FDA Orders Baltimore Plant To Suspend Vaccine Production

BALTIMORE, MD —Emergent BioSolutions, a biotech company known for manufacturing vaccines, agreed on Friday to suspend production at its facility in the Bayview neighborhood of Baltimore. The move came at the request of the Food and Drug Administration, which had conducted an inspection of the facility three days earlier, several sources reported.

The news came to light in Emergent's 8-K filing with the Securities and Exchange Commission in which it wrote:

"At the request of the FDA, Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings."

This was just the latest setback for Emergent. According to CNBC.com, earlier this month the Biden administration put Johnson & Johnson in charge of the Baltimore plant after U.S. officials learned that Emergent, which had been making vaccines for J&J and AstraZeneca, had mixed up ingredients of the two shots in March. Officials also made the plant stop production of the AZ vaccine in order to avoid future mix-ups, the New York Times reported.

The New York Times also reported that an additional batch of between 10 million and 15 million doses of the AZ vaccine was lost last November because of suspected contamination at the Bayview plant.

In a statement to CNBC, J&J said it would work with Emergent and the FDA to address any findings from 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 statement read. "At this time, it is premature to speculate on any potential impact this could have on the time of our vaccine deliveries."

The pause in production at the Bayview plant comes at a time when the FDA and Centers for Disease Control and Prevention (CDC) advised states to temporarily stop using the J&J vaccine "out of an abundance of caution" after six women developed a blood clotting disorder that left one dead and one in critical condition.