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FDA probes why Johnson & Johnson’s Covid-19 vaccine batch failed



A person familiar with the matter said that the U.S. Food and Drug Administration is investigating why a batch of active ingredients of Johnson & Johnson’s Covid-19 vaccine was scrapped because the contract manufacturer failed to meet quality standards.

The person familiar with the matter said that the FDA may send an inspection team to assess the condition of the Baltimore plant operated by the contractor Emergent BioSolutions Inc..

Johnson & Johnson disclosed on Wednesday that a batch of the main components of the Covid-19 vaccine produced in the emergency factory did not meet the standards and therefore underwent regulatory review. The batch did not reach the vial filling and completion stage, and no dose was dispensed.

Johnson & Johnson said that the decline in quality has not affected the vaccine doses distributed in the United States since the vaccine was approved in late February, and the company still has enough supply to meet recent commitments. Johnson & Johnson also produces the main components of the vaccine at its own factory in the Netherlands.

Emergent BioSolutions of Gaithersburg, Maryland said in a statement on Thursday that it isolated a batch of vaccine components because it did not meet specifications and quality standards. Emergent stated that it will dispose of the batch of products appropriately.


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