Health Canada on track to approve AstraZeneca vaccine by mid-February

Health Canada is on track to give the green light to a third COVID-19 vaccine within the next two weeks and a fourth may not be far behind, offering a glimmer of hope at the end of a week of nothing but vaccine vexation.

Eric Morrissette, chief of media relations at Health Canada, said Friday the regulatory team that has been reviewing an application from AstraZeneca since Oct. 1 is just awaiting final submissions from the drugmaker on manufacturing processes before making its decision.

AstraZeneca was the first to apply for approval for a COVID-19 vaccine in Canada and has been greenlit in 15 jurisdictions including the United Kingdom, Mexico, India, and as of Friday, the entire European Union.

Dr. Supriya Sharma, Health Canada’s chief medical adviser, said earlier this month the review was “a bit more complicated” because in AstraZeneca’s trials, some volunteers only received a half dose at first.

A big trial underway in the United States is supposed to provide more clarity, but Morrissette said Friday that trial won’t report findings until March and Health Canada’s team has decided it has all the clinical data it needs.

A fourth vaccine could be close at hand as well, after Johnson and Johnson reported Friday that Phase 3 clinical trial results — typically the last before a drug is approved for wide use — showed its vaccine is about 85 per cent effective against serious illness from COVID-19. Johnson and Johnson, which submitted an application to Canada for approval Nov. 30, offers the only single-dose vaccine thus far.

Health Canada approved PfizerBioNTech’s vaccine on Dec. 9. and Moderna’s on Dec. 23, each time about three weeks after Phase 3 trial results were publicly reported.

Canada has pre-ordered 10 million doses from Johnson and Johnson with the potential to get 28 million more, and 20 million doses from AstraZeneca. But the federal government has not said when those doses would be delivered, and recent days have shown deliveries for COVID-19 vaccines are constantly subject to change.