Tuesday, July 6, 2021

FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys


Johnson & Johnson’s takeover of COVID-19 vaccine manufacturing at an error-prone Emergent BioSolutions plant in Baltimore didn’t last long.

Two weeks after the U.S. stepped in and handed control of vaccine manufacturing at the plant to J&J, Emergent agreed to stop producing drug substance there. 

In March, the factory had to discard up to 15 million vaccine doses when it mixed up materials for the J&J and AstraZeneca vaccines. The New York Times reported  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 plant.

RELATED: Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT

The recent action comes after an FDA inspection last week. On Friday, at the FDA’s request, the company agreed to suspend manufacture of new drug substance and quarantine existing material manufactured there, “pending completion of the inspection and remediation of any resulting findings,” according to an 8-K filing. 

When the U.S. turned over vaccine manufacturing at the plant to Johnson & Johnson, it also earmarked $23 million to boost production. Last year, Emergent received a $628 million contract from the government to produce COVID-19 vaccines.

In April of 2020, the facility was cited for the same quality control problems that led to the COVID-19 vaccine production errors.

RELATED: Emergent’s Baltimore plant flagged for quality control concerns last April, FDA report reveals 

This also is another blow to J&J, whose vaccine is under review after reports of rare and severe blood clot cases among recipients. The U.S. and Europe have stopped distributing the J&J vaccine, though America’s leading infectious disease expert, Anthony Fauci, M.D., predicted this weekend that the shot could be cleared by Friday, with restrictions or warnings.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet this week to present updated findings on the vaccine. Last week, the working group recommended a continued pause in vaccinations as it gathered more information.

RELATED: Johnson & Johnson takes control at troubled Emergent vaccine plant after major production snafu

Meanwhile, other COVID-19 vaccine suppliers have bumped up supply agreements with the U.S. and Europe. And last week, Europe said it would not renew its contract with J&J and AstraZeneca beyond this year.

While its Baltimore plant remains inactive, Emergent said it is working with J&J and the FDA on strengthening the supply chain for the vaccine.

“We recognize the confusion these recent events may have caused our customers, our employees, and the public,” Emergent said in its statement. “We acknowledge that there are improvements we must make … to restore confidence in our quality systems and manufacturing processes.”



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