A major contract manufacturer for Johnson & Johnson’s COVID-19 vaccine has stopped producing and retaining large vaccines already manufactured at its Baltimore Bayview plant, while U.S. regulators continue to inspect them due to quality issues.
A major contract manufacturer for Johnson & Johnson’s COVID-19 vaccine has stopped producing and retaining large vaccines already manufactured at its Baltimore Bayview plant, while U.S. regulators continue to inspect them due to quality issues.
The news was announced Monday in a submission from the Securities and Exchange Commission. This raises questions as to whether problems at the Emergent BioSolutions Inc. plant will prevent Johnson & Johnson from meeting its US offering obligations.
Johnson & Johnson says they are still committed to delivering 100 million doses of single-shot vaccine by the end of June. It is said that ‘it is premature to speculate on the possible impact this could have on the timing of our vaccine delivery.’
Emergent says the U.S. Food and Drug Administration began inspecting the factory on April 12 and four days later requested that Emergent not resume production and quarantine all vaccine material already manufactured there. Emergent said he will do so until the inspection is completed and the company pays attention to problems found.
The FDA declined to comment on how long the inspection will take.
Johnson & Johnson announced on March 31 that they had to discard a large amount of vaccine manufactured in the Emergent plant because it did not meet the standards.
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