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Friday, January 22, 2021

Health Canada to start real-time review of Pfizer-BioNTech COVID-19 vaccine

(Reuters) – Health Canada will start a real-time review of Germany’s BioNTech SE and Pfizer Inc’s experimental COVID-19 vaccine, the companies said yesterday.

The companies said they would submit safety and efficacy data from the trial of their COVID-19 vaccine to Canada’s health ministry under a rolling submission as and when it becomes available.

A rolling review allows researchers to submit findings in real time, without waiting for studies to conclude. Canadian health minister Patty Hajdu last month signed an order allowing companies developing COVID-19 vaccines to submit information as it becomes available.

Health Canada said it will not make a decision on whether to authorize any vaccine under rolling review until it has received the necessary evidence to support the candidate’s safety, efficacy and quality.

The EU health regulator on Tuesday launched a real-time review of the companies’ experimental COVID-19 vaccine to potentially speed up the process of approving a vaccine.

Canada’s health ministry in its attempts to accelerate a potential approval of a COVID-19 vaccine also started a real-time review of AstraZeneca and Oxford University’s vaccine candidate a week ago.

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