Health Canada has approved the use of the updated Pfizer-BioNTech Comirnaty vaccine for those six months of age and older.
The federal agency provided an update on the mRNA vaccine, which is formulated for the XBB.1.5 lineage of the Omicron variant, on Thursday.
Health Canada received a submission from Pfizer-BioNTech on June 29, 2023.
“After a thorough and independent review of the evidence, Health Canada has determined that the vaccine meets the Department’s stringent safety, efficacy and quality requirements,” the federal agency states on its website.
It is the second vaccine approved by Health Canada that targets the subvariant. Earlier this month, it authorized the use of Moderna’s new Spikevax vaccine.
“As per the product label, the vaccine is authorized as a one-dose vaccine for individuals five years of age and older, regardless of their COVID-19 vaccination history,” Health Canada says of the Pfizer vaccine.
“Infants and children between six months and less than five years of age who have not previously received a complete COVID-19 primary series should receive three doses. If they have completed a primary series, they should receive one dose.”
The latest vaccine approval comes as public health officials say the number of COVID-19 infections is climbing again — just in time for respiratory virus season in the fall and winter when respiratory syncytial virus and influenza also come on the scene.
Health Canada says the new formulations of the mRNA vaccines are expected to be available this fall.
The federal agency also says the National Advisory Committee on Immunization (NACI) is “evaluating COVID-19 vaccine options and schedules, with consideration of age and other risk factors for vaccinated and unvaccinated individuals, and is anticipated to provide guidance in the coming months.”
Health Canada is also reviewing a non-mRNA option from Novavax, which has updated its protein subunit vaccine to also target the Omicron XBB.1.5 subvariant for people 12 years of age and older.
With files from The Canadian Press
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