Health Canada Approves Moderna’s Spikevax for Ages Six Months and Up


The use of Moderna’s Spikevax XBB.1.5 COVID-19 vaccine has been given the green light by Health Canada for individuals aged six months and older. This approval was announced in a technical briefing by officials from Health Canada, the Public Health Agency of Canada, and the National Advisory Committee on Immunization.

The stamp of approval came after exhaustive and unbiased reviews of safety, efficacy, and quality reports, which included data from various studies regarding booster doses of the Spikevax vaccine amassed over the last two years. “There is compelling evidence to suggest that the benefits reaped from this vaccine outweigh its potential risks,” stated Dr. Supriya Sharma, Chief Medical Adviser with Health Canada.

The protocol mandates a single dose for those aged five years and above, independent of their COVID-19 vaccination history, one dose for children younger than four years, and a double-dose for unvaccinated children aged between six months and four years. Children from six months to four years who have previously been vaccinated are to receive a sole dose of the updated vaccine.

Dr. Theresa Tam, Canada’s Chief Public Health Officer, noted that each province and territory will disseminate additional information on regional COVID-19 and flu vaccine availability. However, she ensured that Canada possesses an adequate supply of the updated COVID-19 vaccines to sustain nationwide immunization programs.

Health Canada is also evaluating submissions by Pfizer-BioNTech and Novavax for the approval of their Omicron XBB.1.5 vaccines for use in people six months and older, and twelve years and older, respectively.

Looking back to last fall, Canada had an early onset influenza season coupled with a high incidence rate of respiratory syncytial virus (RSV) infections. While COVID-19 indicators in 2023 have so far plummeted to record lows, Dr. Tam warns that infections and hospitalizations have seen an upswing in recent weeks.

An evolution in the Omicron variant with XBB subvariants such as EG.5 seen both domestically and internationally, suggests unpredictable outcomes for the upcoming fall and winter in context to influenza, RSV, and COVID-19. Nevertheless, Dr. Tam emphasizes that preparatory measures such as receiving a COVID-19 vaccine dose and a flu shot this fall are vital for protection against possible concurrent outbreaks of respiratory viruses.

Dr. Tam further encouraged all eligible Canadians to stay current with their COVID-19 vaccinations, urging those who have not contracted COVID-19 or have not been inoculated in the past six months to opt for the latest COVID-19 vaccine.

Preliminary clinical data indicates the XBB.1.5 vaccine incites an immune response against several Omicron subvariants like EG.5 and BA.2.86. Moreover, Dr. Tam ascertained that receiving a flu vaccine and a COVID-19 vaccine concurrently is safe.

The U.S government recently approved revised COVID-19 vaccines to reinforce protection against the novel coronavirus strains, in hopes of blunting the impact of potential surges in the upcoming fall and winter. These are not identified as boosters, but as updated vaccines by the U.S. Food and Drug Administration, a terminology adopted by Health Canada as well.


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