AZN AstraZeneca PLC

By Peter Loftus and Alex Leary 

Johnson & Johnson is taking over manufacturing of its Covid-19 vaccine at a contract manufacturer's plant that makes the main ingredient, after a production problem ruined a batch.

In order to give J&J full control, production of AstraZeneca PLC's vaccine at the Emergent BioSolutions Inc. plant in Baltimore will move elsewhere, according to a person familiar with the matter.

The moves, which the person said were facilitated by the Biden administration and which were confirmed by the companies, mark a rapid response to the recent discovery of the contaminated batch.

The Emergent plant hadn't yet been cleared by regulators when J&J discovered the quality problem during a routine inspection, and none of the batch had been shipped for use to make vaccines.

Yet J&J and U.S. health authorities have looked forward to the plant coming online and producing the key ingredient to bolster the overall supply of vaccine doses.

Under the changes, J&J is assuming full responsibility for operations and manufacturing of its vaccine's key ingredient at the Emergent plant, including installing a new leadership team and boosting the number of technical, quality and other workers.

J&J continues to work through manufacturing issues with the U.S. Food and Drug Administration, and no product will come out of the Baltimore facility without authorization by FDA, the person said.

J&J said it is working with the FDA to secure authorization of the plant, which would clear the way for doses containing the ingredient made at the plant to be distributed.

The federal government worked with AstraZeneca to move production of its vaccine out of the plant so it could focus exclusively on making J&J's vaccine, the person familiar with the matter said.

AstraZeneca said it is working with the U.S. government to find another plant to make the main ingredient for the company's vaccine.

Emergent is committed to supporting production of the Covid-19 vaccines, and it will still control the facility and work with J&J to add its personnel to the plant's staff, an Emergent spokesman said.

The Emergent plant was supposed to play an important role in Covid-19 vaccine production, making the main ingredients for the J&J and AstraZeneca shots.

AstraZeneca's vaccine hasn't been authorized for U.S. use, though the company said it is preparing a submission.

The FDA has been investigating what caused the quality lapse at the Baltimore plant.

J&J has said the failed batch of the vaccine's main ingredient at the Emergent plant never advanced to the vial-filling stage, and no doses were distributed from the batch.

J&J has said the problem didn't affect doses distributed since the vaccine was authorized for U.S. use in late February.

For doses already distributed, J&J has made the main ingredient at its own plant in the Netherlands. J&J also said it expects to distribute to the U.S. government, as planned, 100 million doses of its vaccine by the end of May.

Write to Peter Loftus at peter.loftus@wsj.com and Alex Leary at alex.leary@wsj.com

(END) Dow Jones Newswires

April 04, 2021 13:50 ET (17:50 GMT)

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