Pfizer sends initial kids’ COVID-19 vaccine trial data to Health Canada

In an email to Global News, Pfizer said it has sent in data from COVID-19 vaccine trials on children and continues to work with Canada's regulator ahead of a formal submission.

Pfizer has submitted initial trial data for its COVID-19 vaccine for children five to 11 to Health Canada, the company said Friday.

In an email to Global News, Pfizer said it has sent in its findings and continues to work with the country’s regulator ahead of a formal submission, which it expects to make by mid-October.

The development comes after Pfizer, alongside company BioNTech, submitted initial trial data for its COVID-19 vaccine for children aged five to 11 to U.S. regulators on Tuesday. Health Canada did not immediately respond to Global News’ request for comment.

As part of its trial response, Pfizer and BioNTech said their data showed a strong immune response among 2,268 children ages five to 11.

Data showed the two-shot mRNA vaccine generated an immune response that matched what was observed in those aged 16 to 25. The companies said they used a lower dosage in the children – a third of the amount that’s in each shot given now.

Canada’s chief medical adviser, Supriya Sharma, told reporters at a news conference Friday that Health Canada will be assessing the lower dosage while it examines the data.

“We have a dedicated team that’s ready to receive that information and review it as soon as it’s available,” she said.

“We would only authorize if it was shown that the benefits outweigh the risks, specifically for this group of individuals from five to 11.”