On Wednesday, Johnson & Johnson admitted that it had to throw away a large amount of vaccine (enough to provide 15 million doses) after it was found to be contaminated in the production process. Shortly thereafter, some stores reported that Emergent BioSolutions, the company that produces vaccines at the plant in Baltimore, was repeatedly cited to solve quality control issues. The discarded absolute dose and the idea of “contaminating” the COVID vaccine caused many problems.
In order to understand the true extent of such an error, whether there is a precedent for such a big error, and how the public should deal with the news, Slate talked with Dai Tinglong, associate professor of operations management at Johns Hopkins University Carey. Business school. For the sake of clarity, this interview has been edited and organized.
Molly Olmstead: How important is this?
Dai Tinglong: Well, first of all, the situation is a bit confusing. The original story in The New York Times stated that 15 million doses had to be discarded due to some confusion. Then the “Washington Post” reported that they almost mixed two different vaccines, namely AstraZeneca and Johnson & Johnson. It’s really bad, but yesterday, the CEO of Emergent BioSolutions told people on CNBC that it’s not that two different vaccines are mixed together. Although he never defined what it meant, he used words like “substandard”. Therefore, I think that overall, what really happened is a big unknown. Because we didn’t get any information from Johnson & Johnson. We did not get any meaningful information from Emergence.
What we know is that we have a large batch of Johnson & Johnson vaccines: 15 million doses. This is enough to vaccinate 7% of adults in the United States. This is the number of people vaccinated for the entire state of Maryland, West Virginia, and some other states. It has been thrown away. Therefore, the FDA and the Biden government have requested Johnson & Johnson to strengthen the supervision of Emergent BioSolutions. And the plant in Baltimore has not yet been authorized by the FDA-its authorization process will be delayed.
It does not seem to change Johnson & Johnson’s delivery schedule. By the end of May, this delivery plan will reach 100 million doses. This seems to be going according to plan. This is what we learned.
How unusual is this kind of thing?
Well, this is abnormal. This is an error, but it has happened before. I study flu vaccines; this does happen from time to time. Influenza vaccine manufacturers hope to deliver on time, but the FDA did not tell them what to produce until February or March. The production of the flu vaccine takes about six months. Therefore, sometimes those flu vaccine manufacturers start production before they even know what to produce. Therefore, the products they produce are ultimately different from the products that the FDA requires them to produce, so they must be discarded. And this happens every two years.
Another situation I can think of is in 2004, when there was a factory in the UK that produced influenza vaccine. The inspectors found serious contamination; their bacterial levels exceeded 1,000 times the acceptable level. Therefore, they shut down the entire factory and destroyed everything. This resulted in a severe shortage of flu vaccines that year.
Another major manufacturing error of COVID comes from AstraZeneca. You may remember that in November last year, when AstraZeneca released the results of its clinical trial, we discovered that due to a manufacturing error, they gave 3,000 patients a half dose instead of a full dose. Therefore, this does happen from time to time. But 15 million is still a lot. This is a major manufacturing error. This scale is rare.
Did you know that this can even happen in this situation?
We have no clue. Maybe they got the leveling wrong. Maybe they did not adequately train their employees. Emergent BioSolutions is a small company and they are actively recruiting. When hiring people, you must also keep in mind training and various regulations and compliance. But we just didn’t hear any details. Therefore, we need them to tell us the exact factory situation. Because remember: this happened in February. Now we are in April. It’s been almost two months. I don’t think they need to take so long to find the answer. They have cameras. In fact, I wouldn’t be surprised if the FDA had all the information. I’m sure they will. Therefore, I think they should be transparent about what is really happening.
This is about the public’s trust in Johnson & Johnson vaccine. We talked about all the supply going on as planned. But you must also remember that demand must also go according to plan. When the vaccine is actually released to the public, people should be willing to take the vaccine with confidence.I think we should Confident, but I think they should help us be more confident.
Are there factors that are more error-prone than other medicines in vaccine production?
Well, I think this is very different from other medicines because it is given to healthy people. If you want to provide something to hundreds of millions of healthy people, the quality standard must be higher, because you don’t want people to be vaccinated. sick. This has happened in the past: as early as 1955, hundreds of people were infected with polio from vaccines due to contamination in the production process.
It is composed of many different ingredients and is carried out in multiple steps, so the product is very error-prone. But this is why we have to conduct a lot of testing. With flu vaccines, they spend 70% of their time only for quality control testing, and 30% of their time is spent on vaccine production. We know from Pfizer that it spends half of its time just running tests, and the other half of its time is actually producing. Now, we are talking about making it available to everyone and eventually allowing children, even babies. This is a difficult task. There is almost nothing wrong. Everything must be correct.
What do you really want people to make sure they know about this story?
Most importantly, this is not unique to Johnson & Johnson. Perhaps this factory has a long history of violating safety regulations. [But] All major brands and all major vaccine manufacturers have been severely criticized by the FDA, accusing them of violating quality standards, accusing them of not complying with factory sanitation standards, etc.
But we should have confidence in the final product because In many tests. Quality problems are unlikely to be discovered before they are put on the market. It has a lot to do with the process. Before the production of the COVID vaccine began, almost every factory had a serious problem. If you just look at the results of the FDA, you would think that this is a complete failure. Then, they must transform themselves from a failed student to an A student overnight. But this is exactly what happened. Therefore, violations are very common, and 15 million doses of pollution are not common, but they do happen. We should still be satisfied with the results.