Health Canada Won’t Release 300,000 Doses of J&J Vaccine Due to Quality Issues

The shipment of Johnson & Johnson (J&J) COVID-19 vaccines that arrived in April, and were held back by Health Canada over quality concerns, will not be released in Canada, the agency confirmed Friday.

“To protect the health and safety of Canadians in response to concerns regarding a drug substance produced at the Emergent BioSolutions facility in Baltimore Maryland, Health Canada will not be releasing the shipment,” a statement from Health Canada said.

The drug substance produced at a facility in Baltimore, which was previously found to have been producing vaccines haphazardly, was used in the shipment, the statement read.

The agency also confirmed that Canada would not be accepting any more products or ingredients made at the facility.

The facility’s error involved ingredients from AstraZeneca’s COVID-19 vaccine, which was also being produced at the plant, contaminating J&J’s batch being produced by its Janssen pharmaceutical unit.

Canada has to date ordered 10 million doses of the J&J vaccine, and is expected to receive another 300,000 more doses by the end of June, according to the director-general in charge of vaccine procurement.

When asked by Global News on Friday whether Canada would consider cancelling its existing contract with J&J in light of the quality issues, Procurement Minister Anita Anand’s office responded that the regulator’s decision to not release the over 300,000 doses would not have an impact on Canada’s existing agreement to order 10 million doses.

Minister Anand’s office did not answer specify where further orders of the J&J vaccines would be coming from, given Canada’s statement to not accept any more vaccines from the Emergent BioSolutions facility.

Health Canada’s announcement also comes amid decisions from the U.S. Food and Drug Administration (FDA) and EU to discard batches of the vaccines, though European and U.S. regulators did not specify the size of the batches. The Associated Press reported on Friday that the discarded batches in the U.S. could have yielded tens of millions of doses and were possibly contaminated.


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