Questions are being raised after the news emerged that a huge batch of COVID vaccines had to be thrown out after they had been found to be contaminated during the production process.
On March 31, Johnson & Johnson admitted that enough vaccines for 15 million doses had to be thrown out. Soon, the news broke that the company which produced the vaccine at the specific facility in Baltimore, Emergent BioSolutions, had previously been cited several times for quality control issues.
After learning of this, many Americans are concerned about the quality of the rest of the vaccine doses, worrying that this may be a larger problem than just one batch.
In an interview with Slate, a left-wing news outlet, Tinglong Dai, an associate professor of operations management at Johns Hopkins University Carey Business School, discussed the news of contaminated vaccines.
“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,” says Dai. “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—its authorization process will be delayed.”
When asked whether this issue is unusual, Dai responded:
“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.”
Dai was also unsure of how exactly this could have happened.
“We have no clue. Maybe they got the leveling wrong,” Dai stated. “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.”
