Health Canada approves AstraZeneca COVID-19 vaccine

OTTAWA (NEWS 1130) – Health Canada has given AstraZeneca’s COVID-19 vaccine approval for emergency use in this country.

This is the third vaccine to be given the green light. The Pfizer-BioNTech and Moderna drugs received the go-ahead late last year.

However, unlike the Pfizer-BioNTech and Moderna vaccines — which require special freezers — storage for the AstraZeneca shots is much more flexible. The AstraZeneca vaccines can be kept in a regular refrigerator for up to six months unopened.

The vaccine is approved for use in adults aged 18 and older. Procurement Minister Anita Anand says ongoing studies will provide more information about the safety and efficacy of the shot in children.

“While limited information from clinical trials is available to calculate the efficacy in people 65 years of age and over, Health Canada’s authorization for a broad adult population has taken the available data on immune responses into consideration, and there is emerging, promising evidence that is beginning to be reported from real-world use of the vaccine,” she said Friday.

Canada has already pre-ordered 20 million doses of AstraZeneca’s vaccine, which was produced in partnership with researchers at the University of Oxford. Canada is also expected to receive up to 1.9 million doses of the drug through the global vaccine-sharing initiative known as COVAX by the end of June.

Approval of the AstraZeneca shot comes as Health Canada continues to review two other vaccines made by Johnson & Johnson and Novavax. Approval of Johnson and Johnson’s vaccine will likely not come until late February or early March and Novavax is not expected until April.

Anand says

AstraZeneca’s COVID-19 vaccine received emergency use listing by the World Health Organization earlier in February for use in people 18 years and older.

“The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval,” the company says on its website. “This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.”

The company says the WHO’s Strategic Advisory Group of Experts on Immunization has also recommended use of the shot “in countries where new variants, including the South African B1.351 variant, are prevalent.”

Anand says evidence suggests “efficacy increases with longer dosing intervals.”

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It’s unclear how effective AstraZeneca’s drug is against variants that have been spreading at concerning rates globally.

Health Canada took five months to review AstraZeneca’s vaccine, as different European countries chose to approve or reject it over mixed phase three trial data.

There were no major side effects in the trial stage of the AstraZeneca vaccine, which was one of the key points brought up by Health Canada Friday morning in its reason for approving it.

“The majority of adverse reactions in clinical trials were mild to moderate in severity and resolved within a few days,” Anand said.

The first batch of 500,000 doses is expected to be delivered in the coming days.

“The remaining 1.5 million doses are expected to arrive in the coming months,” Anand added.

Also on Friday, Prime Minister Justin Trudeau announced another partnership with an India-based institute that will deliver two million additional doses of the newly authorized AstraZeneca shot to Canadians by the spring.

The new partnership also means Canada will receive two million doses of the CoviShield vaccine, which is the same as AstraZeneca’s product, through an agreement with Mississauga, Ont.’s Verity Pharmaceuticals and the Serum Institute of India. Trudeau says the first shipment of half a million of CoviShield doses will arrive by March.

Health Canada’s chief medical adviser, Dr. Supriya Sharma, said in a briefing Friday that the CoviShield and AstraZeneca products are “for all intents and purposes” the same vaccine.