A December deadline looms with no vaccine deliveries in sight and questions swirling about the $130-million plant owned by the federal government.
Vaccine production is nearly three years behind schedule at a federally owned plant in Montreal and the future of a deal between Ottawa and an American company to make COVID-19 vaccines here is now under review.
The government’s deal with Maryland-based Novavax requires the company to obtain regulatory approval for a vaccine using ingredients made at the Biologics Manufacturing Centre (BMC) in Montreal before the end of December 2024, something the company said is unlikely to happen.
“The government of Canada is currently assessing options for the way forward,” Michèle LaRose, a spokesperson for Public Services and Procurement Canada, said in an email.
The Canadian government can cancel its contract with Novavax if the company doesn’t meet the December deadline, according to documents the company filed with the U.S. Securities and Exchange Commission. However, Canada will only get back US$28 million of the US$588 million it has already paid for future doses of Nuvaxovid — a vaccine neither the federal government nor Quebec acquired this year.
The impending deadline not only raises questions about the future of the BMC’s partnership with Novavax — the only manufacturing deal that has been announced at the plant — but also about the government’s strategy to rebuild domestic vaccine manufacturing as the federal government continues to put millions of dollars a year into the largely idle facility, which is still looking for other partners to exploit the rest of its production capacity.
In February 2021, less than two months after the first doses of COVID-19 vaccines were administered in Canada, Prime Minister Justin Trudeau stepped out of Rideau Cottage and told those watching a livestreamed press conference that he had good news: Ottawa had signed a deal with Novavax that meant COVID-19 vaccines would soon be manufactured in Canada.
It came with an ambitious timeline. Later that day, Industry Minister François-Philippe Champagne said the $130-million BMC, then under construction at the National Research Council facility on Royalmount Ave., might be able to start producing around two million doses of COVID-19 vaccine a month before year’s end.
Yet today, the facility still hasn’t made a single vial of Novavax’s vaccine for use.
Novavax declined to provide specific details in response to questions from The Gazette about when, or if, production would begin in Montreal.
“We are working with the Canadian government on an amendment to the (advanced purchase agreement) that addresses regulatory approval and future delivery schedules, which may not be achievable on acceptable terms or at all,” the company said in documents it filed with the S.E.C.
That’s a change from March 2023, when the company said it was continuing “to make progress toward” manufacturing its vaccine at the BMC and producing test batches in the near future.
When the Novavax deal was announced, Canada’s vaccine rollout, which depended on shipments from Europe, was slower than that of United Kingdom and the United States, which were producing their own vaccines.
While Canada purchased a number of different vaccines — including 52 million doses of made-in-India Nuvaxovid — shots by Pfizer and Moderna, which capitalize on mRNA technology, quickly became the main vaccines used in the country.
Novavax’s vaccine, which uses a more traditional virus-blocking technique, was approved for use in Canada in February 2022, but demand never caught up to the more popular mRNA shots.
In 2023, 125,000 doses of the vaccine were ordered by the federal government, but only 5,529 doses were administered, said Anna Maddison, a spokesperson for the Public Health Agency of Canada.
According to S.E.C. filings, Canada paid Novavax almost US$350 million in 2023 to forfeit doses it had previously ordered.
The company warned investors in early 2023 that it risked going out of business within a year. Its financial situation has since stabilized, after it signed a licensing deal with French pharmaceutical giant Sanofi worth up to US$1.4 billion.
Now, of course, it’s easy to question the decision to bankroll Novavax’s vaccine.
Yet Andrew Casey, the president and CEO of biotechnology industry association BIOTECanada, defended the government’s approach as prudent. Canada doesn’t want to be caught unprepared, as it was in 2020, in the next health emergency, he said.
By building capacity, through investments in the BMC and similar facilities that can manufacture other types of vaccines and drugs, Canada will be better able to respond to another pandemic, he said.
“We have no idea what the next challenge is going to be and can’t identify the next solution,” he said. “If I took you back in time and said 15 years ago that it was going to be COVID and it was going to be in 2019, very few experts would have said let’s put all of our money on the mRNA vaccine.”
While the need for the specific types of vaccines and drugs that can be made at the BMC may never come, he said, the facility and those like it will help support local research and development when they’re not being used for emergency response.
“One of the things they can do is support some early-stage companies who need to do small-batch manufacturing for clinical trials and that’s going to be, absolutely, really important in keeping some of those technologies in Canada,” he said.
Casey said it will take time for BMC to become an important part of the biotechnology industry. In the meantime, due to the technology used at the facility, and the need to maintain adherence to international standards, it has continue running even when it’s not being used for production.
But Richard Gold, the director of the Centre for Intellectual Property Policy at McGill University, said the government started with an “if you build it, they will come approach,” but “it doesn’t quite work like that.”
There’s a big gap between the early-stage research that’s done at Canadian universities and the final-stage manufacturing that would be done at the BMC, he said.
While Canada used to have pharmaceutical companies that did extensive research and manufacturing, those companies have since been acquired by foreign giants and most of their research and development operations moved outside of Canada.
That includes Laval-founded BioChem Pharma, whose Montreal-area facilities, including research operations, were closed in 2003, slightly more than two years after it was acquired by a British company.
Canada’s pharmaceutical manufacturing capacity was always tied directly to the research and development that was being done here, he said, and without experienced people who could go work at places like the BMC, the government’s timeline was always unrealistic.
There’s still no reason for companies that don’t have any presence in Montreal to begin manufacturing here, said Gold, a law professor who also teaches in McGill’s department of human genetics. While the government can build physical capacity, if there aren’t people here who have the experience and skills to use the facility, the strategy won’t work, he said.
For Gold, it’s part of a larger problem with innovation policy in Canada, where early-stage research is supported, but the policies and support that would help companies take that research to the next level is lacking.
For example, a key component of mRNA vaccines — lipid nanoparticle technology — was developed at the University of British Columbia, Gold said, but it was companies outside of Canada that used that innovation to make vaccines.
The BMC is not designed to manufacture mRNA vaccines.
But building factories is easier for governments than creating an innovation policy that would support the growth of a research-driven domestic pharmaceutical sector.
“It’s not just a question of building the factory, it’s building up a business and having it located in Canada and then exporting to the world,” he said. “There’s a whole chain of things and (the government is) building the last thing, but forgetting about everything that comes before it.”
Champagne’s office declined to comment on the delays in a made-in-Montreal shot and the BMC’s struggle to find other manufacturing partners, directing questions to the National Research Council, which also declined to comment on the delays, and to the non-profit corporation that manages the facility.
Isabelle Caron, the president and CEO of Biologics Manufacturing Centre Inc., which took over management of the facility from the National Research Council in 2023, said she couldn’t comment specifically on the production of Novavax’s vaccine, citing confidentially agreements.
“The BMC does not own any rights to the products it manufactures and does not participate in the procurement and distribution decisions for these products. It is the responsibility of our clients to decide where they will produce and distribute their product for a specific market,” Caron, who declined an interview request, said in an email.
The non-profit, which pays the federal government $1 a year to lease the space and equipment, receives $17 million in annual funding from the federal government to ensure it is ready to “respond to future public health emergencies,” according to the National Research Council.
Caron said the BMC is providing services to two clients — but refused to say in response to a follow-up question whether that includes Novavax — and noted that the facility offers analytical testing and consulting services, as well as manufacturing.
The BMC is currently negotiating with more than a dozen potential clients, she said.
“Like any new biomanufacturing business, we are focused on developing our stream of prospects,” she said. “In this business the prospect development process is lengthy. Many options are explored before one comes to fruition.”