(CMR) Johnson & Johnson has been ordered by Federal regulators to discard about 60 million doses of the COVID-19 vaccine produced at a troubled Baltimore factory due to possible contamination.
The order was made after weeks of review of the factory; however, New York Times reported that the Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.
It is not yet known if Emergent will be allowed to reopen the factory, which has been closed for two months because of regulatory concerns.
For weeks the FDA. has been trying to figure out what to do about at least 170 million doses of vaccine left in limbo after discovering a major production mishap involving two vaccines manufactured at the site, the New York Times reported.
According to the report, more than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s.
Federal officials then ordered the plant to pause production and stopped Emergent from producing AstraZeneca’s vaccine. Johnson & Johnson was also ordered to assert direct control over the manufacturing of its vaccine there.