OTTAWA — Plans to distribute the primary 300,000 doses of the Johnson & Johnson COVID-19 vaccine subsequent week are on maintain after Well being Canada discovered a part of them had been manufactured at a Maryland facility that tousled the elements in 15 million doses certain for the U.S. market.
The Emergent Biosolutions facility in Baltimore was not too long ago cited by the U.S. Meals and Drug Administration for violations together with cleansing and sterilization failures, the potential for cross-contamination and failure to observe required protocols.
The FDA ordered the ability to cease making extra J&J vaccine till the issues are corrected and the sooner mistake on the doses resulted in all 15 million being destroyed.
Well being Canada had already cleared 1.5 million doses of the Oxford-AstraZeneca vaccine made on the facility, however didn’t suppose the Canadian J&J doses had any connection to that plant.
Now Well being Canada says the drug substance that makes up a part of the J&J vaccine was truly produced there after which shipped elsewhere for the vaccines to be completed.
Well being Canada says it’s looking for info from the FDA and J&J’s pharmaceutical arm, Janssen, to find out if the 300,000 doses shipped to Canada meet required security requirements.
“As with all vaccines imported into Canada, the Janssen vaccines will solely be launched for distribution as soon as Well being Canada is happy that they meet the Division’s excessive requirements for high quality, security and efficacy,” Well being Canada stated Friday night in a launch.
“Well being Canada has rigorous processes in place to repeatedly monitor the standard of vaccines which are administered to Canadians.
“We are going to proceed to make sure that merchandise coming from the Emergent facility, or another facility, will solely be imported and distributed in Canada if they’re of top quality and protected to be used.”
Till Friday, Well being Canada had refused to say the place Canada’s doses had been made, citing worry of disrupting a confidential provide chain.
The J&J vaccine has not been utilized in Canada to this point, and the Nationwide Advisory Committee on Immunization hasn’t but offered steerage on how they suppose it needs to be used.
The doses arrived in Canada on Wednesday and are in holding on the Innomar Methods facility close to Toronto’s Pearson airport. Innomar is contracted to obtain and redistribute all vaccines in Canada, besides Pfizer-BioNTech. That vaccine is shipped on to provincial governments.
This report by The Canadian Press was first revealed April 30, 2021
The Canadian Press