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
OTTAWA – Statistics Canada says wholesale sales, excluding petroleum, petroleum products, and other hydrocarbons and excluding oilseed and grain, rose 0.4 per cent to $82.7 billion in July.
The increase came as sales in the miscellaneous subsector gained three per cent to reach $10.5 billion in July, helped by strength in the agriculture supplies industry group, which rose 9.2 per cent.
The food, beverage and tobacco subsector added 1.7 per cent to total $15 billion in July.
The personal and household goods subsector fell 2.5 per cent to $12.1 billion.
In volume terms, overall wholesale sales rose 0.5 per cent in July.
Statistics Canada started including oilseed and grain as well as the petroleum and petroleum products subsector as part of wholesale trade last year, but is excluding the data from monthly analysis until there is enough historical data.
This report by The Canadian Press was first published Sept. 13, 2024.
MIAMI GARDENS, Fla. (AP) — Miami Dolphins quarterback Tua Tagovailoa sustained a concussion for the third time in his NFL career, leaving his team’s game Thursday night against Buffalo after running into defensive back Damar Hamlin and hitting the back of his head against the turf.
Tagovailoa remained down for about two minutes before getting to his feet and walking to the sideline after the play in the third quarter. He made his way to the tunnel not long afterward, looking into the stands before smiling and departing toward the locker room.
The Dolphins needed almost no time before announcing it was a concussion. The team said he had two during the 2022 season, and Tagovailoa was diagnosed with another concussion when he was a college player at Alabama.
Dolphins coach Mike McDaniel said Tagovailoa would get “proper procedural evaluation” and “appropriate care” on Friday.
“The furthest thing from my mind is, ‘What is the timeline?’ We just need to evaluate and just worry about my teammate, like the rest of the guys are,” McDaniel said. “We’ll get more information tomorrow and take it day by day from here.”
Some players saw Tagovailoa in the locker room after the game and said they were encouraged. Tagovailoa spoke with some players and then went home after the game, McDaniel said.
“I have a lot of love for Tua, built a great relationship with him,” said quarterback Skylar Thompson, who replaced Tagovailoa after the injury. “You care about the person more than the player and everybody in the organization would say the same thing. Just really praying for Tua and hopefully everything will come out all right.”
Tagovailoa signed a four-year, $212 million extension before this season — a deal that makes him one of the highest-paid players in the NFL — and was the NFL’s leading passer in Week 1 this season. Tagovailoa left with the Dolphins trailing 31-10, and that was the final score.
“If you know Tua outside of football, you can’t help but feel for him,” Bills quarterback Josh Allen said on Amazon following the game. “He’s a great football player but he’s an even greater human being. He’s one of the best humans on the planet. I’ve got a lot of love for him and I’m just praying for him and his family, hoping everything’s OK. But it’s tough, man. This game of football that we play, it’s got its highs and it’s got its lows — and this is one of the lows.”
Tagovailoa’s college years and first three NFL seasons were marred by injury, though he positioned himself for a big pay bump with an injury-free and productive 2023 as he led the Dolphins into the playoffs. He threw for 29 touchdowns and a league-best 4,624 yards last year.
When, or if, he can come back this season is anyone’s guess. Tagovailoa said in April 2023 that the concussions he had in the 2022 season left him contemplating his playing future. “I think I considered it for a time,” he said then, when asked if he considered stepping away from the game to protect himself.
McDaniel said it’s not his place to say if Tagovailoa should return to football. “He’ll be evaluated and we’ll have conversations and progress as appropriate,” McDaniel said.
Tagovailoa was hurt Thursday on a fourth-down keeper with about 4:30 left in the third. He went straight ahead into Hamlin and did not slide, leading with his right shoulder instead.
Hamlin was the player who suffered a cardiac arrest after making a tackle during a Monday night game in January 2023 at Cincinnati, causing the NFL to suspend a pivotal game that quickly lost significance in the aftermath of a scary scene that unfolded in front of a national television audience.
Tagovailoa wound up on his back, both his hands in the air and Bills players immediately pointed at him as if to suggest there was an injury. Dolphins center Aaron Brewer quickly did the same, waving to the sideline.
