The mix-up prompted federal regulators to delay authorization of the plant’s production lines.
BALTIMORE — The Emergent BioSolutions manufacturing plant in East Baltimore that has been making coronavirus vaccine for months has not yet received emergency use authorization from the federal government, a spokesperson confirmed Wednesday. A report Wednesday from The New York Times attributed the delay to a mix-up of two vaccines’ ingredients several weeks ago, which ruined about 15 million doses of Johnson & Johnson’s vaccine and forced regulators to delay authorization of the plant’s production lines. Emergent, which contracted with Johnson & Johnson as well as AstraZeneca, is an experienced vaccine maker, producing its own products such as a smallpox vaccine kept in U.S. stockpiles. The company, based in Gaithersburg, has received millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at the East Baltimore factory near Johns Hopkins Bayview Medical Center. The company is awaiting emergency use authorization from the U.S. Food and Drug Administration for the Bayview facility, said spokesperson Matt Hartwig, but did not know when it would be granted. Hartwig declined to comment on how many doses of vaccine had been stalled because of the lack of authorization. Representatives from the FDA did not immediately respond to a request for comment. Hartwig did not immediately respond to questions about the Times’ report. Johnson & Johnson said in a statement that one batch of the drug substance at Emergent BioSolutions “did not meet quality standards” and was “never advanced to the filling and finishing stages of our manufacturing process.
