Emergent BioSolutions to restart J&J COVID-19 vaccine production

The Food and Drug Administration (FDA) is permitting Emergent BioSolutions Inc. to resume manufacturing the Johnson & Johnson COVID-19 Janssen vaccine at its Bayview facility in Baltimore, according to the multinational biopharmaceutical company.

“We are proud to be resuming production of bulk COVID-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Emergent CEO Robert Kramer in a July 29 statement. “We’d like to thank our government partners as well as Johnson & Johnson for their support.”

An FDA spokesperson told Reuters on Thursday that Emergent’s Bayview facility has not yet received any authorization for a COVID-19 vaccine, but may produce vaccine substance in advance of future inspections by the agency.

Emergent’s Bayview plant has been closed since April after the FDA determined that the Johnson & Johnson (J&J) vaccine being manufactured there had been cross-contaminated by an AstraZeneca vaccine also being made at the plant. Emergent subsequently quarantined 15 million doses of the J&J vaccine and at the request of the FDA discontinued production of the AstraZeneca vaccine.

The newly announced manufacturing restart of the J&J vaccine follows extensive FDA reviews, according to Kramer’s statement, as well as Emergent’s coordinated work to address quality concerns with both the federal agency and its manufacturing partners, including to develop and execute Emergent’s action plan, the statement says. 

For example, during the company’s investor call on Thursday, Kramer said that Emergent continues “to work collaboratively with AstraZeneca to complete all documents related to their drug substance so they and the U.S. government can make decisions regarding the disposition of this material.”

Emergent also has committed substantial resources to bring its Bayview operations up to FDA standards, according to Kramer.

“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 Kramer. “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.”

The FDA to date has approved five batches of vaccines from Emergent’s Bayview facility since production halted in April and Kramer said during the investor call that the company expects the agency to approve additional batches.

Emergent also will continue to work with the FDA throughout the manufacturing process to help ensure the strength of the J&J COVID-19 vaccine supply chain, he said.