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FDA details contamination event at Baltimore facility that makes COVID vaccines

Top officials at the U.S. Food and Drug Administration detail a series of mistakes and costly human errors that rendered millions of doses of Johnson & Johnson’s COVID-19 vaccine unusable in a memo posted over the weekend.

The memo also elaborates on federal regulators’ decision to authorize use of two batches of the vaccine made around the same time as the tainted ones, saying while the facility did not operate in compliance, those products have been cleared following a testing and records-review period.

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The new documents shed light on the process errors by Emergent BioSolutions, a Gaithersburg-based vaccine producer that runs a Baltimore plant subsidized with millions of dollars in federal money to make COVID-19 vaccines. The information also underscores the high stakes of the missteps, as both Johnson & Johnson and AsztraZeneca had contracted with Emergent to produce their immunizations at the plant also built and operated with federal subsidies.

Public health officials said the situation highlights the challenges of vaccine handling, and the tension that exists between matters involving both speed and efficiency but also precision and delicacy.

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“It shows that making vaccines is complicated,” said Matthew Frieman, a professor of microbiology and immunology and coronavirus vaccine researcher at the University of Maryland School of Medicine in Baltimore.

Emergent BioSoultions’ Baltimore plant still lacks authorization to manufacture vaccines from the federal government, an FDA spokesperson said Monday, adding that the agency continues to work through issues there with Johnson & Johnson’s Janssen unit and Emergent BioSolutions management. Production at the plant near Johns Hopkins Bayview Hospital has been stalled since April.

Matt Hartwig, a spokesperson at Emergent BioSolutions, said the company will “continue working with the FDA and Johnson & Johnson to address any concerns, help get additional doses released and to resume production of this important COVID-19 vaccine.”

Janssen, the pharmaceutical company owned by Johnson & Johnson, detected AstraZeneca’s COVID-19 vaccine virus in a batch of J&J vaccine in March, according to the memo signed by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. AstraZeneca’s vaccine inserts the coronavirus’ DNA inside an adenovirus, a common vehicle used for vaccinations, which can train cells to fight the virus without replicating inside the body.

The discovery surfaced after Emergent workers had been instructed to adjust their practices after a series of visits by federal regulators to the site, where they found “crowded manufacturing areas with equipment and supplies; inadequate quality assurance support; and several issues related to laboratory controls. Additionally, improvements were needed in the material and equipment flows,” according to the latest FDA memo.

Inspectors in February also found “many personnel changes and new hires in Quality and Manufacturing ... as well as the need for better documentation and procedures, and consistency with established practices.”

The FDA investigated Janssen’s finding and concluded that the biologic materials needed for the Johnson & Johnson vaccine had been contaminated with adenovirus as it moved through the facility’s “common weigh and dispense area” with materials from the AstraZeneca manufacturing area, which were not properly separated during the “waste transit” process, according to the FDA memo. It blamed faulty manufacturing practices for the incident.

“Several objectionable conditions were noted at that time, including, for example, the failure to conduct thorough investigations into unexplained discrepancies,” the memo reads.

The memo showcases the FDA’s careful, batch-by-batch review of the facility, and how officials used records and data to reconstruct exactly what happened to cause the contamination, said Tinglong Dai, associate professor of operations management & business analytics in the Johns Hopkins University Carey Business School.

“It shows the FDA tried to be transparent and show the public what happened,” Dai said.

It was not clear where the two batches of J&J vaccine authorized for use would go or how quickly, but a footnote included in the memo notes that other countries interested in deploying the immunizations would have full access to all available information regarding the manufacturing conditions at the facility, including confidential commercial information and trade secret information.

“I don’t think J&J is going to be in the U.S.,” Dai said, “but there’s hope that these doses could help other countries.”

The two batches found to be in suitable condition were made during periods of low waste production, according to the memo, and thus did not come into contact with the AstraZeneca vaccine virus. The FDA decided to authorize them, despite the preexisting problems at the Baltimore plant, in light of the ongoing public health emergency, according to the memo.

A global shortage of vaccines threatens to upend the progress in abating the coronavirus pandemic, which has dramatically slowed in the United States while accelerating in other countries. So far, about 144 million Americans have been fully vaccinated, and slightly more than half of the total U.S. population has received more than one dose, including more than 60% of adults, according to the U.S. Centers for Disease Control and Prevention.

But the picture in other countries has been far less rosy. India, Russia and several African countries have been hit hard in the last several months and weeks, and vaccine uptake in those places has been far less widespread.

Johnson & Johnson’s vaccine has several benefits over others, including its ability to be kept refrigerated rather than frozen, its longer shelf life and its single-dose regimen. This type of vaccine is ideal for remote areas without health care sites; transient populations and those who lack access to transportation.

A country like India, where many people lack national identification cards, and have several adults living in close quarters, would benefit greatly from this vaccine, Dai said.

The U.S. has become less reliant on the Johnson & Johnson vaccine as those made by Pfizer/BioNTech and Moderna scaled up in production, he said. But other places overseas — such as Taiwan ― could vaccinate millions of people quickly with it, Dai said.

“You have to think: What alternatives in other countries do they have?” Dai said. “There’s a strategic advantage to vaccinate the rest of world with it, but not so much for the U.S., unfortunately.”

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