Additional Batch Of Johnson & Johnson Vaccine Authorized For Emergency Use By FDA
BALTIMORE (WJZ) -- The U.S. Food And Drug Administration announced Tuesday that they are authorizing an additional batch of the Johnson & Johnson coronavirus vaccine produced at Emergent BioSolutions.
"To date a total of three batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized, the FDA said in a statement. "The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer."
Based of their review, they determined that the batches are suitable for use.
In statement, Emergent said, "With respect to the news from last night, we did issue a comment: We welcome the approval of an additional batch of J&J vaccine made at Emergent. We remain committed to addressing the FDA's observations in order to resume production as soon as possible and look forward to continuing our work to end this pandemic."
On Friday, the FDA announced the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from Emergent BioSolutions.
The FDA, for months, had been reviewing and testing the doses manufactured at the Emergent Biosolutions facility here in Baltimore.
An FDA report released in April showed a number of issues at the plant, including "the design of the building," "improper medical waste handling," "peeling paint," "black and brown residue on the floors and walls" and "poorly trained staff."
The FDA said "several batches" of the J&J vaccine made here in Baltimore need to be tossed. The New York Times is reporting that number totals 60 million doses.
However, Emergent BioSolutions plant is still not included as an authorized manufacturing facility in the Janssen emergency use authorization.
The FDA continues work through issues at the plant. The Emergent plant has been closed for two months.