Canada well being authorities have halted the distribution of the single-dose Johnson & Johnson Covid-19 vaccine within the nation after it emerged that an energetic ingredient was made at an American facility that has been flagged by the US’ Food and Drugs Administration.

Canada obtained 300,000 doses of the vaccine manufactured by Janssen on April 28. However, in an announcement launched on Friday, Health Canada mentioned these have been being withheld and “will only be released for distribution” as soon as it “is satisfied that they meet the department’s high standards for quality, safety and efficacy”.

This transfer got here after Health Canada learnt {that a} drug substance was produced on the Emergent BioSolutions facility in Baltimore, Maryland, which has been inspected by the FDA with the company noting a number of areas of considerations there.

Health Canada famous the substance is the “active ingredient that undergoes further processing before becoming the final product”, the vaccine. “The final Janssen vaccines were manufactured at a different site located outside of the US,” it mentioned.

It added, “We will continue to ensure that products coming from the Emergent facility, or any other facility, will only be imported and distributed in Canada if they are of high quality and safe for use.”

It mentioned the division is at the moment working with Janssen and the FDA to acquire all the data it wants to finish its “assessment, prior to releasing the Janssen vaccines for distribution.”

Canada has additionally obtained 1.5 million doses of the AstraZeneca vaccine made on the identical facility and Health Canada mentioned additionally it is working with them “to ensure the facility meets manufacturing standards, and that all vaccine supplies for Canada are of high quality”.

However, the AZ vaccines have already been distributed in Canada and administered throughout the nation. Health Canada asserted that it “remains confident that the 1.5 million doses of AstraZeneca vaccine imported into Canada from this facility meet quality specifications.”

On April 25, Health Canada had acknowledged that the Janssen vaccines anticipated to come back into the nation this week didn’t originate from the Emergent facility. The details about the energetic ingredient got here to the division since that assertion was issued.


Follow us on Google News

VNAP News Portal