Emergent wins FDA all-clear to restart J&J COVID-19 vaccine production in Baltimore

COVID-19 vaccine
Prior to this week's manufacturing restart, the FDA had cleared five J&J batches made at Emergent's Baltimore plant. (solarseven/ iStock/ Getty Images Plus)

Some three months after federal officials called for a manufacturing pause, Emergent BioSolutions has righted the ship at its beleaguered Bayview facility.

Emergent won the FDA’s blessing to restart production of Johnson & Johnson’s COVID-19 vaccine at its Baltimore plant, the company said Thursday. The move follows “extensive” FDA reviews, plus “close coordination” with the agency and J&J on the quality enhancement plan Emergent debuted in May.

J&J tapped Emergent last July for large-scale drug substance manufacturing at its Baltimore plant, where the company was also signed on to make AstraZeneca’s vaccine. The FDA halted production there in April after a manufacturing error contaminated a batch containing up to 15 million J&J doses.

Since then, the FDA has signed off on five J&J batches made at Emergent’s Baltimore plant. J&J continues to work with authorities to clear more Emergent batches, Joe Wolk, chief financial officer at J&J, said on an earnings call last week.

RELATED: Johnson & Johnson takes control at troubled Emergent vaccine plant after major production snafu

Emergent, for its part, is “proud” to restart its work on J&J’s vaccine, CEO Robert Kramer said in a statement.

He said Americans should have “high expectations” of the partners the government chooses to help thwart emergencies like COVID-19, opioid overdoses or an anthrax attack—all areas where Emergent chips in.

“[W]e have even higher expectations of ourselves,” Kramer said, noting the company had “fallen short” of its "lofty ambitions" over the past few months.

Beyond its existing remediation efforts with J&J and the FDA, Emergent expects to continue working with the regulator “throughout the manufacturing process,” the CEO added. The company is devoting "extensive resources" to bring its operations up to the FDA's standards, Kramer said. 

Back in early March, out-of-specification testing results on a J&J drug substance batch suggested something was amiss at Emergent, FDA biologics and vaccines official Peter Marks, M.D., Ph.D., said in June. J&J responded with more testing and discovered the batch had been contaminated with AstraZeneca's vaccine, which Emergent was also making in Baltimore at the time. 

RELATED: Johnson & Johnson told to throw out 60M COVID-19 shots made at troubled Emergent site: report

The contamination scare sent regulators back to Emergent's Baltimore plant in April, where the FDA cited the manufacturer for a laundry list of cleanliness and quality control issues. At the time, a company spokesperson told Fierce Pharma that Emergent was "committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified."

The production flub cost AstraZeneca one of its U.S. manufacturing partners, putting the British pharma on the hunt for more vaccine production capacity. Meanwhile, the House Oversight Committee has launched an investigation into Emergent's vaccine fumble, putting the company's lucrative contract from the federal government in the crosshairs. 

CFO Wolk said J&J is "comfortable" meeting its COVID-19 vaccine commitments this year, though the company did recently lower its production target. Originally expecting to make 1 billion doses this year, J&J recently said it now plans to produce 500 million to 600 million doses.