With Novavax deal, Canada could be producing COVID-19 vaccine domestically by the fall

OTTAWA — Prime Minister Justin Trudeau says a deal has been struck with Novavax to produce its COVID-19 vaccine in Canada, but the pharmaceutical company isn’t expected to be ready to roll out doses domestically until the fall at the earliest.

The federal government has signed a “memorandum of understanding” with Novavax to pursue options to produce its COVID-19 vaccine at a new Montreal facility that is under construction.

While the prime minister is calling this a “major step forward,” it could be months before this potential first made-in-Canada vaccine candidate is approved, let alone shipped to delivery sites nationwide.

This is in part because the new National Research Council biomanufacturing facility where the production will happen isn’t set to be completed until July.

Then, it could take “a couple” of months before the facility is Health Canada certified for production and vials begin to be filled, according to Minister of Innovation, Science and Industry Francois-Philippe Champagne.

“We expect by the end of the year to be in a position to be producing vaccines,” said Champagne.

Once the new facility is up and running, it’s designed to produce around two million doses a month and, should the Novavax vaccine be deemed safe and effective, Trudeau says “tens of millions” of doses will be made domestically.

The federal government has a deal with the Maryland-based company to purchase up to 76 million doses of its vaccine candidate. 

“We need as much domestic capacity for vaccine production as possible,” Trudeau said Tuesday, after acknowledging months prior that Canada did not have adequate domestic capabilities.

The National Research Council’s new Biologics Manufacturing Centre at the Royalmount site in Montréal was given $126 million in August 2020, and according to the government, the construction remains “on schedule.” 

While the facility will be able to make various types of vaccines, it will not have the capabilities when it opens to produce MRNA vaccines, however, which are the kind of vaccines Pfizer-BioNTech and Moderna are supplying.

Novavax submitted its vaccine candidate to Health Canada for approval late last week. It is the fifth company to do so, following AstraZeneca and Johnson & Johnson, which are still under review but are set to be the next options granted the green light.

CANADA STILL RELYING ON EUROPE

This news comes as the federal government has been facing numerous questions over the lack of capacity to produce COVID-19 vaccines domestically, and reliance on other countries to deliver the currently approved vaccines.

All of Canada’s vaccine doses are currently coming from Europe. With both Pfizer-BioNTech and Moderna sending smaller deliveries of their COVID-19 vaccines to Canada this week, exacerbating the ongoing dose shortage nationwide, the move to become more self-reliant on vaccine manufacturing provides an eventual new avenue for domestic vaccine supply.

But it remains to be seen how much, or if at all, this new deal will assist the federal government in its goal of starting mass vaccinations in the spring and having all Canadians who want to be vaccinated by the end of September, given the current timeline with Novavax production likely only getting underway around that time.

Trudeau said that with the doses already set to be shipped, Canada will hit its target of vaccinating three million prioritized people by March, and is confident it will have enough doses coming in from already approved manufacturers in the months following to put needles in arms of the entire population.

While the Novavax doses may not contribute to the initial campaign, Trudeau said he wants Canada to be prepared for other iterations of this pandemic or future pandemics.

“As we see new variants rising, as we see a virus that will continue to be present in many places around the world, we don’t know what the future looks like for a year from now, two years from now, three years from now. What we’re very clear on is Canada will be developing domestic manufacturing so regardless of what could happen in the future, we will have domestic production on top of all our partnerships and contracts signed with companies around the world.”

The new focus on domestic capacity also comes amid concerns about a growing sentiment of vaccine nationalism, with vaccine-producing countries looking to keep their doses at home for their own citizens.

The European Union has issued new export controls on COVID-19 vaccines and while Trudeau said Tuesday he’s only received oral promises from European Commission President Ursula von der Leyen that Canada’s shipments won’t be halted as a result, that was enough to assure him.

The prime minister was also asked if Canada’s goal is to be self-sufficient when it comes to COVID-19 vaccines. Trudeau said he’ll keep encouraging international vaccine producers to set up facilities in Canada.

