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Health Canada Gives Green Light to Moderna’s New COVID-19 Vaccine

Health Canada has approved a new Moderna COVID-19 vaccine for all Canadians over the age of six months based on preliminary clinical data.

Health Canada has approved a new Moderna COVID-19 vaccine for all Canadians over the age of six months based on preliminary clinical data.

Health Canada posted authorization of the new shot on Sept. 12, saying the vaccine targets an Omicron subvariant called XBB.1.5.

Shots recommended are as follows: One dose for ages five years and older, and as a booster for ages six years and older. For children between six months and four years old, the government suggests they have two doses if they have not previously been given a COVID shot.

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On Sept. 12, Health Canada officials delivered a technical briefing on the new Moderna vaccine. A spokeswoman said the vaccine was authorized “after an independent and thorough scientific review for safety, efficacy, and quality, including a review of data from several studies of the primary series and booster doses of the VX vaccine collected over the past two years.”

“After assessing all the data, we’ve concluded that there is strong evidence showing that the benefits of this vaccine outweigh the potential risks,” she said, adding that the shot was “anticipated to provide a robust immune response.”

Moderna, in a news release issued Aug. 17, stated its own “preliminary” clinical trial data “confirm its updated COVID-19 vaccine generates robust immune response in humans.”

“These results suggest that Moderna’s updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season,” stated the pharmaceutical giant.

Side Effects

In its safety information, Moderna said the vaccine should not be given to individuals with a known history of severe allergic reaction to any component in its vaccine.

“Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second primary series dose or first booster dose,” said the company. The 72-page fact sheet lists warnings and precautions. The highest risk for myocarditis and pericarditis, it cites, is in males 18 to 24 years old.

The company said “information is not yet available about potential long-term” after effects. It also states, “The vaccines may not protect all vaccine recipients.”

Adverse reactions to the vaccine listed by Moderna for six to 36 months of age include: “injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.”

In ages 37 months and older, adverse reactions include all of the above plus,” arthralgia, chills, fatigue, headache, myalgia, nausea/v

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