FDA asks Emergent to pause vaccine manufacturing

April 19, 2021

Emergent BioSolutions said it has agreed with federal regulators not to manufacture any new material at its Baltimore vaccine plant for the time being, pending the completion of a federal review.

In a filing to the Securities and Exchange Commission, the CDMO also said it will quarantine any existing material manufactured at the facility until the review and necessary remediation is complete. The FDA initiated the facility inspection on April 12.

Last year, Emergent secured deals with both J&J and AstraZeneca to produce their respective coronavirus vaccines and (depending on which media report you read) either conflated the ingredients or had an employee move from AstraZeneca’s section of the plant to J&J section without taking  precautions. Either way, the result was a contaminated a batch – up to 15 million doses – of J&J's vaccine.

Recent reports have emerged detailing that a previous FDA inspection of the Bayview plant last April revealed numerous quality issues, improper employee training, recording-keeping issues, and lack of adherence to established testing procedures.

In a recent op-ed in the Baltimore Sun, Emergent CEO Bob Kramer spoke out against misinformation, also acknowledging in the quality issue saying, "We recently had a setback that was not something we ever like to see...in typical pharmaceutical manufacturing, this does occasionally happen."

Unrelated to issues at Emergent, the J&J COVID-19 vaccine has paused for use by U.S. regulators as they review reports of rare blood clots in people who took the shot.