Production Put on Hold at Emergent’s Bayview Facility as Inspection Continues

Emergent BioSolutions has agreed to an FDA request to temporarily cease manufacturing at its Baltimore, Md.-based Bayview site, a pause that will last at least until the agency’s ongoing inspection concludes and remediation action is taken to clear the way for production of the Johnson & Johnson (J&J) vaccine.

The FDA’s inspection of the Bayview facility got under way on April 12 — according to a Securities and Exchange Commission (SEC) filing by the company — and days into the inspection the agency asked the firm to halt production of any new materials at the plant. The agency’s review of the facility stems from a recent high-profile incident in which vaccine materials were mixed up at the site, making millions of J&J doses unusable.

The company agreed last Friday to the agency’s request and said it will quarantine material already made at the facility. The SEC filing did not elaborate on what may have prompted the agency to call for the production halt or when the inspection is scheduled to end, but the company admitted that there are issues to address.

“We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes,” an Emergent spokesperson told FDAnews.

J&J said that it’s too soon to gauge what impact this latest development could have on the timing for its U.S. vaccine deliveries. The company currently anticipates delivering approximately 100 million doses to the government by the end of May.

The Bayview facility, which previously was contracted to produce both the AstraZeneca (AZ) and J&J COVID-19 vaccines, drew the FDA’s attention earlier this month after a serious mix-up of materials for the two inoculations ruined 15 million J&J doses at the site. The ruined shots, intended for European delivery, led the U.S. government to intervene, with J&J given control of the site and production of AZ vaccines being barred there (DID, April 6).

But even last year the Bayview plant had issues, according to an FDA Form 483, which included an observation related to procedures for contamination or mix-up prevention. Specifically, an agency inspection in April 2020 noted insufficient employee training, unsecured records and a deficient method for preventing contaminations or mix-ups. And there have been other issues related to inspections in prior years.

Until the facility receives Emergency Use Authorization from the FDA, J&J vaccine deliveries in the U.S. are expected to be slow, though a White House official said last week that the plant could possibly be cleared before the end of April. The clearance would enable J&J to provide deliveries of up to 8 million doses per week, he said (DID, April 12). But it’s far from clear how the latest production halt will impact that timeline.

Along with the problem at the Emergent facility, the U.S.’ J&J vaccination program has also been hampered by six reports of extremely rare blood clots in U.S. patients given J&J’s one-dose shot. The safety incidents led the FDA to ask all states to temporarily halt inoculations with the J&J vaccine as the agency and the Centers for Disease Control and Prevention (CDC) investigate. A CDC advisory committee will meet again on Friday to discuss the shot and blood clot cases after postponing a vote at its initial meeting (DID, April 19).

The blood clot incidents have also prompted Europe to investigate and J&J to halt vaccine deliveries there. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee is scheduled to report its conclusions today. — James Miessler