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COVID-19 antivirals: Canada authorizes at-home Pfizer treatment – CTV News

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OTTAWA —
Health Canada has authorized the use of Pfizer’s COVID-19 antiviral treatment Paxlovid, the first oral and at-home prescription medication to be cleared for use in this country.

The federal health agency says the prescription-only medication can be given to adults ages 18 and older to treat mild to moderate cases of COVID-19, if they have a confirmed positive test and are at a high risk of becoming seriously ill. 

The authorization comes with specific instructions on scenarios in which the regime cannot be used, including to prevent COVID-19 infections or to treat patients who are already hospitalized due to severe COVID-19 cases.

The medication— two antiviral medicines co-packaged together— cannot be taken for longer than five days in a row, nor can it be given to teens or children.

“The authorization today provides a new tool the toolkit against COVID-19 at a crucial time the pandemic as we’re faced with new variants. Importantly, it is a more accessible antiviral treatment for those at high risk of progression to severe COVID-19,” said Health Canada’s Chief Medical Adviser Dr. Supriya Sharma, during a technical briefing discussing Paxlovid’s authorization.

She said that while this treatment may help reduce the number of COVID-19 patients who end up in hospital, “no drug, including Paxlovid, is a substitute for vaccination,” when it comes to reducing the risk of hospitalization.

Prior to this oral medication getting authorized, the short list of Canadian-approved COVID-19 treatments had to be given in clinical settings.

“Our healthcare system and hospitals face significant pressures in this ongoing pandemic, this new treatment will provide a new option in the management of COVID-19,” said Pfizer Canada’s Hospital Business Unit Lead Kevin Mohamed in a statement. “Pfizer is ready to begin delivery in Canada immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”

FEDS PRIORITIZING ACCESS GIVEN LIMITED SUPPLY

Facing calls from the provinces for a swift rollout of this medication in the face of an expected surge in Omicron hospitalizations, the federal government announced Monday that the first 30,400 full treatment courses have already arrived in the country and will be distributed this week. 

“Pfizer is ready to start immediate delivery in Canada,” said Pfizer Canada spokesperson Christina Antoniou in an email.

The government has a deal in place with the pharmaceutical giant securing access to an initial one million treatment courses of the therapeutic drug this year, however given the high demand it could take some time before the complete order is fulfilled. Canada is set to receive another 120,000 over the course of February and March.

“My officials and I continue to work with Pfizer in order to finalize the delivery schedule for the remaining treatment courses and to accelerate deliveries of this highly sought after medication wherever possible,” said Procurement Minister Filomena Tassi during a press conference on Monday afternoon, declining to comment on the cost per treatment of this newly-authorized medication. 

Citing the “limited global supply,” Chief Public Health Officer Dr. Theresa Tam said that Public Health Agency of Canada has communicated to the provinces and territories an interim set of guidelines for use of this new treatment while supplies are limited. 

This means that provinces are being asked to prioritize giving this medication to:

  • Individuals who have the highest likelihood of severe illness including those who are immunocompromised regardless of vaccination status;
  • Individuals over the age of 80 whose vaccinations are not up to date; and
  • Canadians aged 60 or older who live in underserved rural or remote communities, long-term care homes, who are from First Nations, Inuit, and Metis communities, or whose vaccinations are not up to date.

Asked why the decision has been made to offer priority access to the unvaccinated, Tam said that’s because those who have not been vaccinated against COVID-19 are at higher risk of getting severely ill.

“This approach shows that we are prioritizing treatments to those most in need,” she said. 

As well, first use should be prioritized for those whose infections have been confirmed and are able to start the treatment within five days of symptom onset. Tam said that if PCR testing is not available, or if results will not be available until more than five days from symptom onset, a rapid antigen test may be used.

Responding to the authorization, Conservative Leader Erin O’Toole said the federal government is “late,” despite Canada being one of the first of a handful of countries that have signed off on use of the drug.

Five other countries have provided an emergency use authorization for the product, including the U.S. and the UK, though Canada is the first country in which the product has received a full authorization according to Pfizer Canada.

O’Toole is also calling for further deliveries to be ramped up, but dodged a question about his position on unvaccinated Canadians being among the priority groups who can access this new treatment.

EFFICACY AND SIDE EFFECTS  

Pfizer submitted its request for authorization to Health Canada, on Dec. 1, 2021. In November 2021, Pfizer released the results of their Phase 2/3 trials for the drug, stating that they had found the pills to significantly reduce hospitalization and death in COVID-19 patients. 

Pfizer said that in a randomized, double-blind study of more than 380 patients, there was an 89 per cent reduction in the risk of being hospitalized or dying of COVID-19 in patients that received Pfizer’s pill within three days of displaying COVID-19 symptoms, compared to the study group that received a placebo.

The drug giant has been submitting data to Health Canada on a rolling basis, with new information recently submitted showing its efficacy against the Omicron variant, with more data expected in the months ahead, said Sharma.

