Canada’s drug regulator on Thursday approved Moderna’s COVID-19 vaccine for infants and preschool children, making it the first approved vaccine for that age group in the country.
Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years in doses a quarter of the size approved for adults.
“After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective in preventing COVID-19 in children 6 months to 5 years of age,” the department said in a statement.
The National Advisory Committee on Immunization gave provinces its consent to offer the vaccine to children in that age group on Thursday, recommending that children “can be offered” the vaccine.
The committee’s executive secretary, Dr. Matthew Tunis, said NACI recognizes this could be an “important protective measure” for parents who want to exercise choice for their children, and the recommendation could be strengthened as more data becomes available. available.
While serious illness among children is rare, the committee said the number of children hospitalized for COVID-19 soared dramatically as the Omicron variant spread rampant last winter.
“This authorization comes at a critical time in the pandemic as we move through the seventh wave and while children are less likely to experience complications from COVID-19, they can still become seriously ill,” said Dr. Supriya Sharma. , medical director of Health Canada. adviser, at a press conference on Thursday.
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The average monthly rate of young children hospitalized due to COVID-19 increased from 1.4 per 100,000 children under the age of five in the first two years of the pandemic to 15.9 per 100,000 in the first three months of 2022.
Sharma pointed out that even children with mild disease can develop long-term symptoms and, in rare but severe cases, multisystem inflammatory syndrome, often requiring acute hospital care.
Deputy Director of Public Health Dr. Howard Njoo advocated that parents vaccinate their children to protect against serious illness, even if they have already been sick with COVID-19.
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Health Canada said it will continue to closely monitor the safety of the vaccine and has asked Moderna to provide updated data on the safety and efficacy of the vaccine.
In its decision posted on Health Canada’s website, the agency said results from the Phase 3 trial for the drug show that the immune response in children aged six months to five years was comparable to Moderna’s vaccine for 18-year-olds. to 25 years.
The approval expands eligibility for the COVID-19 vaccine to nearly two million children in Canada, although provinces will determine where and when children will be given the vaccine.
Njoo said there is a “enough supply” of vaccines, which will be shipped to provinces so they can start offering them to children “very soon.”
Until now, Canadian parents have been more hesitant to vaccinate their children against COVID-19 than to vaccinate themselves. As of June 19, about 42 percent of children between the ages of five and 11 have received two doses of an approved vaccine.
By comparison, about 90 percent of Canadians over the age of 12 have received at least two vaccinations.
Njoo said public health doesn’t want to force the vaccine on families and wants them to feel comfortable with their choice. He encouraged parents to talk to their family doctor or pediatrician if they have any questions about whether their child should get the vaccine.
In Moderna’s trials, two doses of the vaccine were given to children about four weeks apart, but NACI recommends waiting eight weeks between vaccinations.
NACI also recommends a third dose for immunocompromised children, if their parents choose to vaccinate them, with a four to eight week wait between injections.
For now, the committee says the COVID-19 vaccine should not be given to infants, toddlers or preschool children at the same time as vaccines for other diseases to help identify possible reactions.
Health Canada said no safety issues were identified in the study. The most common reactions were similar to those experienced by children with other pediatric vaccines, including soreness at the site, drowsiness, and loss of appetite.
Less commonly, some children had a mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headaches, and muscle aches.
Health Canada said there are still some uncertainties about the vaccine because it is new and long-term data are not yet available. For example, there is little data on the risk of very rare reactions such as myocarditis, an inflammation of the heart tissue, although no cases emerged in the trials.
There is also more to learn about the safety and efficacy of the vaccine in young children with other health conditions or who are immunocompromised, according to the documents.
The United States approved Moderna and Pfizer’s pediatric COVID-19 vaccines last month and, as of July 8, has immunized 267,000 children in that age group.
Pfizer’s pediatric COVID-19 vaccine for young children between the ages of six months and five years was shipped to Health Canada last month and is still under review.
This report from The Canadian Press was first published on July 14, 2022.