Health Canada receives submission to approve Moderna’s COVID-19 vaccine for kids – Toronto Star

Empty Moderna vaccine vials are shown before a COVID-19 vaccine drive-thru clinic in Kingston, Ont., on July 2, 2021.

By Melissa Couto ZuberThe Canadian Press

Tue., Nov. 16, 20213 min. read

Article was updated 28 mins ago

Health Canada says it has received a submission from Moderna to authorize use of its COVID-19 vaccine for children aged six to 11, the first step toward potentially having two kid-specific jabs approved in the country in the near future.

The agency said on Tuesday it will prioritize the review of Moderna’s submission, while maintaining high scientific standards for safety, efficacy and quality.

It said the assessment will consider clinical trial data and emerging research about the impacts of COVID-19 in children to determine if the benefits of the vaccine outweigh the risks in this age group.

Health Canada is currently reviewing Pfizer-BioNTech’s submission for approval of its COVID-19 vaccine for children aged five to 11, and officials have indicated that a decision could come within the month.

The regulator said it’s monitoring the rollout of the Pfizer shot for children in the U.S., where the vaccine was authorized for use about two weeks ago.

Kelly Grindrod, a pharmacy professor at the University of Waterloo, said having two pediatric COVID-19 vaccines potentially authorized in Canada within the coming months would be “very, very helpful for maintaining stability of our supply.”

The federal government announced last month that Canada would receive 2.9 million doses of Pfizer’s kid-specific vaccine shortly after approval.

“By having another (vaccine) approved, it gives us another option and it gives us another supply chain, especially if they’re considered to be generally the same — similarly effective, similar side-effects,” Grindrod said. “It’s really about access. … If you’re stuck with only having one product approved, you can really be stuck if there’s shortages, if there’s problems with the factory, if there’s problems in shipping, if there’s a shortage of certain ingredients.”

The general manager of Moderna Canada has said interim data for its pediatric vaccine shows a strong safety profile as well as a strong immune response.

Moderna’s data has not been published in a scientific journal. Grindrod said that’s been common, noting that Pfizer also sent its data directly to regulators.

“Health Canada (will) review what the company is providing and they’ll determine if it’s sufficient or if they want more data,” she said. “So that’s something that could hold up (approval).”

Health Canada said on Friday that a decision on authorization for the Pfizer kids’ vaccine could come in “one to two weeks.”

Health Canada received Pfizer’s submission for approval and associated data slightly later than U.S. regulators, and Grindrod said that’s part of the reason for the perceived delay in authorization here.

The latest data from the Centers for Disease Control and Prevention suggests that more than 1.7 million kids under age 12 in the U.S. have received at least one COVID-19 shot. This gives Health Canada more real-world data to consider in its own approval process, said Grindrod.

“A lot of Canadians felt like they didn’t want to be the first to give the vaccine to their kids. They wanted to wait and see a bit and we actually are getting to wait and see in Canada as they’re rolling it out in the U.S.,” she said.

“What I’m hoping is if the data that’s been provided is sufficient — and the data shows that the vaccine is safe from everything we’ve seen from the U.S. — then I’m very hopeful we will see an approval (of the Pfizer vaccine) soon.”

— with files from Adina Bresge

This report by The Canadian Press was first published Nov. 16, 2021.

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