NOEL KING, HOST:
There's a problem in Johnson & Johnson's supply chain that could hold up the company's COVID-19 vaccine. A factory that makes a key ingredient for the vaccine made a batch that failed quality standards. The New York Times is reporting that human error is to blame, but this situation could jeopardize the vaccine distribution schedule. Now the FDA is investigating.
NPR pharmaceuticals correspondent Sydney Lupkin is following this one. Good morning, Sydney.
SYDNEY LUPKIN, BYLINE: Good morning.
KING: What happened?
LUPKIN: Well, it looks like there was some kind of cross-contamination involving a key ingredient. This happened at Emergent BioSolutions. That's a Maryland factory that is manufacturing the ingredient for Johnson & Johnson. Now, The New York Times, which first reported on this setback, says 15 million Johnson & Johnson doses were affected. And the company has not confirmed that. But it's important to note that these wouldn't be finished doses, just key ingredients ultimately bound for another factory to be put into vials and prepared for distribution.
KING: So then, how big of a setback is this really?
LUPKIN: Well, there are a few ways to look at it. On the one hand, if it is 15 million doses of a single-dose vaccine, that's a lot, especially if you're waiting your turn to get vaccinated. Here's Saad Omer, the director of the Yale Institute for Global Health.
SAAD OMER: If it was, as it seems the first reports indicate - if this was a human error - and the way it was framed, it was a one-off error - then it will be a hiccup, but then you would expect things to resume.
LUPKIN: But if something more is going on, it could take more time to fix. And that means the Emergent facility won't be able to help Johnson & Johnson meet its goals as soon as expected.
KING: Is this already affecting vaccine delivery?
LUPKIN: Well, so far, Johnson & Johnson hasn't been using the Emergent facility to hit the 20 million doses it promised the U.S. by the end of March. That's because the factory still needed to go through the FDA's validation process before Johnson & Johnson could use what it was making. And that's when this cross-contamination was discovered.
KING: And so I guess, in a way, it's good that they found this contamination earlier rather than later in the process. That's essentially how this is supposed to work.
LUPKIN: Right. So we want the FDA in there inspecting. We want to find problems before drugs and vaccines get out to the American public. You don't want to get a vaccine that's been made wrong. It could not work. Or worse, it could make you sick. So it's good to know these vaccines and ingredients are being carefully examined. And when they're not up to snuff, they're not getting into people's arms.
KING: And lastly, how much is Johnson & Johnson counting on this Emergent facility?
LUPKIN: Well, we don't know when it was expected to become an official part of Johnson & Johnson's supply chain or how many doses it's ultimately responsible for. So the hope is that Emergent works out its problems with help from the federal government and the FDA watching closely because it still needs to pass its inspection. Johnson & Johnson was already behind. That's why the Biden administration brought in Merck to help it with manufacturing as well as some other support. Johnson & Johnson is expected to deliver 100 million doses by the end of May, and that's crucial to the Biden administration's promise to deliver enough vaccine for 300 million adults by that time. But this whole scenario really does show that things can and do happen in drug and vaccine manufacturing, and that can cause setbacks.
KING: Sure. NPR pharmaceuticals correspondent Sydney Lupkin.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.