Bad Batch Of Johnson & Johnson Vaccines Sets Back Production
ARI SHAPIRO, HOST:
A manufacturing error has set back efforts to ramp up production of COVID-19 vaccines in the U.S. One facility preparing to produce the Johnson & Johnson vaccine had to throw away a large batch after discovering the error. The White House today said this problem will not prevent them from reaching their vaccination goals through May.
NPR science correspondent Richard Harris is here to tell us more. Hi, Richard.
RICHARD HARRIS, BYLINE: Hey, Ari.
SHAPIRO: So what happened at this facility?
HARRIS: Well, the problem emerged at a Baltimore facility that's part of a company called Emergent BioSolutions. Johnson & Johnson and AstraZeneca had both contracted with his company to produce their vaccines, and they've been ramping up both of those production lines. According to multiple news reports, there was a mix up in ingredients between these two different products, and that resulted in a ruined batch of the Johnson & Johnson vaccine. Neither Emergent nor J&J would confirm that, but both companies said that the batch was set aside.
SHAPIRO: That sounds like a huge mistake. How often does something like that happen?
HARRIS: Well, vaccine manufacturing is a very complicated process, and errors happen more often than you might think. I spoke to Tinglong Dai, who researches management and operations issues at Johns Hopkins University in Baltimore. Dai says this process is so tricky, vaccine companies spend a surprisingly large amount of their time and effort testing their products along the way.
TINGLONG DAI: AstraZeneca, they're doing 60 different tests. They also have 20 independent laboratories just to make sure they are doing things correctly. Pfizer, they're spending more than half of the production time on quality checks.
HARRIS: Obviously, with a product that could eventually be used by hundreds of millions of people, you want to make sure that it's safe and effective. In fact, the production run at Emergent that failed was part of the company's process to gain approval from the Food and Drug Administration. It still needs that approval before it can actually release vaccines for human use.
SHAPIRO: And what more can you tell us about the company where this incident happened, Emergent BioSolutions?
HARRIS: Right. It's a small company, and before COVID, it was known for producing vaccines against potential biological warfare agents like anthrax. But it has become a central player in the COVID vaccine world. The company has said that it is positioned to manufacture a billion doses of COVID vaccines. That's billion with a B. But Professor Dai says the company has also run into trouble with the FDA over issues like employee training.
DAI: This company has received quite a bit of citations from the FDA for quality control violations. But their situation (ph) is actually not unique at all.
HARRIS: He says the FDA also finds violations in most of the major plants that produce vaccines. Companies do a lot of testing along the way because, of course, they don't want to deal with these FDA citations. And most of the time, the errors don't lead to problems as big as this one. But Norman Baylor, a former vaccine official at the FDA, says trying to produce this much vaccine this fast is unprecedented, so we should expect some issues.
NORMAN BAYLOR: This reassures us that the system for quality control is in place, and it's working.
HARRIS: And it's also a reason that the federal government has ordered more vaccine than it needed, so no single problem would be catastrophic.
SHAPIRO: So how big a disruption is this likely to be for the U.S. vaccine supply?
HARRIS: It's hard to know. Companies don't disclose very much about exactly how much vaccine they're making and where it's being produced, but manufacture is spread out. To date, the Johnson & Johnson vaccine used in the U.S. has come from the Netherlands, professor Dai says. And the company says it is still expecting to produce the 100 million doses that it has promised this spring. So, you know, at this point, it looks as though it's not going to be a huge disruption.
SHAPIRO: NPR's Richard Harris, thank you.
HARRIS: Any time.
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