Production Still On Hold at Emergent’s Bayview Facility as FDA Considers 483 Response

Manufacturing of Johnson & Johnson (J&J)’s COVID-19 vaccine at Emergent BioSolutions’ Bayview, Md., plant remains on pause as the FDA assesses the company’s response to troubling observations by agency officials at the facility last month.

The company said last Wednesday that it had submitted its remediation strategy to the FDA regarding the agency’s inspection observations at the facility in April after a highly publicized mix-up of AstraZeneca (AZ) and J&J vaccine materials that ruined millions of J&J shots. That incident led to government intervention that barred AZ vaccine manufacturing at the site, ground production to a halt and handed the reins of the facility to J&J (DID, April 22). So far, the FDA has been silent about Emergent’s corrective action plan and when production could resume.

The Gaithersburg, Md.-based drugmaker said that it has already moved forward with corrective steps at the Bayview facility as it strives to receive an Emergency Use Authorization that will enable J&J doses to finally start coming out of the plant.

“We have already started making improvements and we are fully committed to making the necessary short- and long-term enhancements to meet or exceed FDA’s standards,” the company said. “We continue to have constructive, on-going dialogue with the FDA and J&J as we work on the path forward to release drug substances currently under evaluation and to resume production.”

Emergent CEO Robert Kramer and executive chairman Fuad El-Hibri will testify before the House Select Subcommittee on the Coronavirus Crisis on Wednesday as lawmakers investigate COVID-19 vaccine manufacturing contracts the company received during the Trump administration. The two executives will also be grilled on the Bayview facility problems that led to the loss of millions of J&J vaccine doses.

Reps. Carolyn Maloney (D-N.Y.) and James Clyburn (D-S.C.) have voiced concerns that the contracts were handed out “despite a long, documented history of inadequately trained staff and quality control issues” at the Bayview site near Baltimore. They allege that Robert Kadlec, a former Emergent consultant and assistant secretary for preparedness and response in the Trump administration, encouraged the awarding of a $628 million federal contract despite red flags at the facility.

The Emergent Bayview facility had issues with FDA inspections earlier in the pandemic, with an inspection in April 2020 observing insufficient employee training, unsecured records and a deficient method for preventing contaminations or mix-ups. Inspections in previous years have also uncovered problems at the plant. — James Miessler