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Baltimore plant pauses COVID vaccine production amid FDA inspection after Johnson & Johnson mistake

Emergent BioSolutions confirmed Monday that it has temporarily stopped production of the Johnson & Johnson COVID-19 vaccine at its East Baltimore plant at the request of government regulators looking into a mistake at the facility that led to the disposal of millions of doses.

The news is the latest setback for the plant, for Rockville-based Emergent BioSolutions and for one of three vaccines crucial to helping end the coronavirus pandemic.

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The Johnson & Johnson vaccine had been circulated less widely than two others with emergency authorization for use in the United States, the Pfizer/BioNTech and Moderna vaccines, but it was the only one that required just a single dose.

None of the vaccine made by the Baltimore plant had been distributed for use because the production line at the Emergent BioSolutions facility had not yet been authorized when officials acknowledged a mix-up with ingredients that led to an estimated 15 million doses being discarded. Millions more were quarantined while officials work to determine whether they’re usable.

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Doses of the Johnson & Johnson vaccine had been coming to the United States from the Netherlands. But the use of even those doses has been paused as government scientists review data from a small number of dangerous blood clots. The vaccine is widely expected to return to use, perhaps with some warnings or restrictions.

Emergent BioSolutions disclosed the temporary halt to production of the Johnson & Johnson vaccine in a Monday filing with the U.S. Securities and Exchange Commission.

The company’s stock plunged nearly $10 a share to close Monday at $67.87 each, down 27% since the end of March when the problems came to light.

In the SEC filing, Emergent said the FDA launched its inspection of the Bayview facility April 12 and the company agreed April 16 “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.”

It’s not clear how many doses Emergent had produced that needed to be isolated. The company, through contracts, makes bulk vaccine that is later sent to another facility to be put into vials and distributed for use.

Matt Hartwig, an Emergent spokesman, said the company has complied with the FDA’s request while the inspection is ongoing.

“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,” Hartwig said in an emailed statement.

“We recognize the confusion these recent events may have caused our customers, our employees, and the public,” the statement said. “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.”

The company has not disclosed how the mistake happened, though vaccine production is complex and facilities are held to strict quality measures. There had been heavy pressure in the plant to produce vaccine quickly.

The plant was, however, set up for this very task. The federal government invested hundreds of millions of dollars in the plant to prepare for a possible pandemic and produce vaccine during times of need.

The facility, next to Johns Hopkins Bayview Hospital, also had been producing AstraZeneca’s COVID vaccine, not yet authorized for use, though officials said that vaccine production would be moved elsewhere.

The FDA declined to comment Monday on the production stop, referring questions to Emergent.

Johnson & Johnson said in a statement emailed to The Baltimore Sun that it was focused on quality and safety, and already had announced that it would increase oversight at the Bayview facility.

“Since then, we have worked closely with the U.S. government, and with the U. S. Food & Drug Administration, including during the ongoing FDA inspection at Emergent Bayview,” the statement said.

“We 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 it was “premature to speculate” on the effects on vaccine deliveries. Johnson & Johnson, however, said it remained committed to providing 100 million single-shot doses to the U.S. government.

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