When an East Baltimore plant run by Emergent BioSolutions found that a large batch of urgently needed COVID-19 vaccine had to be trashed because workers used the wrong ingredients, the company said the episode was “disappointing” but showed that its rigorous quality controls worked.
That’s true, say vaccine supply chain and public health experts. Snafus are not infrequent in plants producing complex vaccines and therapeutics, and the pandemic likely added to the pressure to produce.
Still, this was one giant and unusual mistake — wasting precious ingredients, delaying production and potentially further eroding public trust in vaccines. The 15 million doses discarded were enough to vaccinate about 7% of U.S. adults, if the plant’s output earned FDA approval.
“Their statement is almost like self-congratulating for having quality controls that work,” said Tinglong Dai, associate professor of operations management & business analytics in the Johns Hopkins University Carey Business School.
“The public only wants more assurance they can prevent these mistakes from happening to begin with.”
Before the mistake, first reported by The New York Times, Emergent’s Bayview facility was on track to become a crucial cog in the global vaccine manufacturing network. Infused with hundreds of millions in federal dollars, the plant was generating bulk batches of the vaccine developed by Johnson & Johnson, which recently gained emergency authorization for use.
The plant itself had not yet gained approval from the U.S. Food and Drug Administration to distribute its bulk vaccine, and none left the facility.
After government approval, the vaccine would go to another facility to be put into vials for use.
In a statement Thursday to The Baltimore Sun, the FDA didn’t provide specifics of the problem at the Emergent plant or address how any issues would be resolved. It said its goal was to ensure the public has safe and effective medical products.
“Although the agency has a number of compliance and enforcement tools it can use to address quality system deficiencies or other issues with regulated industry, one of the main ways we achieve our mission is through ongoing interactions with manufacturers to help resolve process and compliance issues,” the statement said.
Experts including Dai who closely follow vaccine supply said production by Emergent was likely set back by weeks or months, which could be a significant delay during the pandemic. It’s not just replacing the batch, which could take three to six weeks, but correcting the lapses in quality control to the satisfaction of Johnson & Johnson and the FDA.
In the meantime, all of the Johnson & Johnson vaccine being used to vaccinate Americans will continue to be made in a plant in the Netherlands.
Johnson & Johnson said in a statement Wednesday that it still aimed to deliver 100 million doses by the end of May in the United States. It has already delivered 20 million doses.
The company also said it had “dedicated specialists on the ground at the companies that are part of our global manufacturing network” to ensure quality, and it was that system that flagged the troubled batch and reported it to the FDA.
Dr. Georges Benjamin, executive director of the American Public Health Association, said Emergent has a contractual obligation to deliver vaccine, but it was hard to predict how timing would be affected given the lack of information about how Emergent made the mistake and what was needed to correct it.
“If they understand how it happened, they could fix it quickly,” he said. “Could be as simple as the wrong product was mislabeled or someone grabbed the wrong jar. FDA will have to go into the plant and do an overview of the whole system, which may take time.”
Dai said review processes are different during a public health emergency, and the mistake was likely caught during a review of data, as during a pandemic the FDA wouldn’t necessarily come and inspect every batch as it would likely do of flu vaccine during flu season.
He said he was confident that the U.S. manufacturing system has proved safe and federal officials have tools to ensure problems are resolved. In the past, federal officials have sent their own experts to fill gaps they find in the quality control workforce in manufacturing plants, and Dai said it’s possible that they would consider such a move in this case.
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This would help build trust with the public, he said. That could be especially important to persuade people already hesitant to take vaccines, though the COVID-19 vaccines have proved highly effective and safe.
The size of the loss, however, will likely grab attention, said Rob Handfield, a professor of supply chain management at North Carolina State University.
“Everybody has likely had some productions problem,” he said. “But I’ve never heard of anyone messing up 15 million doses.”
Handfield said Johnson & Johnson is typically known for running strict operations and is likely on-site to evaluate every aspect of production Still, this could “erode trust” in its vaccine.
“This is unfortunate because we need as many vaccine doses as possible and to vaccinate people as quickly as possible, not just here but globally,” he said. The error “impacts our ability to vaccinate everyone.”
An Emergent spokesman reiterated in a statement that the problem was limited to one batch.
“Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multistep biological process, “ said Matt Hartwig, a spokesman for Emergent. “The company plans to continue to make vaccine on a contract basis with vaccine developers.”