A key contract manufacturer for Johnson & Johnson’s COVID-19 vaccine has stopped making bulk vaccine substance and is retaining what’s already been made at its Baltimore Bayview factory while U.S. regulators continue inspecting it due to quality problems.
The news was disclosed Monday in a Securities and Exchange Commission filing. It raises questions about whether problems at the Emergent BioSolutions Inc. factory will prevent Johnson & Johnson from meeting its U.S. supply commitments.
Johnson & Johnson says it remains committed to providing 100 million doses of the single-shot vaccine pledged by the end of June. It says “it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”
Emergent says the U.S. Food and Drug Administration began inspecting the factory April 12 and four days later asked Emergent not to resume manufacturing and to quarantine all vaccine material already produced there. Emergent said it was doing so until the inspection was completed and the company addresses any problems found.
The FDA declined to comment on how long its inspection will take.
Johnson & Johnson disclosed on March 31 that it had to throw out a batch of bulk vaccine manufactured at the Emergent plant because it didn’t meet quality standards.
