Pfizer and BioNTech secure Health Canada approval for BNT162b2 Covid-19 vaccine

Pfizer, a leading global pharmaceutical company, and BioNTech, a prominent German biotech firm, have officially secured Health Canada’s approval for their BNT162b2 vaccine. This approval, granted under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19, marks a pivotal moment in the ongoing fight against the global pandemic. Canada now joins the UK and Bahrain in recognizing the potential of the mRNA vaccine to prevent Covid-19.

Health Canada’s decision follows rigorous assessments of clinical data, ensuring the vaccine’s safety and efficacy. The approval provides a pathway for widespread vaccination across Canada, with an estimated 20 million to 76 million doses expected to be delivered in 2021, as per the agreement between Pfizer, BioNTech, and the Canadian government signed in August.

A historic moment for Canada’s Covid-19 response

Cole Pinnow, President of Pfizer Canada, described the approval as a “historic moment,” underlining its significance in the collective fight against the pandemic. Pinnow highlighted the global collaboration that made the vaccine’s rapid development possible, thanking the efforts of Pfizer and BioNTech teams around the world. He also acknowledged Health Canada’s thorough and timely review process, which facilitated the swift availability of the vaccine.

In addition, BioNTech holds the Canadian regulatory approval for the BNT162b2 vaccine, while Pfizer’s Canadian subsidiary will manage its commercialization across the country. This division of responsibilities ensures efficient distribution and availability of the vaccine to those in need.

Key features of the BNT162b2 vaccine

The BNT162b2 vaccine is based on BioNTech’s cutting-edge mRNA technology, designed to encode the SARS-CoV-2 spike glycoprotein, a primary target for virus-neutralizing antibodies. This innovative approach to vaccine development has garnered significant attention worldwide, with the vaccine showing promising results in clinical trials.

Health Canada has approved the vaccine for individuals aged 16 years and older, with the possibility of expanding this to younger age groups once further clinical trial data becomes available. Pfizer and BioNTech have already initiated additional studies to address this potential expansion.

Vaccine approval process and ongoing monitoring

Health Canada’s approval was based on the results of a phase 2/3 clinical trial involving nearly 44,000 participants across more than 150 sites worldwide. Health Canada has emphasized the robustness of its review process, ensuring Canadians that the vaccine’s safety and efficacy have been thoroughly evaluated. The Public Health Agency of Canada will work closely with Health Canada to monitor the vaccine’s performance in the real world and will take swift action if any safety issues arise.

Moreover, the terms of the vaccine’s authorization require Pfizer and BioNTech to continue providing data to Health Canada on its safety, efficacy, and overall quality. This ongoing data submission ensures the vaccine’s benefits remain demonstrated throughout its market use.

A crucial step in Canada’s pandemic response

The approval of the BNT162b2 vaccine in Canada represents a significant milestone in the country’s efforts to combat Covid-19. As the vaccine is rolled out, Canadians can trust that Health Canada’s rigorous monitoring systems will continue to safeguard public health. With millions of doses on the way, the partnership between Pfizer and BioNTech is poised to play a critical role in achieving widespread immunity and returning to normalcy in Canada.