J&J Takes Over at Emergent Vaccine Plant With Aid From Biden
The plant was the site of a major manufacturing error that spoiled 15 million doses worth of drug substance for the J&J vaccine.
(Bloomberg) --
Johnson & Johnson, with help from the Biden administration, is taking over a Baltimore vaccine production facility that was the site of a major manufacturing error last month -- and moving production of material for a second company’s shot to minimize risk of another mistake.
J&J announced Saturday that it was “assuming full responsibility regarding the manufacturing of drug substance” at the Emergent BioSolutions Inc. plant. To facilitate that, the Department of Health and Human Services worked with AstraZeneca Plc. to move its production out of that plant so it can focus only on J&J, according to an HHS official familiar with the measure, who spoke on condition of anonymity.
The move came after an error was revealed this week at the plant that spoiled 15 million doses worth of drug substance for the J&J vaccine. President Joe Biden’s administration has acknowledged the delay but said it won’t alter its timeline for when the country will have enough doses for all adults. However, Biden’s team has declined to say how many more doses it would have received this month had the error not occurred.
J&J “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,” the company said in a statement late Saturday.
Even with the vaccine schedule being accelerated in the U.S., which surpassed 100 million people with at least one dose of a Covid-19 shot on Friday, the error at the plant shows there are manufacturing factors that could complicate the rollout. More than 30 million people in the U.S. have been infected with the virus, and over 554,000 have died.
The Baltimore facility isn’t yet authorized by the U.S. Food and Drug Administration. None of the doses administered or available in the U.S. so far have come from that plant -- a fact that Biden officials have pointed to in downplaying the fallout of the error.
After detecting the initial error, Emergent said April 1 a single batch of the drug component was isolated and disposed of. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” the company said.
J&J will install a new senior management team to take charge of the production and manufacturing at the Baltimore plant, and the company will have full responsibility of the operations, production and manufacturing at the site, the administration official said.
In a statement, AstraZeneca confirmed that it would move production from the plant “in full cooperation with the U.S. government” and would work with the government “to identify an alternative location for domestic drug substance production.”
The New York Times first reported that AstraZeneca’s production at the facility had been suspended.
J&J said Saturday it expects to deliver almost 100 million doses of the Covid-19 vaccine to the U.S. government by the end of May. The company, as of now, has produced by far the smallest supply of the U.S.-authorized Covid-19 vaccines. The two other vaccine producers, Pfizer Inc. and Moderna Inc., met their first-quarter targets of 120 million doses and 100 million doses, respectively.
The Biden administration has touted J&J’s one-dose, refrigerator-stored Covid shot as an efficient way to confer protection to Americans, particularly those in hard-to-reach places. However, the administration has said people should get the first vaccine they can.
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