In a statement on Tuesday, the agency said it authorized a batch of the J&J vaccine made at a facility in Baltimore run by Emergent BioSolutions, bringing the total number of FDA-authorized J&J batches made at the facility to three.
The FDA did not specify how many doses were in the new batch authorized under the emergency use authorization (EUA).
Federal authorities in April halted production of the J&J vaccine at the site after they discovered that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine.
An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant. J&J was put in charge of manufacturing at the plant and AstraZeneca’s shot is no longer being made there.
The agency said in its latest announcement that it “conducted a thorough review of facility records and the results of quality testing performed by the manufacturer.”
“Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use,” the FDA said. It added that while it “is not yet ready” to include the Baltimore facility as an authorized manufacturer in the EUA, it “continues to work through issues there with Janssen and Emergent BioSolutions management.”
Emergent BioSolutions said in a statement to news outlets late Tuesday that it welcomes the new authorization. “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,” the company added.
In April, the FDA and the Centers for Disease Control and Prevention (CDC) recommended a pause in the J&J vaccine amid several reports of blood clots. The two health bodies later that month advised that administration of the vaccine could resume, but attached warnings to their recommendations, including advice about possible risks.
The J&J vaccine is developed by the company’s subsidiary, Janssen Pharmaceutical Companies. Like the AstraZeneca vaccine, it is based on a new technology that uses a modified version of adenoviruses, which cause the common cold, as vectors to ferry instructions to human cells.
J&J scientists have refuted the idea that the design of the vaccine is linked to clots.
Reuters contributed to this report.
From The Epoch Times