TORONTO —
Health Canada says it is working with international counterparts to review an experimental pill from drugmaker Merck, which the company reports can reduce hospitalizations and deaths by half in patients sick with COVID-19.
During a news briefing Friday, the Public Health Agency of Canada (PHAC) said Merck first submitted an approval request for molnupiravir, a twice-daily oral antiviral agent taken within five days after the onset of symptoms, as a potential treatment for COVID-19 on Aug. 13.
According to PHAC, the submission was accepted under the Minister of Health’s Interim Order, which allows for the review of “early safety, quality and efficacy data” while later-stage clinical trials take place
Canada’s chief medical adviser Dr. Supriya Sharma said review of the treatment is ongoing as more data from trials becomes available. Sharma said Health Canada will make an approval decision only when all necessary evidence has been submitted and reviewed.
“We are looking at it. We’re going through … the data,” she said.
Sharma said Health Canada has no specific time for completion of the review as it can take “months,” but also that the pill will be evaluated and “held to the standards” as any other medication or treatment.
According to Health Canada, it only authorizes treatments, including those for COVID-19, following a “thorough scientific review of the safety, efficacy and quality data.”
“A treatment must show evidence that it works well, is of high quality and is safe. The available data must demonstrate that the treatment’s benefits outweigh its risks,” the agency said in a statement.
Canada currently has four approved treatments for COVID-19, including Canadian-made COVID-19 monoclonal antibody bamlanivimab and antiviral medication remdesivir. However, these treatments require an IV or injection.
If cleared, molnupiravir would be the first oral pill shown to treat COVID-19.
Merck and its partner Ridgeback Biotherapeutics announced Friday that early results from its trials show that patients who received molnupiravir within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a placebo.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered to be at higher risk for severe disease because of health problems such as obesity, diabetes or heart disease. Among patients taking molnupiravir, 7.3 per cent were either hospitalized or died at the end of 30 days, compared with 14.1 per cent of those who recieved the placebo.
The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.
“It really takes what is the devastating disease and hopefully gives people confidence that it can be manageable,” Merck CEO Robert Davis said in an interview with CTV News.
Davis called the pill a “game-changer” that could potentially be used to treat non-hospitalized, less severe cases of COVID-19 from home.
Earlier study results from Merck showed the drug did not benefit patients who were already hospitalized with severe disease. Experts say this is expected, given that antiviral drugs are most effective before the virus ramps up in the body.
The study results have not been reviewed by outside experts, which is the usual procedure for vetting new medical research.
Merck said it plans to submit the data in the coming days to health officials in the U.S. and other countries to authorize the pill’s use.
A decision from the U.S. Food and Drug Administration could come within weeks after that, and be distributed soon after.
Similar to other antivirals, molnupiravir works by interfering with the virus’s ability to copy its genetic code and reproduce itself, a process known as excessive mutagenesis or “error catastrophe.”
Matthias Gotte, a professor of medical microbiology and immunology at the U of A, led the research and said in an interview with CTV News that the drug attacks the virus, but doesn’t block or inhibit its replication.
Gotte said molnupiravir changes the viral genome, causing the replication engine of the virus to make “sloppy copies” of these altered genomes that are useless and not viable.
While Merck only studied its drug in people who were not vaccinated, Gotte said it may also potentially work in vaccinated patients who get less severe, breakthrough COVID-19 infections.
However, Gotte said it is important to note that molnupiravir is not a replacement for vaccines.
“The principles are completely different. Vaccines, they prevent severe disease, and the drugs are used to treat,” he said. “Once you are infected, the big problem is with these antiviral drugs you can’t use them late, you have to use them as early as possible.”
Eleanor Fish, a senior immunologist with the Toronto-based University Health Network who is not affiliated with the U of A study or Merck, says the approval of molnupiravir would help those who are ineligible for vaccination as well as those most at risk of severe disease.
“We can jump up and down in the U.S. and Canada and say, ‘Hey, we’ve got another tool in our armoury,’ [and] that’s going to be great,” Fish told CTV News.
She added that the drug’s approval in other parts of the world will help countries that are struggling to acquire COVID-19 vaccines.
“I see this more as [an] incredible opportunity, with a limited number of vaccines available globally, to send this out to those jurisdictions where vaccination rates are very, very low,” she said.
VANCOUVER – Contract negotiations resume today in Vancouver in a labour dispute that has paralyzed container cargo shipping at British Columbia’s ports since Monday.