According to Pfizer, Paxlovid is designed to block the activity of an enzyme in SARS-CoV-2 that is essential for the virus to replicate itself, and also help to slow the breakdown of the pill’s ingredients in order to help combat the virus for longer.

“PAXLOVID stops the virus from multiplying. This can help your body to overcome the virus infection and may help you get better faster,” reads Health Canada’s authorization.

Paxlovid contains two medicines co-packaged together, a 150mg pink tablet of Nirmatrelvir and a 100mg white tablet of Ritonavir, which has been used in combination with other antiviral medications before.

The regime requires taking three pills taken consistently twice a day, for five days in a row. The agency has outlined on their website the detailed instructions for taking this medication, as well as a list of potential contraindications.

For example, Health Canada has issued warnings for patients with kidney or liver problems; patients with a human immunodeficiency virus (HIV) infection; patients who are pregnant, breastfeeding, or are planning to become pregnant; and patients who take a series of other commonly-used medicines which may interact with Paxlovid causing decreased drug effectiveness, or in some cases cause potentially serious effects.

Side effects can include an altered sense of taste, diarrhea, muscle pain, vomiting, high blood pressure, and headache. Though, given the limited use of this medication to date, the agency cautions that it is possible not all side effects are known at this time and advise speaking with a healthcare professional if other side “troublesome” effects arise.

“Health Canada’s review determined that the benefits pf Paxlovid outweigh its potential risks, but it’s important to remember that inherently all drugs carry some risks, and this is no different,” said Sharma. “As a prescription medication, patients need to discuss the risks and benefits of treatment with the healthcare provider who’s aware of their health conditions and other medications.”

“It’s not perfect by any stretch of the imagination. It’s good, and it’s very useful… But it’s not by any means, a panacea,” said Dr. Michael Reider with Western University’s Schulich School of Medicine in an interview with CTV News, adding that one key way that Paxlovid will be helpful is in keeping people out of ICUs, which will also help hospitals manage capacity.

“I think this is really encouraging to get our hospitals back to functioning at some level of near normal,” he said.

MERCK DRUG REVIEW ONGOING

Health Canada has also been reviewing an experimental pill from drugmaker Merck, called molnupiravir, since mid August.

The federal government has a contract to purchase 500,000 of Merck’s antiviral medication, with an option for 500,000 more pending regulatory approval.

In late December, the U.S. Food and Drug Administration issued an emergency use authorization for both Pfizer and Merck’s drugs. 

With files from CTV News’ Avis Favaro, Alexandra Mae Jones and Sarah Turnbull 

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Canada’s response to Trump deportation plan a key focus of revived cabinet committee

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OTTAWA, W.Va. – U.S. president-elect Donald Trump’s promise launch a mass deportation of millions of undocumented immigrants has the Canadian government looking at its own border.

Deputy Prime Minister Chrystia Freeland said Friday the issue is one of two “points of focus” for a recently revived cabinet committee on Canada-U.S. relations.

Freeland said she has also been speaking to premiers about the issue this week.

“I do want Canadians to know it is one of our two central points of focus. Ministers are working hard on it, and we absolutely believe that it’s an issue that Canadians are concerned about, Canadians are right to be concerned about it,” Freeland said, after the committee met for the first time since Trump left office in 2021.

She did not provide any details of the plan ministers are working on.

Public Safety Minister Dominic Leblanc, whose portfolio includes responsibility for the Canada Border Services Agency, co-chairs the committee. Freeland said that highlights the importance of border security to Canada-U.S. relations.

There was a significant increase in the number of irregular border crossings between 2016 and 2023, which the RCMP attributed in part to the policies of the first Trump administration.

The national police service said it has been working through multiple scenarios in case there is a change in irregular migration after Trump takes office once again, and any response to a “sudden increase in irregular migration” will be co-ordinated with border security and immigration officials.

However, Syed Hussan with the Migrant Rights Network said he does not anticipate a massive influx of people coming into Canada, chalking the current discussion up to anti-migrant panic.

“I’m not saying there won’t be some exceptions, that people will continue to cross. But here’s the thing, if you look at the people crossing currently into the U.S. from the Mexico border, these are mostly people who are recrossing post-deportation. The reason for that is, is that people have families and communities and jobs. So it seems very unlikely that people are going to move here,” he said.

Since the Safe Third Country Agreement was modified last year, far fewer people are making refugee claims in Canada through irregular border crossings.

The agreement between Canada and the U.S. acknowledges that both countries are safe places for refugees, and stipulates that asylum seekers must make a refugee claim in the country where they first arrive.

The number of people claiming asylum in Canada after coming through an irregular border crossing from the U.S. peaked at 14,000 between January and March 2023.

At that time, the rule was changed to only allow for refugee claims at regular ports of entry, with some specific exemptions.

This closed a loophole that had seen tens of thousands of people enter Canada at Roxham Road in Quebec between 2017 and 2023.

In the first six months of 2024, fewer than 700 people made refugee claims at irregular crossings.

