Health Canada approves Pfizer-BioNtech COVID-19 vaccine for kids aged 5-11 – The Globe and Mail

Children aged 5 and older are now eligible to be vaccinated against COVID-19 for the first time in Canada, a key milestone that can help families return to some prepandemic ways of life, Health Canada’s chief medical adviser announced on Friday.

“Overall, this is very good news for adults and children alike. It provides another tool to protect Canadians and, to the relief of many parents, will help bring a degree of normality back to children’s lives,” Dr. Supriya Sharma said on Friday.

Pediatric COVID-19 vaccines will start to arrive in Canada on Sunday, with 2.9 million doses – enough to provide a first dose to every five- to 11-year-old in Canada – expected to be delivered by the end of next week, Public Services and Procurement Minister Filomena Tassi announced Friday. The timing on delivery of second doses has yet to be determined, Ms. Tassi said.

What to know about the Pfizer COVID-19 vaccine for kids aged 5-11: efficacy, side effects and more

The authorization comes at a critical time in the pandemic, as the incidence rate of COVID-19 among those aged 5 to 11 is currently higher than in any other age group, said Theresa Tam, Canada’s Chief Public Health Officer. While most children will fully recover from COVID-19, a small number are at risk for serious cases and long-lasting severe health problems, including multisystem inflammatory syndrome, long COVID and other issues.

Marie Tarrant, a professor in the school of nursing at the University of British Columbia, said vaccinating school-aged children could go a long way to controlling spread of COVID-19.

“There is a lot of anticipation and expectation that this will help us curb some of these outbreaks that we’ve been having,” she said.

The newly authorized mRNA vaccine, produced by Pfizer-BioNTech, is a 10-microgram dosage – which is one-third the amount used in the adult version. Children tend to produce strong immune responses, which is why a smaller dose is being used. A clinical trial showed the vaccine is about 91 per cent effective after two doses and no serious side effects were reported. Canadian regulators will closely monitor for any reports of adverse events as the vaccine is rolled out.

Health Canada authorized two doses of the Pfizer-BioNTech vaccine for kids 5 to 11, to be given three weeks apart – the same dosing interval used in the clinical trial.

But the National Advisory Committee on Immunization is recommending that kids wait eight weeks between the first and second dose in order to maximize the immune response. Evidence also shows that cases of heart inflammation, a rare side effect linked to the COVID-19 mRNA vaccines, are also lower when doses are spaced farther apart. Although NACI’s guidelines aren’t binding, provinces typically follow the recommendations, which are based on science and real-world evidence.

Dr. Sharma said there may be a need for more flexibility on dosing schedules. The holidays are approaching and many families want to celebrate together or enjoy travel as safely as possible. For that reason, health professionals may want to consider offering first and second doses more closely together than the eight-week timeline, Dr. Sharma said.

“I think it really is a discussion with health care practitioners,” Dr. Sharma said. “I think all of that needs to be considered as people are making their vaccination choices.”

NACI is also recommending that the COVID-19 shot not be combined with other vaccines for the time being. They say five- to 11-year-olds should not receive another vaccine for two weeks before or after their COVID-19 shot to help regulators monitor the safety of the vaccine and more easily determine if any reported side effects are linked to it.

Officials noted that it’s safe to combine vaccines, such as the flu shot and the COVID-19 shot, and there may be instances, such as during this year’s influenza season, when children are advised to receive both together.

The most common side effects linked to the newly authorized COVID-19 vaccine are soreness at the injection site, fatigue and headache.

The mRNA vaccines have been linked to rare cases of heart inflammation, or myocarditis and pericarditis, primarily in young men after the second dose. Most of the cases are mild and resolve with medication.

While no cases of heart inflammation were reported in children during the clinical trial, it’s possible some may occur, Dr. Sharma said, which is why officials will be closely watching for any side effects. She noted that the health risks of COVID-19 are much higher than any risks linked to the vaccine.

Now that the shot has been approved, provincial and local health officials across Canada are readying plans to start the largest mass vaccination campaign in children in decades.

Clinical studies with children under the age of 5 are continuing, but a COVID-19 vaccine for that age group is not expected until some time next year.

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