Quality woes thrust Emergent back in the spotlight

April 2, 2021

Earlier this week, new reports revealed that a production mistake at an Emergent BioSolutions facility contracted by Johnson & Johnson to make its COVID-19 vaccines lead to the loss of 15 million doses.

Last year, Emergent secured deals with both J&J and AstraZeneca to produce their respective coronavirus vaccines and apparently conflated the ingredients several weeks ago, contaminating a batch of Johnson & Johnson’s vaccine.

The mistake was caught by J&J's quality control process and the batch was never advanced to the filling and finishing stages, so it does not affect any shipments of finished doses.  All current vaccines supplied to the U.S. were produced in the Netherlands.

The error happened at Emergent's Bayview plant in West Baltimore — a facility that was awaiting authorization to manufacture drug substance for J&J's vaccine. The CDMO — who was awarded $628 million by the U.S. government as part of Operation Warp Speed — has taken heat for its aggressive lobbying for government contracts, particularly in relation to the Strategic National Stockpile.

Recent reports have emerged detailing that an 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.

A senior Biden administration official told POLITICO that the administration has ordered J&J to directly take over on the Emergent manufacturing process. A recent statement from J&J said the drugmaker will provide "additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine."

J&J said it will continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview facility. 

J&J has committed to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The drugmaker says it can still hit its commitment  by June target despite the Emergent delays

Yesterday, Emergent issued a brief statement reaffirming that its Bayview facility is cGMP compliant and that in fact the detection of this recent issue is confirmation that the quality control system works. "Through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly," read the statement.

"Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," said the CDMO.