Pfizer to seek approval for its vaccine for kids as young as five in about a week

Pfizer

Pfizer Canada says it is preparing to ask Health Canada to authorize its COVID-19 vaccine for kids as young as five by mid-October.

The U.S. drugmaker submitted a formal request to the U.S. Food and Drug Administration today and the FDA intends to meet to discuss the submission on Oct. 26.

Last week Pfizer submitted data to both governments from a clinical trial on children five to 11 but hadn’t formally requested authorization.

A spokeswoman for the company’s Canadian arm says it is in the final stages of working with Health Canada ahead of the submission being made so kids between five and 11 can be given the shots here.

It comes the same day a new B.C. COVID-19 modelling report shows kids are now driving the pandemic curve.

“At this point the under 12-year-olds are a major determinate of the growth rate of COVID within a community,” said UBC professor and BC COVID-19 Modelling Group member Sally Otto.

The group also looked at the potential for adverse effects from the vaccine compared to COVID, with one of the key concerns being myocarditis, or heart inflammation.

Using data from teens, they found they are much likelier to get myocarditis from COVID than from the Pfizer vaccine, with 544 cases in a million compared to 64 in a million. For hospitalizations it was 5,000 per million for COVID-19 compared to 60 per million for vaccinations, and for deaths in teens there were 15 per million from COVID compared to less than 0.2 per million from the vaccine.

But they say it all comes down to how likely children here are to contract the virus.

“If you think you have no chance of getting COVID then you don’t need the vaccine but if you think there’s a reasonable chance of getting COVID, like 10 per cent, than the risk of getting myocarditis from COVID is much greater than the vaccine,” said SFU professor and modelling group member Paul Tupper.

“The vaccines for five to 11-year-olds will only be approved if the experts believe it is much safer to get vaccinated than to risk getting COVID.”

The Pfizer vaccine was authorized for people at least 16 years old in December 2020 and for teenagers between 12 and 15 in May.

The dose for younger children is one-third the size given to adults and Pfizer and Health Canada have not yet said if vaccine supplies already in Canadian freezers can be adapted for use on children or if new shipments must be made.

This report by The Canadian Press was first published Oct. 7, 2021.

The Canadian PressThe Canadian Press
April LawrenceApril Lawrence

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