Moderna applies to Health Canada for approval of its youth vaccine for kids 6-11

Health Canada has received a submission from Moderna to approve its mRNA COVID-19 vaccine for use among children ages 6 to 11.

The department says it will now begin a review of the scientific evidence and data from the company’s clinical trials.

Health Canada will only authorize the vaccine’s use for children if its independent and thorough review shows the benefits of the treatment outweigh the risks in this age group.

A review could take weeks or months, they said, as studies with the Moderna Spikevax vaccine are ongoing in children less than six years of age. Health Canada says other manufacturers are also testing their vaccines in children of various age ranges.

“As with all COVID-19 vaccines, the Department will prioritize the review of this submission, while maintaining its high scientific standards for safety, efficacy and quality,” Health Canada said on Tuesday.

Moderna said late last month that a low dose of its COVID-19 vaccine is safe and appears to work in 6 to 11-year-old children, as the manufacturer joins its rival Pfizer-BioNTech in moving toward expanding shots to youth.

Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults. Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, Moderna said in a news release.

The study involved 4,753 children ages 6 to 11 who got either the vaccine or dummy shots. Moderna said that like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever, and injection site pain.

The news comes as we await a decision from Health Canada on Pfizer-BioNTech’s pediatric vaccine, which could come as early as this week. Pfizer-BioNTech submitted its youth vaccine data for review on Oct. 18.

RELATED:

Health Canada ‘rigorously’ reviewing Pfizer vax for kids

Pfizer vaccine approved for U.S. youth aged 5-11. When can Canadians expect the same?

“Health Canada continues to closely monitor all safety and effectiveness data from real-world use of COVID-19 vaccines since their deployment in Canada and internationally,” the health regulator said in a news release.

“This includes data on the use of the Pfizer-BioNTech Comirnaty vaccine in children 5 to 11 years of age where it has already been authorized for use. If any new issues are identified with any of the COVID-19 vaccines authorized for use in Canada, the Department will take action as required.”

The Pfizer vaccine for children uses the same mRNA technology as the one for adults but in a smaller dosage. It is sold under the name Comirnaty.

Pfizer recently released data from its own study which found their vaccine is nearly 91 per cent effective at preventing symptomatic infections in kids aged 5 to 11.

With files from Michael Talbot of CityNews and The Associated Press