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Health Canada updates label on Janssen COVID-19 vaccine, but says benefits outweigh risk

Health Canada updates label on Janssen COVID-19 vaccine, but says benefits outweigh risk

Health Canada updates label on Janssen COVID-19 vaccine, but says benefits outweigh risk image
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The label on the Johnson & Johnson COVID-19 vaccine has been updated to reflect the possible side effects including the risk of blood clotting, Health Canada says.

“Cases of rare blood clotting events reported in the U.S. after immunization with the #Janssen vaccine are similar to those reported after the #AstraZeneca vaccine, which Health Canada has communicated about recently,” the agency said in a series of tweets Monday afternoon.

The agency said it has worked closely with the manufacturer, Janssen Pharmaceuticals — a pharmaceutical company of Johnson & Johnson — and “other international regulators to assess the most current evidence and is taking action before the vaccine is available to Canadians.”

Read more: Johnson & Johnson vaccine is coming to Canada. How do we use it best?

 

As a result, the label on the Janssen vaccine has been updated to educate Canadians of the “signs and symptoms” of the possible side effects of the shot, Health Canada says.

In a safety alert on the agency’s website, it said “very rare cases of thrombosis in combination with thrombocytopenia, in some cases accompanied by bleeding, have been observed following vaccination with Janssen COVID-19 Vaccine.”

“A causal relationship with the vaccine is considered plausible,” the post reads.

Health Canada said it has deemed the benefits of the vaccine still outweigh these “very rare potential risks.”

The agency said it will continue to keep Canadians informed about any safety issues with any COVID-19 vaccines and will “take immediate further action as necessary.”

Click to play video: U.S. resuming Johnson & Johnson COVID-19 vaccine

The move comes just days after U.S. health officials lifted a 10-day pause on the vaccine after a handful of people suffered rare blood clotting after having received a dose.

Canada has not yet received any of the J&J vaccines, however, a total of 300,000 doses will arrive “around the end” of this week, according to Federal Procurement Minister Anita Anand.

Read more: Some U.S. areas stop using J&J COVID-19 vaccine after ‘adverse reaction’ reports

Distribution to provinces and territories will begin the first week of May.

Canada has pre-ordered 10 million doses of the J&J vaccine.

More to come…

-With files from Global News’ Rachael D’Amore

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