The Canadian Drug Regulator approved Moderna’s COVID-19 vaccine 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 six months and five years in doses of a quarter of the size approved for adults.
The National Immunization Advisory Committee offers advice on its use today at 12 pm ET.
You can watch this live press conference at the top of this page.
“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 closely monitor vaccine safety 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.
A four-year-old boy receives a dose of the Modern COVID-19 vaccine in New York on June 21st. (Mary Altaffer / The Associated Press)
Approval extends eligibility for the COVID-19 vaccine to nearly two million children in Canada, although the provinces will determine where and when the vaccine will be given to children.
The vaccine requires two doses given about four weeks apart.
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 site, drowsiness, and loss of appetite.
Less commonly, some children had mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headaches, and muscle aches.
Health Canada said there are still some uncertainties about the vaccine because it is new and no long-term data is available yet. For example, there is little data on the risk of very rare reactions such as myocarditis, a swelling of the heart tissue, although no cases emerged in the trials.
There is also more information about the safety and effectiveness of the vaccine in young children with other health conditions or immunocompromised, according to the documents.
The United States approved pediatric vaccines against COVID-19 from Moderna and Pfizer last month and has so far 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 sent to Health Canada last month and is still under review.