A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George’s University hospital in London Wednesday, Oct. 7, 2020. Novavax Inc. said Thursday Jan. 28, 2021 that its COVID-19 vaccine appears 89% effective based on early findings from a British study and that it also seems to work — though not as well — against new mutated strains of the virus circulating in that country and South Africa. (AP Photo/Alastair Grant)

A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George’s University hospital in London Wednesday, Oct. 7, 2020. Novavax Inc. said Thursday Jan. 28, 2021 that its COVID-19 vaccine appears 89% effective based on early findings from a British study and that it also seems to work — though not as well — against new mutated strains of the virus circulating in that country and South Africa. (AP Photo/Alastair Grant)

Canada signs deal with Novavax to make its COVID-19 vaccine at new Montreal facility

Novavax’s vaccine is likely at least two months away from being approved in Canada

Prime Minister Justin Trudeau is expected to announce today a deal with Novavax to produce doses of its new COVID-19 vaccine at a new National Research Council biomanufacturing facility in Montreal.

More details are expected on making some COVID-19 therapeutic drugs at other facilities in Canada.

The deal could help Trudeau tamp down the political headache caused by Canada’s skeletal vaccine production capacity.

But Novavax’s vaccine is likely at least two months away from being approved in Canada, while the NRC facility is still under construction and designed to produce only about two million doses a month.

Canada has a deal to buy 52 million doses from Novavax after it is approved by Health Canada.

Canada’s inability to produce any COVID-19 vaccines at home has left the country at the mercy of foreign governments, who could at any time slam the doors shut to vaccine exports until their own people are vaccinated.

That risk became ever more real this week as Europe’s new export controls on vaccines take hold, putting at risk Canada’s entire supply of COVID-19 vaccines.

All doses from the currently approved vaccines being produced by Pfizer-BioNTech and Moderna are being made in Europe.

Maryland-based Novavax applied Friday to start the regulatory review process for its experimental vaccine, after announcing a clinical trial in the United Kingdom showed it was more than 89 per cent effective against COVID-19.

The trial in the U.K. showed significant effectiveness against both the original virus behind COVID-19, and the variant known as B. 1.17 that was first identified there. A smaller Phase 2 trial in South Africa showed the vaccine was also effective against a variant that first emerged there, known as B. 1.351.

The Pfizer-BioNTech and Moderna vaccines have shown potential in lab tests against the variants, which are believed to spread more easily and may cause more serious illness. However, the trials that led to those vaccines being approved were completed before the variants had been identified.

More than half the COVID-19 cases identified in Novavax’s British trial were the B. 1.17 variant and 90 per cent of the cases in South Africa were B. 1.351.

Novavax is also in the midst of a big trial in the United States, but a spokeswoman told The Canadian Press safety results are not expected for at least another month.

The federal department of Innovation, Science and Economic Development and the National Research Council have been in talks with all the front-running vaccine makers in the world for months, trying to lure at least one of them to make some of their vaccines at the new facility, which is on track to be finished this summer.

None of those talks have borne any fruit until now.

“I have received positive feedback from some leading vaccine manufacturers in these discussions, and so we are moving full steam ahead to build Canada’s domestic production of vaccines,” said Industry Minister Francois-Phillippe Champagne, in a statement to The Canadian Press.

The National Research Council was even rebuffed in offers to help all leading vaccine makers do research on scaling up their production processes to make the precious doses as fast as possible.

None of those offers was accepted.

Talks to do that with Novavax fell apart at the 11th hour last fall, right before an initial agreement for Canada to buy 52 million doses of Novavax’s vaccine was announced.

READ MORE: Novavax submits vaccine for approval as Ottawa seeks EU reassurances on export rules

An email chain, released to the House of Commons health committee as part of a new batch of documents on Canada’s pandemic response, shows a reference to the agreement was deleted from the memorandum of understanding with Novavax the day before the deal was made public.

The National Research Council was also going to make doses of CanSino Biologic’s vaccine, in a deal that included a $44-million upgrade of the NRC’s Royalmount facility in Montreal.

But Canada’s partnership with CanSino fell apart almost as quickly as it began, when China refused to allow any doses of the vaccine to be exported to Canada for use in a clinical trial here.

The vaccine is made using technology that was developed at the NRC and then licensed to CanSino for use in an Ebola vaccine.

After that deal fell apart, the Trudeau Liberals added $123-million for the NRC to not only expand the Royalmount facility, but also build an entirely new production site beside it capable of pumping out two million doses of vaccine a month.

It won’t be able to produce the messenger RNA vaccines, like those from Pfizer-BioNTech and Moderna, but can make most other types of vaccines. Once the deal is finalized, Novavax will have to transfer its technology to the NRC, which can then begin scaling up production.

Canada invested another $173 million to Quebec’s Medicago to push research on its vaccine and build a new production plant in Quebec. If Medicago’s vaccine turns out to be safe and effective for COVID-19, it will initially be made in North Carolina.

Canada’s only vaccine production exists with Sanofi in Toronto and GlaxoSmithKline in Quebec. Sanofi pumps out millions of doses of vaccine in Toronto for diseases like whooping cough, polio and tetanus, while GSK’s Quebec plant is where Canada gets most of its annual flu vaccine.

The two are collaborating on a COVID-19 vaccine, which was delayed until at least the fall after initial results were not as good as hoped. But their plan, like that of Pfizer, Moderna, Novavax and Johnson and Johnson, does not involve making any of that vaccine in Canada.

Canada used to have a strong domestic vaccine industry. Federal records show in 1973, Canada relied on imports for only about one-fifth of its domestic pharmaceutical requirements including both vaccines and therapeutic drugs.

But the industry began to dry up in the 1980s, with multiple firms closing their Canadian operations, including AstraZeneca, Bristol Myers and Johnson and Johnson.

Today, Canada relies on imports for at least 85 per cent of the vaccines and other pharmaceuticals it uses.

Mia Rabson, The Canadian Press


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