FDA to allow export of certain lots of AstraZeneca COVID-19 vaccine made at Baltimore plant

FILE PHOTO: Vials labelled “Astra Zeneca COVID-19 Coronavirus Vaccine” and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. REUTERS/Dado Ruvic/Illustration

(Reuters) -The U.S. Food and Drug Administration said on Friday certain lots of AstraZeneca’s COVID-19 vaccine manufactured at a problem-plagued Baltimore facility are fit to be shipped outside the United States.

The plant, owned by Emergent Biosolutions, was producing vaccines for AstraZeneca and Johnson & Johnson but U.S. health regulators in April halted operations following a discovery that J&J’s vaccine was contaminated with material used in the AstraZeneca shots.

“The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency,” FDA spokesperson Stephanie Caccomo said in a statement.

Late in July, Emergent said it would resume production of J&J’s vaccine at the plant following additional reviews and collaboration with the FDA and manufacturing partners.

“We will continue working closely with the FDA to facilitate the review and release of additional batches of drug substance,” Emergent said on Friday, adding that it is also working with the agency and Johnson & Johnson to resume full-scale production as soon as possible.

The two-dose AstraZeneca vaccine made in collaboration with the Oxford University is not yet authorized in the United States but has gained regulatory nods in several countries across the globe.

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