Factory Error Contaminated 15 Million Doses Of Johnson & Johnson's Vaccine
By Bill Galluccio
April 1, 2021
Johnson & Johnson has temporarily halted shipments of its coronavirus vaccine after a mix-up at a factory contaminated 15 million doses. The Food and Drug Administration learned about the issue a few weeks ago and delayed certifying the Baltimore plant, which is run by Emergent BioSolutions.
Johnson & Johnson said that their quality controls identified the issue before the vaccines were finished.
"This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site 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 pharmaceutical company said in a statement. "This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA)."
The issue does not affect any vaccines that have been shipped out. Vaccines set to be delivered next week are also fine, as they were manufactured at a facility in the Netherlands, which has been approved by the FDA.
Despite the setback, Johnson & Johnson believes it can still deliver 24 million doses by the end of April. Federal officials believe the U.S. will have enough vaccines to meet President Joe Biden's updated goal of vaccinating 200 million people during the first 100 days of his presidency.
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