Biotechnology / COVID-19 / Federal government / Health

Emergent BioSolutions to restart COVID-19 vaccine manufacturing in Baltimore

Months after pausing operations, the Maryland biotech company's Bayview plant was approved by the FDA to start making J&J shots once again.

Emergent Biosolutions' Bayview facility. (Courtesy photo)
COVID-19 vaccine manufacturing is set to resume in Baltimore.

Maryland biotech company Emergent BioSolutions said on Thursday that it was approved by the U.S. Food and Drug Administration (FDA) to resume manufacturing of Johnson & Johnson’s COVID-19 vaccine at its Bayview plant in East Baltimore. The Gaithersburg-based company, which serves as a contract manufacturer for pharma companies, has an agreement with J&J to provide doses of its one-shot vaccine.

It marks a restart of production at the plant for the first time since April, when the FDA asked the company to pause its operations. A couple weeks earlier, when The New York Times reported that millions of doses of the vaccine were ruined after ingredients of the AstraZeneca and J&J vaccines were mixed up. An inspection turned up more issues at the plant.

The company said its restart “follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.”

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” said Emergent CEO Robert Kramer, in a statement. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end.”

It comes at a critical time in the pandemic. The Delta variant is leading to a new rise in cases and the resumption of mask mandates in some U.S. cities.

Emergent’s presence in Baltimore predates COVID-19. The Bayview facility was purchased by the company in 2009, and expanded after receiving official designation from the U.S. government as a Center for Innovation in Advanced Development and Manufacturing. Check out a timeline of the company’s Baltimore operations.


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