Moderna says vaccine results for children under 6 are encouraging and will soon file for approval

Moderna’s COVID-19 vaccine works in babies, toddlers and preschoolers, the company announced Wednesday – and if regulators agree, it could mean a chance to finally start vaccinating children. younger children by summer.

Moderna said in the coming weeks it will ask regulators in the United States and Europe to allow two small-dose injections for young people under the age of six. A company representative in an email to CBC News predicted a similar timeline for Canada.

Early results of the study revealed that toddlers developed high levels of anti-virus antibodies from vaccines containing a quarter of the dose given to adults – although they were less effective against the super-variant. contagious from Omicron than the previous variants.

“The vaccine provides the same level of protection against COVID in young children as it does in adults. We think that’s good news,” Dr. Stephen Hoge, president of Moderna, told The Associated Press.

Parents eagerly awaited protection for young children, disappointed by setbacks and confusion over which vaccines might work and when. Pfizer is testing even lower doses for children under five, but had to add a third dose to its study when two were not found to be strong enough, leading to the postponement of an already scheduled committee meeting. Vaccine Advisory with the United States Food and Drug Administration. These results from Pfizer are expected in early April.

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Vaccination of younger children “has been somewhat of a moving target over the past couple of months,” said Dr. Bill Muller of Northwestern University, a researcher in Moderna’s pediatric studies, in an interview before the company released. its findings. “There is still, I think, a lingering urgency to try to do this as soon as possible.”

The younger the child, the smaller the dose tested. Moderna enrolled about 6,900 children under the age of six — including babies as young as six months — in a study on the 25-microgram doses. They developed antibody levels as strong as young adults who receive full-strength injections, the company said.

Increase in hospital visits during Omicron push

Moderna’s toddler study was conducted during the Omicron push and revealed the same pattern: Although there were no serious illnesses, the vaccine was found to be effective at a little less than 44% effective in preventing milder infections in babies up to two years of age, and nearly 38% effective in preschoolers.

But Hoge said high antibody levels should still translate into protection against serious disease in young children, just as it does in adults, “which is probably the strongest reason for someone to get vaccinate”.

Moderna said the small doses were safe and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.

Although COVID-19 is generally not as dangerous for young people as it is for adults, some do get seriously ill. The CDC says about 400 U.S. children under the age of five have died of COVID-19 since the pandemic began, while Health Canada has documented 24 coronavirus deaths under the age of 11, more than has been reported. observed in Canadians aged 12 to 19 (10 deaths in total).

Health officials in Canada and the United States noted that under-fives were seen in hospitals at higher rates during the Omicron surge than for the original strain of the virus and other variants. The more exponential growth of Omicron and the fact that the variant impedes the upper respiratory tract, where children may be more susceptible to disease than adults, were noted.

Read Moderna’s statement on the vaccine study for the under-6 age group:

Moderna’s vaccine for group 6 to 11 has just been authorized in Canada

Canada and the United States diverge in terms of the authorization of Moderna’s COVID-19 vaccines.

The US government has made a heavy investment in the Massachusetts-based company, among others, as part of an order to get vaccines into arms as soon as possible as part of Operation Warp Speed ​​after the eruption. of the pandemic in 2020.

Some Canadian clinics, like here in Ottawa on January 27, have used costume performers, stickers and balloons to make the vaccination process more comfortable for children aged 5 to 11. (Francis Ferland/Radio-Canada)

But so far, the company’s vaccine for adults is the only one approved in the United States. The FDA never ruled on Moderna’s application for the teen injections due to a very rare side effect. Cardiac inflammation has occurred occasionally in adolescents and young adults, primarily males, after receiving Pfizer or Moderna vaccines.

Cardiac risk also appears to be linked to puberty, and regulators in Canada, Europe and elsewhere have recently extended Moderna vaccinations to children as young as six years old.

“This concern has not been observed in young children,” said Muller of Northwestern.

Moderna’s vaccine for ages 12 to 17 was licensed in Canada in August last year, while last week the green light was given by Health Canada for its COVID-19 shots for children aged 6. at age 11, nearly four months after Pfizer’s product for a similar age group (five to 11 years) was approved.

It’s unclear what adopting a COVID-19 vaccine among under-fives in Canada would look like.

Health Canada tracking indicates that 84% of Canadians aged 12 to 17 have been fully immunized.

When it comes to Canadians aged 5-11, almost 57% have received a dose, with 37% fully vaccinated since the vaccines were administered starting in December. Although the rate of vaccination in this age cohort has concerned some Canadian health officials, it is not out of step with what has been seen around the world – Canada’s vaccination rate for this cohort exceeds most Western European countries, the United States and Israel.