US FDA asks J&J to discard millions of Covid-19 vaccine doses

Two sources familiar with situation told Reuters that the agency had cleared about 10 million doses

Reuters June 15, 2021

The US Food & Drug Administration on Friday said Johnson & Johnson (JNJ.N) must throw away millions of doses of its Covid-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.

Two sources familiar with the situation told Reuters that the agency had cleared about 10 million doses. The New York Times said that the batches being discarded amount to around 60 million doses, citing people familiar with the matter.

Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorised two batches of the vaccine for use, that several other batches were not suitable for use and that others were being evaluated.

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The agency said it was not yet ready to authorise Emergent BioSolutions Inc's (EBS.N) plant for manufacturing the J&J vaccine. Production of J&J's vaccine at the Baltimore site was halted by US authorities in April and J&J was put in charge of manufacturing at the plant.

One source familiar with the matter told Reuters that the J&J doses are expected to be exported to other countries. The doses are already in vials and ready for use, the other source said.

Safety concerns about the J&J vaccine paired with flagging US demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Close to half of the 21 million doses produced for the United States sit unused.

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The FDA said its decision allows for the J&J doses to be used in the United States or exported. The agency said the drugmaker and Emergent must agree that the FDA can share relevant information about the manufacturing of the doses with regulators where the vaccine is shipped.

J&J, in a statement, confirmed that the FDA authorised the two batches, but did not acknowledge the doses regulators decided should be tossed.


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