(Reuters) – The U.S. Food and Drug Administration has asked Emergent BioSolutions Inc to stop manufacturing new drug material at its plant in Baltimore, which was responsible for millions of ruined COVID-19 vaccine doses earlier this month.
The U.S government had put Johnson & Johnson in charge of the plant following the incident when workers conflated ingredients for the J&J and AstraZeneca Plc vaccines. U.S. regulators also stopped the British drugmaker from using the facility.
The request to stop manufacturing is the latest setback to Emergent and the J&J 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 shot.
JNJ was not immediately available for comment.
Emergent said the U.S. FDA had started a review of the plant last week and requested the halt in manufacturing. Emergent said it would also quarantine existing material manufactured at the Bayview, Baltimore facility pending completion of the review and remediation.
The U.S. government had also earlier increased Emergent’s order by $23 million for expansion of production specific to J&J’s vaccine doses.
J&J tapped contract manufacturers Catalent Inc and Emergent 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 had also been made at the company’s plant in Leiden, Netherlands.
(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta and Saumyadeb Chakrabarty)
