On Wednesday, Johnson & Johnson acknowledged that a large batch of vaccines – enough for 15 million doses – had to be discarded after it was discovered that it had been contaminated during the production process. Soon after, several establishments reported that the company that produced the vaccine at the Baltimore facility, Emergent BioSolutions, had been cited several times before for quality control reasons. The large number of doses that were discarded and the idea of a “contamination” of a COVID vaccine raised many doubts.
To get an idea of how unusual this error really is, whether there is precedent for such a big mistake and how the public should process the news, Slate spoke with Tinglong Dai, an associate professor of operations management at Johns Hopkins Carey School of Business. This interview has been edited and condensed for clarity.
Molly Olmstead: How important is this business?
Tinglong Dai: Well, first of all, the situation is a little confusing. The original New York Times story said that 15 million doses had to be thrown away because of some confusion problem. And then the Washington Post published a report saying that they practically mixed the two different types of vaccines, AstraZeneca and Johnson & Johnson. This is very bad. But then, yesterday, the CEO of Emergent BioSolutions went to CNBC telling people that it was not the case that two different types of vaccines were mixed. He used some words like “out of specification”, although he never defined what that meant. So I think in general, what is really happening is a big unknown. Because we have not received any information from Johnson & Johnson. We did not receive any significant information from Emergence.
What we do know is that we have this big batch of a Johnson & Johnson vaccine: 15 million doses. That is enough to vaccinate 7 percent of the US adult population. This is the number to vaccinate the entire state of Maryland, plus West Virginia, in addition to some other states. And it was thrown away. And so the FDA and the Biden administration asked Johnson & Johnson to step up their oversight of Emergent BioSolutions. And this plant in Baltimore, which has not yet been authorized by the FDA – its authorization process will be delayed.
It does not look like it will change Johnson & Johnson’s delivery schedule, which is 100 million doses by the end of May. This seems to be on schedule. So that’s what we learned.
How unusual is that kind of thing?
Well, it’s not normal. This is a mistake – but it has happened before. I study flu shots; it happens from time to time. Flu vaccine manufacturers want to deliver on time, but the FDA does not tell them what to produce until February or March. The production of a flu vaccine takes, like, six months. So sometimes these flu vaccine manufacturers start production before they even know what to produce. So what they produce ends up being different from what the FDA asked them to produce, and they have to throw it away. And it happens every two years.
The other scenario I can think of is the case in 2004, when there was a factory in the UK that produced flu vaccines. Inspectors found serious contamination; they had that level of bacteria more than 1,000 times the accepted level. Then, they closed the entire factory and destroyed everything. This led to a major shortage of flu vaccines that year.
The other major manufacturing error with COVID was from AstraZeneca. You probably remember last November, when AstraZeneca released its results of clinical tests and we found that, due to a manufacturing error, they gave 3,000 patients half doses instead of full doses. So, it happens 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 happen in this case?
We have no idea. Perhaps they did the wrong leveling. Or maybe they didn’t train their people enough. Emergent BioSolutions is a small company and is hiring very aggressively. When hiring people, you should also keep in mind the training and all kinds of regulations and compliance. But we just don’t hear the details. So we need them to tell us exactly what happened on the shop floor. Because remember: it happened in February. And now it’s April. That is almost two months. I don’t think it takes too long for them to find out. They have cameras. In fact, I wouldn’t be surprised if the FDA already had all the information. I’m sure yes. So I think they should be really transparent about what really happened.
It is the public’s confidence in the Johnson & Johnson vaccine. We talked about how the entire supply will be on time. But it is also necessary to remember that the demand must also be on schedule. When vaccines are actually released to the public, people must be willing to take it with confidence. I think we we must be confident, but I think they should help us to have more confidence.
Are there elements in the production of vaccines that can make it more prone to errors than other pharmaceutical products?
Well, I think it’s very different from other pharmaceuticals because it’s 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 for having been vaccinated. This has happened in the past: in 1955, hundreds of people became infected with polio with the contamination vaccine in the production process.
There are many different ingredients, in several stages, and this makes the product very prone to errors. But that’s also why we have a lot of tests going on. With the flu vaccine, they spend 70% of their time just doing quality control tests and 30% producing the vaccine. We heard from Pfizer that it spends half the time just running the tests and the other half doing the actual production. Now we are talking about giving this to everyone, to allow children, even babies, eventually. This is a big undertaking. Almost nothing can go wrong. Everything has to be right.
What do you really want people to understand about this story?
The end result is that this is not exclusive to Johnson & Johnson. Perhaps this plant has a long history of security breaches. [But] all major brands, all major vaccine manufacturers, received very ugly quotes from the FDA, accusing them of violating quality standards, accusing them of not following factory hygiene standards, etc., etc.
But we must be confident about the final product Why of the many tests. It is very unlikely that quality problems will go unnoticed before they go on the market. It has a lot to do with the processes. Almost all factories, before they started producing COVID vaccines, had a serious problem. If you just looked at the results of the FDA, you would think it is a total failure. And then they have to turn from a failed student to an A student overnight. But that is exactly what happened. Therefore, violations are very common and contaminating 15 million doses is not common, but it does happen. We should still be comfortable with the results.