The Current

Canada could approve COVID-19 vaccine in 'week to 10 days,' says Health Canada senior adviser

Health Canada could be in a position to approve Pfizer's COVID-19 vaccine within 10 days, says a senior medical adviser at the agency.

Health Canada still receiving info from Pfizer but review 'progressing really well'

A participant receives an injection during Pfizer's COVID-19 vaccine clinical trials in Mainz, Germany, in this undated photo. On Wednesday, the U.K. approved the vaccine for emergency use. (Reuters)

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Health Canada could be in a position to approve Pfizer's COVID-19 vaccine within 10 days, said the senior medical adviser in the agency's health products and food branch.

"It's a bit difficult to say exactly the day, because we're still getting, as we said, information submitted by the company," said Dr. Supriya Sharma, who is also the chief medical adviser to Health Canada's deputy minister.

"But things have been progressing really well, and we're expecting within the next week to 10 days to be making a final decision," she told Matt Galloway, host of CBC Radio's The Current.

Health Canada is currently reviewing four vaccines, from Pfizer, Moderna, AstraZeneca and Jannsen. The federal and provincial governments are working on the logistics of rolling out vaccines once approval is granted.

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Prime Minister Justin Trudeau says his government will be ready to deploy COVID-19 vaccines to Canadians soon after they are approved by Health Canada. He says four promising vaccine candidates are currently under review. 

Last week, Public Services and Procurement Minister Anita Anand said she "will personally make sure we have vaccines in place in Canada once Health Canada has provided its regulatory approval."

"Once we have Health Canada approvals, deliveries will start as soon as possible," Anand said.

Estimates 'mid-December at the latest'

Sharma explained that to expedite the review process, Health Canada has been receiving information from the drug companies as soon as it is prepared — rather than waiting for a complete batch of data.

"We're expecting some information today and some information tomorrow as well, and then of course we'll be working through the weekend — as we always do — to take a look at it," she said. "I think we're saying around mid-December at the latest, but it really depends on the data."

Health Canada has pulled its most senior and experienced reviewers to focus on the potential vaccines, working in the organization's Biologic and Radiopharmaceutical Drugs Directorate, she said.

"There's a group of seven to 10 reviewers that are working on all aspects of the submission — there's hundreds of thousands of pages," she told Galloway.

"And their only criteria is really making sure that the science is sound and that the vaccine is safe."

Health Canada could approve a COVID-19 vaccine 'around mid-December at the latest, but it really depends on the data,' said Dr. Supriya Sharma, a senior medical adviser at the agency. (CBC)

She said it's important for Canadians to know "that we really need to finish that review and make sure that it is complete, and that the vaccine does meet the standards for safety and efficacy and quality before we give it any sort of authorization." 

On Wednesday, the U.K. approved Pfizer's vaccines for emergency use as early as next week. In the U.S., the Food and Drug Administration will discuss the vaccine on Dec. 10, with vaccinations possible as early as Dec. 12 if it's approved.

Sharma said that doesn't necessarily mean Health Canada will reach the same conclusion.

"[The U.K.] did a temporary authorization for a very limited quantity, so one lot [batch] of the vaccine," she said.

"We are looking at it a bit more broadly — we're looking at the vaccine as a whole for an authorization, and for those lots that are specifically expected to come to Canada."

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Dr. Supriya Sharma is the chief medical advisor for Health Canada

Sharma said once an authorization is granted, Health Canada will post all the data behind the decision online for public review.

"It's important for us to make sure that we're open and transparent," she said. "We know that these authorizations are eagerly anticipated, [but also] that it's important that we take the time to do it and get it right."

She said the team working at Health Canada understands the anticipation around vaccine approval.

"We're all Canadians as well, we know that the vaccine will be a really important part of our fight against COVID and getting us back to somewhere close to normal," Sharma said.

"But we will not make any decision until the science says that it meets those criteria."

Written by Padraig Moran. Produced by Alex Zabjek and Samira Mohyeddin.

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