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Moderna asks Health Canada to approve its COVID-19 vaccine for children

Moderna has asked Health Canada to approve its COVID-19 vaccine, for children six to 11 years of age, the department announced.

This is the second pediatric COVID-19 vaccine awaiting authorization in Canada. Health Canada is still reviewing Pfizer-BioNTech’s application for its kid-sized shots. 

Pfizer’s submission, received by Health Canada on Oct. 18, is for kids age five to 11. It would be one-third the size of the dose given to adults and kids 12 and older. 

Pfizer’s COVID vaccine is now officially called Comirnaty while Moderna’s COVID-19 vaccine is marketed under the name Spikevax.  

Last week, Health Canada’s chief medical adviser said the agency’s review of the pediatric Pfizer vaccine should be completed within “one to two weeks.” 

A news release issued by Health Canada on Tuesday didn’t give specific information about Moderna’s pediatric version of its vaccine, but the company’s clinical trials for children used two doses, given a month apart, that were each half the size of its adult shots.

Moderna’s booster shots for adults are also half doses.   

In its release, Health Canada said it would “prioritize” its review of Moderna’s submission, as it does with all COVID-19 vaccines, “while maintaining its high scientific standards for safety, efficacy and quality.”

“Health Canada will only authorize the use of Spikevax in children if its independent and thorough scientific review of the data in the submission shows that the benefits of the vaccine outweigh the risks in this age group,” the release said. 

“The assessment will include a detailed review of clinical trial results, as well as other evolving data and information about the health impacts of COVID-19 and variants of concern on children in Canada.”

In an emailed response to a CBC News request for additional information, Health Canada said it could not provide “specific timelines for completion or specific information on the submission until it has received regulatory approval.”

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