Johnson & Johnson admitted on Wednesday that a large amount of vaccines – enough for 15 million doses – had to be discarded after being infected during the production process. Shortly afterwards, several stores reported that the company that manufactures the vaccine at the Baltimore plant, Emergent BioSolutions, had previously been cited for quality control issues. The sheer amount of doses thrown away, and the idea of a ‘contamination’ of a COVID vaccine have raised many questions.
To get an idea of how unusual such a mistake is, whether there is a 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 the Johns Hopkins Carey University, chat. Business school. This interview has been edited and summarized for clarity.
Molly Olmstead: How big is it?
Tinglong Dai: Well, the situation is a bit confusing in the first place. The original story from the New York Times said that 15 million doses had to be discarded due to a mixture. And then the Washington Post had a report saying they were almost confusing the two different types of vaccines, AstraZeneca and Johnson & Johnson. This is really bad. But yesterday, the CEO of Emergent BioSolutions told CNBC that it was not the case that two different types of vaccines were confused. He used some words like ‘out of spec’, though he never defined what it meant. So, I think in general it is very unknown what is really going on. Because we did not receive any information from Johnson & Johnson. We did not receive any meaningful information from Emergence.
What we do know is that we have this huge amount of Johnson & Johnson vaccine: 15 million doses. That’s enough to vaccinate 7 percent of the U.S. adult population. This is the number that vaccines the entire state of Maryland, plus West Virginia, plus a few other states. And it’s been thrown away. And so the FDA and the Biden Administration have asked Johnson & Johnson to step up oversight of Emergent BioSolutions. And this Baltimore factory, which has not yet been approved by the FDA – the 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. It seems to be on schedule. So this is what we have learned.
How unusual are these kinds of things?
Well, that’s not normal. This is a mistake – but it’s happened before. I study flu vaccines; it does happen from time to time. Influenza vaccine manufacturers want to deliver on time, but the FDA first tells them what to produce by February or March. The production of a flu vaccine takes about six months. Sometimes the manufacturers of flu vaccines start even before they learn what to produce. So, what they produce eventually becomes different from what the FDA asked them to produce, and they have to throw it away. And it happens every few years.
The other scenario I can think of is the case in 2004 when the factory in the UK was producing flu vaccines. The inspectors found a serious contamination; they had these bacteria more than 1000 times the accepted level. Therefore, they closed the whole factory and destroyed everything. This led to a huge shortage of flu vaccines for that year.
The other major manufacturing defect with COVID was from AstraZeneca. You probably remember November last year, when AstraZeneca announced its clinical trial results, and we found that due to a manufacturing error, they gave 3000 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. Maybe they did the leveling wrong. Or maybe they did not train their people enough. Emergent BioSolutions is a small business that rents very aggressively. When hiring people, you should also keep in mind the training and all kinds of regulations and compliance. But we just have not heard any details yet. So we have to tell you exactly what happened on the factory floor. Because remember: It happened in February. And now we’re already in April. It’s almost two months. I think it does not take that long before they realize it. They have cameras. In fact, I would not be surprised if the FDA has all the information. I’m sure they do. So I think they need to be really transparent about what really happened.
It’s about the public’s confidence in the Johnson & Johnson vaccine. We talk about how all the stock will be according to schedule. But you must also remember that the question must also be according to schedule. When the vaccines are actually released to the public, people must be willing to take the vaccine with confidence. I think we must be confident, but I think they should help us to be more confident.
Are there elements of vaccine production that are more prone to defects than other pharmaceutical products?
Well, I think it differs a lot from other pharmaceutical products in that it is given to healthy people, and if you want to give something to hundreds of millions of healthy people, the quality has to be higher because you do not want people. to get sick from vaccination. This has happened in the past: In 1955, hundreds of people became infected with the polio of the vaccine due to contamination in the production process.
There are many different ingredients in many steps, and this makes the product very faulty. But that’s also why we have a lot of tests in place. With the flu vaccine, they spend 70 percent of their time just on quality control tests, and 30 percent on manufacturing the vaccine. We learned from Pfizer that it spends half the time just on the tests, and the other half of the time on the actual production. Now we’re talking about giving it to everyone, finally allowing children and even babies. It’s a big business. Almost nothing can go wrong. Everything must be right.
What is one thing you really want people to do to make sure they understand this story?
The bottom line is that this is not unique to Johnson & Johnson. Perhaps this factory has a long history of security breaches. [But] all the major brands, all the major vaccine manufacturers, have received very bad references from the FDA and accused them of violating the standards, accusing them of not violating the factory hygiene standards, etc., etc. does not follow.
But we need to be confident about the end product because of the many tests. It is very unlikely that the quality issues will not be detected before it goes to the market. It has a lot to do with the processes. Nearly every factory, before they started manufacturing COVID vaccines, had a serious problem. If you just looked at the results of the FDA, you would think that it has completely failed. And then they have to change themselves overnight from a failed student to an A student. But that is exactly what happened. Violations are therefore very common, and pollution of 15 million doses is not common, but it is. We still need to be comfortable with the results.