There's a children's COVID-19 vaccine awaiting approval in Canada. What do we know about it?
CBC
Since Health Canada announced last week that Pfizer-BioNTech is seeking authorization for its COVID-19 vaccine for younger children, many people have been asking questions. Here's what we've been able to find out:
Pfizer-BioNTech is the first company to seek Health Canada's approval for a pediatric COVID-19 vaccine (although other companies, such as Moderna, are working on children's formulations).
The pediatric version of the vaccine is for kids age five to 11. Those 12 and older get the already approved adult formulation.
The pediatric formulation will be given in smaller doses — 10 mcg (micrograms) instead of the 30 mcg used for people 12 years of age and older.
According to a spokesperson for Pfizer Canada, the vials for the pediatric version will each contain 10 doses and have a "unique label," and the cap will be a different colour — so health-care workers will be able to tell the difference between the adult and child versions.
What's unclear is whether or not the pediatric version is identical to the adult vaccine and simply given in smaller doses, or a different formulation. CBC News was unable to get a specific answer from either Pfizer or Health Canada on that question.
Like the adult version, kids will get two doses of the vaccine. The manufacturer's instructions will say to space them approximately 21 days apart, the Pfizer spokesperson said.
But it's possible that if Health Canada approves the vaccine for younger children, the National Advisory Committee on Immunization (NACI) could recommend a longer gap of up to 12 weeks between doses, like it did for the adult version earlier this year, said Dr. Caroline Quach-Thanh, a pediatric infectious disease specialist and medical microbiologist at Chu Ste. Justine in Montreal.
As the former chair of NACI, Quach-Thanh is familiar with how it operates, but does not speak on NACI's behalf.
There's a lot of evidence now that the longer time between doses produced a better immune response in adults, which the committee would take into account, she said.
"What helps in NACI's decisions is that there's ... vaccinology expertise within the committee," Quach-Thanh said. "And so you can generalize from your prior knowledge [of] this vaccine and make recommendations that are off-label."
That depends on how long it takes Health Canada to approve the vaccine.
"The Department is currently reviewing the submission and will only issue a decision following a thorough scientific review of the vaccine's safety and efficacy in this younger age group," a spokesperson said in an email to CBC News. "As with all COVID-19 submissions, Health Canada is prioritizing this review." .
The submission includes Pfizer's clinical trial data, which included 2,268 children aged five to 11, according to the company's news release.
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