Health Canada has authorized one of Moderna's Spikevax Omicron-targeting bivalent COVID-19 boosters for use in children and teens aged six to 17 years. The booster targets the Omicron variant BA.1.
The BA.1 booster was previously only approved for people aged 18 and over. Moderna's Omicron-targeting bivalent booster for variant BA.4/5 has not yet been approved for use in children and teens under 18.
"We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern," Shehzad Iqbal, country medical director of Moderna Canada, said in a media release issued Friday, "especially as this virus continues to circulate across the country and around the world."
Moderna announced in November that its bivalent Omicron-targeting booster candidates for variants BA.1 and BA.4/5 triggered a stronger antibody response than a booster dose of the company's original COVID-19 vaccine in Phase 2 clinical trials.
Health Canada approved the booster as safe and effective for use in children and teens under 17 based on data from clinical trials of Moderna's original Spikevax vaccine. Those trials showed that, beginning two weeks after the second dose, the Spikevax vaccine was 100 per cent effective in trial participants 12 to 17 years old and more than 94 per cent effective in participants aged six to 11 years old. The bivalent COVID-19 vaccine for strain BA.1 was shown in trials to further increase the immune response against the variant.
The vaccine will be administered as a 25-microgram booster dose for children aged six to 11 years and a 50-microgram booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster.
Common side effects can include redness, soreness and swelling at the site of injection, as well as more general temporary symptoms including chills, fatigue, joint pain, headache, mild fever, muscle aches, nausea, vomiting, dizziness and enlarged lymph nodes.
"The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada," said Stephane Bancel, chief executive officer of Moderna, in a media release published on Friday.
"This decision highlights the effectiveness and safety of our vaccine in this important age group."
