Pfizer Canada and BioNTech have received Interim Order authorisation from Health Canada for the use of their Covid-19 vaccine in adolescents aged 12 to 15 years.
This Covid-19 vaccine is the first product authorised for this population in Canada, Pfizer noted. It is allowed for active immunisation to prevent the disease and must be given intramuscularly.
Health Canada authorisation is based on the Phase III clinical trial results from 2,260 subjects aged 12 to 15 years in the US. All participants will be followed-up for long-term protection and safety for two years after receiving their second dose.
Furthermore, a paediatric trial to assess the safety and efficacy of the vaccine in children aged six months to 11 years is underway.
BioNTech co-founder and chief medical officer Özlem Türeci said: “Since securing the Interim Authorization in December for individuals 16 years and older, we have been working tirelessly to get our Covid-19 vaccine authorised around the world in order to provide access to as many countries as possible.
“Our work is not yet complete, as we continue our research into the use of our vaccine in paediatric populations.”
Pfizer Canada vaccines lead Fabien Paquette added that the latest authorisation will enable the Canadian government to expand its vaccination programme against Covid-19.
Developed by BioNTech and Pfizer, the Covid-19 vaccine is based on BioNTech’s mRNA technology. The vaccine generated $3.5bn in global revenues during the first quarter of this year, reported Pfizer.
Anticipating further increase in the Covid-19 vaccine sales, Pfizer increased its revenue guidance for the product from $15bn to $26bn.
BioNTech holds marketing authorisation for the vaccine in the European Union. It also secured the emergency use authorisations or equivalent in the US, along with Pfizer, as well as the UK and Canada, among other countries.