Canada joins countries in real-time AstraZeneca COVID vaccine review

Steve Scherer, Reuters

Posted at Oct 03 2020 02:06 AM

EU started similar review on Thursday

Canada joins countries in real-time AstraZeneca COVID vaccine review 1
A test tube labeled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. Dado Ruvic via Reuters/File

OTTAWA - Canada launched a real-time review of data from AstraZeneca and Oxford University's potential COVID-19 vaccine on Friday, the latest country to speed up its approval process.

As the battle against the coronavirus pandemic intensifies, with infections and deaths still rising, Canada's health ministry said it had received its first submission for authorization for the vaccine on Thursday.

The aim of a rolling review is to accelerate the process and last month, Canada's health minister Patty Hajdu signed an order allowing companies developing vaccines to submit safety and efficacy data and information as they become available.

The European Union's health regulator on Thursday also started a rolling review of the first batch of data for the potential vaccine being worked on by AstraZeneca.

Canada's health regulator will first evaluate pre-clinical data from studies conducted by Oxford University and will then assess pre-clinical and clinical studies as data becomes available, the British drugmaker said, as it welcomed the move.

Oxford University did not immediately respond to requests for comment.

The Canadian ministry will not decide whether to authorize this or any other vaccine until it has received the necessary evidence to support its safety, efficacy and quality, it said.

It is also in talks with several vaccine manufacturers and said any company can apply to use the rolling review process.

The news comes almost a month after several global trials of the shot were halted due to an unexplained illness in a study participant. While most studies have resumed, US trials are still on pause as regulators widened their probe.

Last week, Canada agreed to buy up to 20 million doses of the vaccine candidate, one of several deals it has signed to secure around 300 million potential shots as the global death toll from coronavirus exceeds 1 million.

Called AZD1222 or ChAdOx1 nCoV-19, the AstraZeneca vaccine is seen as leading the race to inoculate people against COVID-19. Other vaccine hopefuls in advanced stages include those from Pfizer, Moderna and Sinovac.