Pfizer formally submitted an application to Health Canada on Monday, seeking permission to use its injections in children between the ages of five and 11.
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In a statement, Health Canada said it would only give the green light after a thorough review of the data to ensure that the benefits of the injections outweigh the potential risks for this age group.
While Pfizer’s COVID-19 vaccine targets the same virus, SARS-CoV-2, there are notable differences for adults and children, according to the drug maker.
Pediatric doses are one-third (10 micrograms) the size given to adults and adolescents 12 years of age and older (30 mcg).
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If approved, each vial will contain 10 doses for the younger age group, said Christina Antoniou, director of corporate affairs at Pfizer Canada.
This is different from the six doses per vial currently used for adults and adolescents in Canada.
Children’s vaccines will also have a unique label and a different color for the cap.
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Variations in presentation and dosage are not unusual, experts say, as has been the case with other vaccines.
“This wouldn’t be the first time we’ve seen that a vaccine needs to be dosed differently or even packaged differently for children,” said Dr. Shazeen Suleman, pediatrician at Unity Health Toronto.
However, the formulation of the vaccine itself is the same, Antoniou confirmed to Global News in an emailed statement.
Pediatric doses are not recommended to be withdrawn from existing vials for adults “for a number of reasons,” Dr. Theresa Tam, Canada’s chief public health officer, said on Friday in a statement. press conference.
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A spokesperson for Health Canada said the agency would notify Canadians of the appropriate details once its review is complete.
Children also undergo three phases of vaccine trials, but the sample size is not as large.
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Since the efficacy of vaccines has already been tested in large-scale clinical trials in the adult population, the same steps are not necessary for children.
As part of its trial, Pfizer and BioNTech said their data showed a strong immune response in 2,268 children aged 5 to 11.
The data showed that the two-shot mRNA vaccine elicited an immune response that matched what was seen in people aged 16 to 25.
While the federal government has a contract with Pfizer that includes pediatric injections, Ottawa is yet to say how quickly they will arrive, if and when Pfizer’s under-12 vaccine will receive the green light from Health Canada.
Pfizer calls on Health Canada to approve vaccine for children ages 5-11
– with files from Abigail Bimman of Global News.
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