WASHINGTON – The Biden government on Saturday hired Johnson & Johnson to run a troubled Baltimore manufacturing facility that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and prevented the facility from producing another vaccine from AstraZeneca manufacture.
The Department of Health and Human Services' extraordinary move came just days after officials learned that Emergent BioSolutions, a contract manufacturer that makes both Johnson & Johnson and AstraZeneca's vaccines, was mixing the ingredients in the two, which regulators did delayed the approval of the plant's production lines.
By outsourcing the AstraZeneca vaccine, according to two senior federal health officials, the facility can be dedicated solely to Johnson & Johnson's single-dose vaccine to avoid future breakdowns.
The Department of Health and Human Services directed Johnson & Johnson to establish a new leadership team to oversee all aspects of manufacturing and manufacturing at the Emergent Baltimore facility. The company said in a statement that it took "full responsibility" for the vaccine manufactured at the Emergent facility.
Given President Biden's aggressive efforts to provide enough doses for every adult by the end of May, federal officials fear the mix-up will undermine public confidence in Covid-19 vaccines. The AstraZeneca vaccine in particular has raised safety concerns. Germany, France and other European nations have temporarily discontinued use in some vaccine recipients after reports of rare cerebral blood clots.
The ingredient mix-up and move of administration on Saturday is a major setback and PR debacle for Emergent, a Maryland-based biotech company that has built a profitable business by working with the federal government, largely selling its Anthrax vaccines against the Strategic National Stockpile.
An Emergent spokesman declined to comment, except that the company will continue to manufacture AstraZeneca cans until it receives a contract amendment from the federal government.
Unlike Johnson & Johnson, AstraZeneca does not yet have an emergency approval from the Food and Drug Administration for its vaccine. With three federally approved vaccines (the other two are from Pfizer-BioNTech and Moderna), it's not clear whether the AstraZeneca vaccine, which has had regulatory issues in the past, could even get approved in time to meet U.S. needs .
However, one of the federal officials said the Department of Health and Human Services is discussing working with AstraZeneca to adapt its vaccine to fight new coronavirus variants. AstraZeneca said in a statement that it would work with the Biden administration to find a new location to manufacture its vaccine.
To date, none of the Johnson & Johnson cans manufactured by Emergent has been approved by the F.D.A. for distribution. Officials have said it could take weeks to find out if other batches of vaccine were contaminated and for F.D.A. Inspectors to see if the emergent plant can be released to release the doses it made.
Updated
April 5, 2021, 4:37 p.m. ET
The incumbent F.D.A. Commissioner Dr. Janet Woodcock said in a statement on Saturday that the agency "takes its responsibility for ensuring the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously".
However, she made it clear that the ultimate responsibility would rest with Johnson & Johnson, saying, “It is important to note that even if companies employ contract manufacturing companies, the ultimate responsibility is the company that has the emergency use authorization to do so ensure FDA quality standards are met. "
In another agreement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck, one of the world's largest vaccine manufacturers. Officials said Merck would help manage the Baltimore facility.
The Emergent facility in Baltimore is one of two federally designated "Centers for Innovation in Advanced Development and Manufacturing" and was built with taxpayer support. Last June, the Emergent government paid $ 628 million to reserve space as part of Operation Warp Speed, the Trump administration's rapid initiative to develop coronavirus vaccines.
Johnson & Johnson and AstraZeneca both signed a contract with Emergent to use the space. Both vaccines are called live virus vector vaccines, which means they use a modified, harmless version of another virus as a vector or carrier to deliver instructions to 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 F.D.A. had the rule of preventing such mishaps by not allowing a plant to produce two live vaccines against viral vectors, as this can lead to mix-ups and contamination.
Last month, Mr Biden canceled a visit to Emergent's Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the country's Strategic National Stockpile. Both measures came after an investigation by the New York Times that looked at how the company had gained oversized influence on the repository.
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