The renaming was announced on September 16, as the Interim Order under which the vaccines were approved expired.
With the order lapsed, Health Canada has now granted full approval to the Pfizer and Moderna vaccines for those aged 12 and older.
Review of the AstraZeneca COVID-19 vaccine will continue, but will not include the COVISHIELD version of the shot.
Henceforth, the Pfizer vaccine will be known as Comirnaty, Moderna’s will be called Spikevax, and AstraZeneca’s will go by Vaxzevria.
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The decision marks the first full approval of Moderna’s COVID-19 vaccine. The FDA granted full approval to Pfizer in August, and doesn’t recognize AstraZeneca as an approved vaccine.
Stéphane Bancel, Moderna’s chief executive officer, called the approval an “important milestone” and thanked the federal government for its trust in mRNA vaccines.
“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, vaccines lead at Pfizer Canada.
“While a significant number of eligible Canadians are fully vaccinated, there is still much work to be done as infection and hospitalization rates continue to rise across the country, primarily among unvaccinated populations.”
Health Canada’s full approval of the vaccine candidates comes after a review of clinical data submitted by the companies.
According to Moderna, Spikevax showed a 93% efficacy rate, with protection remaining “durable” six months after the second dose.
Pfizer noted that the information it submitted to Health Canada also included data that looked at the vaccine’s efficacy up to six months after the second dose.
Ugur Sahin, CEO and co-founder of BioNTech, called Health Canada’s approval “a testament” to the vaccine’s efficacy and safety.
“Our companies have shipped more than 1.4 billion doses worldwide,” Sahin said.
“We will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”