J&J plans to resume vaccine production at Baltimore plant

Emergent BioSolutions Inc. EBS 0.09% plans to resume Covid-19 vaccine production at its Baltimore plant after getting the green light from the Food and Drug Administration, according to a statement from the company and an FDA letter reviewed by the Journal.

“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” Emergent CEO Robert Kramer said in a statement late Wednesday. “We are grateful for the opportunity to help bring this global pandemic to an end.”

The plant makes vaccines for Johnson & Johnson.

While domestic demand for the Johnson & Johnson shot has dwindled in recent months, the Biden administration is seeking the shots to be exported to countries needing protection against Covid-19.

The Baltimore plant had been shut down after FDA inspectors determined there was severe contamination at the plant.

J&J confirmed that the FDA had authorized the Emergent plant to resume manufacturing of the company’s vaccines and said it would continue to work toward securing clearance of doses manufactured at the plant as quickly as possible.

In a letter from the FDA to Emergent on Wednesday viewed by the Journal, the federal agency said, “Based upon our current observations of the implemented corrective actions, FDA does not object to the resumption of manufacturing” at the Baltimore plant.

One person familiar with the issue said the Emergent plant in Baltimore, once it is operating at full capacity, could make as many as 120 million doses a month. Those finished doses might not be available until this fall, however, the person said.

J&J confirmed that the FDA had authorized the Emergent plant to resume manufacturing of the company’s vaccines and said it would continue to work toward securing clearance of earlier doses manufactured at the plant as quickly as possible.

J&J still has up to 30 million doses that were made earlier at the Baltimore plant left to be potentially cleared for use. J&J’s vaccines are one-dose shots.

That vaccine, along with other doses from AstraZeneca PLC, was made at the plant before the FDA action in April leading to the shutdown of the facility. The AstraZeneca vaccine is given as a two-shot regimen.

The AstraZeneca vaccine doses that were produced at the facility still haven’t been cleared for use by the FDA.

The FDA still plans a further, more comprehensive review of the plant after production is under way. WSJ