No more than 300,000 doses of Johnson & Johnson’s single-shot COVID-19 vaccine will be released for use in Canada.
The vaccines were quarantined in April before being distributed to provinces because Health Canada reported that the drug was manufactured at the Emergent BioSolutions facility in Baltimore, where there were quality control issues.
J&J was forced to dispose of more than 15 million doses of the factory-made vaccine in early April after it was discovered that workers had mixed the formula with the AstraZeneca-Oxford vaccine, which was also being made there.
Health Canada says the substance in 310,000 Canadian doses was manufactured at the same time as the contaminated one and the department cannot determine if it meets Canadian standards.
As a result, it will not be released for use in Canada.
The department says it plans to conduct an on-site inspection of the Maryland facility this summer, but until that is complete, Canada will not accept any product or components made there.
“Canadians can be assured that any vaccines will be released for distribution only once Health Canada is satisfied that they meet the administration’s high standards of quality, safety and efficacy,” the department said in a statement late Friday.
Earlier on Friday, Joel Paquette, director general of Canadian Public Services and Procurement, said at a media briefing that an unspecified number of J&J doses are expected by the end of the month. It was not immediately clear where the second batch was manufactured or whether it would be affected by Health Canada’s decision.
The FDA also announced Friday that about 60 million doses of the J&J vaccine will have to be disposed of from the Baltimore plant.