Statement on UK's authorization of its first COVID-19 vaccine, manufactured by Pfizer/BioNTech

OTTAWA, ON, Dec. 2, 2020 /CNW/ - Health Canada is aware that the UK Medicines and Healthcare Products Regulatory Agency has issued a temporary authorization for temporary limited supply of its first COVID-19 vaccine, manufactured by Pfizer/BioNTech.

Health Canada's independent review of this vaccine is ongoing, and is expected to be completed soon.

The Department is working closely with international regulators including in the United Kingdom to share information and data on vaccines currently under review. A vaccine would only be authorized in Canada following the completion of an independent review process assessing its safety, efficacy and quality.

The vaccine has been under review since October 9, 2020, under Health Canada's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This allows Health Canada to review data submitted by manufacturers on an ongoing basis, instead of waiting for all the data to be collected and then submitted at once.

While this is an expeditied approval process, a vaccine will only be authorized if it meets Health Canada's stringent safety, efficacy and quality requirements.

SOURCE Health Canada

Media Relations, Health Canada, 613-957-2983, [email protected]