Canada authorizes first COVID-19 vaccine for kids

Health Canada has authorized the first COVID-19 vaccine for children, giving the regulatory green light to Pfizer-BioNTech’s two-dose vaccine.

Children ages five to 11 are now eligible to receive this vaccine, in a smaller dosage than has been offered to those ages 12 and above.

The pediatric doses that will be offered to younger children will be one-third of what has been offered to those ages 12 and above.

While Health Canada has approved the doses to be given 21 days apart, the National Advisory Committee on Immunization (NACI) is recommending a dosing interval of eight weeks or more between the first and second dose.

Further, NACI is recommending that children wait at least 14 days before or after receiving another vaccine before getting a COVID-19 vaccine, calling it a “precaution” being suggested to help determine whether side-effects that may arise are due to one immunization or the other, unless otherwise advised by a doctor.

“This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada’s fight against COVID-19,” said Canada’s regulatory agency in a statement. “After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks.”

During a press conference discussing the long-anticipated authorization, Health Canada’s chief medical adviser Dr. Supriya Sharma said that the formulation approved for children is “slightly different” than the version authorized for adults, but the immune responses were “comparable.”

“The main adverse events reported were similar to those and in adolescents and young adults, but were less frequent, except for redness and swelling at the injection site, which were slightly higher. Other adverse events reported included fatigue, and headache. Most reactions were mild to moderate in severity, and resolved quickly on their own,” Sharma said of the clinical and safety data evaluated by Health Canada.

Health Canada had been prioritizing the review of Pfizer’s submission to use its vaccine in those ages five to 11 since Oct. 18, and a similar review is ongoing for Moderna’s two-dose mRNA vaccine for those ages six to 11. 

According to Health Canada’s authorization, clinical trials have shown that the Pfizer vaccine was 95 per cent effective in protecting trial participants from COVID-19 for those 16 years and older, 100 per cent effective for those 12 to 15 years old, and 90.7 per cent effective for those five to 11 years old.

Sharma said that in the data reviewed by Health Canada, the four reported serious adverse events were ultimately determined to be unrelated to vaccination, and there were no reports of myocarditis, pericarditis, or severe allergic reactions.

Dr. Tam said that evidence emerging from adult immunization indicates that longer intervals between doses results in a longer-lasting immune response, and may lower the risk of myocarditis and pericarditis.

Should NACI’s dose interval be observed by provinces and territories, it means that those aged five to 11 will not be able to be fully vaccinated before the Christmas holiday season.

Still, Dr. Tam is viewing the authorization as a “welcome additional prevention option,” given “the current and prevailing epidemiology of COVID-19 in Canada, where incidence rates have remained highest in children aged five to 11 years for most of the fourth wave.”

The Public Health Agency of Canada says there will be efforts taken to inform parents and encourage them to vaccinate their children.

“During this time, it is very important that we support children and their caregivers and making informed decisions about COVID-19 vaccination while respecting their choices and pace of decision making,” Tam said.

Reacting to the news, CTV News medical specialist Dr. Marla Shapiro said that the side-effects from COVID-19 vaccines are “well outweighed” by the risks associated with a COVID-19 infection.

“Mostly, what we expect to see is sore arms, redness, maybe a little bit of flu like symptoms if some kids experience that… But every parent has to ask their questions, be comfortable with their decision, and I think it’s really to understand what’s the downside of not getting vaccinated and then the risk of getting COVID in a child,” she said on CTV News Channel.

Pfizer will be required to continue providing Canada with safety and efficacy information from ongoing studies and real-world usage, with Health Canada and the Public Health Agency of Canada pledging to “closely monitor” the usage of this vaccine, which has been given the brand name of “Comirnaty.”

Sharma had been signalling for a few weeks that the authorization was around the corner, and in anticipation provinces and territories have been putting plans in place to administer these doses as soon as supply is ready.

The federal government has procured 2.9 million doses of this vaccine, and has promised that deliveries would land in Canada shorty after regulatory authorization.

The first shipments will be enough to supply the country with a first dose for every eligible Canadian child, according to former procurement minister Anita Anand.

Anand has said that Canada has enough syringes and other supplies necessary to administer the pediatric COVID-19 vaccines, and that delivery of second doses will be “driven by the rapidity of the rollout and administration of first doses.”

More coming.

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