Canada approves Moderna’s Omicron COVID vaccine

By Hana Mae Nassar and Michael Ranger

Health Canada has given Moderna’s new Spikevax Bivalent vaccine, which is designed to cover the Omicron variant of COVID-19, the green light.

The updated shot is approved for use in adults 18 years of age and older.

The agency says the new mRNA-based vaccine is “indicated as a booster dose for the prevention” of COVID-19, and that the proposed dosing regimen is “an interval of at least four months” after a primary series of shots and/or a previous booster dose in people 18 and up.

In its decision, Health Canada notes the results of the study of this latest shot indicate it “induces similar responses to the original virus and significantly higher responses to the Omicron BA.1 virus when compared to the Spikevax™ Original approved vaccine.”

It goes on to say that the findings overall show the bivalent shot “provides better immune response to the Omicron BA.1.”

“We know that this vaccine also generates a good immune response against the Omicron subvariants BA.4 and BA.5 that have more recently emerged,” Dr. Supriya Sharma, Health Canada’s chief medical advisor, added Thursday.

“This booster is also intended to extend the durability of protection. This will help us face the next waves.”

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Sharma says the approval of the updated vaccine “marks a milestone in Canada’s response to this pandemic.”

“Up to now, all authorized COVID-19 vaccines in Canada have targeted one strain of the virus — the original SARS-COV-2 virus from 2019. These vaccines have served us well over time and continue to be very effective at preventing what matters most: severe illness, hospitalization, and death,” Sharma said following word of the approval.

“With billions of vaccine administered around the world, we now have more knowledge about how vaccines respond to new variants. With the Omicron variant now circulating, we know that the existing vaccines can be less effective or wane over time.”

She notes mRNA vaccine technology can be “adapted relatively quickly to new variants.” However, any updated shots currently have to be re-reviewed and approved by Health Canada before they are administered in this country.

When it comes to the safety of the vaccine, Sharma says the updated shot is “similar to the previous approved Moderna Spikevax booster, with the same mild adverse events that resolve quickly.”

Deal for millions of Omicron-targeted vaccine already signed

Moderna has said it will supply Canada with 12 million doses of its Omicron-targeted vaccine. They are expected to start arriving on Friday, Sept. 3.

The first shipment will include 780,000 doses, according to federal Health Minister Jean-Yves Duclos.

He notes Canada will have received 10.5 million doses by the end of the month.

A supply deal signed last year between the company and the federal government allows for access to new vaccine adaptations. The agreement is dependent on Health Canada approvals.

“Canada has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate,” a previous release reads. “In addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022.”

Moderna and the federal government have also agreed to convert six million doses of the company’s COVID-19 vaccine to the bivalent shot.

The pharmaceutical company’s trial data has showed that when given as a fourth dose, its variant-adapted booster raised antibodies by eight-fold against Omicron.

The Pfizer-BioNTech Omicron-specific bivalent vaccine is still being reviewed by Health Canada.

“To ensure we have as many options as possible for dealing with current and future variants, we have reached out to both Pfizer-BioNTech and Moderna to request that they file submissions for vaccines specifically targeting the BA.4 and BA.5 subvariants. We are awaiting confirmation on their plans, including submission timelines,” Sharma added.

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