A clinical trial examining the safety and effectiveness of Moderna’s COVID-19 vaccine in very young children has started recruiting participants between the ages of six months to five years in Halifax.
With Health Canada’s announcement on Friday that Pfizer’s COVID-19 vaccine is now approved for use in children ages five to 11, the only group for whom such vaccines aren’t an option are infants and children under five.
The Halifax-based Canadian Center for Vaccinology (CCfV) is participating in the international KidCOVE study, an international pediatric COVID-19 vaccine clinical trial looking at the Moderna vaccine’s safety in children six months to 11 years old.
Researchers in Halifax are currently looking for participants between the ages of six months old to five years old (“less than six years old”). They’ll be measuring children’s immune responses to the vaccine through blood samples that will be tested for antibodies to help determine how well the study vaccine is working.
The KidCOVE study is divided into two parts. The first part was intended to identify the optimal dose level for each of three age groups: children six months to under two years; children two years to under six years; and children six years to under 12 years.
The second part of the study — and the one in which Halifax participants will be involved — will study that optimal dose from the first part of the study to determine how well it works to prevent COVID-19 in children.
Participants will either be given two doses of the study vaccine (a 75% chance) or two doses of placebo (a 25% chance).
“It’ll be very similar to all our clinical trials. We have a conversation with the parents to let them know everything about the study, the benefits, the risks,” Dr. Joanne Langley said in an interview on Monday.
Langley is a pediatric infectious disease specialist at the IWK Health Centre, a researcher at the CCfV, and one of the study’s co-investigators.
She said interested parents and children would visit the IWK for a detailed history and physical exam. If it’s determined the child can safely participate, they’d have blood collections, receive their two injections, and be followed closely.
Participants can expect clinic visits, telemedicine visits, and brief telephone calls over a period of 14 months.
‘We want the same good science’
“Health Canada wouldn’t authorize it (the study) unless they thought it was a safe study for children in this age group to be enrolled in,” Langley said.
“The amount of data collection and the way we observe the children is much more than when you go to get your regular vaccines. So there will be a number of visits, you’ll be in touch with the study by virtual visits as well, and you’ll have an electronic diary to record anything about your child after the vaccine.”
Langley said trials like this are essential and she encourages parents to reach out to learn more.
“Just like any pediatrics study, we want the same good science to support vaccines we give to children as we have for adults. Studies have been done in adults and we know that there are millions and millions and millions of adults that have gotten these vaccines across the world,” Langley said.
“Now we have millions of adolescents, and based on that large foundation of data we think it will be safe for children and effective for them to get these vaccines in the context of a trial and that will lead to their approval in this age group.
More than 13,000 children from 100 study sites are participating. This includes 10 Canadian sites and 90 in the US. About 675 Canadian children will take part, including 30 to 50 via the (CCfV) located at the IWK Health Centre in Halifax.
While most participants will likely be from the Halifax area because they must be willing to travel to the IWK for clinic visits, it is open to all Nova Scotians who fit the criteria and can travel.