There are 34,000 people waiting to have their refugee claims processed in Canada, according to government data.

In the first 10 months of this year, U.S. border officials recorded nearly 200,000 encounters with people making irregular crossings from Canada. Around 27,000 encounters took place at the border during the first 10 months of 2021.

Hussan said the change to the Safe Third Country Agreement made it less likely people will risk potentially dangerous crossings into Canada.

“Trying to make a life in Canada, it’s actually really difficult. It’s more difficult to be an undocumented person in Canada than the U.S. There’s actually more services in the U.S. currently, more access to jobs,” Hussan said.

Toronto-based immigration lawyer Robert Blanshay said he is receiving “tons and tons” of emails from Americans looking at possibly relocating to Canada since Trump won the election early Wednesday.

He estimates that about half are coming from members of the LGBTQ+ community.

“I spoke to a guy yesterday, he and his partner from Kansas City. And he said to me, ‘You know, things weren’t so hunky-dory here in Kansas City being gay to begin with. The entire political climate is just too scary for us,'” Blanshay said.

Blanshay said he advised the man he would likely not be eligible for express entry into Canada because he is at retirement age.

He also said many Americans contacted him to inquire about moving north of the border after Trump’s first electoral victory, but like last time, he does not anticipate many will actually follow through.

This report by The Canadian Press was first published Nov. 8, 2024



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Surrey recount confirms B.C. New Democrats win election majority

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VANCOUVER – The British Columbia New Democrats have a majority government of 47 seats after a recount in the riding of Surrey-Guildford gave the party’s candidate 22 more votes than the provincial Conservatives.

Confirmation of victory for Premier David Eby’s party comes nearly three weeks after election night when no majority could be declared.

Garry Begg of the NDP had officially gone into the recount yesterday with a 27-vote lead, although British Columbia’s chief electoral officer had said on Tuesday there were 28 unreported votes and these had reduced the margin to 21.

There are ongoing recounts in Kelowna Centre and Prince George-Mackenzie, but these races are led by John Rustad’s B.C. Conservatives and the outcomes will not change the majority status for the New Democrats.

The Election Act says the deadline to appeal results after a judicial recount must be filed with the court within two days after they are declared, but Andrew Watson with Elections BC says that due to Remembrance Day on Monday, that period ends at 4 p.m. Tuesday.

Eby has said his new cabinet will be announced on Nov. 18, with the 44 members of the Opposition caucus and two members from the B.C. Greens to be sworn in Nov. 12 and the New Democrat members of the legislature to be sworn in the next day.

This report by The Canadian Press was first published Nov. 8, 2024.

The Canadian Press. All rights reserved.



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Port of Montreal employer submits ‘final’ offer to dockworkers, threatens lockout

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MONTREAL – The employers association at the Port of Montreal has issued the dockworkers’ union a “final, comprehensive offer,” threatening to lock out workers at 9 p.m. Sunday if a deal isn’t reached.

The Maritime Employers Association says its new offer includes a three per cent salary increase per year for four years and a 3.5 per cent increase for the two subsequent years. It says the offer would bring the total average compensation package of a longshore worker at the Port of Montreal to more than $200,000 per year at the end of the contract.

“The MEA agrees to this significant compensation increase in view of the availability required from its employees,” it wrote Thursday evening in a news release.

The association added that it is asking longshore workers to provide at least one hour’s notice when they will be absent from a shift — instead of one minute — to help reduce management issues “which have a major effect on daily operations.”

Syndicat des débardeurs du port de Montréal, which represents nearly 1,200 longshore workers, launched a partial unlimited strike on Oct. 31, which has paralyzed two terminals that represent 40 per cent of the port’s total container handling capacity.

A complete strike on overtime, affecting the whole port, began on Oct. 10.

The union has said it will accept the same increases that were granted to its counterparts in Halifax or Vancouver — 20 per cent over four years. It is also concerned with scheduling and work-life balance. Workers have been without a collective agreement since Dec. 31, 2023.

Only essential services and activities unrelated to longshoring will continue at the port after 9 p.m. Sunday in the event of a lockout, the employer said.

The ongoing dispute has had major impacts at Canada’s second-biggest port, which moves some $400 million in goods every day.

On Thursday, Montreal port authority CEO Julie Gascon reiterated her call for federal intervention to end the dispute, which has left all container handling capacity at international terminals at “a standstill.”

“I believe that the best agreements are negotiated at the table,” she said in a news release. “But let’s face it, there are no negotiations, and the government must act by offering both sides a path to true industrial peace.”

Federal Labour Minister Steven MacKinnon issued a statement Thursday, prior to the lockout notice, in which he criticized the slow pace of talks at the ports in Montreal and British Columbia, where more than 700 unionized port workers have been locked out since Nov. 4.

“Both sets of talks are progressing at an insufficient pace, indicating a concerning absence of urgency from the parties involved,” he wrote on the X social media platform.

This report by The Canadian Press was first published Nov. 8, 2024.

The Canadian Press. All rights reserved.

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