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Johnson & Johnson vaccine production restarts in Baltimore but still not authorized for distribution - The Washington Post

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Emergent BioSolutions said Thursday it has received the go-ahead from the Food and Drug Administration to resume manufacturing Johnson & Johnson coronavirus vaccine after a suspension of more than 100 days because of cross-contamination at its Baltimore factory.

The company still does not have full FDA approval that would allow any bulk vaccine produced there to be distributed in the United States without additional reviews, but the company called the restart an important step toward getting the only domestic source of Johnson & Johnson vaccine back on track.

The plant has been shut down since April after it was discovered a month earlier that Johnson & Johnson vaccine had been contaminated by a different vaccine also being made at the plant for AstraZeneca.

The AstraZeneca vaccine, which is not approved for use in the United States, was removed from the facility, and Emergent has spent the last three months cleaning the plant and correcting myriad problems. A scathing FDA inspection report on the Emergent plant in April cited unsanitary conditions and a lack of adherence to basic protocols intended to prevent contamination of the vaccine. At least 75 million doses worth of Johnson & Johnson vaccine have been discarded.

“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,” Emergent chief executive Robert Kramer said in a news release Thursday.

“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,'' he said.

The supply of the Johnson & Johnson vaccine has fluctuated. About 21 million doses have been delivered throughout the United States, of which about 13 million have been administered, according to Centers for Disease Control and Prevention data. They were imported from the company’s operation in the Netherlands. No shots from the Emergent plant have been distributed in the United States.

Demand for Johnson & Johnson vaccine in the United States has lagged behind after the CDC suspended use of the shots for nine days in April in response to a side effect of very rare blood clots. But the Biden administration has agreed to include Johnson & Johnson in vaccine exports to help closed the enormous gap between wealthy and developing nations.

The amount of Johnson & Johnson vaccine administered domestically compares with about 330 million shots administered in the United States of the two-dose vaccines made by Pfizer and Moderna.

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Johnson & Johnson vaccine production restarts in Baltimore but still not authorized for distribution - The Washington Post
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