attention catherine owen

J&J Takes Over Contractor’s Covid-19 Vaccine

Manufacturing Plant

By Peter Loftus and Alex Leary

Updated April 4, 2021 1:38 pm ET

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’s vaccine at the Emergent

BioSolutions 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 New York Times first reported J&J’s takeover of the plant.

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.