How Alarmed Should We Be About the 15 Million Tossed J&J Vaccines? – Slate

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 is almost two months. I don’t think it takes that long for them to find out. They have cameras. In fact, I wouldn’t be surprised if the FDA has all the information already. I’m sure they do. So I think they should be really transparent about what really happened.

This is about the public’s trust in the Johnson & Johnson vaccine. We talk about how all of the supply will be on schedule. But you also have to remember that demand will also need to be on schedule. When the vaccines are actually released to the public, people should be willing to take the vaccine with confidence. I think that we should be confident, but I think they should help us be more confident.

Are there elements of vaccine production that might make it more prone to errors than other pharmaceutical products?

Well, I think it’s very different from other pharmaceutical products in that this is given to healthy people, and if you want to give something to hundreds of millions of healthy people, the quality standard has to be higher, because you don’t want people to get sick from getting vaccinated. That has happened in the past: Back in 1955, hundreds of people got infected with the polio from the vaccine from contamination in the production process.

It’s many different ingredients, in many steps, and that makes the product very error-prone. But that’s also why we have a lot of tests in place. With the flu vaccine, they spend 70 percent of the time just doing quality control tests, and 30 percent producing the vaccine. We have heard from Pfizer that it’s spending half of the time just running the tests, and the other half of the time doing actual production. Now we’re talking about giving that to everyone, to allow kids, even infants eventually. This is a huge undertaking. Almost nothing can go wrong. Everything has to be right.

What is something that you really want people to make sure they understand about this story?

The bottom line is that this is not unique to Johnson & Johnson. Maybe this factory has a long history of safety violations. [But] all the major brands, all the major vaccine manufacturers, got very bad-looking citations from the FDA, accusing them of violating quality standards, accusing them of not following the factory hygiene standards, etc., etc.

But we should be confident about the end product because of the many tests. It is very unlikely that the quality issues would go undetected before they go to market. It has a lot to do with the processes. Pretty much every factory, before they started producing COVID vaccines, had a serious issue. If you just looked at those results from the FDA, you would think that’s a complete failure. And then they have to transform themselves from a failed student to an A student overnight. But that’s exactly what has happened. So violations are very common, and contaminating 15 million doses isn’t common, but does happen. We should still be comfortable with the results.

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