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About 15 million doses of the Johnson & Johnson COVID-19 vaccine were ruined after workers at a manufacturing plant mixed up ingredients, The New York Times reported.
The Baltimore, MD, plan is operated by a company called Emergent BioSolutions, the Times said. The company works with both Johnson & Johnson and AstraZeneca.
The mistake has stopped shipments of the vaccine until the FDA investigates, the paper said. The mishap, however, does not affect doses of the J&J one-shot vaccine already delivered and being used.
The problem is that tens of millions of doses were supposed to come from the Baltimore plant.
The Associated Press reported that Emergent has had numerous problems with the FDA, with the agency citing the company for poorly trained employees, cracked vials and mold.
The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn't corrected "continued low level mold and yeast isolates" found in the facility. Nearly a year later, agency investigators questioned why Emergent had "an unwritten policy of not conducting routine compliance audits" at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.
Meanwhile, in a statement, Johnson & Johnson said its own quality control process identified the problem in one batch of ingredients. The company said the Emergent plant in Baltimore is "not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process."
The company said it plans to still seek emergency use authorization for a different Emergent facility and will provide more experts on site at Emergent.
The Times reports that President Joe Biden's team still believes the administration can meet its commitment to have enough vaccine doses to immunize every adult by the end of May.
Johnson & Johnson said it still plans to deliver an additional 24 million doses through April.
The New York Times: "Johnson & Johnson Covid-19 vaccine doses are delayed by a U.S. factory mix-up."
Johnson & Johnson: "Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing."
The Associated Press: "Johnson & Johnson COVID-19 vaccine batch fails quality check."
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Cite this: Mishap Ruins Millions of J&J COVIDVaccine Doses - Medscape - Apr 01, 2021.