WASHINGTON — The Biden administration on Saturday put Johnson & Johnson answerable for a troubled Baltimore manufacturing plant that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and moved to cease the plant from making one other vaccine by AstraZeneca, senior federal well being officers stated.
The extraordinary transfer by the Department of Health and Human Services got here simply days after officers had discovered that Emergent BioSolutions, a contract producer that has been making each the Johnson & Johnson and the AstraZeneca vaccines, combined up elements from the 2, which led regulators to delay authorization of the plant’s manufacturing strains.
By shifting the AstraZeneca vaccine out, two senior federal well being officers stated, the plant could be solely devoted to the Johnson & Johnson single-dose vaccine and keep away from future mishaps.
The Department of Health and Human Services directed Johnson & Johnson to set up a brand new management crew to oversee all facets of manufacturing and manufacturing on the Emergent Baltimore plant, the officers stated. The firm stated in an announcement that it was “assuming full responsibility” for the vaccine made on the Emergent plant.
With President Biden making an aggressive push to have sufficient doses to cowl each grownup by the tip of May, federal officers are apprehensive that the mix-up will erode public confidence in Covid-19 vaccines. The AstraZeneca vaccine particularly has generated security considerations; Germany, France and different European nations briefly suspended its use after studies of uncommon mind blood clots in some vaccine recipients.
The ingredient mix-up, and Saturday’s transfer by the administration, is a big setback and a public relations debacle for Emergent, a Maryland-based biotech firm that has constructed a worthwhile enterprise by teaming up with the federal authorities, primarily by promoting its anthrax vaccines to the Strategic National Stockpile.
A spokesman for Emergent declined to remark, besides to say that the corporate would proceed making AstraZeneca doses till it acquired a contract modification from the federal authorities.
Unlike Johnson & Johnson, AstraZeneca doesn’t but have emergency authorization from the Food and Drug Administration for its vaccine. With three federally approved vaccines (the opposite two are by Pfizer-BioNTech and Moderna), it isn’t clear whether or not the AstraZeneca vaccine, which has had a troubled historical past with regulators, might even be cleared in time to meet U.S. wants.
However, one of many federal officers stated the Department of Health and Human Services was discussing working with AstraZeneca to adapt its vaccine to fight new coronavirus variants. AstraZeneca stated in an announcement that it might work with the Biden administration to discover a new website to manufacture its vaccine.
So far, not one of the Johnson & Johnson doses made by Emergent have been launched by the F.D.A. for distribution. Officials have stated it might take weeks to kind out whether or not different batches of vaccine had been contaminated and for F.D.A. inspectors to decide whether or not the Emergent plant could be cleared to launch any doses that it has made.
The appearing F.D.A. commissioner, Dr. Janet Woodcock, stated in an announcement on Saturday that the company “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 final word duty would relaxation 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 one other association brokered by the Biden administration final month, Johnson & Johnson is now working with Merck, one of many world’s greatest vaccine producers. Officials stated Merck would assist with administration of the Baltimore plant.
Emergent’s Baltimore plant is certainly one of two which can be federally designated as “Centers for Innovation in Advanced Development and Manufacturing” and had been constructed with taxpayer assist. Last June, the federal government paid Emergent $628 million to reserve area there as a part of Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.
Johnson & Johnson and AstraZeneca each contracted with Emergent to use the area. Both vaccines are so-called reside viral-vector vaccines, which means they use a modified, innocent model of a distinct virus as a vector, or provider, to ship directions to the physique’s immune system. The Johnson & Johnson vaccine is run in a single dose, AstraZeneca’s in two doses.
Experts in vaccine manufacturing stated that previously, the F.D.A. had a rule to stop such mishaps by not permitting a plant to make two reside viral vector vaccines, due to the potential for mix-ups and contamination.
Last month, Mr. Biden canceled a go to to Emergent’s Baltimore plant, and his spokeswoman introduced that the administration would conduct an audit of the Strategic National Stockpile, the nation’s emergency medical reserve. Both actions got here after a New York Times investigation into how the corporate had gained outsize affect over the repository.