The US drug agency, the FDA, has called for production of the Johnson & Johnson vaccine to be stopped at a plant that has reportedly produced 15 million deficient doses.
The pharmaceutical giant told AFP at the end of March that it had identified in a plant in Baltimore (Maryland) managed by the firm Emergent BioSolutions a batch of doses “which did not comply with quality standards”. Johnson & Johnson did not specify the amount of doses involved.
The New York Times subsequently reported that this batch consisted of 15 million doses.
Emergency BioSolutions said in a file sent Monday to the Securities and Exchange Commission, the federal financial market regulator, that the FDA on April 16 requested a pause in vaccine production in Baltimore pending inspection.
“On April 16, 2021, at the request of the FDA, Emergent agreed not to start manufacturing any new material at its Bayview plant and to isolate existing material manufactured at the Bayview plant pending completion of the inspection and the correction (of any problems, editor’s note) noted during the findings ”, declares the file.
Johnson & Johnson said in March it was sending additional experts to the site to oversee vaccine production, and that it planned to deliver 24 million doses in April.
The Emerging BioSolutions plant had not at the time been cleared by US regulators to manufacture a “drug substance” for the Johnson & Johnson vaccine, the drug company said.
But US media have reported that the plant is expected to produce tens of millions of doses in the near future.
This requested break in manufacturing is the latest of problems with the vaccine in the United States, where regulators temporarily halted its use after authorities reported six cases of women who developed blood clots in association with low platelet levels, including one fatal case, within two weeks of an injection of the Johnson & Johnson vaccine.
The European Medicines Agency (EMA) is due to rule on whether Johnson & Johnson’s vaccine is safe on Tuesday.