Hindered by past government missteps, Canada’s vaccine efforts may have to heavily rely on other countries for manufacturing
|Toronto Star 14 May 2020 at 00:54|
There are more than 100 COVID-19 vaccine candidates being developed, and with each one scientists are trying to condense a process that historically takes 10 years into just 12 to 18 months.
Even if a safe and effective vaccine is made under that accelerated timeline, however, “that’s kind of the end of the beginning,” said Andrew Casey, president of BIOTECanada, an industry group whose members include companies working on COVID-19 treatments and vaccines.
“That puts into motion all of the other challenges we have to overcome, not least to manufacture it.”
The development of a vaccine has been described by policy makers as the world’s best bet to snuff out the coronavirus . But making those vaccines into doses that can then be distributed to the public will be an obstacle-ridden road. Experts say this will be particularly true in Canada, where a limited manufacturing capacity — hindered by past government missteps and inaction — means our immunization efforts may be heavily reliant on other countries.
“At one point, Canada was well positioned in terms of manufacturing capacity...that capacity was lost,” said Dr. Volker Gerdts, director and chief executive of the Vaccine and Infectious Disease Organization’s International Vaccine Centre, known as VIDO-InterVac, at the University of Saskatchewan.
“We had always raised concern that if an emergency disease or a pandemic hits the country, then Canada may not have enough capacity to produce vaccines. That is where we are at the moment.”
Canada is now trying to beef up its vaccine-making capacity. The federal government announced $29 million for the National Research Council of Canada for critical upgrades to its Human Health Therapeutics facility in Montreal, and $12 million for VIDO-InterVac’s new vaccine manufacturing facility.
Construction there is expected to be done in late 2021.
The rush for expanded manufacturing capacity is essential and highlights “mistakes we made in the past,” said Dr. Eric Arts, chair of Western University’s department of microbiology and immunology.
In 2007, the federal government partnered with the Bill and Melinda Gates Foundation, and there were plans to build an $88-million manufacturing facility in Canada to produce HIV vaccine candidates for use in clinical trials. But both sides abandoned the project, and the facility was never built.
“Looking back at it, it was the stupidest, most horrible mistake that could have been made. Because look where we are now,” said Arts, who is part of a team developing a COVID-19 vaccine at Western’s newly constructed facility.
Gerdts’ VIDO-Intervac is almost finished its pre-clinical tests of a COVID-19 vaccine in animals and aims to begin human trials as early as the fall. If Canada already had the necessary manufacturing infrastructure, Gerdts said, “We would have been faster in developing a vaccine. I think the lessons we learn from this is that we weren’t ready.”
Instead, Canada will likely have to rely on other countries for vaccine production as its own capacity catches up. And that scenario is fraught with uncertainty, vaccine makers say.
“Strange things happen to borders during pandemics and we’ve seen pretty much all of them happen in this one,” said Bruce Clark, president and CEO of Quebec-based Medicago.
Medicago uses a distant cousin of the tobacco plant to grow virus-like particles for its vaccine candidate. The company has the ability to manufacture more than 100 million doses a year, more than half of that coming out of its facilities in North Carolina.
The company is building a new facility in Quebec that would boost its production to more than a billion doses of a COVID vaccine per year, but that won’t open until 2023.
Until then, it’s unknown whether the U.S. government would let vaccines made on American soil be shipped north.
“Governments ultimately control the passage of goods across their borders. Definitely, we’ve seen this me-first mentality for whatever region and jurisdiction we’re looking at,” Clark said. “I think that unfortunately is something that’s going to persist until there is enough capacity worldwide to ease the concerns, to vaccinate enough people.”
Casey, of the industry association Biotec, said he believes part of the government’s strategy in funding research is to ensure Canada keeps its foot in the door once a vaccine becomes available.
“If part of the Canadian discovery is what goes into the ultimate solution, then for sure we would be part of the allotment process,” he said. “You want to accelerate as much as possible (anything) that puts you into the queue.”
During a pandemic, however, nothing replaces domestic capacity. “You need domestic capacity in some fashion because you need to be able to distribute quickly and without restriction,” Medicago’s Clark said.
Rather than a single vaccine immediately dominating the global market, he expects there will be different products used in different regions based on what is locally available.
The mere presence of manufacturing plants, however, does not guarantee the COVID-19 vaccine will be easily manufactured.
Many manufacturers are already committed to producing other important vaccines, Casey said, limiting their ability to ramp up production of a COVID vaccine once it’s ready.
The two largest vaccine makers with facilities in Canada, Sanofi Pasteur and GSK, are collaborating on a COVID vaccine. However, GSK, which has a contract to supply Canada with a pandemic influenza vaccine, already uses its Quebec plant to pump out seasonal flu doses. Sanofi, whose $500-million bulk manufacturing plant in Toronto will be up and running in 2024, said the new facility’s objective will be “to meet the growing demand” for antigens used in pertussis, diphtheria and tetanus vaccines.
Even if a facility has the capacity, it may not be designed to manufacture whatever COVID-19 vaccines become viable.
Researchers are using different methods in the race to make a vaccine. Some are based on proteins, while others use a benign virus, harmless to humans, to elicit an immune response. Others still are trying more novel methods, including RNA vaccines, which introduce a molecule that is coded to instruct the body to build specific antigens.
A manufacturing facility set up for one vaccine type may not be able to easily pivot to another. “It would be like asking a car plant to manufacture iPods,” Casey said.
Reconfiguring a facility could take months or years, and costs millions of dollars. “There are going to be companies who come up with a candidate vaccine but can’t produce it on commercial scale, so there is going to be this gap, where depending on the nature of the vaccine developed, it may not be able to be produced in a commercial capacity for a number of years,” Medicago’s Clark said.
The challenges do not end once the vaccines are manufactured. In a 2010 report on how Ontario fared during the H1N1 pandemic, which killed a reported 426 Canadians, the province’s top doctor describes an over-confident health system overwhelmed by “a mismatch between supply and demand” of vaccines.
The province believed its experience delivering the seasonal flu vaccine prepared it for handling “the largest and most rapidly executed immunization program in Ontario’s history.”
“As it turns out, that was a little like assuming that because you take a brisk walk every morning, you could compete in the Olympic 100 yard dash,” the report found.