Health Canada approves first COVID-19 vaccine for youngest kids

Health Canada has approved a COVID-19 vaccine for infants and preschoolers between the ages of six months and five years, making Moderna’s shot the first of its kind to be allowed for that age group in this country.

The approved Moderna Spikevax vaccine for this demographic is set to be given to eligible kids in two doses that are each a quarter of the adult dose.

Health Canada announced the approval Thursday, while also outlining recommendations from the National Advisory Committee on Immunization (NACI).

NACI recommends that a primary series of two doses, each 25 mcg, be offered to children six months to five years at least eight weeks apart. For children in this age group who are moderately to severely immunocompromised, NACI recommends a primary series of three doses be offered, with an interval of four to eight weeks between doses.

The Moderna vaccine should not be given to a child the same day they receive any other shot, NACI urges, adding the COVID-19 vaccination should take place 14 days before or after any other immunization.

The most common side effects after vaccination were irritability or crying, as well as pain at the injection site and sleepiness. other noted side effects of the pediatric vaccine include fever, nausea or vomiting, swollen or tender lymph nodes under the arm, and headaches. Those reactions were usually mild or moderate and resolved within a few days.

Less common side effects of the pediatric vaccine include fever, swelling at injection site, nausea or vomiting, swollen or tender lymph nodes under the arm, & headaches. Those reactions were usually mild or moderate and resovled within a few days. #cdnpoli

— Cormac Mac Sweeney (@cmaconthehill) July 14, 2022

NACI’s review of the Spikevax vaccine approval application included a close look at clinical trial data, as well as the spread and severity of the virus in kids under five. Clinical trials involved nearly 6,500 children. There were no deaths and no cases of myocarditis or pericarditis reported during the study.

The vaccine advisory body notes that while most children who contract COVID-19 have mild illness or are asymptomatic, some others get very sick and even require hospitalization.

Meanwhile, NACI says children who’ve had the virus “are at risk of experiencing multisystem inflammatory syndrome in children (MIS-C), a rare but serious complication from COVID-19 that usually requires hospitalization.”

Kids with underlying medical conditions are at higher risk of severe outcomes, NACI adds.

Health Canada said earlier this month that it expected to reach a decision on Moderna’s application by mid-July.

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• FDA authorizes 1st COVID-19 vaccines for infants, preschoolers

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There are nearly two million children under five in Canada. NACI points to studies condutcted in B.C. and Quebec which show many children in this age group have had COVID-19. The majority of these infections occurred after Omicron became the dominant strain, the agency notes.

“It is not clear if these studies are generalizable to other parts of Canada,” NACI adds.

So far, NACI says preliminary data shows the vaccine is 50.6 per cent effective in preventing symptomatic COVID-19 in children six to 23 months of age when Omicron is the dominant variant. Efficacy is estimated at 36.8 per cent in children two to five years starting two weeks after the second dose.

Pfizer-BioNTech has also submitted to Health Canada for approval its pediatric vaccine for children between six months and four years. That submission was made on June 23, with no word yet on when a decision will be made.

Health Canada will provide an update at noon EST/9 a.m. PST.