When the federal government announced in November that it had signed a $32.5-million agreement to buy thousands of doses of an antibody treatment for COVID-19, the deal was touted as a rare Canadian success in the fight against the global pandemic.
Bamlanivimab, a treatment similar to an experimental drug U.S. President Donald Trump took for his coronavirus infection, was developed by Eli Lilly and Co. in partnership with AbCellera Biologics Ltd., a Vancouver startup whose initial public offering last month was the largest ever by a Canadian biotechnology company.
But so far, Canada’s homegrown COVID-19 treatment is proving to be a flop in Canada.
Provincial health ministries and front-line doctors are rejecting Bamlanivimab, saying the scientific evidence is too thin and the intravenous delivery method too difficult to pull off during a health care crisis. But Eli Lilly says the evidence is promising and more study results are on the way.
None of the 17,000 doses shipped to Canada – at a cost to the federal government of nearly $1,600 a dose – has been administered to a patient, despite the dire need for drugs to treat COVID-19.
AbCellera’s home province of British Columbia has refused to take delivery of the doses that Ottawa paid for. The Quebec government, after the recommendation of an expert report released in late December, has decided not to use the drug outside of clinical trials.
Other jurisdictions have been waiting for guidance from the Canadian Agency for Drugs and Technologies in Health (CADTH), the organization that advises the provinces and territories on how to use new drugs. On Thursday, CADTH said Bamlanivimab should not be given to patients as part of routine care for COVID-19 until there is more proof it works.
“I do think it’s unfortunate. The reality is that there’s a real paucity of effective drugs to treat COVID,” said Matthew Miller, a viral immunologist at McMaster University’s Institute for Infectious Diseases Research. “It’s not really that it’s not a good drug, it’s just that the window of opportunity is somewhat narrow.”
Bamlanivimab is a monoclonal antibody, a lab-created version of antibodies the human body makes when fighting off a viral infection. AbCellera uses artificial intelligence to identify which antibodies might work as drugs. In May, Ottawa announced $175.6-million in federal funding for the company for “medical countermeasures” against COVID-19, and for the building of an antibody-manufacturing facility.
When the pandemic hit, AbCellera passed blood samples from recovered coronavirus patients through its credit-card sized “antibody discovery engine” to find the best antibody, then partnered with Eli Lilly to turn it into a treatment for COVID-19.
The U.S. Food and Drug Administration granted Bamlanivimab emergency use authorization on Nov. 9. Health Canada followed suit 11 days later, authorizing the drug for COVID-19 patients who were at high risk of serious complications, but who were not yet sick enough to be admitted to hospital.
(The U.S. FDA has also granted an emergency-use authorization to a similar drug, a monoclonal antibody cocktail made by New York-based Regeneron Pharmaceuticals. It was Regeneron’s antibody treatment that Mr. Trump received in October.)
Monoclonal antibodies are designed to stop or slow down SARS-CoV-2, the virus that causes COVID-19, from replicating inside the body. The treatments have to be given as soon as possible after a person is infected, and are meant to provide temporary immunity, unlike vaccines.
The rub is that most people made seriously ill by COVID-19 don’t experience severe symptoms until later in the course of their illness, when the immune system goes into overdrive to fight off the virus.
By the time they’re sick enough to check into hospital, where IV drugs are most often administered in Canada, it’s too late for monoclonal antibodies to help.
Windsor, a border city that currently has the highest per-capita rate of active coronavirus cases in Ontario, has concluded it doesn’t have the resources to administer the 500 doses of Bamlanivimab it received from Toronto’s University Health Network, the hospital that initially received Ontario’s allotment of 3,400 doses. (UHN itself is still deciding what to do with the remaining doses, spokeswoman Ingrid Yu said.)
UHN dispatched the doses to help the Windsor region cope with an escalating crisis in its long-term care homes. But Bill Marra, a spokesman for recipient Hôtel-Dieu Grace Healthcare, said the crisis itself made administering the doses impractical.
The antibody treatment can’t be safely infused inside nursing homes without paramedics on site to monitor for adverse reactions, Mr. Marra said. The local paramedic service, now grappling with an outbreak in its ranks, was already stretched too thin answering emergency calls and transferring patients out of the region’s overwhelmed hospitals, he added.
Another hurdle is the dearth of robust clinical trial evidence for Bamlanivimab, according to CADTH, as well as the expert committees that advised British Columbia and Quebec.
Health Canada’s authorization of the antibody treatment was based primarily on the interim results of a trial called BLAZE-1 that found patients who took the drug were less likely to go the emergency room or be admitted to hospital than those who took a placebo. But the number of severe cases of COVID-19 in both groups was tiny.
“If this were any other disease, there would be no way that anyone would say we should be using this treatment,” said Andrew Morris, an infectious diseases physician and medical director of the antimicrobial stewardship program at UHN and Sinai Health System. “People are proposing using this drug on some of our most vulnerable patients. And I would say it’s a coin toss on whether it’s going to help or harm them.”
Eli Lilly disagrees. The company says that more promising evidence is emerging as clinical trials continue, and as Bamlanivimab is administered more widely in the U.S., where state governments and health care organizations are figuring out how to administer the drug in dedicated infusion centres and through home nursing services.
“The fact that we’re not seeing Bamlanivimab being used in Canada is deeply disappointing because case counts continue to increase and because patients who could potentially benefit from treatment with Bamlanivimab are waiting,” Michael McDougall, a spokesman for Eli Lilly Canada, said in a statement.
AbCellera said it couldn’t provide comment by deadline.
The Public Healthy Agency of Canada referred questions about the use of Bamlanivimab to provincial governments. A spokeswoman for Anita Anand, the federal Minister of Public Services and Procurement, said the initial, $32.5-million deal for Bamlanivimab was for up to 26,000 doses, 17,000 of which have delivered so far.
It’s up to the federal government to decide whether it wants to accept future allocations of the drug, Mr. McDougall of Eli Lilly Canada said.
With a report from Sean Silcoff
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