Toronto Star

Pfizer also testing smaller dose for kids as young as six months

- With files from David Rider

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. The statement from Health Canada said that, like all of the COVID vaccines, this applicatio­n will be prioritize­d, “while maintainin­g its high scientific standards for safety, efficacy and quality.”

Its assessment, which is done by a team of experts in everything from epidemiolo­gy to drug manufactur­ing, will include a review of all clinical trial results as well as evolving informatio­n about the risks of COVID and variants to children.

The agency “continues to closely monitor all safety and effectiven­ess data from the real-world use of the vaccine since its deployment in Canada and internatio­nally, including data in the younger age group where it is authorized for use, and will take action, if required.”

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.

Some jurisdicti­ons have already begun planning for what will be one of the biggest childhood vaccinatio­n campaigns Canada has ever taken on.

Toronto’s board of health chair, Coun. Joe Cressy, called the update good news on Monday, and said that plans were already underway to get shots out to kids in the city.

“Earlier this month we launched Toronto’s 5-11 Year Old Vaccine Working Group to prepare for the next phase of our immunizati­on campaign. In partnershi­p with hospitals, school boards, and community agencies, our plans are well underway for a multi-pronged clinic model, outreach program, and educationa­l campaign — for parents and kids alike.”

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.

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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