Health Canada approves updated Moderna XBB.1.5 COVID vaccine

Health Canada has approved the use of Moderna’s Spikevax XBB.1.5 COVID-19 vaccine for all Canadians over the age of six months.

Officials from Health Canada, the Public Health Agency of Canada and the National Advisory Committee on Immunization discussed details of the approval during a technical briefing on Tuesday.

“The vaccine was authorized after an independent and thorough scientific review for safety, efficacy and quality, and this included a review of data from several studies of the primary series of booster doses of the Spikevax vaccine collected over the past two years,” Dr. Supriya Sharma, chief medical adviser with Health Canada, said during the briefing.

“After assessing all the data we have concluded that there is strong evidence showing that the benefits of this vaccine outweigh the potential risks.”

Sharma said recommendations include one dose for people five years old and older – regardless of COVID-19 vaccination history – one dose for children under four, and two doses for children between six months and four years old who haven’t been vaccinated against COVID. She said children six months to four years old who have received a previous dose of a vaccine should receive a single dose of the updated vaccine.

Dr. Theresa Tam, Canada’s chief public health officer, said each province and territory will provide additional information about regional COVID-19 and flu vaccine availability, but that “we will have enough supply of the updated COVID-19 vaccines to support immunization programs across Canada.”

Health Canada is also reviewing a submission by Pfizer-BioNTech to have its Omicron XBB.1.5 vaccine approved for use in people six months and older, as well as a submission by Novavax for its Omicron XBB.1.5 vaccine for people 12 years and older.

Last fall, Canada experienced an early start to the influenza season as well as high numbers of respiratory syncytial virus (RSV) infections. While 2023 has so far seen COVID-19 indicators drop to historically low levels, Tam said COVID-19 infections and hospitalizations have been on the rise in the last several weeks.

“The Omicron variant continues to evolve with XBB subvariants such as EG.5 continuing to circulate in Canada and globally,” she said, adding that Canada has recorded 11 cases of Omicron subvariant BA.2.86.

“It is difficult to predict what will happen this fall and winter regarding the circulation of influenza, RSV and COVID-19 given that it is still early in the season,” she said. “But the good news is we can get prepared and protect ourselves in case simultaneous surges of respiratory viruses occur. This is why receiving a COVID-19 vaccine dose as well as a flu shot this fall is especially important.”

Tam urged all eligible Canadians to roll up their sleeves and stay up-to-date with their COVID-19 vaccinations. Anyone who has not been infected with COVID-19 or received a COVID-19 vaccination in the past six months is encouraged to get vaccinated with the latest version of a COVID-19 vaccine.

Tam said preliminary clinical data has shown the XBB.1.5 vaccine triggers an immune response against several Omicron sublineages, including EG.5 and BA.2.86. She also reiterated that it is safe to receive a flu vaccine and a COVID-19 vaccine at the same time.

The United States government on Monday approved updated COVID-19 vaccines in a bid to bolster protection against the latest coronavirus strains and soften any surges this fall and winter.

The U.S. Food and Drug Administration isn’t calling those a booster, but rather an updated vaccine. Health Canada is using the same language.

– With files from The Canadian Press and The Associated Press