Emergent: FDA approved troubled facility to resume vaccine production

The Food and Drug Administration (FDA) granted approval for the troubled Emergent BioSolutions plant to resume production of Johnson & Johnson vaccine doses, the company announced on Thursday. 

The reopening of the Baltimore factory, which the FDA closed down in April amid contamination concerns, follows “extensive reviews” from the agency as well as the development of a quality enhancement plan, Emergent said in a press release. The company did not give a timeline for when it expects to restart production. 

An FDA spokesperson told The Hill that the agency informed Emergent that it “would not object to the facility resuming production” of the COVID-19 vaccine, noting it completed a small investigation at the facility earlier this week.

“Emergent BioSolutions’ manufacturing facility has not yet been added to any authorization for a COVID-19 vaccine, but may produce vaccine substance in advance of future FDA inspections,” the spokesperson said. “The vaccine substance being manufactured at this plant will not be distributed until the FDA confirms the plant’s conditions meet the FDA’s rigorous standards for safety, effectiveness and manufacturing quality.”

The Bayview facility came under scrutiny after batches of Johnson & Johnson doses were found to be contaminated with parts of the AstraZeneca COVID-19 vaccine, which the factory also produced. The mistake resulted in tens of millions of doses being thrown away.  

The FDA stopped manufacturing once it issued a report naming several violations, including the contamination, lack of effort to prevent it, unsanitary conditions and inadequate training. 

The agency worked with Emergent to improve its manufacturing and reviewed data on the vaccines made at the facility, permitting a few large batches of doses to be given out. 

Emergent CEO Robert Kramer said the company was “proud” to be continuing the production, while acknowledging the company had “fallen short” of expectations. 

“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,” he said in a statement.  “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.” 

Johnson & Johnson also confirmed the FDA approved the resumption of manufacturing, saying in a statement, “We will continue to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible.”

The FDA did not immediately return a request for comment. 

The agency had said in June that the factory was not ready to return to production as an “authorized manufacturing facility” but committed to working with Emergent on the remaining issues. 

The Trump administration had given the company a $628 million contract to become the main factory for producing Johnson & Johnson and AstraZeneca vaccines. A congressional investigation revealed that Emergent had been warned about manufacturing issues before being given the contract.

Emergent’s founder and executive chair, Fuad El-Hibri, testified in May that AstraZeneca, Johnson & Johnson and the federal government were aware of the facility’s shortcomings before the agreements. 

“Everyone went into this with their eyes wide open, that this was a facility that had never licensed a product before, it’s a facility that although not in perfect condition, far from it, it’s the facility that had the highest level of state of readiness,” El-Hibri said. 

— Updated at 4:06 p.m.