![]() "This is a critical part of ensuring quality and safety of vaccine product."Įmergent said the quality control systems in place worked as planned and it will continue to work toward FDA approval. "J&J continues to work through manufacturing issues with the FDA, and no product will come out of the Baltimore facility without authorization by FDA," a senior health official told NPR. The government is working with AstraZeneca to relocate that production. But following the incident, it will no longer use the facility to produce ingredients for the AstraZeneca vaccine. Instead, the batch was disposed of.Įmergent was also producing a substance for AstraZeneca's vaccine - a vaccine that so far has not been authorized for use in the U.S. Had this portion of ingredients been approved it would have contributed to vaccine production. No vaccine it has produced has been used in U.S. The Emergent facility has been producing one substance that goes into the Johnson & Johnson vaccine, but the facility has not yet received authorization from the FDA. J&J confirmed over the weekend that it will take a more hands-on approach at the Baltimore facility, and will increase "the number of manufacturing, quality and technical operations personnel to work with the Company specialists already at Emergent." The papers reported the mix-up ruined a batch equivalent to about 15 million doses.Ī senior government health official said the Department of Health and Human Services and the Food and Drug Administration have now determined it is "most appropriate" for the facility to produce only one vaccine. The facility had been working to produce ingredients for both the Johnson & Johnson and AstraZeneca vaccines and had mixed up ingredients from the two vaccines, according to The New York Times and The Washington Post. But on March 31, J&J announced its quality control process had detected one batch of ingredients for its single-dose vaccine, produced by Janssen Pharmaceuticals, did not meet the necessary standards at the Emergent BioSolutions facility in Baltimore. The company has pledged to deliver 100 million doses by the end of May. The Biden administration has facilitated for Johnson & Johnson to assume "full responsibility" of a production plant after a mishap botched likely millions of doses-worth of COVID-19 vaccine. ![]() The Biden administration and the Department of Health and Human Services facilitated the change in management. Johnson & Johnson will oversee all aspects of vaccine production at the Emergent BioSolutions facility in Baltimore.
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