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OTTAWA – Canada is closely monitoring the United States Food and Drug Administration now that it has approved Pfizer-BioNTech’s COVID-19 vaccine for children aged five to 11.

The FDA approved the vaccine for emergency use on Friday afternoon, citing data that shows the vaccine is 90% effective in preventing COVID-19 in children and that there has been no ‘serious side effects.

The FDA advisory committee recommended approval of the vaccine after hours of expert testimony on Tuesday.

Health Canada officials attended this meeting and are closely monitoring the process in the United States as Canada makes its own decision on the pediatric vaccine.

“These deliberations and discussions will also be part of our review,” Health Canada’s chief medical adviser, Dr. Supriya Sharma, said in a briefing on Friday.

Health Canada received Pfizer-BioNTech’s application for approval and associated data a little later than the FDA, and Canadian authorities are still reviewing it.

“Our scientists are reviewing not only the results of clinical trials and studies performed, but also the details of the new formulation,” said Sharma.

The pediatric COVID-19 vaccine differs slightly from the adult formulation of Pfizer-BioNTech. For this reason, the company will need to deliver new vials of vaccine before Canadian children can get vaccinated.

Canada expects 2.9 million pediatric doses of the new formulation to be approved, enough for every child to receive their first dose.

But Sharma said it could still be a few weeks before Health Canada makes a final decision.

“We received additional information last week that we are reviewing,” Sharma said.

“I think it’s going, it’s going very well. I don’t see a decision before mid-end of November.

The FDA and the U.S. Centers for Disease Control and Prevention will monitor the rollout of childhood vaccines for any adverse reactions, and public health officials in Canada will also keep tabs on this data.

CDC to meet next week to discuss clinical recommendations in administering the vaccine to children in the United States

Meanwhile, Health Canada expects more requests for pediatric vaccines to be submitted in the coming weeks.

Moderna will be submitting a request for a pediatric vaccine “soon,” according to Patricia Gauthier, Executive Director of Moderna Canada.

Moderna’s provisional data for its vaccine for children six to 11 years old shows a strong safety profile as well as a strong immune response, Gauthier said at a public event hosted by the Canadian Club on Tuesday.

“We now need to have a similar future analysis, but it’s very positive, which now leads us to be able to have conversations with Health Canada and start thinking about this submission,” she said.

This report by The Canadian Press was first published on October 29, 2021.

Laura Osman, The Canadian Press

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