The first COVID-19 vaccine for infants and preschoolers has been approved in Canada.

Health Canada announced on Thursday that it had authorized the Moderna Spikevax mRNA vaccine for children six months to five years of age.

“Most children who are infected with the SARS-CoV-2 virus that causes COVID-19 have mild or no symptoms of the illness. However, some children experience severe COVID-19 disease and require hospitalization,” said Dr. Theresa Tam, Canada’s Chief Public Health Officer. “The availability of the Moderna Spikevax COVID-19 vaccine for children aged six months to five years provides families with a vaccine option to help protect their young children from COVID-19. It is very important that all children and their caregivers are supported during the decision-making process and that their decisions related to COVID-19 vaccination are respected.”

The decision was made based on recommendations from the National Advisory Committee on Immunization (NACI), which reviewed clinical trial data on the safety, efficacy, and immune response generated by the vaccine in children under 5. The NACI also reviewed data on the spread and severity of COVID-19 in children in that age group.

The vaccine can be administered in two doses of 25 micrograms with an interval of at least eight weeks between the first and second dose.

According to the clinical data, the vaccine produces an immune response in children under 5 years of age equivalent to the the immune response seen in young adults between the ages of 18 to 25 who received a 100 microgram dosage of the initial vaccine.