Novavax submits coronavirus vaccine to Health Canada for approval

Canada’s hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work to approve a new inoculation, even as the federal government sought to head off any restrictions on vaccine shipments from Europe.

The Maryland-based company applied less than two weeks after Ottawa finalized its agreement to buy 52 million injections if approved.

Due to the urgent nature of the pandemic, Health Canada is accepting vaccine applications before the final test data is available, allowing the review team to begin studying the documents continuously, instead of waiting until everything is done.

Continued review of data through rotational submission in the approval process allows for much faster progress when final results from clinical trials are complete.

“Health Canada is expediting the review of all COVID-19 vaccines,” Health Canada spokesman Andre Gagnon said in an email. “This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.”

Novavax is the fifth vaccine maker to submit an application for rolling review. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October, and Johnson and Johnson followed suit at the end of November.

Health Canada approved the Pfizer-BioNTech vaccine on Dec. 9 and gave Moderna the green light on Dec. 23, both about three weeks after the companies completed their Phase 3 trials. A decision on AstraZeneca is expected in the next couple of weeks.

Johnson and Johnson reported results from its Phase 3 trial just last week.

Novavax also reported results Thursday from a trial in the United Kingdom, but a large trial in the U.S. is still at least a month or two away from yielding final results.

The company has said its vaccine was 89 percent effective in the U.K. trial. It also touts its product as very effective against the new British and South African strains of COVID-19 and says it could start delivering doses in the spring once it has received regulatory approval.

Novavax’s application comes as the federal Liberal government faces withering criticism for the pace of vaccinations across the country, with opposition parties and some provincial governments complaining about a lack of shots.

There are also concerns that Canada’s troubled vaccine supplies will be further affected by new controls on vaccine exports that have been imposed by the European Union, which is also struggling with delivery shortfalls from manufacturers.

The measures allow the European Union to deny vaccine exports if the manufacturer has not fulfilled its promised deliveries to the 27-country bloc, which is where most of Canada’s shots are being made.

After Prime Minister Justin Trudeau’s private phone call with European Commission President Ursula von der Leyen last weekend, Trudeau later confirmed that the new export control measures would not affect vaccines for Canada.

Former Canadian diplomat Colin Robertson, who is now vice-president of the Canadian Global Affairs Institute, said the number of calls between the government and European officials _ and the fact they have been revealed publicly _ is unusual and “is the kind of thing you would do if you’re concerned.”

Robertson nonetheless expressed his hopes that Ottawa’s close relationship with the EU, formalized in various trade and political agreements, along with the contracts between Ottawa and the drug companies would prevent the Europeans from curtailing shipments to Canada.

Both Pfizer-BioNTech and AstraZeneca are behind on their scheduled deliveries to European nations, but it is the latter with which Europe is having the loudest fight.

The EU is demanding the company ship doses made in the United Kingdom to make up for shortfalls due to production issues in its European plants.

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