Moderna has asked Health Canada to approve its COVID-19 vaccine for six-month-old children, a day after asking US regulators to do the same.
If approved, it will be the first COVID-19 vaccine for children under five in Canada, an age group that remains ineligible for vaccination since the vaccine began in late 2020.
Moderna Canada unveiled its vaccine candidate for children between six months and five years old for review on Thursday, a spokesman for Global News said. Health Canada updated its submission page on Friday, confirming its receipt.
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The Moderna vaccine for children aged 6 to 11 was approved in March. Late last month, Moderna said a low dose of the COVID-19 vaccine works for babies, young children and preschoolers.
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The company said a study of 6,700 children showed the vaccine was safe and produced a similar response to antibodies seen in adults. The single dose for children under the age of six is 25 micrograms – about a quarter of the amount given to adults and teenagers and half the amount used for children aged six to 11.
Moderna said its vaccine is 51% effective in preventing symptoms in children aged six months to two years and 37% effective against symptoms in children aged two to five years. Its use requires that the vaccine be given in two doses four weeks apart.
“We will not go through this pandemic until we have the opportunity to offer protection to all Canadians; We currently have a huge group of Canadians, our youngest Canadians, who don’t have that opportunity, “said Dr. Catherine Smart, president of the Canadian Medical Association and a pediatrician in Whitehorse, Yukon.
“It will be a huge step forward and many parents will be very relieved after that, which probably seems like an incredibly long wait for this information.”
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Moderna provided data to the US Food and Drug Administration (FDA) on Thursday, hoping to prove that two low-dose injections can protect babies, young children and preschoolers – though not as effectively during the jump of Omicron, as earlier during the pandemic.
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The FDA said on Friday it had set guidelines in June for a public review of COVID-19 vaccines for America’s youngest children, usually the last step before allowing vaccines in the country.
Pfizer, meanwhile, is in “ongoing discussions with Health Canada about the vaccine in this population,” but could not comment on the deadline for submission in Canada, a spokesman said.
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Pfizer was also testing small doses for children under five, but had to add a third dose to its study when two were not strong enough.
“If these applications happen sometime in May, we can expect it to take maybe a month or two, if not more, to review them,” said Dr. Omar Khan, a professor of biomedical engineering at the University of Toronto. Global news this week.
“It is safe to say that we do not know when it will be approved, but it just has to take time and sometimes you can’t know how much it is because you really want to pour out this data and make sure everything is perfect.”
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Canada, which is in the sixth wave of COVID-19, reported 3,008 children under the age of 12 who contracted the virus during the week of April 10-16.
During the same period, 93 children under the age of 12 were admitted to hospital due to COVID-19. More than 1,000 Canadians aged 80 and over were admitted to hospital this week.
Children are less likely to suffer from severe COVID-19 disease, but its effects may be delayed in some cases, according to a recent study.
If the Moderna vaccine is found to be safe for children aged five and under, Smart encourages parents with children in this age group to inoculate them. Vaccination for children aged 5 to 11 lags behind that in older age groups in Canada.
“I have not yet seen the data for children from six months to five, but I expect it to show safety and be approved,” she said.
“If this is the case, parents can feel confident that choosing vaccination again is a way to protect their children from something they will encounter in their daily lives, and vaccination is one of our best tools in terms of preventing these rare but serious results. “
– with files from Jamie Maurasher from Global News, The Canadian Press and The Associated Press
© 2022 Global News, a division of Corus Entertainment Inc.
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