Errors by employees at a Baltimore, Maryland, contractor site for Johnson & Johnson’s COVID-19 vaccine resulted in the need to destroy bulk material that would have amounted to 15 million doses planned for distribution in the United States.

UPDATE

On June 11, 2021, the FDA ruled that about 60 million Johnson & Johnson vaccine doses produced at the Baltimore facility must be discarded.

Key Takeaways

  • A manufacturing error at a plant in Baltimore resulted in bulk Johnson & Johnson COVID-19 vaccine material being discarded.The FDA is investigating the cause of the error.The Johnson & Johnson vaccines being distributed in the U.S. right now are made in the Netherlands and were not part of the quality control inspection or cause for concern.

In a statement late Wednesday, March 31, Johnson & Johnson said that during the quality control process, the contractor, Emergent BioSolutions, “identified one batch of drug substance that did not meet quality standards.”

According to Johnson & Johnson, the Emergent BioSolutions site is not yet authorized to manufacture the drug substances for its COVID-19 vaccine. So no doses were ever produced from the botched batch.

Now, the Food and Drug Administration (FDA) is investigating the Baltimore plant’s mixup, putting a hold on future shipments of the Johnson & Johnson vaccine in the United States.

What Went Wrong?

The specific error, according to reporting by the New York Times and other outlets, was that Emergent BioSolutions is a contractor for both Johnson & Johnson and AstraZeneca (whose vaccine has not yet been submitted to the FDA for use in the U.S.) and that ingredients from both vaccines were mistakenly mixed together. 

What This Means For You

If you recently received or are slated to receive the Johnson & Johnson vaccine in the next week, this manufacturing error does not affect you. All of the doses previously administered in the U.S. and being delivered in the immediate future are from the Netherlands, not Baltimore.

Johnson & Johnson says that “this is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).”

Will This Hurt Vaccine Supply In the U.S.?

Amesh Adalja, MD, FIDSA, senior scholar at the Johns Hopkins Bloomberg School of Public Health Center for Health Security, tells Verywell that in terms of vaccine supply for the U.S., the error is not a major issue.

No contacts from Johnson & Johnson, Emergent BioSolutions, the FDA or the HHS responded to calls or emails from Verywell upon time of publication.

“We have a supply redundancy, so it won’t affect the timeline of getting people vaccinated,” Adalja says, predicting a surplus of Pfizer and Moderna vaccines.

Even in its latest statement, Johnson & Johnson attempted to take a positive spin, stating the company met its commitment to “deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States.”

Adalja says he wasn’t surprised that an error occurred.

“When you are talking about manufacturing processes on such a scale, there are always going to be unforeseen errors; there is always some level of human error that can occur,” he says. 

Errors May Stoke Vaccine Mistrust

Adalja is concerned that the error will exacerbate hesitancy in people.

“Any time there is a negative headline about any of the vaccines, it can add to concern among people who are hesitant,” he says. “They won’t remember the details—that it was a manufacturing error—and that can lead to vaccine hesitancy. They’ll think the vaccine is something they’re just not comfortable with. We are currently encouraging everyone to get the vaccine."