The BC Maritime Employers Association and International Longshore and Warehouse Union Local 514 are scheduled to meet for the next three days in mediated talks to try to break a deadlock in negotiations.
The union, which represents more than 700 longshore supervisors at ports, including Vancouver, Prince Rupert and Nanaimo, has been without a contract since March last year.
The latest talks come after employers locked out workers in response to what it said was “strike activity” by union members.
The start of the lockout was then followed by several days of no engagement between the two parties, prompting federal Labour Minister Steven MacKinnon to speak with leaders on both sides, asking them to restart talks.
MacKinnon had said that the talks were “progressing at an insufficient pace, indicating a concerning absence of urgency from the parties involved” — a sentiment echoed by several business groups across Canada.
In a joint letter, more than 100 organizations, including the Canadian Chamber of Commerce, Business Council of Canada and associations representing industries from automotive and fertilizer to retail and mining, urged the government to do whatever it takes to end the work stoppage.
“While we acknowledge efforts to continue with mediation, parties have not been able to come to a negotiated agreement,” the letter says. “So, the federal government must take decisive action, using every tool at its disposal to resolve this dispute and limit the damage caused by this disruption.
“We simply cannot afford to once again put Canadian businesses at risk, which in turn puts Canadian livelihoods at risk.”
In the meantime, the union says it has filed a complaint to the Canada Industrial Relations Board against the employers, alleging the association threatened to pull existing conditions out of the last contract in direct contact with its members.
“The BCMEA is trying to undermine the union by attempting to turn members against its democratically elected leadership and bargaining committee — despite the fact that the BCMEA knows full well we received a 96 per cent mandate to take job action if needed,” union president Frank Morena said in a statement.
The employers have responded by calling the complaint “another meritless claim,” adding the final offer to the union that includes a 19.2 per cent wage increase over a four-year term remains on the table.
“The final offer has been on the table for over a week and represents a fair and balanced proposal for employees, and if accepted would end this dispute,” the employers’ statement says. “The offer does not require any concessions from the union.”
The union says the offer does not address the key issue of staffing requirement at the terminals as the port introduces more automation to cargo loading and unloading, which could potentially require fewer workers to operate than older systems.
The Port of Vancouver is the largest in Canada and has seen a number of labour disruptions, including two instances involving the rail and grain storage sectors earlier this year.
A 13-day strike by another group of workers at the port last year resulted in the disruption of a significant amount of shipping and trade.
This report by The Canadian Press was first published Nov. 9, 2024.
The Royal Canadian Legion says a new partnership with e-commerce giant Amazon is helping boost its veterans’ fund, and will hopefully expand its donor base in the digital world.
Since the Oct. 25 launch of its Amazon.ca storefront, the legion says it has received nearly 10,000 orders for poppies.
Online shoppers can order lapel poppies on Amazon in exchange for donations or buy items such as “We Remember” lawn signs, Remembrance Day pins and other accessories, with all proceeds going to the legion’s Poppy Trust Fund for Canadian veterans and their families.
Nujma Bond, the legion’s national spokesperson, said the organization sees this move as keeping up with modern purchasing habits.
“As the world around us evolves we have been looking at different ways to distribute poppies and to make it easier for people to access them,” she said in an interview.
“This is definitely a way to reach a wider number of Canadians of all ages. And certainly younger Canadians are much more active on the web, on social media in general, so we’re also engaging in that way.”
Al Plume, a member of a legion branch in Trenton, Ont., said the online store can also help with outreach to veterans who are far from home.
“For veterans that are overseas and are away, (or) can’t get to a store they can order them online, it’s Amazon.” Plume said.
Plume spent 35 years in the military with the Royal Engineers, and retired eight years ago. He said making sure veterans are looked after is his passion.
“I’ve seen the struggles that our veterans have had with Veterans Affairs … and that’s why I got involved, with making sure that the people get to them and help the veterans with their paperwork.”
But the message about the Amazon storefront didn’t appear to reach all of the legion’s locations, with volunteers at Branch 179 on Vancouver’s Commercial Drive saying they hadn’t heard about the online push.
Holly Paddon, the branch’s poppy campaign co-ordinator and bartender, said the Amazon partnership never came up in meetings with other legion volunteers and officials.
“I work at the legion, I work with the Vancouver poppy office and I go to the meetings for the Vancouver poppy campaign — which includes all the legions in Vancouver — and not once has this been mentioned,” she said.
Paddon said the initiative is a great idea, but she would like to have known more about it.
The legion also sells a larger collection of items at poppystore.ca.
This report by The Canadian Press was first published Nov. 9, 2024.
