Canada has announced on Wednesday, its approval of administering the Pfizer-BioNTech Covid-19 vaccine to children ages 12 to 15.
Xinhua news agency reported that Canada is now the first country in the world to have okayed the two-dose Pfizer vaccine shots to the younger age group.
“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” Health Canada’s Chief Medical Advisor Supriya Sharma said at a press conference on Wednesday.
It should know that the Canadian government has last year also authorized the vaccine for use in individuals 16 years of age and older. Health Canada based its decision on data from Phase 3 clinical trial in participants aged 12 to 15 years old.
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” said Sharma.
She also added that while the younger people are less likely to experience serious cases of Covid-19, having access to a safe and effective vaccine will help control the disease’s spread to their family and friends.
Usually, the vaccine submission review process can take much longer, but because of an emergency order, Health Canada has been able to expedite the authorisation process.
With nearly 11 million doses sent to Canada till date, Pfizer has committed to sending more than 2 million doses each week, until end of June.
The US Food and Drug Administration (FDA) also said that it will authorize Pfizer/BioNTech’s coronavirus vaccine in children and teens ages 12 to 15 by early next week.
Speaking to news agency CNN, a federal government official said that Pfizer has applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. He also added that the FDA will have to amend the emergency use authorization for the vaccine, but the process should be straightforward.
According to the report by CNN, the FDA said it is currently reviewing data submitted by Pfizer to support the extended use. On the other hand, Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100% and it is well tolerated.