FDA asks Emergent plant behind botched COVID-19 vaccines to pause manufacturing

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(Reuters) -The U.S. Food and Drug Administration has asked Emergent BioSolutions Inc to halt producing new materials for COVID-19 vaccines until the regulator completes an inspection of its plant in Baltimore, which is under scrutiny after millions of doses were thrown away due to a manufacturing error.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Johnson & Johnson, which was put in charge of manufacturing at the plant in early April after the incident by the U.S. government, said it would work with Emergent and the FDA to address any findings at the end of the inspection.

“At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries,” J&J said. The company has previously said it would deliver 100 million doses of its vaccine to the United States by the first half of 2021.

The request to pause manufacturing is the latest setback to the company’s COVID-19 vaccine, which has been paused for use by U.S. regulators as they review reports of rare but serious blood clots in people who took the one-dose shot.

Emergent said on Monday in a regulatory filing that the U.S. FDA started the review on April 12 and requested the halt in manufacturing on April 16 pending completion of the review and remediation. (bit.ly/32oEg7A)

The company said it would quarantine existing material manufactured at the Bayview, Baltimore facility until the review is complete.

European regulators are also reviewing cases of blood clots and J&J has delayed the vaccine’s rollout in the region.

J&J tapped contract manufacturers Emergent and Catalent Inc to scale up production of the vaccine and meet its global supply targets.

Catalent provides the final stage – where vials are filled and labeled – while Emergent makes the drug substance. Initial U.S. doses are being made at J&J’s plant in Leiden, Netherlands.

In March, J&J said it had found a problem with a batch of the drug substance for its COVID-19 vaccine being produced by Emergent.

J&J did not say how many vaccine doses the batch would have produced, but the New York Times, without citing a source, reported that about 15 million doses were ruined.

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