Canada rejects 300,000 doses of the J&J vaccine made in the U.S. because of contamination issues.


Canada’s well being merchandise regulator has rejected the nation’s first and solely cargo of Johnson & Johnson’s Covid vaccine because of contamination points at the U.S. plant that produced it.

The 300,000 doses had been held in storage since April to permit Health Canada to conduct a security evaluate. The regulator, in a press release issued on Friday night, stated that Emergent BioSolutions had made these doses at the identical time as different batches of the Johnson & Johnson vaccine that were found to be contaminated with the innocent virus used to fabricate the AstraZeneca vaccine.

Health Canada stated its evaluate was unable to find out that the vaccines despatched to Canada met “the department’s rigorous quality standards.” The regulator additionally stated that it will not approve the use of any vaccines or vaccine substances made at the manufacturing unit till it sends inspectors there, more than likely in the summer season.

The announcement got here after the Food and Drug Administration advised Johnson & Johnson that 60 million doses of vaccine produced at the Baltimore manufacturing unit can’t be used because of contamination. The F.D.A., nonetheless, will enable about 10 million different doses of the Johnson & Johnson vaccine to be distributed in the United States or different international locations, with the warning that it can’t assure that Emergent adopted good manufacturing practices.

U.S. regulators have put the Baltimore facility underneath a microscope since March, once they found {that a} main manufacturing mishap had resulted in the contamination of a batch of Johnson & Johnson vaccines. Emergent later discarded the equal of 15 million doses. The New York Times has documented months of problems at the plant, together with failures to correctly disinfect gear and to guard in opposition to viral and bacterial contamination.

The Emergent manufacturing unit stays closed.



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