In a Securities and Exchange Commission filing on Monday, Emergent said it “agreed not to initiate the manufacturing of any new material” for Johnson & Johnson’s vaccine “and to quarantine existing material” until the Food and Drug Administration finishes its inspection, according to The Hill.
The U.S. Food and Drug Administration began an inspection of the facility on April 12, and following that inspection, the agency asked Emergent to temporarily stop manufacturing. The pause in manufacturing will remain in place pending completion of the FDA’s review and remediation.
In a statement by email to news sources, Emergent said: “While we await the FDA’s full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine.”
“We recognize the confusion these recent events may have caused our customers, our employees, and the public. We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”
In a statement to CNBC, Johnson&Johnson said it will work with Emergent and FDA “to address any findings at the conclusion of the FDA inspection.”
“Our goal remains ensuring all drug substance for our COVID-19 vaccine meets our high-quality standards and securing Emergency Use Authorization for drug substance manufactured at Emergent Bayview,” the company said. “At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”
At the present time, it is questionable whether J&J will be able to meet its contractual agreement with the federal government to produce nearly 100 million doses of its vaccine by June. Administration officials were counting on the Baltimore facility to produce millions of doses a week by the end of this month, even though the plant has yet to receive FDA authorization.