J&J Takes Over Baltimore Vaccine Plant Where 15 Million Doses Were Contaminated

April 4, 2021 Updated: April 4, 2021

Pharmaceutical giant Johnson & Johnson said on April 3 that it’s taking charge of a Baltimore manufacturing plant where 15 million doses of its COVID-19 vaccine were spoiled last month.

The move came after workers at the facility of Emergent BioSolutions, a Maryland-based biotech company that has been manufacturing both the Johnson & Johnson and the AstraZeneca vaccines, accidentally swapped materials for the two vaccines.

While the AstraZeneca vaccine has yet to be authorized for use by the U.S. Food and Drug Administration (FDA), the Biden administration has entered loan deals to send 2.5 million and 1.5 million U.S.-manufactured doses to Mexico and Canada, respectively.

In a statement, Johnson & Johnson said it is “assuming all responsibility for the manufacture of the drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facilities.”

Johnson & Johnson is “adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality, and technical operations personnel to work with the company specialists already at Emergent,” according to the statement.

The company added that the doses distributed to date “have complied with the rigorous quality standards of the company and the regulations,” and that it expects to deliver about 100 million single-shot doses of its vaccines to the U.S. government.

Meanwhile, AstraZeneca confirmed April 3 in a statement that it’s relocating the production of its vaccines from the Baltimore facility.

“The company will work with the U.S. Government to identify an alternative location for domestic drug substance production,” AstraZeneca said, adding that it’s currently progressing submission to the FDA for an Emergency Use Authorization.

Emergent said last week that the single contaminated batch of the drug component was identified and properly disposed of before it was shipped.

“Importantly, the quality control systems worked as designed to detect and isolate this single batch,” Emergent said. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”

President Joe Biden last month announced his intention to order another 100 million doses of Johnson & Johnson’s one-dose, refrigerator-stored vaccines. The company has supplied about 4 million doses to the U.S. government since the vaccine received FDA approval in February.

“I’m doing this because, in this wartime efforts, we need maximum flexibility,” Biden said at a White House meeting with J&J CEO Alex Gorsky and Merck CEO Ken Frazier. “There is always a chance that we’ll encounter unexpected challenges or we’ll—there will be a new need for a vaccine effort—or vaccination effort.”