Health Canada offered parents anxious about their unvaccinated children some fresh hope today by clearing the Pfizer-BioNTech COVID-19 vaccine for use in people as young as 12 years old.
After reviewing clinical trial data submitted by the New York-based company last month, regulators have determined the mRNA shot is safe to use in people 12 to 15 years of age. The previous age cutoff for the vaccine was 16.
The Pfizer vaccine is the first product to be authorized for use in this younger age category. The three other products authorized for use in Canada — AstraZeneca, Johnson & Johnson and Moderna — can be given only to people over the age of 18 for now.
Dr. Supriya Sharma, the chief medical adviser at Health Canada, called the new authorization "a significant milestone in Canada's fight against the pandemic" and said it could allow young people to safely return to school and extracurricular activities.
Pfizer enrolled 2,000 adolescents between the ages of 12 to 15 in its U.S.-based trial, giving half that group a placebo and the other cohort the same vaccine that is used in adults.
None of the adolescents in the clinical trial who received the vaccine developed symptomatic infections, a sign of significant protection. In the group that did not receive the vaccine, there were 18 cases of COVID-19.
Strong antibody responses
The vaccinated adolescents also produced strong antibody responses and experienced roughly the same side effects seen in people ages 16 to 25. The most commonly reported side effects were temporary and mild, like a sore arm, chills or fever, Sharma said.
Sharma said it's crucial to get this younger demographic vaccinated because up to 20 per cent of the COVID-19 cases reported in Canada have been among people under 19. While rare, there have also been reports of COVID-related deaths among people as young as 13.
"While younger people are less likely to experience serious cases of COVID-19, having access to a safe and effective vaccine will help to control the disease's spread to their families and friends — some of whom may be at a higher risk of complications," Sharma said.
"It will also support the return to a more normal life for our children, who have had such a hard time over the past year."