Nearly two million of Canada’s youngest children will soon be eligible for immunization against COVID-19, now that the federal drug regulator has approved Moderna’s COVID-19 vaccine for infants and preschoolers.
Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years in doses one-quarter the size of those approved for adults.
Moderna’s product is the first COVID-19 vaccine approved for children under five in Canada.
“After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective in preventing COVID-19 in children six months to five years of age,” the Public Health Agency of Canada announced on Twitter. on thursday. .
The agency said it will continue to carefully monitor the vaccine’s safety and has asked Moderna to provide updated data on the vaccine’s safety and effectiveness.
In the decision posted on the Health Canada website, the agency said Phase 3 trial results for the drug show that the immune response in children aged six months to five years was comparable to Moderna’s vaccine for 18- to 25-year-olds.
FRIEND | Health Canada says it will continue to monitor the safety and effectiveness of the vaccine after approval
Canada’s Health Advisor, Dr. Supriya Sharma says the agency will continue to receive data from Moderna about its safety and effectiveness after it is approved for use in younger children.
Trials studying the effectiveness of the vaccine in young children were conducted this past winter when the Omicron variant became dominant.
Preliminary data showed that the Moderna vaccine prevented symptomatic COVID-19 at a rate of 50.6 percent in children between 6 and 23 months of age and at a rate of 36.8 percent in children 2 to 5 years of age.
About 1.7 million children are now eligible for vaccination
The approval expands the eligibility of the COVID-19 vaccine to approximately 1.7 million children in Canada. Provinces will decide where and when children will be vaccinated.
Dr. Howard Njoo, Canada’s deputy chief of public health, said even children already infected with COVID-19 would benefit from the vaccine’s increased protection.
“Vaccinating against COVID-19 in younger children will increase their protection against serious diseases,” Njoo said at a press conference. “Even if a child has been previously infected with COVID-19, vaccination is still important.”
Health officials said children who test positive for COVID-19 or show symptoms should wait eight weeks before starting the vaccination series.
The authorized interval for two doses of the vaccine is four weeks, although NACI recommends a period of eight weeks between injections. He says the longer period may result in a stronger and more durable immune response.
No safety concerns were detected
Health Canada said there were no safety concerns identified in the study. The most common reactions were similar to what children experience with other pediatric vaccines, such as pain at the injection site, drowsiness and loss of appetite.
Less common reactions included mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headache, and muscle pain.
The advisory panel noted that unwanted side effects occurring at a rate of less than 6 per 100,000 would likely not have been detected during the trial.
Health Canada said there is still some uncertainty about the vaccine because it is new and researchers do not yet have long-term data. For example, there is little information about the risk of very rare reactions such as myocarditis – a swelling of heart tissue – although no such cases occurred during the trials.
Dr. Tehseen Ladha, an Edmonton-based pediatrician, said the evidence in favor of vaccination remains overwhelming.
FRIEND | The pediatrician offers vaccination tips for parents of young children
Pediatrician Dr. Tehseen Ladha says Moderna’s newly approved COVID-19 vaccine for children under five is safer than potentially exposing children to the virus.
“If we’re going to weigh the risks and the benefits, we’re looking at giving a vaccine that’s been rigorously studied … against the Covid infection, where we don’t know the long-term effects and we know for sure that it can cause serious consequences “, Ladha told CBC News Network.
To parents of young children, Ladha said, “I would certainly recommend you to go for the vaccine instead of exposing them to the infection.”
There is also more to learn about the vaccine’s safety and effectiveness in young children with other health conditions or who are immunocompromised, the NACI documents said.
The United States approved the Moderna and Pfizer pediatric COVID-19 vaccines last month and has immunized 267,000 children in that age group as of July 8.
Pfizer’s pediatric COVID-19 vaccine for young children between six months and five years old was submitted to Health Canada last month and is still under review.
Dr. Marc Berthiaume of Health Canada’s Bureau of Medical Sciences said Canada is not aware of any ongoing studies examining the use of COVID-19 vaccines for children under six months of age. He said babies of that age could benefit from antibodies against the coronavirus that are passed down from their mothers.
