Moderna Canada president Patricia Gauthier said on Friday that the company filed an application with the Canadian regulatory authority on Thursday evening for a vaccine to protect six-month-to-five-year-old children against SARS-CoV-2 and COVID. -19. Health Canada confirmed Friday that it has begun reviewing Moderna’s application for authorization.
The pharmaceutical company says a clinical study of 6,700 children determined the vaccine was safe and produced an antibody response similar to that seen in adults.
A single dose for children under six years of age is 25 micrograms, one quarter the dose given to adults and adolescents and half the dose given to children aged six to 11 years. Moderna proposes that his vaccine be given in two doses, four weeks apart.
Less effective against the Omicron variant, as for adults
Clinical trials in young children were conducted primarily during the wave of the Omicron variant, and the vaccine was found to be less effective at preventing infection in children than previous clinical trials in adults.
The vaccine’s efficacy against infections in adults also declined during the Omicron surge, although the vaccine maintained excellent protection against serious illness, hospitalization and death.
The company said the vaccine was 51 percent effective in preventing symptoms in children between the ages of six months and two and 37 percent effective against symptoms in children between the ages of two and five. Moderna said these findings are similar to those seen in terms of efficacy against the Omicron variant for adults.
Dr Supriya Sharma, Health Canada’s chief medical consultant overseeing the vaccine licensing dossier, said in an interview that she couldn’t set a timeline for the Moderna review because she didn’t receive the request until Thursday evening.
It clarified that the application will be analyzed using the same risk-benefit approach applied to vaccines authorized for the older age groups.
We always look at the same componentsshe explained.
So it’s about safety, efficiency and quality. These are the same types of components we get for the presentation and we are really looking for benefits that outweigh the risks.
Because children rarely suffer from severe symptoms due to COVID-19, the clinical trial could not determine the impact on the prevention of serious illness in this cohort.
A low, but not zero, risk of serious illness
Moderna’s COVID-19 vaccine was first approved for use in adults in December 2020, then for children aged 12 to 17 in August 2021, and finally for children aged six to 11 last March. .
No vaccines have yet been authorized in Canada for children under the age of five. Pfizer-BioNTech’s pediatric vaccine is licensed for children ages five to eleven, at a dose one-third the dose given to adolescents and adults.
Pfizer’s clinical study for children under five found that two doses that were one-tenth the adult dose were not enough to generate a good enough antibody response. The company then expanded the clinical trial to include a third dose. The results of this study are expected in May.
Dr Sharma said it is true that the risk of serious illness for young children is low, but
It’s nothing, which plays into the risk-benefit analysis. About 2% of Canadians admitted to hospital with COVID-19 are under the age of 11, and about 25 children under the age of 11 have died.
Fourteen of these deaths have occurred since Omicron became dominant and infection rates have soared.
Officially, more than 385,000 children under the age of 11 have tested positive for COVID-19 and nearly half of them since Omicron arrived in Canada in late November.
However, most provinces have stopped extensively testing children after the December holidays. Infection rates in recent months are said to be 10 to 25 times higher than those recorded since then.
A study by the United States Centers for Disease Control and Prevention recently reported that about 75 percent of American children had been infected with COVID-19 by the end of February.
Yukon pediatrician Dr. Katharine Smart, president of the Canadian Medical Association, also explained that the risk to children cannot be assessed by comparing it to the risk to adults.
He said COVID-19 poses different risks for many age groups and one needs to look specifically at what is happening with young children. On this front, she made it clear that COVID-19 is one of the biggest disease risks children face right now.
The message that is important for parents to understand is that given Omicron’s infection and the speed at which it spreads, your child will encounter Omicronshe explained.
It is only a matter of time. So the decision, I think, for a parent to be, do you want them to meet Omicron vaccinated or not? Because he will meet him.
Nationally, 40% of children between the ages of 5 and 11 are fully immunized, as are 84% of children and adolescents between the ages of 12 and 17 and 88% of adults.