Health Canada Approves Moderna’s Spikevax XBB.1.5 for Infants Above Six Months

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Health Canada has greenlighted the application of Moderna’s Spikevax XBB.1.5 COVID-19 vaccine for Canadians above the age of six months. The decision emerged following a comprehensive technical briefing on Tuesday involving representatives from Health Canada, the Public Health Agency of Canada, as well as the National Advisory Committee on Immunization.

Dr. Supriya Sharma, Health Canada’s chief medical adviser, revealed during the briefing that the vaccine underwent an intensive, independent scientific inspection for safety, efficacy, and quality. “This incorporated a detailed review of various studies examining the primary series of booster doses of Spikevax vaccine gathered over the last two years,” said Sharma. She asserted that “the benefits of this vaccine far outweigh the potential risks” based on their thorough evaluation of all available data.


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The recommendations include a single dose for people five years or older irrespective of their COVID-19 vaccination status, one dose for individuals younger than four, and two doses for unvaccinated children between six months and four years. Children aged six months to four years who have previously received a vaccine dose should get a single dose of the updated vaccine.

Dr. Theresa Tam, Canada’s chief public health officer, mentioned that additional information about regional COVID-19 and influenza vaccines’ availability would be provided by each province and territory. Meanwhile, Health Canada is reviewing the Omicron XBB.1.5 vaccines by Pfizer-BioNTech and Novavax, aimed for people aged six months and above and twelve years and above, respectively.

In the wave of 2023, Canada saw a drastic reduction in COVID-19 indicators to historically low figures. However, it also noted a surge in COVID-19 infections and hospitalizations in recent weeks. “The evolving Omicron variant continues to circulate in Canada and worldwide, with the presence of XBB subvariants such as EG.5,” Dr. Tam noted. A total of 11 cases of Omicron subvariant BA.2.86 have been recorded in the country.

Predicting the fall and winter scenario concerning influenza, RSV, and COVID-19 circulation is challenging given the present early phase of the season. However, Dr. Tam highlights the importance of getting a COVID-19 vaccine dose and a flu shot, given the potential simultaneous surges of various respiratory viruses.

Dr. Tam urged all eligible Canadians to stay vigilant about their COVID-19 vaccinations, encouraging those who are not infected or have not received a COVID-19 vaccine within the past six months to get inoculated with the most recent COVID-19 variant. According to preliminary clinical data, the XBB.1.5 vaccine triggers an immune response against several Omicron sublineages.

Equally significant, the U.S. government have consented to the updated COVID-19 vaccines to enhance protection against evolving coronavirus strains in anticipation of any surges this fall and winter. The U.S. Food and Drug Administration categorizes these as updated vaccines, an approach echoed by Health Canada.