OTTAWA-
Health Canada has authorized the use of the country’s first COVID-19 booster shot targeting variants, marking what health officials call a “milestone” in Canada’s response to the pandemic.
On Thursday, the federal health regulator announced it had given the green light to the bivalent COVID-19 vaccine targeting Moderna’s Omicron, for people ages 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 as well as the Omicron variant. The mutated and highly transmissible version of the novel coronavirus has been circulating widely in Canada since November 2021.
According to Health Canada, according to a study comparing people immunized with the bivalent vaccine and those who received the original dose of Moderna’s mRNA, the results indicate that the updated vaccine “provides a better immune response to Omicron BA. 1”.
“After a thorough and independent scientific review of the evidence, Health Canada has determined that the 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, and should extend the durability of protection.”
Additional information on the authorization is provided by officials from the Public Health Agency of Canada during a technical briefing which will be followed by an announcement from the Minister of Health, Jean-Yves Duclos, on “the importance of vaccination against COVID-19 as we approach the fall”.
“Keeping COVID-19 vaccinations up to date, including getting recommended booster doses, will help protect an individual from serious illness and other complications of COVID-19 infection,” said Health Canada in a press release announcing the authorization of the bivalent dose. .
WHO SHOULD RECEIVE THIS PHOTO?
According to the authorization information published by Health Canada, the proposed dosing regimen is an interval of “at least four months after a primary series and/or a previous booster dose”.
The National Advisory Committee on Immunization (NACI) released guidelines Thursday saying that adults 18 and older who are recommended to receive a booster dose in the fall should be offered a shot of the bivalent vaccine.
However, NACI said those who are eligible for a booster this fall and who are most at risk “should not delay their scheduled vaccination in anticipation of a bivalent vaccine containing Omicron against COVID-19,” because the original mRNA vaccines will still provide timely protection.
Moderna submitted its bivalent recall to Health Canada for regulatory approval on June 30. While the booster was submitted by Moderna for approval for ages 12 and older, Health Canada decided to limit its authorization for use in adults.
Despite this, NACI said on Thursday that adolescents aged 12 to 17 with “moderately to severely immunocompromised conditions and/or who have biological or social risk factors that put them at high risk for serious consequences” could be suggest an injection of the bivalent booster. “without label.”
NACI said that while there are no data on the efficacy, immunogenicity, or safety of this booster in people under 18, its benefits may “outweigh the risks.” potential unknown at present”.
Given as an intramuscular injection – compatible with other COVID-19 vaccines – the 50 microgram dose can cause common side effects, including pain, swelling or redness at the injection site, as well as fatigue , muscle aches and stiffness, fever and chills.
The federal health agency warns against receiving this injection if you have had an allergic reaction to a previous dose of Moderna’s COVID-19 vaccine.
PFIZER BIVALENT IN PROGRESS
Moderna’s bivalent vaccine will be the first such vaccine available in Canada. Pfizer-BioNTech has also submitted its bivalent recall for regulatory review. That submission was sent to Canada’s federal health regulator on July 25, and while clearance may be imminent, it is not expected to be part of Thursday’s announcement.
“Our regulatory colleagues at Health Canada are working very quickly to review the submissions from Moderna and Pfizer-BioNTech on bivalent booster doses,” said Dr. Theresa Tam, Chief Public Health Officer, during a press conference on August 22.
The move follows the U.S. Food and Drug Administration Wednesday granting emergency use authorizations to bivalent vaccines from Moderna and Pfizer for use as single booster doses at least two months after the release. primary or booster vaccination.
The UK approved the bivalent Moderna vaccine on August 15.
As has been the case with previous COVID-19 vaccine authorizations, Health Canada imposed conditions on the authorization, requiring the pharmaceutical giant to continue to provide information on safety and effectiveness.
12 MILLION DOSES PURCHASED
The federal government has already purchased 12 million doses of the vaccine, reaching an agreement with Moderna to replace some of the planned supply of the original mRNA with the newer version, with delivery expected before the end of the month. ‘year.
As has been the case throughout the pandemic, provincial health authorities will be responsible for determining their deployment of this vaccine and who would be prioritized to receive it.
Questions have been raised about whether Canadians should wait until bivalent doses are available before rolling up their sleeves for a vaccine, something Tam said should be decided based on individual risk factors.
“The exact timing of booster doses and the appropriate populations to administer booster doses to will depend on a variety of factors, including local epidemiological contexts which are continually changing and may vary by province and territory,” Health Canada said in its summary of regulatory decisions. .
With pandemic restrictions largely lifted in all provinces and Canadians expected to spend more and more time indoors, doctors and epidemiologists are warning of an increase in COVID-19 cases this fall and winter.