FDA confirms Baltimore plant J&J jabs decision reports

Friday, 11. June 2021 17:57

The United States Food and Drug Administration (FDA) confirmed on Friday earlier reports about their decision regarding the Johnson & Johnson vaccines manufactured at the problematic Emergent BioSolutions plant.

According to the agency, two batches of the Johnson & Johnson vaccine have been given emergency authorization to be used either domestically or internationally, adding that for vaccine exports they will inform the respective country regulators about "relevant information about the manufacture of the batches" under a confidentiality agreement. Additionally, the FDA determined that "several" batches are not suitable for use, but noted that there are still batches left to be investigated.

The Director of the FDA Center for Biologics Evaluation and Research Peter Marks commented on the decision: "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."

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Breaking the News / OL