WASHINGTON • The Biden administration put Johnson & Johnson (J&J) in charge of a Baltimore manufacturing plant that ruined 15 million doses of the company's coronavirus vaccine, and moved to stop the facility from making another vaccine by AstraZeneca.
The extraordinary action by the Department of Health and Human Services came just days after officials learnt that Emergent BioSolutions, a contract manufacturer that has been making both the J&J and AstraZeneca vaccines, mixed up ingredients from the two, which led regulators to delay authorisation of the plant's production lines.
By moving the AstraZeneca vaccine out, two senior federal health officials said, the factory can be devoted to the J&J single-dose vaccine and avoid future mishaps.
The Department of Health and Human Services directed J&J to install a new leadership team to oversee all aspects of production and manufacturing at the Baltimore facility, the officials said. The company said in a statement that it was "assuming full responsibility" for the vaccine made there.
With President Joe Biden making an aggressive push to have enough vaccine doses to cover every American adult by the end of next month, officials are worried that the mix-up will erode public confidence in Covid-19 shots.
The AstraZeneca vaccine has generated safety concerns. Germany, France and other European nations briefly suspended its use after reports of rare brain blood clots in some recipients.
The ingredient mix-up, and last Saturday's move by the administration, is a significant setback and a public relations debacle for Emergent. The Maryland-based biotech company has built a profitable business by teaming up with the federal government - primarily by selling its anthrax vaccines to the Strategic National Stockpile.
An Emergent spokesman said it would continue making AstraZeneca doses until it received a contract modification from the federal government.
Unlike J&J, AstraZeneca does not yet have emergency authorisation from the Food and Drug Administration for its vaccine.
With three federally authorised vaccines (the other two are from Pfizer-BioNTech and Moderna), it is not clear whether the AstraZeneca one, which has had a troubled history with regulators, could even be cleared in time to meet United States needs.
So far, none of the J&J doses made by Emergent has been released by the Food and Drug Administration for distribution.
NYTIMES
