Canadian Manufacturing

Approval for Moderna’s vaccine ‘looks positive’ but a few more documents still needed

Sharma says that it's possible the Moderna timeline could be similar to Pfizer's.

December 15, 2020  The Canadian Press

The chief medical adviser at Health Canada says things are on track for her department to approve a second vaccine for COVID-19 very soon.

Dr. Supriya Sharma says things “look positive” for the vaccine from U.S. biotech firm Moderna but there are still some outstanding manufacturing documents needed before the decision can be made.

Ongoing reviews of two more vaccines are less certain, with AstraZeneca’s potentially needing more study before Health Canada is ready to make a decision, and the Johnson & Johnson vaccine candidate’s review still in the very early stages.

Health Canada approved the vaccine from Pfizer-BioNTech Dec. 9, and the first doses began arriving in Canada Sunday.

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The Pfizer-BioNTech vaccine has also been approved in several other countries including the United Kingdom, the United States, Bahrain and Saudi Arabia.

The U.S. Food and Drug Administration is to meet Dec. 17 to discuss Moderna’s application. Health Canada has been reviewing Moderna’s vaccine since October, and Sharma said the final clinical data was provided from the company Friday.

She said the review team spent the weekend poring over those documents, and now all that is left is data on the manufacturing plants. Those documents are expected by week’s end and then she’ll know better when the Moderna decision can be issued.

“It does look promising and it does look positive,” said Sharma.

It took only five days from the final delivery of manufacturing data for Pfizer’s vaccine to secure Health Canada approval but Sharma said Moderna’s facilities are not familiar to Health Canada. The manufacturing sites Pfizer is using have been reviewed by Health Canada before.

Sharma said that means there is more uncertainty about how long it might take to go over the data, though it’s possible the Moderna timeline could be similar to Pfizer’s.

Health Canada’s review team uses experts in a variety of areas, from toxicology and pharmacology to infectious diseases and manufacturing practices.

Pfizer and Moderna together are expected to deliver 60 million doses of vaccine to Canada by next fall, enough to vaccinate 30 million people.

Enough doses are to start arriving in April for provinces to expand the vaccination program beyond the initial priority groups. Canada expects to be able to vaccinate every Canadian who wants an inoculation by the end of September 2021.

Authorities are still calling on Canadians to keep apart, wear face masks and practise careful hygiene to keep the virus that causes the illness from spreading.


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