Tagovailoa appeared to be making a fist with his right hand as he lay on the ground. It was movement consistent with something that is referred to as the “fencing response,” which can be common after a traumatic brain injury.
Tagovailoa eventually got to his feet. McDaniel grabbed the side of his quarterback’s head and gave him a kiss on the cheek as Tagovailoa departed. Thompson came into the game to take Tagovailoa’s spot.
“I love Tua on and off the football field,” Bills edge Von Miller said. “I’m a huge fan of him. I can empathize and sympathize with him because I’ve been there. I wish him the best.”
Tagovailoa’s history with concussions — and how he has since worked to avoid them — is a huge part of the story of his career, and now comes to the forefront once again.
He had at least two concussions during the 2022 season. He was hurt in a Week 3 game against Buffalo and cleared concussion protocol, though he appeared disoriented on that play but returned to the game.
The NFL later changed its concussion protocol to mandate that if a player shows possible concussion symptoms — including a lack of balance or stability — he must sit out the rest of the game.
Less than a week later, in a Thursday night game at Cincinnati, Tagovailoa was concussed on a scary hit that briefly knocked him unconscious and led to him being taken off the field on a stretcher.
His second known concussion of that season came in a December game against Green Bay, and he didn’t play for the rest of the 2022 season. After that, Tagovailoa began studying ways where he may be able to fall more safely and protect himself against further injury — including studying jiu-jitsu.
“I’m not worried about anything that’s out of my hands,” McDaniel said. “I’m just worried about the human being.”
TORSBY, Sweden (AP) — David Beckham and former England coach Roy Hodgson were among the soccer dignitaries who attended the funeral of Sven-Goran Eriksson on Friday in the Swedish manager’s small hometown of Torsby.
Eriksson’s wooden coffin was covered in white flowers and surrounded by six tall candles and other floral wreaths as the ceremony began inside the 600-seat Fryksande church.
“It is a day of grief but also a day of thankfulness,” the priest, Ingela Älvskog, told those in attendance.
Beckham, who arrived by private jet on Thursday, greeted Eriksson’s 95-year-old father Sven and other family members with hugs inside the church before the funeral started.
Eriksson became England’s first foreign-born coach when he led the national team from 2001-06, and made Beckham his captain.
Eriksson, who also won trophies at club level in Italy, Portugal and Sweden, died on Aug. 26 at the age of 76, eight months after he revealed he had been diagnosed with pancreatic cancer and had at most one year to live.
Some 200 seats in the neo-Gothic church from 1898 were reserved for his family, friends and players from his career in the football world, according to his agent. The remaining seats were open for the public, according to Eriksson’s wish, with a big screen set up outside the church where hundreds more gathered to watch the ceremony. The funeral was also broadcast live on some Swedish media websites.
The wooden coffin was wheeled in by pallbearers at the church Friday morning as fog wrapped Torsby — a town of about 4,000 people located about 310 kilometers (193 miles) west of Stockholm. Next to the casket was a photo of Eriksson on a small table. The floral wreaths included ones sent by FIFA and Lazio, the Italian team that Eriksson led to the Serie A title in 2000.
The ceremony began with somber piano and organ music, but later took on a more upbeat note with Swedish singer Charlotta Birgersson performing Elton John’s song “Candle In The Wind” and then “My Way” in a duet with Johan Birgersson, who later intoned the popular Italian song “Volare” after the family had gathered around the casket to lay flowers.
Beckham also visited Eriksson in Sweden in June to say goodbye. Others attending the funeral included the Swedish coach’s longtime partner Nancy Dell’Olio. Eriksson’s agent had said that guests from England, Italy and Spain were expected.
After the funeral, the casket was carried out of the church by eight men to the hearse. The guests then walked in a procession accompanying the coffin to a nearby museum where speeches and eulogies to the coach fondly known as “Svennis” were planned on an outdoor stage. A brass band played during the procession through Torsby, including the tune “You never walk alone” from the musical “Carousel” which has become the anthem of Liverpool, the club Eriksson supported since childhood.
The local soccer club Torsby IF, where Eriksson started his career in the 1960s, wrote on its webpage that “you also showed your greatness by always being yourself, the caring Svennis who talked to everyone and took the time, for big and small, asking how things were and how the football was going. We will miss you.”
