Babies and toddlers are getting COVID-19 vaccines in Montreal as part of a clinical trial

Vaccine being tested on babies and toddlers A clinical trial in Montreal is now underway, testing the efficacy and safety of the Moderna COVID-19 vaccine in kids 6 months-6 years old.

MONTREAL — A Montreal infectious diseases specialist is leading a new COVID-19 vaccine trial testing the Moderna vaccine on six-month-old to six-year-old children, the last and youngest group of kids to be eligible for vaccination in Canada.

The MUHC Vaccine Study Centre located in Pierrefonds, in western Montreal, just started vaccinating children in this age range last week and so far, 12 children have received the first shot, as part of Moderna’s KidCove clinical trial.

“It's going really well,” said the principal investigator Dr. Soren Gantt, from Sainte-Justine Hospital, because “there’s been a lot of interest.”

Families have primarily been recruited by word of mouth. The vaccine centre has also reached out to those who participated in vaccine trials before.

It is the only Moderna trial of its kind in Quebec. There is a handful underway in other parts of Canada, and more than 80 in the United States.

“We anticipate enrolling more than 50 kids here in Montreal. The entire trial involves more than 12,000 kids in Canada in the U.S.,” Gantt said.

The injection contains the same Moderna mRNA Spikevax product that is already approved by Health Canada, but only a 25-microgram dose, compared to the 50 micrograms being considered by the regulator now for six- to 12-year-olds and far smaller than the 100-microgram dose already approved for teens and adults.

With one survey showing that in Quebec, only about 60 per cent of parents of five- to 11-year-olds plan to get their kids vaccinated, it’s reasonable to assume that some parents might be hesitant to volunteer their baby for a vaccine study.

“People who volunteer for a vaccine trial are fairly pro-vaccine in general,” he said, though, “it's normal to have questions and we recognize that it's a different calculus to vaccinate your kid than to vaccinate yourself,” he said.

Study coordinators also inform parents that as the trial aims “to prove effectiveness, efficacy and safety in these age groups at this dose,” the study design dictates that “one-quarter of kids will get a placebo and may not directly benefit from participating in the trial,” said Gantt.

Although there are risks to any vaccine, Gantt said “the risks are anticipated to be lower than getting COVID-19.”

And as both of Montreal’s pediatric hospitals have reported throughout the pandemic, children can suffer from complications of the disease.

They see it "a bit rarely, but we're seeing kids, especially in the less than two years old age range, hospitalized with COVID,” Gantt said.

There have not been any signals of serious adverse effects in the trial so far, according to Gantt.

And he reiterated what many infectious diseases experts have been espousing for so long - that the ability to safely vaccinate every age group “is how we're going to get through the pandemic, by stopping transmission, much of it now occurring in the youngest age groups,” he said.

If families with children six months to six years old would like to participate in the vaccine trial, they can contact the MUHC Vaccine Study Centre, in Pierrefonds, at 514-624-7855 and ask for Giuliana.

The centre coordinates studies for both the McGill University Health Centre and the Centre hospitalier universitaire Sainte-Justine.