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FDA authorizes additional batch of Johnson & Johnson COVID vaccine from Baltimore plant

Regulators at the U.S. Food and Drug Administration authorized Tuesday the release of an additional batch of Johnson & Johnson’s COVID-19 vaccine made at the troubled Baltimore plant where production was halted earlier this year due to critical manufacturing errors.

The move brings to three the total number of Baltimore-made batches deemed sufficient for use. Neither regulators nor the company have disclosed how many doses of vaccine were included in the new batch.

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After receiving millions of dollars in federal subsidies to produce the vaccines, Emergent BioSolutions shut down work at the Baltimore facility in April due to a mix-up of ingredients for the Johnson & Johnson vaccine. The FDA put Johnson & Johnson in charge of the plant and launched a review of the facility. The federal government invested millions in the development of the plant, designed to produce vaccines and drugs quickly in the event of a health crisis.

The Emergent plant also was producing the AstraZeneca coronavirus vaccine, which has not yet been authorized for use in the U.S.

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On Friday, the FDA authorized distribution of two batches of the Johnson & Johnson vaccine made in Emergent’s Baltimore plant, widely reported to be about 10 million doses. But the agency also recommended that Johnson & Johnson destroy about 60 million doses made there due to potential contamination, according to media reports.

On Wednesday, The New York Times reported that 15 million doses of vaccine were included in the newly authorized batch, and about 100 million more doses of Johnson & Johnson and AstraZeneca vaccine are being held in Baltimore as regulators weigh their sufficiency.

U.S. officials have largely stopped deploying Johnson & Johnson as production of the immunizations made by Pfizer/BioNTech and Moderna scaled up and the Baltimore plant’s production became delayed. But the single-dose vaccine could help other countries where vaccine distribution has been far less widespread.

Matt Hartwig, a spokesperson for Emergent, said the new batch is separate from those revealed to be insufficient for use last week. He declined to say when the newly authorized batch was produced.

“We welcome the approval of an additional batch of J&J vaccine made at Emergent,” the company said in a statement. “We remain committed to addressing the FDA’s observations in order to resume production as soon as possible and look forward to continuing our work to end this pandemic.”

The plant, located near Johns Hopkins Bayview Hospital, still has not received emergency use authorization to manufacture more of the vaccines, according to an FDA statement. But given the continued severity of the public health crisis globally, the agency conducted a review of facility records and the results of quality testing performed by the manufacturer and concluded the additional batch was safe to use.

Representatives from the FDA did not comment Wednesday, including about the status of the Baltimore plant’s pending authorization.

Despite Johnson & Johnson’s sparse use in the U.S., public health experts have said it holds several strategic advantages over the other two authorized vaccines. The single-dose series could be ideal for transient populations and those who live in remote areas, as well as those who remain skeptical about the Pfizer and Moderna vaccines, which use new messenger RNA technology to produce an antibody response in the body.

The Johnson & Johnson vaccine also is easier to store and handle, as it can be kept in a refrigerator for more than four months, unlike the other two, which must be stored in a deep freeze. The FDA extended the J&J vaccine’s shelf life from three months to four-and-a-half last week.

In a statement released Friday, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency’s review of the newly authorized vaccine included studying the “production history of the facility and testing ... to evaluate the quality of the product.”

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 a memo signed by Marks and released last weekend. AstraZeneca’s vaccine, which has not been approved for use in the United States, 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 had been instructed to adjust its 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” according to the latest FDA memo. “Additionally, improvements were needed in the material and equipment flows.”

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.”

Inspection reports made public in April also showed a range of problems at the Baltimore plant, including cleaning and sterilization failures; lack of adherence to protocols; and potential cross-contamination in multiple areas.

While Emergent BioSolutions’ stock now trades for about half of its February peak due to problems at the plant, its shares rose 41 cents to close at $61.96 each Wednesday.

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