Pfizer has officially applied for Canadian authorization for its kid-sized
COVID-19 vaccine meant for those aged five to 11, bringing the country one step closer to protection for the school-aged population.
The news means that the final data from the drug manufacturer still has to be vetted by experts from Health Canada, who will comb through the results of a trial done on thousands of child volunteers before signing off.
The government isn’t starting from scratch, since Pfizer, which is working with Germany biotech company BioNTech, submitted a first look at its numbers at the beginning of the month. But the official submission means the ball is now in Health Canada’s court.
The introduction of the country’s first
vaccine for kids younger than 12 would offer critical protection for students as
schools continue to struggle with
outbreaks of COVID-19. Having a bigger share of the population vaccinated would also mean a big step toward slowing the pandemic.
It’s not clear how long a decision will take since this application is being done through the normal vaccine authorization process, and not the interim order that was created at the beginning of the pandemic to speed along any treatments related to COVID.
However, Dr. Supriya Sharma, told media in early October that the department was standing by for the application.
“We have a dedicated team that’s ready to receive that information and review it as soon as it is available and we would only authorize if it was shown that the benefit outweighs the risks,” she said.
With about
10 per cent of the Canadian population between the ages of five and 14, extending vaccination to children is an important step toward population immunity and slowing the virus, experts say.
On an individual level, it would also be a welcome development for the many parents who have been waiting for a way to protect their children, especially as schools continue to face outbreaks. Such is the demand that some clinics have already begun pre-registering kids as young as five for the vaccine.
While kids are less likely to have a serious outcome from a bout of COVID, doctors stress that they still do face risk and it’s important that they be vaccinated.
A recent British study found that four per cent of young children and teens continued to experience symptoms a month after they’d been infected.
Dr. Stephen Freedman, lead investigator in a Canadian Institute of Health Research study on COVID-19 outcomes in kids, has said that about
one in 3,500 kids who get the virus will also experience multi-system inflammatory syndrome of children, or MIS-C.
The vaccine Pfizer is proposing for kids is a slightly tweaked version of the adult dose. The biggest difference is that it has about one-third of the active ingredient, an amount tested by the company in the hopes it would be effective but also minimize side effects for kids.
Trials done on more than 2,000 volunteers in the U.S., Finland, Poland and Spain suggest that the approach works. Like adults, kids got two shots of vaccine, with immunity kicking in about a month after the second.
According to results from Pfizer, which still need to be reviewed by other scientists and vetted by Health Canada, the dose generated a similar immune response to people just a few years older who got the full dose.
It was also “well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said.
This trial was much smaller than the testing done on adults because it’s what’s called a bridging trial, Dr. Jim Kellner, a professor of pediatrics at the University of Calgary,
previously told the Star.
This is a standard way of testing vaccines that are already in use in which researchers try to prove that the shot worked basically the same in kids as it did in slightly older people, which would then allow them to conclude that it would work the same in both groups.
Some questions remain, however, as it’s not yet publicly known how well these shots protect in the real world and the possible side effects. These are among the issues Health Canada will be looking at and would be providing more information on if the shots are authorized.
Some Canadian pharmacists have wondered whether it would be possible to use smaller amounts of the adult vaccines for children, once the government greenlights doses for kids. But both Health Canada and Pfizer say the children’s version is a slightly different formulation, in addition to having a smaller amount of active ingredient.
In an email, a spokesperson for Pfizer said a deal for children’s vaccine doses was built into the supply agreement with the government of Canada.
If the vaccine is approved a delivery schedule will be created “with the intent of bringing doses to Canada as quickly as possible.”
This isn’t the only vaccine for children Pfizer is working on — the company is also testing an even smaller dose for use in kids as young as six months. Moderna is also well into trials of its vaccine for children.
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