Manitoba kids under age of 6 part of clinical trial for Moderna’s pediatric COVID-19 vaccine

A group of roughly 20 Manitoba kids under the age of six have joined the fight against COVID-19. 

They’re part of a clinical trial looking at the safety and efficacy of Moderna’s pediatric COVID-19 vaccine.   

“I’m ecstatic that we have this trial here in Manitoba,” said Dr. Sergio Fanella, an associate professor of pediatric infectious disease at the University of Manitoba and the principal investigator for the study in Winnipeg.  

Families of kids in the study should be proud of the young participants, he said.

“They’re doing something not only for themselves but something that benefits their extended family, their grandparents, their friends, their neighbours, their local community, but also the global population.”

Health Canada approved Pfizer-BioNTech’s pediatric COVID-19 vaccine for use with kids aged five to 11 last month. It’s delivered in doses one-third the size of those given to people 12 and up.

Moderna’s pediatric vaccine hasn’t yet been approved, and no vaccine has been approved for anyone under the age of five.

Fanella said Moderna’s study uses the same vaccine that has been given to teens and adults, but is looking at how a smaller dose works on kids as young as six months old and up to age 12. 

The Children’s Hospital Research Institute of Manitoba, where Fanella is a researcher, is one of more than 80 sites participating in Canada and the United States, he said. 

Moderna estimates more than 13,000 kids are enrolled in the study. All of the Manitoba participants are under the age of six. 

The Children’s Hospital Research Institute of Manitoba has enrolled roughly 20 kids in the clinical trial testing Moderna’s pediatric COVID-19 vaccine. (Gary Solilak/CBC)

Fanella hopes the study will not only help prevent severe outcomes due to COVID-19 in children, but that it will also eventually allow families a chance to return to some kind of normalcy. 

“Now that we’re immunizing kids down to as young as five years of age, very quickly the kids under the age of five will become the cohort or group of our population that will be the only ones that will still remain susceptible to infection,” he said in an interview with CBC News earlier this week. 

COVID ‘a truly vaccine-preventable disease’

For most of the population, even with the rapidly spreading Omicron variant, COVID-19 is now “a truly vaccine-preventable disease,” said University of Manitoba virologist Jason Kindrachuk.

“We need to be able to make that available not only to the rest of the global population, but also to those age groups that have yet to be able to be protected and are directly in the line of fire for this virus.”

Kids can get infected with COVID-19, but they experience less frequency of severe disease than older age groups, Kindrachuk said.

However, he points out that experts can’t anticipate whether new variants that emerge could end up causing more severe illness, so pediatric vaccines are important.

He also said having Canadian data from a clinical trial like Moderna’s is helpful, and hopes it can play a role in improving vaccine uptake by providing transparency on how vaccine trials work.

With Manitoba kids involved, “we are not just hearing about clinical trials that are occurring in other areas of the globe,” said Kindrachuk. “We now have direct connections to people in our community who are participating in this.”

Could be in use by mid-2022: U of M prof

Fanella said the kids enrolled in the study will be given two shots roughly a month apart. About 75 per cent of participants will receive the vaccine, while 25 per cent will get a placebo. 

He said he won’t know who gets the vaccine, since it’s randomly assigned. 

The children will be monitored for about 14 months after getting their first dose. 

“[In] all vaccine clinical trials, including the ones done for COVID-19 by Moderna, by Pfizer, the emphasis … is always on safety and monitoring of the study participants,” said Fanella. 

In fact, he said that vaccines are the most closely regulated medication or product given to patients. 

“Even after licensure and use, there’s very close monitoring that goes on for even rare events,” said Fanella. 

While he doesn’t want to speak for Moderna, his guess is that if all goes well with the study and it’s approved, Moderna’s pediatric vaccine could be in use by mid-2022.

While the Children’s Hospital Research Institute of Manitoba isn’t currently enrolling any more children in this clinical trial, Fanella said there is a possibility that they may have openings for kids from six months old to under two years old in January.

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