Plans to distribute the first 300,000 doses are on hold after Health Canada learned part of the vaccines were manufactured at a Maryland facility that messed up the ingredients in 15 million doses bound for the U.S. market.
Health Canada says it’s seeking information from the FDA and J&J’s pharmaceutical arm, Janssen, to determine if the doses shipped to Canada meet required safety standards.
“Like other communities, we will wait our turn and remain vigilant in following all health protocols to stop the spread until everyone is immunized,” Sorensen says.
The Emergent Biosolutions facility in Baltimore was recently cited by the U.S. Food and Drug Administration for violations including cleaning and sterilization failures, the potential for cross-contamination and failure to follow required protocols.
Health Canada had already cleared 1.5 million doses of the Oxford-AstraZeneca vaccine made at the facility, but did not think the Canadian J&J doses had any connection to that plant.
Now Health Canada says the drug substance that makes up part of the J&J vaccine was actually produced there and then shipped elsewhere for the vaccines to be completed.
Word of the delay came hours before a number of COVID-19 hot spots reported continued high case counts and troubling virus-related hospitalization rates, though there were signs of hopein some jurisdictions.
While Ontario recorded 900 patients in its intensive care units for the first time since the onset of the pandemic, overall hospitalizations dipped slightly to 2,152. The province recorded 3,369 new infections.
Hospitalizations also declined in Quebec for the fourth straight day, with the province reporting 578 patients seeking treatment for COVID-19. The province also added 1,101 new infections to its overall tally.
Nova Scotia recorded a single-day high for new cases with 148, though Premier Iain Rankin had warned residents of an impending spike as provincial laboratories work their way through a testing backlog.
This report by The Canadian Press was first published May 1, 2021.
Michelle McQuigge, The Canadian Press
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