Tuesday, October 26, 2021

Canada’s regulator holds Johnson & Johnson vaccine for safety review.

Canada’s drug and vaccine regulator said on Friday that it was withholding the country’s first shipment of the Johnson & Johnson vaccine to verify its safety and quality.

Health Canada, the regulator, said on Tuesday that none of the Johnson & Johnson vaccine, developed by the company’s Janssen subsidiary, had been made at an Emergent BioSolutions factory in Baltimore which had discarded millions of possibly contaminated doses of AstraZeneca’s coronavirus vaccine.

But in a statement issued on Friday evening, it said that since then it has “learned that a drug substance produced at the Emergent site was used in the manufacturing of the initial Janssen vaccines.”

The regulator said that it is now working with Janssen and the Food and Drug Administration in the United States to make sure that the vaccines meet Canada’s standards for “quality, safety and efficacy.”

It did not identify what part of the vaccine came from Emergent beyond saying that it was an “active ingredient.” Nor did it identify the plant were the vaccine was produced.

About 1.5 million doses of the AstraZeneca vaccine sent to Canada by the Biden administration in early April were also produced at the Baltimore plant. Health Canada said last week that its review of that vaccine uncovered no problems or contamination.

Vaccine production at the plant has been suspended. Up to 15 million doses of the Johnson & Johnson vaccine made there were thrown away because contamination fears. Inspectors from the F.D.A. later found that Emergent did not fully investigate the contamination and found problems with the factory’s disinfection practices, it size and design, how it handled raw materials and trained its workers.

On Thursday, Emergent announced that it had removed some of its senior managers. Robert Kramer, the chief executive, acknowledged that the “loss of a batch for a viral contamination is extremely serious” but said that he hoped production would start again in Baltimore soon.

The F.D.A. had earlier paused shipments of the Johnson & Johnson vaccine as it looked into rare blood clots among young women who got the shot. That was lifted a week ago after a warning label about the clotting issue was added.

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