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Quality problem at Johnson & Johnson plant could ruin millions of COVID-19 vaccine doses

April 01, 2021
Drugmaker Johnson & Johnson said on Wednesday it had found a quality problem at a Baltimore plant helping manufacture its single-dose coronavirus vaccine. — Courtesy file photo
Drugmaker Johnson & Johnson said on Wednesday it had found a quality problem at a Baltimore plant helping manufacture its single-dose coronavirus vaccine. — Courtesy file photo



NEW YORK — Drugmaker Johnson & Johnson said on Wednesday it had found a quality problem at a Baltimore plant helping manufacture its single-dose coronavirus vaccine.

The New York Times reported on Wednesday that workers at Emergent BioSolutions, the Baltimore plant that has been making Johnson & Johnson's COVID-19 vaccine, accidentally mixed up some of the ingredients, ruining as many as 15 million potential doses of vaccine and delaying US Food and Drug Administration authorization of the plant.

Emergent is also making the AstraZeneca vaccine, which has yet to be authorized for use in this country.

Johnson & Johnson said in a statement to CNN that the quality control process at the plant identified "one batch" of drug substances that did not meet quality standards. The batch in question was part of a test run and quality check. The site is not yet authorized by the FDA to make the drug substance used in the vaccine.

"This batch was never advanced to the filling and finishing stages of our manufacturing process," the emailed statement from the company said.

None of the lost doses impact the company's goal of delivering 20 million COVID-19 vaccine doses in March. For that, the company said Wednesday, it is on track. Those doses come from J&J's Janssen vaccine plant in the Netherlands. — Courtesy CNN




April 01, 2021
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