Bivalent vaccine in Canada: Omicron booster authorized

OTTAWA –

Health Canada has authorized the usage of the nation’s first variant-targeting COVID-19 booster shot.

On Thursday, the federal well being regulator announced it has given the green light to Moderna’s Omicron-targeting bivalent COVID-19 vaccine, for these ages 18 years and older.

A technical briefing with Public Health Agency of Canada officers is scheduled for Thursday morning. Then, Health Minister Jean-Yves Duclos will likely be making an announcement about “the significance of COVID-19 vaccination as we head into the autumn.”

Moderna submitted its bivalent booster to Health Canada for regulatory approval on June 30. While the booster shot was submitted by Moderna for approval for ages 12 and over, it seems Health Canada has determined to restrict its authorization to be used in adults.

The booster shot targets each the unique pressure of COVID-19 in addition to the Omicron variant. The mutated and highly-transmissible model of the novel coronavirus has been broadly circulating in Canada since November 2021.

Moderna’s bivalent shot would be the first such vaccine out there in Canada. Pfizer-BioNTech has additionally submitted its bivalent booster for regulatory evaluation. That submission went to Canada’s federal well being regulator on July 25, and whereas authorization may very well be imminent it isn’t anticipated to be a part of Thursday’s announcement.

“Our regulatory colleagues in Health Canada are working very quick at reviewing the submissions from Moderna and from Pfizer-BioNTech on the bivalent booster doses,” stated Chief Public Health Officer Dr. Theresa Tam throughout a press convention on Aug. 22.

This resolution comes on the heels of the U.S. Food and Drug Administration granting emergency use authorizations on Wednesday, to each Moderna and Pfizer’s bivalent vaccines to be used as single booster doses at the least two months following major or booster vaccination.

The United Kingdom authorized the Moderna bivalent vaccine on Aug. 15.

The federal authorities has already purchased 12 million doses of the vaccine, making an settlement with Moderna to exchange a number of the deliberate provide of the unique mRNA shot with the newer model, with supply anticipated earlier than the top of the yr.

As has been the case all through the pandemic, provincial well being authorities will likely be accountable for figuring out their rollout of this shot, and who’d be prioritized to obtain it.

Questions have been raised about whether or not Canadians ought to be ready for the bivalent doses to develop into out there earlier than rolling up their sleeve for a shot, one thing Tam has stated ought to be determined based mostly on particular person threat components.

With pandemic restrictions largely lifted throughout provinces, and Canadians anticipated to more and more spend extra time indoors, docs and epidemiologists are cautioning towards a rise in COVID-19 cases this fall and winter.