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Emergent resumes production of Johnson & Johnson’s COVID vaccine

The Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson.
The Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson.Mary Altaffer/Associated Press

(Bloomberg) -- The U.S. Food and Drug Administration cleared Johnson & Johnson’s Covid-19 vaccine manufacturer Emergent BioSolutions Inc. to resume production of the shot after a series of mishaps that led it to halt manufacturing.

The Gaithersburg, Maryland-based contract manufacturer said in statement on Thursday that U.S. regulators decided to allow it to resume manufacturing after completing extensive reviews at its facility in Baltimore’s Bayview neighborhood. A Biden administration official said that the FDA decided to allow Emergent to resume production after visiting the facility earlier this week.

U.S. regulators have visited the Bayview site at least three times since a cross-contaminated batch of the J&J vaccine was discovered this winter, according to a person familiar, who asked not to be named as the details of the meetings aren’t public.

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At the outset of the pandemic, Emergent was tasked by the U.S. government with manufacturing the main ingredient of J&J’s single-shot coronavirus vaccine, known as the underlying drug substance. The Bayview facility still hasn’t yet received an emergency-use authorization to be able to deploy the product it’s made to the American public.

The plant had been expected to receive such a clearance earlier in the year, but faced delays after staff conflated materials for the J&J vaccine with those for doses from U.K. drugmaker AstraZeneca Plc that were also being made at the facility. The error led Emergent to discard millions of doses worth of J&J’s vaccine substance and prompted the FDA to start an inspection of the facility.

On April 16, the FDA said Emergent should stop production altogether and quarantine already-made materials. Emergent has remained in limbo for more than three months since.

Johnson & Johnson said in a statement that will continue working toward securing an emergency-use authorization for the Bayview facility as quickly as possible.

Emergent Chief Executive Officer Robert Kramer said he’s proud to see the facility resume production.

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“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Kramer added. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end.”

Emergent said it will continue to work closely with the FDA and J&J to address quality concerns, “committing extensive resources” to bring operations up to the agency’s standards.