WASHINGTON – The Biden administration on Saturday put Johnson & Johnson in charge of a troubled Baltimore manufacturing plant that wasted 15 million doses of the Johnson & Johnson Coronavirus vaccine and to prevent the plant from making another vaccine of AstraZeneca Gone, senior federal health officials said.
The extraordinary move by the Department of Health and Human Services came just days after officials learned that Emergent Biosolutions, a contract manufacturer that manufactures both Johnson & Johnson and AstraZeneca vaccines, mixes the composite materials from both regulators. Leads. Delay authorization of plant production lines.
By phasing out the AstraZeneca vaccine, two senior federal health officials said, the plant could be completely dedicated to the Johnson & Johnson single-dose vaccine and avoid future accidents.
The Department of Health and Human Services directed Johnson & Johnson to establish a new leadership team to oversee all aspects of production and manufacturing at the Emergent Baltimore plant. The company said in a statement that it was assuming “full responsibility” for the vaccine made at the Emergent plant.
President Biden made an aggressive push to deliver enough doses to cover each adult by the end of May, with federal officials worried that the mix-up would destroy public confidence in Kovid-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 mix-up by Ingredient, and Saturday’s move, is a significant setback and a public relations defeat for Emergent, a Maryland-based biotech company that has built a profitable business primarily in association with the federal government. Selling anthrax vaccines For the Strategic National Stockpill.
A spokesperson for Emergent declined to comment, saying the company would continue to manufacture AstraZeneca supplements until it received a contract amendment from the federal government.
Unlike Johnson & Johnson, AstraZeneca does not yet have an emergency authorization from the Food and Drug Administration for the vaccine. With three federally authorized vaccines (the other two by Pfizer-BioNotech and Modern), it is unclear whether the AstraZeneca vaccine, which has a troubled history with regulators, was approved in time to meet US needs. May go.
However, one of the federal officials said that the Department of Health and Human Services was discussing working with AstraZeneca to optimize its vaccine to combat the new coronovirus 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 no dose of Johnson & Johnson made by Amergent has been released for delivery by the FDA. Officials have said that it could take weeks to find out if other batches of the vaccine were contaminated and for FDA inspectors to determine if the Amergent plant could be approved to release any doses that it had Is made
Acting FDA Commissioner, Drs. Janet Woodcock said in a statement on Saturday that the agency “takes its responsibility very seriously to help ensure the quality of manufacturing vaccines and other medical products for use during this epidemic.”
But she made it clear that the ultimate responsibility would rest with Johnson & Johnson, saying: “It is important to note that when companies use contract manufacturing organizations, the company that ultimately holds the Emergency Use Authority to ensure It is the responsibility of the FDA to meet the quality standards. “
In another system Brokered by the Biden administration In the past month, Johnson & Johnson is now working with Merck, one of the world’s largest vaccine manufacturers. Officials said Merck would help manage the Baltimore plant.
Emergent’s Baltimore plant is one of two, designated as “Centers for Advanced Development and Innovation in Manufacturing” and built with taxpayer support. Last June, the government paid Emergent $ 628 Million To reserve space there as part of Operation Tana pace, the Trump administration increasingly took initiative to develop coronovirus vaccines.
Johnson & Johnson and AstraZeneca both contracted with Emergent to use the space. Both vaccines are so-called live viral-vector vaccines, meaning that they use a modified, harmless version of a different virus as a vector, or carrier, to direct the body’s immune system. The Johnson & Johnson vaccine is given in one dose, AstraZeneca in two doses.
Experts in vaccine manufacturing said that in the past, the FDA had regulations preventing such accidents by not allowing a plant to produce two living viral vector vaccines because of its ability to mix-up and contamination.
Last month, Mr. Biden canceled Emergent’s visit to the Baltimore plant, and his spokesman announced that the administration would audit the country’s emergency medical reserve, the Strategic National Stockpill. Both actions came one after the other New York Times investigation How the company gained more influence on the reserves.