East Baltimore plant run by Emergent BioSolutions was disappointed after finding out that a large batch of urgently needed COVID-19 vaccine had to be trashed because workers used the wrong ingredients.
Although The Biden administration knew about the contaminated coronavirus vaccine batch that forced 15 million doses to be trashed last month they still choose to hide the debacle from the public, according to high-level insiders.
Three top administration officials told Politico, “Senior Biden administration health officials, including some within the White House, knew two weeks ago that a Johnson & Johnson contractor’s production problems could delay delivery of a significant number of future vaccine doses.”
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.”
The Biden administration kept the mishap under wraps, despite this alarming accident and the accompanying supply delays this could unleash, until insiders leaked the intel this week.
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.
Two senior administration officials told Politico that the debacle will delay future shipments of the Johnson & Johnson vaccine and will disrupt the distribution of doses to states for the next few weeks.
As it is, vaccine supplies are dwindling in Texas and California.
COVID-19 vaccines remain in short supply in Texas, and it is difficult to secure an appointment to get vaccinated. https://t.co/BSqw4u3LdY
— Texas Tribune (@TexasTribune) March 29, 2021
While Americans who want to get vaccinated find they are unable to due to supply shortages, scores of wealthy Mexican nationals have jumped the line to get their injections by chartering private jets to the United States.
Georges Benjamin, executive director of the American Public Health Association, said Emergent has a contractual obligation to deliver the vaccine, but it was hard to predict how the 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 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.
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.
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