A nurse injects a volunteer with the Novavax vaccine during a trial at Howard University Hospital in Washington, on Jan. 22, 2021.Kenny Holston/The New York Times News Service
At the height of the pandemic in February of 2021, Prime Minister Justin Trudeau announced he had found a partner to make millions of doses of COVID-19 vaccines in a new factory his government was building to assuage concerns that Canada didn’t have enough manufacturing capacity to make its own shots.
More than three years later, that partner, Novavax Inc., won’t be making vaccines at the publicly owned plant in Montreal for the 2024-2025 season, which is part of the reason the federal government isn’t ordering any of the company’s shots for Canadians.
Novavax’s decision has left managers of the Biologics Manufacturing Centre (BMC), which was built with nearly $130-million in federal funds, working to drum up other business for a 55,000-square-foot plant that was completed in the summer of 2021. No other vaccines or biologic medications are currently being made there, according to the president of the non-profit corporation that oversees the BMC.
Meanwhile, the Public Health Agency of Canada says provinces that want to offer the Novavax vaccine can order doses made in India.
The BMC’s hunt for new clients after the years spent preparing to make the Novavax shot underscores the challenges of operating a public vaccine plant whose raison d’être is fighting an unknown pathogen years or decades in the future. The country doesn’t want to be caught without spare domestic capacity to make shots as it was when COVID-19 hit, but nor can it afford to let a publicly owned vaccine plant sit nearly idle.
Churning out annual COVID boosters isn’t a solution because demand for the shots has plunged, which is likely a key reason Novavax opted not to manufacture its shot in Montreal this year. The company declined to answer that question.
“What do you do with these facilities between now and when we next need them for that 9-1-1 response?” said Andrew Casey, the president and chief executive officer of BIOTECanada, a lobby group for the life sciences industry. “Because they’re not like a warehouse where you can build it, put paper on the windows, turn the lights out, shut the door, and then, in 30 years, come back and say, ‘Oh, we need the extra space, so let’s open it up.’”
That said, Mr. Casey doesn’t think that will be the fate of the Biologics Manufacturing Centre. He and other industry experts say the facility fills an important gap in Canada’s biotechnology landscape, particularly for domestic startups looking for a factory that can take experimental vaccines and biologics from early-stage trials to Health Canada approval.
“It took COVID to stimulate the government to make this facility, which is a great step forward,” said Tony D’Amore, a biotech consultant who worked in product development at Sanofi Canada for nearly 30 years. “I think it’s a great investment – an investment that came too late.”
The BMC is a contract manufacturing organization, which means it makes vaccines and biologic medicines for other companies.
Isabelle Caron, president and chief executive officer of the BMC, said it is typical for a startup plant to take some time to find clients. “In this business, the prospect development process is lengthy,” she said in a written statement. “Many options are explored before one comes to fruition. Given this, we are engaging with as many prospects as possible, which would be more than a dozen.”
Ms. Caron added that although no vaccines or biologics are currently being made at the facility, the BMC’s staff is providing unspecified contract services to two clients. She declined to name the clients, citing confidentiality provisions in their contracts.
She also declined to say how many people are employed at the BMC, or reveal its annual budget, most of which is provided by the federally funded National Research Council. The BMC was built on the NRC’s Royalmount site in Montreal.
François-Philippe Champagne, the federal Minister of Innovation, Science and Industry, declined an interview request. His office referred The Globe and Mail’s questions to the BMC, Novavax and the Public Health Agency of Canada.
One of those questions was about the status of Novavax’s deal with Canada. The Maryland-based startup was one of eight suppliers with which the Liberal government signed advanced purchase agreements in 2020, when it wasn’t clear which vaccine-makers would be the first to produce safe and effective shots. The federal government committed to buying 52 million doses of the Novavax shot, with an option to purchase 24 million more.
Pfizer-BioNTech and Moderna, makers of vaccines using new mRNA technology, crossed the finish line first. They continue to dominate what’s left of the global market for COVID vaccines.
Novavax, whose shot is made with longer-established protein subunit technology but took longer to be licensed, struggled to gain a foothold. Canada is a case in point: Last season, only 5,529 of the 125,000 Novavax doses Ottawa ordered were administered, the Public Health Agency of Canada said.
Novavax said it risked going out of business before the French pharmaceutical giant Sanofi tossed it a lifeline by taking a minority stake in the company in May.
A year earlier, in June of 2023, the federal government and Novavax amended their advance purchase deal. Ottawa agreed to pay Novavax US$349.6-million to forfeit most of the shots it pre-ordered, while Novavax confirmed that it would make shots at the BMC in 2024 and 2025, according to filings with the U.S. Securities and Exchange Commission. The filing notes that the Canadian government may terminate its agreement with Novavax, “if the company fails to achieve regulatory approval for use of BMC for Vaccine production on or before December 31, 2024.”
Public Services and Procurement Canada, the federal ministry that signed the original vaccine deals, told The Globe it was still “assessing options for the way forward,” with Novavax. Novavax said it could not comment on continuing contract discussions and would not say whether it plans to make vaccines at the Montreal plant in the future.
In the meantime, Alan Bernstein, a member of Canada’s COVID-19 vaccine task force who is now a professor and director of global health at the University of Oxford, said if the BMC doesn’t begin making products for companies other than Novavax soon, there is a risk that good staff will leave.
“Canada is better off having domestic capacity than not having domestic capacity,” Dr. Bernstein said. “Public funds were paid for the BMC, so I think it’s reasonable to ask: What are they doing to hustle up business?”