(Reuters) – The U.S. Food and Drug Administration has asked Emergent BioSolutions Inc to discontinue new products for COVID-19 vaccines until the regulator completes an inspection of its Baltimore plant, which is under scrutiny after millions of doses were discarded due to a manufacturing defect.
Johnson & Johnson, which was in charge of manufacturing the factory by the U.S. government in early April after the incident, said they would work with Emergent and the FDA to address any findings at the end of the inspection.
“At the moment, it is premature to speculate about the possible impact this could have on the timing of our vaccine delivery,” J&J said. The company previously said it would deliver 100 million doses of its vaccine to the United States by the first half of 2021.
The request to suspend production is the latest setback for the company’s COVID-19 vaccine, which has been suspended for use by US regulators as they review reports of rare but serious blood clots in people who took the single-dose shot. .
Emergent said in a regulatory dossier on Monday that the U.S. FDA began the investigation on April 12 and requested an end to production on April 16, pending the completion of the review and repair. (https://bit.ly/32oEg7A)
The company said it would quarantine existing materials manufactured at the Bayview, Baltimore plant until the investigation is complete.
European regulators are also reviewing cases of blood clots and J&J has delayed the roll-out of the vaccine in the region.
J&J has appointed contract manufacturers Emergent and Catalent Inc to scale up vaccine production and meet global supply targets.
Catalent provides the final stage – where vials are filled and labeled – while Emergent makes the remedy. Initial doses in the US are made at the J&J plant in Leiden, the Netherlands.
In March, J&J said they had found a problem with the manufacture of a group of medicines for the COVID-19 vaccine manufactured by Emergent.
J&J did not say how many vaccine doses the group would deliver, but the New York Times reported, without naming a source, that about 15 million doses had been destroyed.
(Reporting by Manas Mishra and Ankur banerjee in Bengaluru; editing by Saumyadeb Chakrabarty and Sriraj Kalluvila)