Troubled Maryland plant told to toss part of the J&J vaccine ingredient it manufactured
WASHINGTON — Federal health regulators have instructed Maryland’s Emergent BioSolutions to scrap some batches of the Johnson & Johnson COVID-19 vaccine substance manufactured at the company’s troubled Baltimore plant, while clearing a small portion to be used in the U.S. or sent abroad.
Two batches of the J&J vaccine substance made in Baltimore were deemed “suitable for use” by U.S. Food and Drug Administration regulators, but “several other batches” were deemed not usable and other batches remain under review, according to an agency news release Friday.
Agency officials did not estimate how many doses are in those batches. The New York Times reported Friday that the equivalent of 10 million J&J vaccine doses was cleared for use, and roughly 60 million doses’ worth of ingredients would need to be discarded.
Previous estimates from company officials had projected that the drug substance that was quarantined for review could be used to produce more than 100 million doses.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements.”
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