Ottawa Citizen

First COVID-19 vaccine could get Canadian approval next month

If all goes well, first shipment January or earlier

- RYAN TUMILTY rtumilty@postmedia.com

OTTAWA • Canadian regulators could approve the first promising COVID-19 vaccine as early as next month, but it will likely take weeks after that for Canadians to be able to get a dose.

Government officials held the first of what they promise will be weekly briefings on the rollout for COVID-19 vaccines, a question which has dominated the House of Commons this week. Several companies have reported strong results from their last phase of clinical trials and countries around the world are making plans for their rollout.

Prime Minister Justin Trudeau said earlier this week Canadians would likely not get the first doses of any vaccines, because Canada doesn't have manufactur­ing capacity here.

Pfizer's vaccine, which has shown to be very effective in clinical trials, is the furthest along in the review process and could be approved in the U.S. by mid-December.

Dr. Supriya Sharma, the chief medical adviser at Health Canada, said they're working closely with U.S. and other internatio­nal approval bodies and she is confident if the data proves accurate they will be approving the vaccine around the same time.

“We're expecting to make a final decision on the vaccines around the same time as both the U.S. FDA and the European Medicines Agency,” she said.

Sharma said if that schedule holds true, they expect doses to arrive in early January and possibly even earlier.

“We' re talking about January in terms of getting our first shipment. If everything goes well and if it goes smoothly they might be earlier,” she said.

Health Canada has instituted a rolling regulatory process for COVID-19 vaccines, allowing companies to submit data piece by piece, rather than waiting until all informatio­n is available before submitting their product for approval.

Sharma said that should help speed up the process, but regulators still have to review thousands of pages of informatio­n and data.

Pfizer and Moderna are the furthest in that process and both use a new technology, with manufactur­ing based in other countries.

Arianne Reza, assistant deputy minister, procuremen­t, said they are in regular talks with manufactur­ers and have been assured vaccines will begin to flow soon after regulatory approval.

“We've talked with the vaccine manufactur­ers and they have assured us that the minute regulatory approval goes through they will be able to go quite quickly afterwards.”

The government has not revealed the precise delivery timelines in their contracts with manufactur­ers. Government sources speaking on background said when they were first detailed in the summer, the contracts specified only delivery dates in the first quarter of 2021, but talks have continued since to refine timelines.

Health ministers in several provinces have said this week they need more details from Ottawa to plan a vaccine campaign.

Conservati­ve MP Michelle Rempel Garner said there is too little clarity for something so essential.

“Provincial government­s are saying the same thing. We've got Manitoba, Saskatchew­an, Ontario within the last 24 hours saying that they don't have details,” she said. “These are basic questions that should have been answered months ago. What has the government been doing for 11 months?”

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