Health Canada announced Thursday that both Pfizer-BioNtech and Moderna’s mRNA vaccines have formally been granted full approval for anyone 12 years of age and older in the country.
This comes after the interim order for both the vaccines expired on Thursday. The interim order initially allowed for the necessary and accelerated rollout of vaccine doses across Canada, based on preclinical and clinical data, to help provide protection during the COVID-19 pandemic.
“Based on the long-term follow-up data we have presented, Health Canada’s decision today confirms the efficacy and safety profile of our vaccine when it is needed urgently,” said Fabian Paquet, vaccine lead for Pfizer Canada.
“While a significant number of eligible Canadians are fully vaccinated, much work remains to be done as infection and hospitalization rates continue to rise across the country, primarily among unvaccinated populations.”
“Today’s full approval is a testament to the vaccine’s efficacy and safety profile,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
AstraZeneca’s COVID-19 vaccine, which is still authorized under an interim order, is under review. Health Canada says the vaccine had not been converted into Food and Drug Regulations when the interim order expired on Thursday.
Health Canada has also formally authorized a name change. for three COVID-19 vaccines, including Pfizer-BioNtech, Moderna and AstraZeneca.
The Pfizer-BioEntech vaccine will now be named Comirnati, the modern vaccine will be named SpikeVax and the AstraZeneca vaccine will be named Vaxjeveria.
(1/4) Health Canada has authorized a brand name change for the Pfizer-BioNtech, Moderna and AstraZeneca COVID-19 vaccines.
— Health Canada and PHAC (@GovCanHealth) September 16, 2021
Health Canada clarified these only name changes and that nothing has been modified with the vaccine itself.
“All COVID-19 vaccines authorized in Canada are proven to be safe, effective and of high quality,” he wrote on Twitter.
As of September 9, Canada’s Central Vaccine List has only 10.5 million COVID-19 vaccine doses.
Pfizer’s vaccine, now known as Comirnati, is approved for individuals 12 years of age and older.
Clinical trials showed that one week after the second dose, the Pfizer-BioNTech Cominternity Vaccine was about 95 percent effective in protecting trial participants from COVID-19 for people 16 years of age and older and 12 to 15 years. It was 100 percent effective for people of the age of 50. .
This vaccine requires two doses for maximum protection.
The dosing schedule approved by Health Canada is to deliver 2 doses 21 days apart based on evidence from clinical trials.
Canadians receiving the Pfizer-BioNTech comirante as the first dose may be offered Modern SpikeVax as a second shot and vice versa. This is known as a mixed vaccine series. The National Advisory Committee on Immunization (NACI) recommends an mRNA vaccine (Pfizer-BioEntech Cominternati or Modern SpikeVax) as an interchangeable second dose.
Moderna Spikewax is approved for people who are 12 years of age and older. Clinical trials showed that 2 weeks after the second dose, Moderna SpikeVax vaccine was 94.1 percent effective in protecting trial participants 18 years of age and older from COVID-19 and 100 percent in trial participants 12 to 17 years of age. was effective.
This vaccine requires two doses for maximum protection. Based on evidence from clinical trials, the accepted dosing schedule is to give two doses one month apart.
AstraZeneca vaccinia vaccine is approved for people who are 18 years of age and older in Canada. Clinical trials showed that two weeks after the second dose, the AstraZeneca vaccinia vaccine was 62 percent effective in protecting trial participants from the virus.
This vaccine requires two doses for maximum protection. The dosing schedule approved by Health Canada is to give two doses at four to 12-week intervals based on evidence from clinical trials.
The NACI recommends that an mRNA vaccine (Pfizer-BioEntech Comirneti or Moderna SpikeVax) be offered as a second dose to people who received AstraZeneca as the first shot.
As of Wednesday, 74 percent of Canadians have received at least one dose of an approved COVID-19 vaccine, while about 68 percent have been fully vaccinated.