New brand names authorized for 3 Covid-19 vaccines in Canada, Details

In light of the aforementioned developments, Health Canada and PHAC tweeted, "Health Canada has authorized brand name changes for the Pfizer-BioNTech, Moderna, and AstraZeneca COVID-19 vaccines. The Pfizer-BioNTech vaccine will now be named Comirnaty, the Moderna vaccine will be named SpikeVax, and the AstraZeneca vaccine will be named Vaxzevria."

"These are only name changes. There are no changes to the vaccines themselves. All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality", the tweet further added.

As per a recent release by the company, the Pfizer-BioNTech vaccine has been named Comirnaty, which is a combination of the terms COVID-19, mRNA, community, and immunity. The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020.

On September 16, the Health Canada granted full approval for COMIRNATY to prevent COVID-19 in individuals 12 years of age and older. The authorization permitted the essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the Phase 3 clinical trial.

"Today's full approval is a testament to the vaccine's efficacy and safety profile," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

"Our companies have shipped more than 1.4 billion doses worldwide, and we will continue to work tirelessly to broaden access to our vaccine and to be prepared for potential emerging escape variants," he added.

Although the vaccine's brand name will be COMIRNATY following this approval, Canada will continue to receive vials of the vaccine labelled as Pfizer-BioNTech COVID-19 Vaccine. The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date.

Fabien Paquette, Vaccines Lead, Pfizer Canada said in a release, "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,"

Meanwhile, Health Canada has also approved the New Drug Submission for SPIKEVAX, which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

The Moderna COVID-19 vaccine, brand name SPIKEVAX, is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.

"Health Canada's approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process, "said Stéphane Bancel, Chief Executive Officer of Moderna.

"I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic," he

Health Canada approved the New Drug Submission for SPIKEVAX based on clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S. In final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose. The safety profile based on extended safety follow-up was consistent with the Phase 3 COVE study primary results.

However, in the case of AstraZeneca's COVID-19 vaccine, the Canadian drug regulator, Health Canada, said that the AstraZeneca Vaxzevria COVID-19 vaccine is authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. Canadians will continue to have access to AstraZeneca Vaxzevria after September 16, 2021 while the submission is under review for transition to the Food and Drug Regulations.