OTTAWA –
Canada’s drug regulator approved Moderna’s COVID-19 vaccine for infants and preschoolers on Thursday, making it the first vaccine approved for this 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 between the ages of 6 months and 5 years,” the department said in a statement.
The National Advisory Committee on Immunization gave its consent to provinces to offer the vaccine to children in that age group on Thursday, recommending that children “may” be offered the vaccine.
The committee’s executive secretary, Dr Matthew Tunis, said the NACI recognized this could be an “important safeguard” for parents who want to exercise the option for their children, and the recommendation could be strengthened as more emerged. data.
Although serious illness among children is rare, the commission said the number of children hospitalized for COVID-19 has increased dramatically since the Omicron variant spread rampantly last winter.
“This authorization comes at a critical time in the pandemic as we move through the seventh wave, and although children are less likely to experience complications from COVID-19, they can still get very sick,” said Dr. Supriya Sharma, chief Health Canada’s physician advisor, at a media briefing Thursday.
The average monthly rate of young children hospitalized due to COVID-19 increased from 1.4 per 100,000 children under 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 go on to develop long-term symptoms and, in rare but serious cases, multisystem inflammatory syndrome, which often requires emergency hospital care.
Deputy Chief Public Health Officer Dr Howard Nju has advocated for parents to vaccinate their children as protection against serious illness, even if they have already had COVID-19.
Health Canada said it will continue to closely monitor the vaccine’s safety and has asked Moderna to provide updated data on both the vaccine’s safety and effectiveness.
In its decision, posted on Health Canada’s website, the agency said the results of a phase 3 trial of the drug showed that the immune response in children aged six months to five years was comparable to Moderna’s vaccine for 18 to 25-year-olds .
The approval expands eligibility for the COVID-19 vaccine to nearly two million children in Canada, but where and when the vaccine will be given to children will be determined by the provinces.
Njoo said there is “sufficient quantity” of vaccines that will be sent to the provinces so that 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 get vaccinated themselves. As of June 19, about 42 percent of children between the ages of five and 11 had received two doses of an approved vaccine.
By comparison, about 90 percent of Canadians aged 12 and over have had at least two shots.
Njoo said public health does not want to force the vaccine on families and wants them to feel comfortable with their choice. He encouraged parents to talk to their family doctors or pediatricians if they have questions about whether their child should get the vaccine.
In Moderna’s trials, two child-sized doses of the vaccine were given about four weeks apart, but NACI recommends waiting eight weeks between shots.
NACI also recommends a third dose for immunocompromised children if their parents choose to vaccinate them, with four to eight weeks waiting between shots.
For now, the committee says the COVID-19 vaccine should not be given to infants, toddlers or preschoolers at the same time as vaccines for other diseases to help identify potential reactions.
Health Canada said no safety concerns were identified in the study. The most common reactions are similar to those children experience with other pediatric vaccines, such as pain at the site, drowsiness, and loss of appetite.
Less commonly, some children get a mild to moderate fever, swelling at the injection site, nausea, painful lymph nodes under the arm, headache, and muscle aches.
Health Canada said there is still some uncertainty 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, swelling of the heart tissue, although no cases were found in the studies.
In addition, there is still much to learn about the vaccine’s safety and effectiveness in young children with other health problems or who are immunocompromised, the documents said.
The United States approved Moderna and Pfizer’s pediatric COVID-19 vaccines last month and has so far immunized 267,000 children in that age group as of July 8.
Pfizer’s pediatric COVID-19 vaccine for young children between the ages of six months and five years was submitted to Health Canada last month and is still under review.
This report by The Canadian Press was first published on July 14, 2022.
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