OTTAWA –
Health Canada has authorized the use of the country’s first variant-targeted COVID-19 booster vaccine, marking what health officials are calling a “milestone” in Canada’s pandemic response.
On Thursday, the federal health regulator announced that it has given the green light to Moderna’s Omicron-targeted bivalent COVID-19 vaccine for adults 18 and older.
The “Spikevax Bivalent” booster dose is an adapted version of the original Moderna mRNA vaccine and targets both the original strain of COVID-19 and the Omicron variant.
“It’s essentially two vaccines in one,” said Canada’s chief medical adviser, Dr. Supriya Sharma. “This boost is also intended to extend the durability of the protection. This will help us face the next wave.”
The mutated, highly transmissible version of the novel coronavirus and its subvariants have been circulating in Canada since November 2021, and currently make up the majority of new cases.
Health Canada said, according to a study comparing individuals immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the results indicated that the updated vaccine “provides a better immune response to the Omicron BA. 1”.
Moderna submitted its bivalent booster to Health Canada for regulatory approval on June 30.
“After a thorough and independent scientific review of the evidence, Health Canada has determined that Moderna Spikevax bivalent booster is safe and effective,” the health agency said. “It was also found to generate a good immune response against the Omicron BA.4 and BA.5 subvariants.”
This news comes before Health Minister Jean-Yves Duclos makes an announcement in the afternoon about “the importance of vaccination against COVID-19 as we head into autumn”.
“Since vaccine protection wanes over time, it’s important to stay up-to-date,” said Assistant Director of Public Health Dr. Howard Njoo. “If it’s been six months since your last dose, or six months since you got infected with COVID-19, you get another booster dose.”
Asked what he would say to Canadians who may feel overwhelmed by the evolving vaccine options, Njoo said people should know that there is nothing wrong with the original COVID-19 vaccines that are being offered , either as a series of primary vaccinations or as booster doses.
WHO SHOULD RECEIVE THIS BENEFIT?
According to the authorization information published by Health Canada, the proposed dosing regimen is an interval of “at least four months after a previous primary series and/or booster dose.”
The National Advisory Committee on Immunization (NACI) issued guidance on Thursday, indicating that adults 18 years of age and older who are recommended to receive a fall booster dose should be offered a shot of the bivalent vaccine. This is what NACI has listed as a “strong” recommendation.
However, NACI said those who are eligible for a booster this fall and are at the highest risk “should not delay their planned vaccination in anticipation of a bivalent vaccine containing Omicron against COVID-19.” , as the original mRNA vaccines will still provide timely protection.
Although Moderna submitted the booster vaccine for approval for ages 12 and older, Health Canada has decided to limit its authorization for use in adults.
Despite this, NACI said Thursday that adolescents aged 12 to 17 with “moderate to severe immunocompromised conditions and/or who have biological or social risk factors that put them at high risk for serious outcomes” could be offered a injection of bivalent reinforcement. “off label.” This is what NACI has labeled a “discretionary” recommendation.
NACI said that while there are no data on the efficacy, immunogenicity, or safety of this booster in individuals younger than 18 years of age, its benefit may “overweigh any potential risks that are unknown in this moment”.
Given as an intramuscular injection, consistent with other COVID-19 vaccines, the 50-microgram dose may cause common side effects such as pain, swelling, or redness at the injection site, as well as muscle fatigue, aches, and stiffness , fever and chills.
The federal health agency warns against getting this vaccine if you’ve had an allergic reaction to a previous dose of Moderna’s COVID-19 vaccine.
BIVALENT PFIZER UNDER REVIEW
Moderna’s bivalent vaccine will be the first vaccine of its kind available in Canada. Pfizer-BioNTech has also submitted its bivalent booster for regulatory evaluation. That filing went to Canada’s federal health regulator on July 25, and approval could be imminent.
Sharma said Health Canada has also contacted the two drug companies to request that they submit vaccine submissions specifically targeting Omicron’s BA.4 and BA.5 subvariants, “to make sure we have as many options as possible” as the virus continues to change.
Those submissions are expected to be received in the coming weeks, Sharma said.
Moderna’s bivalent approval on Thursday comes after the US Food and Drug Administration on Wednesday granted emergency use authorizations to both Moderna’s and Pfizer’s bivalent vaccines for use as doses of single boosters at least two months after the primary or booster vaccination.
The UK approved the Moderna bivalent vaccine on 15 August.
As has been the case with previous authorizations of COVID-19 vaccines, Health Canada has placed terms and conditions on the authorization, requiring the pharmaceutical giant to continue to provide safety and efficacy information.
12 MILLION DOSES PURCHASED
The federal government has already bought 12 million doses of the vaccine, striking a deal with Moderna to replace some of the planned supply of the original mRNA vaccine with the newer version, with delivery expected before the end of the year.
As has happened throughout the pandemic, the provincial health authorities will be in charge of determining their deployment of this vaccine and who will have priority to receive it.
“Canada is well positioned to deliver a robust bivalent reinforcement campaign and shipments will begin to arrive over the coming days and months,” Njoo said. “Check your provincial, territorial or local health authority’s website for information on when the vaccine will be available in your area.”
“The exact timing of booster doses and the appropriate populations to administer booster doses will depend on a number of factors, including local epidemiological contexts that are continually evolving and may vary between provinces and territories,” Health Canada said in its regulatory decision summary. .
With pandemic restrictions largely lifted in the provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning against a spike in COVID-19 cases this fall and winter.