety concern. An independent data safety monitoring board recommended the halt, and the company said it supports the decision.
SHAPIRO: But there are still other vaccines in development where the trials are ongoing. Bring us up to speed on what's happening there. How are they doing?
LUPKIN: Pfizer's experimental vaccine looks to be in the lead followed by Moderna's. Pfizer's CEO has predicted that it would know whether the vaccine worked this month. Moderna isn't expecting trial data until November at the earliest. Overall, these trials can only move as fast as they can enroll patients. But enrollment requires resources, money. The federal government has awarded billions of taxpayer dollars to accelerate things through Operation Warp Speed, but that process has its own pitfalls.
SHAPIRO: Like what? What do people have to be worried about?
LUPKIN: Well, the goal is a vaccine that's safe and effective as soon as possible, but federal contracting can be slow. So the government is using a non-traditional contracting mechanism to speed things along, and NPR has learned that it's issuing contracts through a third party. But that can leave out some taxpayer protections and limit transparency.
Rick Bright headed the federal Biomedical Advanced Research and Development Authority until he was ousted in April. The next month he filed a whistleblower complaint alleging that the administration was awarding some contracts based more on politics than science. The third-party contracting concerns him.
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RICK BRIGHT: We don't know the rewards or the incentives that the companies are getting, which might drive some companies to take additional risk or maybe do things inappropriately.
LUPKIN: So several lawmakers and advocacy groups are calling for the contracts to be made public.
SHAPIRO: That's NPR pharmaceuticals correspondent Sydney Lupkin.
LUPKIN: You bet.
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