Canada’s drug regulator has approved Moderna’s vaccine against COVID-19 for preschool infants and children, making it the first vaccine approved for this age group in the country.
Health Canada now says the Modern vaccine can be given to young children between the ages of six months and five years in doses about a quarter the size of those approved for adults.
“Following 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 between six months and five years of age,” he announced on Twitter on Thursday. ‘Public Health Agency of Canada. .
The agency said it will continue to monitor vaccine safety closely and has demanded that Moderna provide up-to-date data on vaccine safety and efficacy.
In the decision posted on the Health Canada website, the agency said the results of phase 3 of the drug trial show that the immune response in children aged six months to five years was comparable to the Modern vaccine for to young people aged 18 to 25 years.
MIRAR | Health Canada says it will continue to monitor the safety and effectiveness of the vaccine after approval
Health Canada approves Modern vaccine for children 6 months to 5 years of age
Health Canada adviser Dr Supriya Sharma says the agency will continue to receive data from Moderna on 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 last winter when the Omicron variant became dominant.
Preliminary data showed that the Modern vaccine prevented symptomatic COVID-19 at a rate of 50.6% in children aged 6 to 23 months, and at a rate of 36.8% in children aged 2 to 5 years.
Nearly 2 million children are now eligible for vaccination
Approval extends eligibility for the COVID-19 vaccine to nearly two million children in Canada. Where and when the vaccine will be given to children will be decided by the provinces.
Dr. Howard Njoo, Canada’s deputy director of public health, said even children already infected with COVID-19 will benefit from the additional protection of the vaccine.
“Vaccination against COVID-19 in younger children will increase their protection against serious illness,” Njoo said at a news conference. “Even if a child has been previously infected with COVID-19, vaccination is still important.”
Vaccines given to children between six months and five years of age will be about a quarter of the size of adult doses. (Garrett Barry / CBC)
Health officials said children who tested positive for COVID-19 or had symptoms should wait eight weeks before starting the series of vaccinations.
The authorized interval for both doses of the vaccine is four weeks, although NACI recommends an eight-week period between doses. He says the longer period can lead to a more robust and lasting immune response.
No security issues were detected
Health Canada said there were no safety issues identified in the study. The most common reactions were similar to those experienced by children with other pediatric vaccines, such as pain at the injection site, drowsiness, and loss of appetite.
Less common reactions include mild to moderate fever, swelling at the injection site, nausea, sensitive lymph nodes under the arm, headaches, and muscle aches.
The advisory body noted that adverse side effects occurring at a rate of less than 6 per 100,000 were unlikely to have been detected during the trial.
Health Canada said there are still some uncertainties about the vaccine because it is new and researchers do not yet have long-term data. For example, there is little information on the risk of very rare reactions such as myocarditis, a swelling of the heart tissue, although there are no such cases during the trials.
Dr. Tehseen Ladha, an Edmonton-based pediatrician, said the evidence in favor of vaccination remains overwhelming.
“If we are going to weigh the risks and benefits, we are looking at whether to give a vaccine that has been rigorously studied … versus Covid infection, where we do not know the long-term effects and we know for sure that it can cause serious consequences Ladha told CBC News Network.
To the parents of the young children, Ladha said, “I would definitely recommend going for the vaccine instead of exposing them to the infection.”
There is also more information about the safety and effectiveness of the vaccine in young children with other health conditions or who are immunocompromised, according to NACI documents.
The United States approved the Moderna and Pfizer pediatric vaccines against COVID-19 last month and has immunized 267,000 children in that age group as of July 8th.
Pfizer’s pediatric COVID-19 vaccine for young children between six months and five years old was sent to Health Canada last month and is still under review.
Dr. Marc Berthiaume, of the Health Sciences Office of Health Canada, said Canada is not aware of any ongoing studies examining the use of COVID-19 vaccines for children under six months of age. She said babies this age can benefit from coronavirus antibodies transmitted by their mothers.