Health Canada has authorized an adapted version of the Moderna Spikevax COVID-19 vaccine. This vaccine (known as a “bivalent” vaccine) targets the original SARS-CoV-2 virus from 2019 and the Omicron (BA.1) variant, and is authorized for use as a booster dose in individuals 18 years of age or older.
This is the first bivalent COVID-19 vaccine authorized in Canada and marks a milestone in Canada’s response to COVID-19.
After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent Moderna Spikevax booster is safe and effective.
Clinical trial results showed that a booster dose of the bivalent Moderna Spikevax vaccine triggers a strong immune response against both Omicron (BA.1) and the original SARS-CoV-2 virus strain.
It was also found to generate a good immune response against the Omicron BA.4 and BA.5 subvariants, and is expected to extend the durability of protection.
This adapted vaccine has a similar safety profile to the previously approved Moderna Spikevax booster, with the same mild adverse reactions that resolved quickly.
Health Canada has placed terms and conditions on the authorization requiring Moderna to continue providing information to Health Canada on the safety and efficacy of the bivalent vaccine. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals.
Dr. Bonnie Henry, B.C.’s provincial health officer, said, “Once the supply arrives, we are all set to begin distribution. We expect the vaccines to come over several weeks and most people should be able to get one in September or October. As before, the vaccines will be available in health-authority clinics and pharmacies. More information about timing and eligibility will be presented to the public on Sept. 6. With the start of the respiratory illness season, it is especially important to make sure that people are up to date on their vaccines.”
