- The vaccine was approved under Canada's interim order system, which allows for accelerated approvals similar to the US Food and Drug Administration's emergency use authorizations.
- Canada has secured access to 20 million doses of the AstraZeneca vaccine.
OTTAWA: Canada's drug regulator on Friday approved AstraZeneca's COVID-19 vaccine, the third to have been given a green light, paving the way for health authorities to accelerate Canada's lagging vaccination campaign.
The vaccine was approved under Canada's interim order system, which allows for accelerated approvals similar to the US Food and Drug Administration's emergency use authorizations.
Canada has secured access to 20 million doses of the AstraZeneca vaccine.
Health Canada approved the vaccine for all adults, saying its efficacy in those over 65 was supported by factors outside of clinical trials. Germany, by contrast, is using the product only in those under 65.
"Overall, there are no important safety concerns and the vaccine was well tolerated by participants," Health Canada said. It said the efficacy of the vaccine was 62.1%.
It was not immediately clear if the approval covered both AstraZeneca's own application and a second application by Verity Pharmaceuticals Inc and Serum Institute of India to import doses made in India.
Canada approved vaccines developed by Pfizer and BioNTech and Moderna in December, but did not follow the British drug regulator's lead in approving AstraZeneca's vaccine based on trial data published in November.
The United States has not yet approved the vaccine, but the European Union has. The drugmaker has told the EU it expects to deliver less than half the COVID-19 vaccines it was contracted to supply in the second quarter.
That would be a problem for Canada, which is eager to speed up its slow inoculation campaign. Canada trails many other nations, and critics accuse Prime Minister Justin Trudeau's Liberal government of bungling the rollout.
Canada has ordered more COVID-19 vaccine doses per capita than any other country, according to publicly announced procurement deals, but its early rollout has been relatively slow in part because of temporary disruptions in deliveries from manufacturers.
None of the approved COVID vaccines are manufactured in Canada. Pfizer and Moderna have been shipping doses from Europe, where drug manufacturers are under pressure to meet local demand for vaccines during a slow manufacturing scale-up.
Johnson & Johnson and Novavax Inc have applied to Health Canada's rolling review system for their own vaccines, which have yet to be approved.