Pfizer’s vaccine approved for kids
Since U.S. started giving shots, ‘no known safety issues’ have emerged, Health Canada says
The next chapter in Canada’s COVID-19 vaccination campaign started Friday when Health Canada approved the Pfizer-BioNTech shot for children aged five to11, and the federal government prepared to receive enough doses from abroad to inoculate 2.9 million kids across the country.
In approving the shot as safe and effective for this young age group, the federal health department reviewed evidence of the vaccine’s use on children, and concluded the benefits of a lower-dose inoculation against the deadly coronavirus outweigh the potential risks.
“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 bring back a degree of normality to children’s lives,” said Dr. Supriya Sharma, Health Canada’s chief medical adviser.
While Pfizer’s product becomes the first COVID-19 vaccine approved in Canada for children aged five to 11, Sharma said it has already been given to roughly 2.5 million children in the United States, where “no known safety issues” have emerged.
Sharma said Health Canada examined a study conducted by Pfizer-BioNTech that involved 4,600 children. Of those, 3,100 got two doses of the shot three weeks apart and 1,500 received placebos. The dose of this mRNA vaccine for children is smaller than that given to adolescents and adults — 10 mg instead of 30 mg, she said.
She said the main side effects observed were similar but less severe than those seen among older recipients, including fatigue and headaches, although swelling at the site of the injection was more pronounced in children.
The study included four reports of serious adverse events, but Sharma said these were determined to be unrelated to the vaccine. There were no cases of severe allergic reaction or heart problems, she added.
Dr. Theresa Tam, Canada’s chief public health officer, said the Pfizer vaccine has shown an estimated efficacy rate of 90.7 per cent among children aged five to 11, which is similar to the rate for adolescents and adults who receive larger doses.
Health Canada is also advising that children not receive a COVID-19 shot within 14 days of receiving any other vaccination, such as a flu shot.
This will make it easier to monitor for reactions to the COVID-19 shot specifically, Tam said.
“It’s really just about having an accurate picture of side effects and what they might be related to,” Sharma added.
The study used a three-week interval between doses for the children, but officials said Friday that evidence suggests a longer gap between shots promotes a stronger immune response, and that each province and territory will decide how to spread out the doses.
At this point, the National Advisory Committee on Immunization (NACI) is advising an interval of at least eight weeks. On Thursday, Ontario’s chief medical officer said the vaccine doses would be offered to children at an eight-week interval once it was approved.
NACI also concluded the PfizerBioNTech vaccine is safe and that it “may be offered” to children aged five to 11, although officials said Friday that that phrasing is normal and could be updated to “should be offered” once more evidence is examined.
Children now represent the age group with the highest rates of infection in Canada, Tam said. And while children generally get milder symptoms of COVID-19, some get “severely sick” and have been hospitalized with an inflammatory syndrome associated with the coronavirus and reported longer lasting symptoms of infection, she added.
About 123,379 children aged five to 11 have been infected in Canada, Tam said. Of those, 300 have been hospitalized, eight have been admitted to intensive care and two have died.
Meanwhile, Ontario reported 793 new cases of COVID-19 on Friday, including 166 in the five to 11 age group. There were 45 cases in the 12 to 19 age group that is 80.5 per cent fully vaccinated, and 28 cases in kids four and younger, who do not qualify for shots.
To date, there have been seven deaths of children 19 and under from the virus in Ontario, a tiny fraction of the 9,559 fatalities from the pandemic.
“As you can see, the severe outcomes are relatively low, but the broader impacts are quite high amongst the age group and I think parents need to be provided with that information to make informed choices,” Tam said.
Later Friday, Procurement Minister Filomena Tassi said Canada will receive 2.9 million doses of the Pfizer-BioNTech vaccine next week, with the first shipment set to arrive on Sunday.
“That’s enough doses to offer a first shot to all eligible children in this country,” Tassi said.
She said the schedule for second doses remains to be determined, but that she would have more details “soon.”
In Toronto, city officials are already planning to extend the hours of city-run clinics and book vaccines for 20,000 children between Thursday and Dec. 5.
The city is also working to open vaccine clinics in Toronto schools “as quickly as possible next week, once the vaccine arrives,” according to a press release published Friday.
Health Canada is also reviewing evidence for the Moderna vaccine, which also uses mRNA technology, for children aged 6 to 11.