On Wednesday, Johnson & Johnson acknowledged that a huge batch of vaccines—enough for 15 million doses—had to be tossed out after it was found to have been contaminated during the production process. Soon afterward, several outlets reported that the company producing the vaccine at that Baltimore facility, Emergent BioSolutions, had been cited multiple times before for quality control issues. The sheer number of doses that were discarded, and the idea of a “contamination” of a COVID vaccine, has raised plenty of questions.
To get some idea of just how unusual such a mistake really is, whether there is precedent for such a large error, and how the public should process the news, Slate spoke with Tinglong Dai, an associate professor of operations management at Johns Hopkins University Carey Business School. This interview has been edited and condensed for clarity.
Molly Olmstead: How big of a deal is this?
Tinglong Dai: Well, first of all, the situation is a little bit confusing. The original story from the New York Times said 15 million doses had to be thrown away because of some mix-up issue. And then the Washington Post had a report saying that they pretty much mixed up the two different kinds of vaccines, AstraZeneca and Johnson & Johnson. That’s really bad. But then yesterday, the CEO of Emergent BioSolutions went on CNBC telling people that it wasn’t the case that two different kinds of vaccines were mixed up. He used some words like “out of spec,” although he had never defined what that meant. So I think overall, what’s really going on is a very big unknown. Because we didn’t get any information from Johnson & Johnson. We didn’t get any meaningful information from Emergence.
What we know is that we have this one large batch of a Johnson & Johnson vaccine: 15 million doses. That’s enough to vaccinate 7 percent of the U.S. adult population. That’s the number to vaccinate the entire state of Maryland, plus West Virginia, plus a few other states. And it had been thrown away. And so the FDA and the Biden administration has asked Johnson & Johnson to step up its supervision of Emergent BioSolutions. And this factory in Baltimore, which hasn’t been authorized by the FDA yet—it’s authorization process will be delayed.
It does not look like it’s going to change Johnson & Johnson’s delivery schedule, which is 100 million doses by the end of May. That seems to be on schedule. So that’s what we have learned.
How unusual is this sort of thing?
Well, it’s not normal. This is an error—but this has happened before. I study flu vaccines; this does happen from time to time. Flu vaccine manufacturers want to deliver on time, but the FDA doesn’t tell them what to produce until February or March. The production of a flu vaccine takes, like, six months. So sometimes those flu vaccine manufacturers start production even before they learn what to produce. So then what they produce ends up being different from what the FDA asked them to produce, and they have to throw it away. And that happens every couple of years.
The other scenario I can think of is the case of 2004 when there was this factory in the U.K. producing flu vaccines. The inspectors found a serious contamination; they had this bacteria level more than 1,000 times the accepted level. So they shut down the whole factory and destroyed everything. That led to a major shortage of flu vaccines for that year.
The other major manufacturing error with COVID was from AstraZeneca. You probably recall last November, when AstraZeneca released its clinical trial results, and we found out that due to a manufacturing error, they gave 3,000 patients half doses instead of full doses. So this does happen from time to time. But the 15 million is still a lot. This is a major manufacturing error. This scale is rare.
Do you know how something like this would even happen in this case?
We have no clue. Maybe they got the leveling wrong. Or maybe they didn’t train their people enough. Emergent BioSolutions is a small company, and they’re hiring very aggressively. When hiring people, you also have to keep in mind the training and all kinds of regulations and compliance. But we just haven’t heard any details. So we need them to tell us exactly what happened on the factory floor. Because remember: This happened in February. And now we’re already in April. That…