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Moderna says vaccine results for kids under 6 are encouraging, will file for authorization soon

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March 24, 2022
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Moderna says vaccine results for kids under 6 are encouraging, will file for authorization soon
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The company announced Wednesday that Moderna’s COVID-19 vaccine works in infants, toddlers and preschoolers — and if regulators agree it could mean a chance to finally begin vaccinating young children by summer.

Moderna said in the coming weeks it will require regulators in the United States and Europe to allow two small doses for children under six. In an email to CBC News, a company representative predicted a similar timeline for Canada.

Early results from the study found that children developed higher levels of anti-virus antibodies from shots containing a quarter of the dose given to adults – although they were less effective against the highly infectious Omicron variant than 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 Hogg, president of Moderna, told The Associated Press.

Parents anxiously awaited protection for young children, disappointed with setbacks and confusion over which shots might work and when. Pfizer is testing smaller doses for children under five, but had to add a third dose to its study when two didn’t prove strong enough, which postponed a vaccine advisory committee meeting with the U.S. Food and Drug Administration. Pfizer’s results are expected in early April.

Dosage23:12What do we know about COVID-19 vaccines for children 5 years old and younger?

Children under five are the only age group not yet eligible for a vaccine. Vaccine manufacturers are working on vaccines for young children, but parents and guardians have a lot of questions while they wait. What do we know about COVID-19 vaccines for children 5 years old and younger? We find out from Dr. Cora Constantinescu, a pediatrician and infectious disease physician at Alberta Children’s Hospital in Calgary. 23:12

Vaccinating the youngest children “has been a fairly moving target over the past two months,” Dr. Bill Muller of Northwestern University, a pediatric studies investigator at Moderna, said in an interview before the company released its findings. “There is still, I think, an urgent need to try to do that as quickly as possible.”

The younger the child, the lower the dose tested. Moderna enrolled nearly 6,900 children under the age of six — including children under six months of age — in a study of 25 microgram doses. The company said they developed levels of antibodies just as strong as the youngsters getting the full-strength injections.

Increased hospital visits during an omicron increase

The Moderna study was done in children during an omicron increase and found the same trend: While there were no serious illnesses, the vaccine proved less than 44 percent effective in preventing mild infections in children up to age 2, and about 38 percent effective in children. for pre-school.

But Houghey said higher levels of antibodies should translate into protection against severe disease in young children just as they do in adults, “which is probably the strongest reason to vaccinate someone.”

Moderna said smaller doses were safe, and the main side effects were mild fevers like those associated with other commonly used children’s vaccines.

While COVID-19 in general is not as dangerous to young adults as adults, some do get very sick. The Centers for Disease Control and Prevention says about 400 American children under the age of five have died from COVID-19 since the start of the pandemic, while Health Canada has documented 24 deaths attributed to coronavirus for those under the age of 11, more than seen in Canadians. 12-19 year olds (10 deaths in total).

health officials In all of Canada The United States noted the fact that those under five years of age were seen in hospitals at higher rates during the omicron increase than in the original strain of the virus and other variants. Exponential omicron growth and the fact that the variable obstructs the upper respiratory tract are noted, as children can be more susceptible to disease than adults.

Read Moderna’s edition of the Vaccine Study for the U-6 Cohort:

Moderna vaccine for 6 to 11 groups has just been approved in Canada

Canada and the United States differ regarding the licensing of COVID-19 vaccines from Moderna.

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

Some Canadian clinics, such as here in Ottawa on January 27, have used artists in costumes, posters and balloons to make the vaccination process more comfortable for children ages 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 U.S. Food and Drug Administration (FDA) has never issued a ruling on Moderna’s request for teen shots due to concern about very rare side effects. Carditis sometimes occurs in adolescents and young adults, mostly males, after receiving the Pfizer or Moderna vaccines.

Heart disease risk also appears to be linked to adulthood, and regulators in Canada, Europe, and elsewhere have recently expanded Moderna’s vaccines for children up to six years of age.

“This concern has not been shown in young children,” said Northwestern’s Mueller.

Moderna’s vaccine for those ages 12 to 17 was licensed for use in Canada in August last year, while Health Canada last week gave the green light for COVID-19 shots for children ages 6 to 11, nearly four months after A Pfizer product for a similar age group (5 to 11) approved.

It’s not clear what uptake of the COVID-19 vaccine will look like for under-fives in Canada.

Health Canada tracking indicates that 84 percent of Canadians between the ages of 12 and 17 have been fully vaccinated.

And for Canadians ages 5 to 11, nearly 57 percent have received a single dose, with 37 percent fully vaccinated since the vaccinations were given at the beginning of December. While the pace of vaccination in that age group has alarmed some Canadian health officials, it does not contrast with what has been seen globally – Canada’s vaccination rate for that group is higher than most Western European countries, the United States and Israel.

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