Emergent Factory Halt Adds to Obstacles for J&J’s Covid Vaccine

Emergent BioSolutions Inc. was told by U.S. regulators to stop making Johnson & Johnson’s Covid-19 vaccine at a facility where 15 million doses worth of a key ingredient had to be discarded, adding to roadblocks preventing wider use the single-dose shot.

Use of J&J’s vaccine has been paused since last week as health officials probe a possible link to life-threatening blood clots. The halt at Emergent, a contract manufacturer, could add to questions about how many Americans will ultimately receive J&J’s shot even if it is found to be safe.

On April 12, the U.S. Food and Drug Administration began inspecting a plant in Baltimore where Emergent was making the drug substance used in the J&J vaccine. Four days later, the FDA asked the company to stop making new materials there and quarantine existing materials until the inspection and any remediation are concluded, according to a company filing with securities regulators on Monday.

“We are steadfastly committed to full compliance with the FDA’s strict requirements,” Emergent spokesman Matt Hartwig said in an emailed statement. “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.”

J&J’s shot had been seen as a crucial part of the immunization campaign in the U.S. But after the dosing pause, Biden administration officials said there would be enough two-dose vaccines from Pfizer Inc.-BioNTech SE and Moderna Inc. to meet demand for inoculations.

People 16 and older are eligible to receive a vaccine in all 50 states, and a quarter of Americans are now fully vaccinated, according to Bloomberg’s Vaccine Tracker.

As of April 15, 7.7 million people in the U.S. had received the J&J shot. The company said that it is committed to delivering 100 million doses to the U.S., though it didn’t repeat its previous target date of the end of June.

“At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries,” spokesman Jake Sargent said in an email. He said the drugmaker will work with Emergent and the FDA to address any findings at the conclusion of the inspection.

Emergent’s shares closed down 13% at $67.87 in New York on Monday, while J&J’s rose 0.5%. The FDA declined to comment on the inspection.

Production Setbacks

Last month, staff at the Emergent facility accidentally conflated ingredients belonging to the J&J vaccine and another manufactured by AstraZeneca Plc. That led to the discarding of an ingredient used in the J&J vaccine.

J&J said on April 3 that it would boost oversight of manufacturing at the Emergent site, bringing in new leadership and increasing the number of personnel working on the effort.

The Biden administration, meanwhile, said it was helping install the new team at the Baltimore facility, and has asked Emergent to ramp down production of the AstraZeneca vaccine. It’s currently in the process of seeking a new U.S.-based production partner for the British drugmaker.

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The Bayview facility was expected to receive an emergency-use authorization to make J&J’s drug substance in March.

J&J has partnered with other U.S. contract manufacturers, including Catalent Inc. and Grand River Aseptic Manufacturing Inc., to make the the vaccine and fill it into sterile vials. In April, drug giant Merck & Co. also agreed to produce the vaccine and conduct the so-called fill-finish process.

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