The Biden administration on Saturday put Johnson & Johnson in charge of a troubled Baltimore manufacturing plant that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and moved to stop the plant from making another vaccine by AstraZeneca, senior U.S. health officials said.
The extraordinary move by the Department of Health and Human Services came just days after officials had learned that Emergent BioSolutions Inc., a contract manufacturer that has been making both the Johnson & Johnson and the AstraZeneca vaccines, mixed up ingredients from the two, which led regulators to delay authorization of the plant’s production lines.
By moving the AstraZeneca vaccine out, two senior federal health officials said, the plant can be solely devoted to the Johnson & Johnson single-dose vaccine and avoid future mishaps.
The Department of Health and Human Services directed Johnson & Johnson to install a new leadership team to oversee all aspects of production and manufacturing at the Emergent Baltimore plant, the officials said. The company said in a statement that it was “assuming full responsibility” for the vaccine made at the facility.
With U.S. President Joe Biden making an aggressive push to have enough doses to cover every American adult by the end of May, federal officials are worried that the mix-up will erode public confidence in COVID-19 vaccines. The AstraZeneca vaccine in particular has generated safety concerns; Germany, France and other European countries briefly suspended its use after reports of rare brain blood clots in some vaccine recipients.
The ingredient mix-up, and Saturday’s move by the administration, is a significant setback and a public-relations debacle for Emergent, a Maryland-based biotech company that has built a profitable business by teaming up with the federal government – primarily by selling its anthrax vaccines to the Strategic National Stockpile.
A spokesman for Emergent declined to comment, except to say that the company would continue making AstraZeneca doses until it received a contract modification from the federal government.
Unlike Johnson & Johnson, AstraZeneca does not yet have emergency authorization from the Food and Drug Administration for its vaccine. With three federally authorized vaccines (the other two are by Pfizer-BioNTech and Moderna), it is not clear whether the AstraZeneca vaccine, which has had a troubled history with regulators, could even be cleared in time to meet U.S. needs.
However, one of the federal officials said the Department of Health and Human Services was discussing working with AstraZeneca to adapt its vaccine to combat new coronavirus variants. AstraZeneca said in a statement that it would work with the Biden administration to find a new site to manufacture its vaccine.
So far, none of the Johnson & Johnson doses made by Emergent have been released by the FDA for distribution. Officials have said it may take weeks to sort out whether other batches of vaccine were contaminated and for FDA inspectors to determine whether the Emergent plant can be cleared to release any doses that it has made.
The acting FDA commissioner, Janet Woodcock, said in a statement Saturday that the agency “takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously.”
But she made it clear that the ultimate responsibility would rest with Johnson & Johnson, saying: “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.”
In another arrangement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck & Co. Inc., one of the world’s biggest vaccine manufacturers. Officials said Merck would help with management of the Baltimore plant.
Emergent’s Baltimore plant is one of two that are federally designated as “Centers for Innovation in Advanced Development and Manufacturing” and were built with taxpayer support. Last June, the government paid Emergent US$628-million to reserve space there as part of Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.
Johnson & Johnson and AstraZeneca both contracted with Emergent to use the space. Both vaccines are so-called live viral-vector vaccines, meaning they use a modified, harmless version of a different virus as a vector, or carrier, to deliver instructions to the body’s immune system. The Johnson & Johnson vaccine is administered in one dose, AstraZeneca’s in two doses.
Experts in vaccine manufacturing said that in the past, the FDA had a rule to prevent such mishaps by not allowing a plant to make two live viral vector vaccines, because of the potential for mix-ups and contamination.
Last month, Mr. Biden cancelled a visit to Emergent’s Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the nation’s emergency medical reserve. Both actions came after a New York Times investigation into how the company had gained outsize influence over the repository.
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