Moderna submits COVID-19 vaccine for kids 5 and under to Health Canada for review
Moderna has asked Health Canada to approve its COVID-19 vaccine for children as young as six months old, a day after requesting U.S. regulators do the same.
If approved, it would be the first COVID-19 vaccine for children under five in Canada — an age group that has remained ineligible for inoculation since the vaccine rollout began in late 2020.
Moderna Canada submitted its vaccine candidate for children between six months and five years old for review on Thursday night, a spokesperson told Global News. Health Canada updated its submission page on Friday, confirming its receipt.
Moderna’s vaccine for children six to 11 was approved in March. Late last month, Moderna said a low dose of its COVID-19 vaccine works in babies, toddlers and preschoolers.
The company said a trial of 6,700 children showed the vaccine was safe and produced a similar antibody response seen in adults. A single dose for children under six is 25 micrograms – about one quarter of the size given to adults and teens, and half the size used for kids ages six to 11.
Moderna submitted data to the U.S. Food and Drug Administration on Thursday that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers — albeit not as effectively during the Omicron surge as earlier in the pandemic.
The FDA said on Friday it set tentative dates in June to publicly review COVID-19 vaccines for the youngest of American children, usually the final step before authorizing shots in the country.
Pfizer, meanwhile, is in “ongoing discussions with Health Canada about the vaccine in this population,” but can’t comment on filing timelines in Canada, a spokesperson said.
Pfizer is also testing small doses for children under five, but had to add a third shot to its study when two didn’t prove strong enough.
“If those submissions happen sometime in May, we can expect that it’ll take maybe a month or two, if not more, to have that reviewed,” Dr. Omar Khan, a professor of biomedical engineering at the University of Toronto, told Global News this week.
“It’s safe to say that we don’t know when it will be approved, but that it should just take the appropriate amount of time, and sometimes you can’t know how much that is because you really want to pour through that data and make sure everything is perfect.”
Yet it is frustrating that a vaccine is not yet available for children under five, said Dr. Anna Banerji, a pediatric infectious disease specialist at the University of Toronto.
“That’s disappointing that it might not be out for a couple of months, and kids continue to be in schools, continue to play together and they are a vector for transmission as well,” she told Global News this week.
“I’ll be happy when the vaccine is out for the younger kids, especially kids that are in daycare and who are exposed to a lot of other kids.”
— with files from Global News’ Jamie Mauracher, The Canadian Press and The Associated Press
by Global News
