Health Canada Approves Pfizer’s COVID-19 Vaccine for Children Ages 5-11

OTTAWA – The next chapter of Canada’s COVID-19 vaccination campaign began Friday when Health Canada approved the Pfizer-BioNTech vaccine for children ages 5 to 11.

The federal health department reviewed the science and evidence for the vaccine’s use in children and concluded that the benefits of a lower-dose inoculation against the deadly coronavirus outweigh the potential risks for the age group.

“This is very good news for both adults and children. It provides another tool to protect Canadians and, to the relief of many parents, will restore a degree of normalcy to children’s lives, ”said Dr. Supriya Sharma, Chief Medical Advisor for Health Canada.

While Pfizer’s product becomes the first COVID-19 vaccine approved in Canada for children ages 5 to 11, Sharma said it has already been administered to approximately 2.5 million children in the United States, where “there have been no known security issues have arisen ”.

Sharma said that Health Canada examined a study by Pfizer-BioNTech that involved 4,600 children. Of those, 3,100 received two doses of the injection three weeks apart and 1,500 received placebos. The dose of this mRNA vaccine for children is lower than that given to adolescents and adults: 10 mg instead of 30 mg, he said.

He said the main side effects seen were similar but less severe than those seen among older recipients, including fatigue and headaches, although injection site swelling was more pronounced in children.

The study included four reports of serious adverse events, but Sharma said they were determined not to be related to the vaccine. There were no cases of serious allergic reactions or heart problems, he added.

Dr. Theresa Tam, Canada’s director of public health, said that the Pfizer vaccine has shown an estimated efficacy rate of 90.7 percent among children ages 5 to 11, which is similar to the rate for adolescents and adults. who receive larger doses.

Health Canada also recommends that children not receive a COVID-19 vaccine within 14 days of receiving any other vaccine, such as the flu shot. This will make it easier to monitor reactions to the COVID-19 trigger specifically, Tam said.

“It’s really about getting an accurate picture of the side effects and what they might be related to,” Sharma added.

The study used a three-week interval between doses for children, but authorities said Friday that evidence suggests that a longer gap between vaccines promotes a stronger immune response, and that each province and territory will decide how to distribute the doses. dose.

At this point, the National Immunization Advisory Committee (NACI) is advising an interval of at least eight weeks. On Thursday, Ontario’s medical director said doses of the vaccine would be offered to children eight weeks apart once it was approved.

The NACI also concluded that the Pfizer-BioNTech vaccine is safe and “can be offered” to children ages 5 to 11, although authorities said Friday that that wording is normal and could be updated to “should be offered” once it is released. look at more evidence.

Children now represent the age group with the highest rates of infection in Canada, Tam said. And while children generally have milder symptoms of COVID-19, some become “seriously ill” and have been hospitalized with an inflammatory syndrome associated with the coronavirus and have reported longer-lasting symptoms of infection, he added.

About 123,379 children ages 5 to 11 have been infected in Canada, Tam said. Of these, 300 have been hospitalized, eight have been admitted to intensive care and two have died.

“As you can see, the harsh outcomes are relatively low, but the broader impacts are quite high across the age group and I think parents need to be given that information to make informed decisions,” he said.

Sharma added that the risk of having heart problems from a COVID-19 infection is also significantly higher than from receiving the vaccine.

“We are authorizing the vaccine for this age group because those benefits outweigh the risk of COVID-19,” he said.

Dr. Howard Njoo, deputy director of public health, noted that the virus has disrupted the school year and children’s activities. He said that if his children were still in that age group, he would vaccinate them “without hesitation.”

Now that it is approved, Tam said the government hopes to get supplies of the vaccine from Pfizer-BioNTech “very quickly,” but deferred further details to cabinet ministers who would speak later on Friday. He also said it is too early to say whether children will need to get vaccinated against COVID-19 every year.

Tam said the government is also working with pediatricians, family doctors, pharmacists and others to encourage parents to learn about the vaccine as one of the largest pediatric vaccination campaigns in the country is launched.

“You’ll see that increase in the next few days,” he said.

Health Canada is also reviewing the evidence for the Moderna vaccine, which also uses mRNA technology, for children ages 6 to 11.

As of November 6, 74.6 percent of the total Canadian population was fully vaccinated, according to federal figures.