The US 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 US 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.
The two-dose 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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