A key contract maker for Johnson & Johnson’s COVID-19 vaccine has stopped producing bulk vaccine and is keeping what has already been done at its Baltimore Bayview plant, while U.S. regulators continue to inspect it. due to quality issues.
A key contract maker for Johnson & Johnson’s COVID-19 vaccine has stopped producing bulk vaccine and is keeping what has already been done at its Baltimore Bayview plant, while U.S. regulators continue to inspect it. due to quality issues.
The news was revealed on Monday in a deposit of the Securities and Exchange Commission. It raises questions about whether the problems at the Emergent BioSolutions Inc. plant. they will prevent Johnson & Johnson from fulfilling its US supply commitments.
Johnson & Johnson says it is committed to providing 100 million doses of single-injection vaccine, committed by the end of June. It is said that it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.
Emergent says the US Food and Drug Administration began inspecting the factory on April 12 and four days later asked Emergent not to resume production and quarantine all vaccine material already produced there. Emergent said it is doing this until the inspection is completed and the company solves any problems found.
The FDA declined to comment on how long its inspection will take.
Johnson & Johnson revealed on March 31 that it had to dispose of a batch of bulk vaccine manufactured at the Emergent plant because it did not meet quality standards.
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