Following an inspection in which it noted a number of quality issues, the U.S. Food and Drug Administration (FDA) asked Emergent BioSolutions to pause new production of Johnson & Johnson’s COVID-19 vaccine.
The vaccines already manufactured will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential eventual distribution.
The FDA noted that it has not authorized the facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S.
The FDA’s decision follows an announcement from Johnson & Johnson in which it said its manufacturing quality-control process identified one batch of drug substance for the COVID-19 vaccine produced at Emergent BioSolutions that did not meet Johnson & Johnson’s standards.
FDA officials said the agency is working “with the company to address the conditions identified.”
