US Government Directs Johnson & Johnson to Run Vaccine Plant

Carolyn Crist

April 05, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Federal health officials on Saturday put Johnson & Johnson in charge of a vaccine manufacturing plant in Baltimore that contaminated 15 million doses of the COVID-19 vaccine and ordered the plant to stop making AstraZeneca doses, according to The New York Times .

The move came days after federal health officials discovered that the plant mixed up ingredients from the two vaccine companies. Emergent BioSolutions, a contract manufacturer, had been making both the Johnson & Johnson and AstraZeneca vaccines at the plant.

The Department of Health and Human Services directed Johnson & Johnson to place new leadership at the plant to oversee production and manufacturing, the newspaper reported.

"Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility," the vaccine company wrote in a statement on Saturday.

"Specifically, [Johnson & Johnson] is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel," the company wrote.

The Johnson & Johnson vaccine has received FDA authorization in the U.S., but the AstraZeneca vaccine hasn't. The 15 million contaminated Johnson & Johnson doses weren't released for distribution, The New York Times reported, and officials are now evaluating whether other batches were contaminated. In addition, AstraZeneca will find a new site to manufacture its vaccine, the newspaper reported.

Emergent's coronavirus vaccine production line hasn't yet been certified by the FDA, so vaccines made there can't be distributed yet, according to The Washington Post . The doses made at the plant have been set aside while the FDA reviews the plant.

The FDA "takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously," Janet Woodcock, MD, the acting FDA commissioner, told the newspaper in a statement on Saturday.

At the same time, Woodcock said the ultimate responsibility falls to Johnson & Johnson to ensure quality control.

"It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the FDA are met," she said.


New York Times, "U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant."

Johnson & Johnson, "Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing (Updated)."

Washington Post, "Johnson & Johnson says it will take full control of its coronavirus vaccine production at Baltimore plant."