so far, according to figures from the Centers for Disease Control and Prevention. Nearly 6.8 million doses of the COVID-19 vaccine developed by Janssen, a Johnson & Johnson subsidiary, have been delivered to the U.S. In a statement sent to NPR, an FDA spokesperson confirmed that the agency is aware of the situation but said it cannot comment further, citing the confidentiality that surrounds relationships between drugmakers and their contract manufacturers. When asked why the administration didn't disclose it earlier, Psaki cited the fact that the plant is not yet authorized by the FDA for distribution of the vaccine. White House press secretary Jen Psaki said Thursday that the Department of Health and Human Services notified the White House late last week about the production mistakes at the Emergent plant in Baltimore. government, and we remain confident in our ability to meet the FDA requirements." "We continue to manufacture in support of our customers and the U.S. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," he added. We isolated this batch and it will be disposed of properly," Matt Hartwig, a spokesperson for Emergent, said in a statement to NPR. "here are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. "In late February, one or more workers somehow confused the two during the production process, raising questions about training and supervision."Įmergent said that quality control systems "worked as designed" to detect the issue and isolate the batch. But Johnson and Johnson's and AstraZeneca's vectors are biologically different and not interchangeable," The Times reported. "The two vaccines use the same technology employing a harmless version of a virus - known as a vector - that is transmitted into cells to make a protein that then stimulates the immune system to produce antibodies. The Times and The Washington Post reported that the issue was a mix-up between the coronavirus vaccine material that Emergent is producing for Johnson & Johnson and AstraZeneca. Neither Johnson & Johnson nor Emergent have confirmed that figure. The snag was first reported by The New York Times, which said 15 million vaccine doses were potentially affected. "It's important to note that these wouldn't be finished doses, just key ingredients ultimately bound for another facility to be put into vials and prepared for distribution," NPR's Sydney Lupkin reported. In a news release, Johnson & Johnson said quality control checks had flagged the problem before the problematic batch affected more doses. This batch was part of the approval process, and would have been used if successful. It said the apparent mix-up happened at an Emergent site that is part of its manufacturing network but does not yet have FDA authorization to produce part of the COVID-19 vaccine.Įmergent is not currently part of the coronavirus vaccine supply chain but was ramping up to be. The drug company said the problem involved one batch of a substance that goes into its coronavirus vaccine. Johnson & Johnson said the issue "was identified and addressed with Emergent," adding that it also informed the U.S. The material was made by Emergent BioSolutions, according to Johnson & Johnson. Johnson & Johnson is reporting a setback in its effort to produce tens of millions of COVID-19 vaccine doses, saying a contract production plant in Baltimore produced an ingredient that failed quality control tests. An Emergent BioSolutions facility in Baltimore on Thursday.
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