To get some concept of just how unusual such a mistake actually is, whether there is precedent for such a big mistake, and how the general public should process the news, Slate consulted 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.
On Wednesday, Johnson & & Johnson acknowledged that a huge batch of vaccines– enough for 15 million doses– had actually to be thrown out after it was discovered to have actually been contaminated during the production procedure. Soon afterward, several outlets reported that the business producing the vaccine at that Baltimore facility, Emergent BioSolutions, had actually been mentioned several times before for quality control concerns. The sheer variety of doses that were disposed of, and the idea of a “contamination” of a COVID vaccine, has raised lots of concerns.
Molly Olmstead: How huge of an offer is this?
What we understand is that we have this one large batch of a Johnson & & Johnson vaccine: 15 million doses. Thats enough to vaccinate 7 percent of the U.S. adult population. Thats the number to vaccinate the entire state of Maryland, plus West Virginia, plus a couple of other states. And it had been gotten rid of. Therefore the FDA and the Biden administration has asked Johnson & & Johnson to step up its supervision of Emergent BioSolutions. And this factory in Baltimore, which hasnt been authorized by the FDA yet– its permission procedure will be postponed.
It does not look like its going to change Johnson & & Johnsons shipment schedule, which is 100 million doses by the end of May. That seems to be on schedule. So thats what we have found out.
Tinglong Dai: Well, to start with, the scenario is a little bit complicated. The original story from the New York Times stated 15 million dosages needed to be gotten rid of because of some mix-up issue. And after that the Washington Post had a report saying that they quite much mixed up the 2 different type of vaccines, AstraZeneca and Johnson & & Johnson. Thats actually bad. However then the other day, the CEO of Emergent BioSolutions went on CNBC telling individuals that it wasnt the case that two different sort of vaccines were mixed up. He utilized some words like “out of spec,” although he had never ever defined what that implied. I think in general, whats really going on is a really big unidentified. Because we didnt get any information from Johnson & & Johnson. We didnt get any meaningful information from Emergence.
How unusual is this sort of thing?
We have no idea. Possibly they got the leveling incorrect. Or maybe they didnt train their people enough. Emerging BioSolutions is a little company, and theyre hiring really aggressively. When employing people, you likewise have to bear in mind the training and all type of regulations and compliance. But we simply havent heard any details. So we need them to tell us precisely what took place on the factory flooring. Because keep in mind: This took place in February. And now were currently in April. That is practically 2 months. I dont believe it takes that long for them to discover. They have electronic cameras. In fact, I wouldnt be amazed if the FDA has all the details currently. Im sure they do. So I believe they need to be actually transparent about what actually occurred.
Well, its not normal. This is a mistake– however this has actually occurred before. I study flu vaccines; this does occur from time to time. Flu vaccine makers desire to provide on time, however the FDA does not tell them what to produce until February or March. The production of an influenza vaccine takes, like, six months. In some cases those flu vaccine producers start production even prior to they learn what to produce. So then what they produce wind up being various from what the FDA asked to produce, and they have to throw it away. Which happens every number of years.
The other major production error with COVID was from AstraZeneca. You probably remember last November, when AstraZeneca launched its scientific trial outcomes, and we learnt that due to a manufacturing mistake, they provided 3,000 clients half doses instead of complete doses. So this does occur from time to time. However the 15 million is still a lot. This is a major production mistake. This scale is rare.
This is about the publics trust in the Johnson & & Johnson vaccine. When the vaccines are actually released to the public, people ought to be ready to take the vaccine with confidence.
Do you understand how something like this would even take place in this case?.
When there was this factory in the U.K. producing influenza vaccines, the other situation I can believe of is the case of 2004. The inspectors found a serious contamination; they had this germs level more than 1,000 times the accepted level. So they shut down the entire factory and ruined whatever. That led to a significant shortage of influenza vaccines for that year.
Exist aspects of vaccine production that might make it more vulnerable to mistakes than other pharmaceutical products?
With the flu vaccine, they spend 70 percent of the time just doing quality control tests, and 30 percent producing the vaccine. We have actually heard from Pfizer that its spending half of the time simply running the tests, and the other half of the time doing actual production. Practically absolutely nothing can go incorrect.
Well, I believe its very various from other pharmaceutical products in that this is given to healthy people, and if you wish to give something to numerous millions of healthy people, the quality requirement has to be higher, since you dont want people to get ill from getting immunized. That has happened in the past: Back in 1955, hundreds of individuals got contaminated with the polio from the vaccine from contamination in the production procedure.
What is something that you actually want people to make certain they comprehend about this story?
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I study influenza vaccines; this does take place from time to time. When the vaccines are really released to the public, people must be willing to take the vaccine with confidence. With the flu vaccine, they invest 70 percent of the time just doing quality control tests, and 30 percent producing the vaccine.
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Soon later, numerous outlets reported that the company producing the vaccine at that Baltimore center, Emergent BioSolutions, had been pointed out numerous times prior to for quality control problems. The sheer number of dosages that were disposed of, and the concept of a “contamination” of a COVID vaccine, has actually raised plenty of concerns.
The bottom line is that this is not unique to Johnson & & Johnson. Maybe this factory has a long history of security infractions. [However] all the significant brand names, all the major vaccine producers, got very bad-looking citations from the FDA, implicating them of breaching quality standards, implicating them of not following the factory hygiene standards, etc., and so on
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. But we should be confident about the end product since of the numerous tests. It is extremely unlikely that the quality problems would go undetected prior to they go to market. It has a lot to do with the procedures. Practically every factory, before they started producing COVID vaccines, had a major problem. If you just took a look at those outcomes from the FDA, you would believe thats a complete failure. And then they have to change themselves from a failed trainee to an A student over night. Thats exactly what has actually happened. So infractions are very typical, and polluting 15 million doses isnt typical, however does happen. We need to still be comfy with the results.
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