“I think it’s going to be important that Canada be self-sufficient, but we’re also a trading nation that understands that good solid trading relationships with countries around the world are also a way of keeping Canadians properly supported and flourishing,” he said.

Federal opposition parties said that while Canada becoming more self-reliant is welcome news, they questioned what took so long for the federal government to make a deal like this.

“Why did the Liberal government take so long to act?… How does today’s announcement help us now?” asked Conservative Leader Erin O’Toole.

“Canadians need access to these vaccines as soon as possible. If we are six months behind most other developed countries, we are going to be six months slower reopening our economy, so securing that supply as quickly as possible has to be key,” O’Toole said.

NDP Leader Jagmeet Singh is calling for more transparency around the Novavax deal and asserted that Canada shouldn’t “be at the mercy of these massive pharmaceutical companies,” suggesting public ownership of vaccine facilities would be the best approach. 

OTHER FACILITIES COMING

Trudeau also announced on Tuesday that a second company, Precision NanoSystems, is “on track” to manufacture vaccines domestically, but in 2023 at the earliest.

On Tuesday, the prime minister announced $25.1 million for the Vancouver-based biotechnology company, which is in the process of building a $50.2 million biomanufacturing centre “to produce vaccines and therapeutics for the prevention and treatment of diseases such as infectious diseases, rare diseases, cancer and other areas of unmet need,” according to the government.

The government says the project proposal was reviewed by the COVID-19 joint biomanufacturing subcommittee. Its target date for completion is March 2023, and at that point it would have the capacity to produce up to 240 million doses of its self-amplifying ribonucleic acid (RNA) COVID 19 vaccine every year.

The Liberals had previously put $18.2 million towards trials for its vaccine candidate.

The prime minister also provided an update on the pre-existing investments made with Canadian bio manufacturers, including $46 million towards the vaccine development facility at the University of Saskatchewan’s Vaccine and Infectious Disease Organization. Known as VIDO-Intervac, it’s now projecting they will be able to produce up to 40 million doses annually once it is completed by the end of 2021.

Similarly, the federal government has put $173 million into Quebec-based Medicago’s plant-based COVID-19 vaccine candidate and the production of it, but the company’s initial plans are to mass produce its doses in North Carolina while work is underway to build a new Quebec facility that is planning to be ready in late 2023.

The move to revive more Canadian vaccine manufacturing was sparked amid the pandemic, after the industry dwindled considerably over the preceding decades. As The Canadian Press has reported, the existing vaccine producers Sanofi in Toronto and GlaxoSmithKline in Quebec are collaborating on a COVID-19 vaccine, but it’s not expected to be made in Canada.

Asked whether he regrets not having built Canadian facilities earlier to be in a better immunization position as Canada falls behind other nations, Trudeau said there “is always more” that can be done, or that he might have wished to have done faster in hindsight. He said that the capacity is being built now so that Canada will be on better footing in the future.

As The Canadian Press has reported, over the pandemic Innovation, Science and Economic Development Canada and the National Research Council have been in talks with international front-running vaccine manufacturers, seeking to have them scale up production in Canada. This included unsuccessful talks with CanSino Biologic over producing its vaccine candidate. That partnership was halted after China refused to export doses to Canada for a clinical trial.

On Tuesday, the prime minister noted that while COVID-19 cases have been declining nationwide for three weeks, the country is still far from returning to some sense of normalcy, restating that vaccinations will be central to that eventual resumption of pre-pandemic life.

To date, the federal government has spent more than $1 billion on vaccine procurement agreements, locking in a supply of up to 429 million doses of seven promising vaccines, which would mean Canada would have at least 10 doses for every Canadian — if all came through.

In an effort to promote immunization take-up once the country has enough doses to start mass vaccination, Trudeau announced Tuesday that the federal government is launching a $64 million public education and awareness campaign and enhancements to record-keeping of vaccine appointments to ensure Canadians know when and where to get their shots.  

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