That’s because officials are still waiting for AstraZeneca to provide information and data for review, the department said in a statement issued Wednesday morning.
“Health Canada is aware that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca,” the statement read.
“There is still information and data to be provided by AstraZeneca for review. Health Canada cannot provide a definite timeline for the completion of the review at this time.”
Health Minister Patty Hajdu said the regulators will continue assessing data on the vaccine candidate as soon as it arrives.
“There are a number of packets of data that still need to arrive, and as soon as we get the data, we’ll be reviewing with the same process that we’ve reviewed Moderna and Pfizer with a rolling regulatory review so that we can assess that data as quickly as it comes in,” she said, speaking during a Wednesday press conference.
The department said the Oxford-AstraZeneca vaccine candidate has been undergoing a rolling approval process since Oct. 1, with officials delving into any and all data the manufacturer provides the moment it arrives. Health Canada also added that it’s working “closely” with international regulators, including the U.K. regulator that just approved the vaccine.
“Health Canada is working hard to give Canadians access to COVID-19 vaccines as quickly as possible without compromising its safety, efficacy and quality standards,” read the statement from Health Canada.
“Protecting the health and safety of Canadians is a top priority.”
Health Canada has already authorized two vaccines for use in Canada. The first, manufactured by Pfizer-BioNTech, was approved on Dec. 9. Just weeks later, on Dec. 23, Moderna’s vaccine was also approved.
The U.K. was also the first country to approve the use of the Pfizer-BioNTech vaccine, which it did on Dec. 2. Canada’s approval followed just one week later.
Should Canada decide to approve the vaccine, it would set in motion the agreement Canada signed with the company for up to 20 million vaccine doses. Those doses are slated to be delivered in 2021, according to that agreement.
The U.K. approved the vaccine as a two-dose regimen, to be delivered four to 12 weeks apart. Should Canada do the same, its agreement with the company would lead to the vaccination of up to 10 million additional Canadians.
The deal would also be in addition to the 60 million doses Canada is already set to receive from Pfizer and Moderna by September.
That means that Canada would have enough doses in its arsenal to vaccinate 40 million Canadians next year – which is more than Canada’s population of 38 million.View link »