Canada’s drug regulator on Friday approved AstraZeneca’s COVID-19 vaccine, including the version produced by the Serum Institute of India, paving the way for health authorities to accelerate Canada’s lagging vaccination campaign.
The vaccines produced by AstraZeneca Plc and the Serum Institute were approved under Canada’s interim order system, which allows for accelerated approvals similar to the US Food and Drug Administration’s emergency use authorisation.
Canada has ordered 20 million doses of the vaccine from AstraZeneca, which it developed with Oxford University, and is due to receive 1.9 million doses through COVAX – the international initiative set up to provide equitable access to vaccines – in the first half of the year.
Health Canada approved the vaccine for all adults, saying its efficacy in those over age 65 was supported in part by evidence gathered 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 percent.
Canada approved vaccines developed by Pfizer with BioNTech and Moderna in December. It 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 AstraZeneca vaccine, but the European Union has. The British drugmaker has told the EU it expects to deliver fewer than half of the COVID-19 doses it was contracted to supply in the second quarter.
Canada hopes to avoid similar supply disruptions as it is eager to speed its lagging inoculation campaign. Canada trails many other nations, and critics accuse Prime Minister Justin Trudeau‘s Liberal government of bungling the roll-out.
Canada has ordered more COVID-19 vaccine doses per capita than any other country, according to publicly announced procurement deals. But its early roll-out has been relatively slow in part because of temporary disruptions in deliveries from manufacturers.
None of the approved COVID-19 vaccines is 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.
The timing of Health Canada’s decisions on two other COVID-19 vaccines, produced by Johnson & Johnson and Novavax Inc, is likely to be “in line with the other major regulators,” said Supriya Sharma, the chief medical adviser at the regulator.
The J&J review is pretty much complete, with some manufacturing information expected on Friday, Sharma said. The US FDA’s expert advisory panel is expected to recommend authorisation for J&J’s one-shot vaccine on Friday.