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Health Canada still reviewing Merck COVID-19 drug – CTV News

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Health Canada says it’s still reviewing data on an antiviral COVID-19 drug that was authorized Thursday in the United Kingdom.

The federal regulator said it continues to receive data “as new information becomes available” from pharmaceutical company Merck on their drug molnupiravir, considered the first pill to successfully treat COVID-19.

It offered no timeline for completion of the review process.

“As the review is still ongoing, it is not possible to predict when a regulatory decision will be made,” Health Canada stated by email.

While molnupiravir was granted conditional authorization for use in Britain, it wasn’t immediately clear how quickly the pill would be available there.

Merck has been supplying data to Health Canada on a rolling basis since August, when the product was still undergoing clinical trials.

Health Canada said earlier Thursday by email that it was “awaiting the final package of manufacturing data” from Merck, but said later in the day that statement was issued in error, however did not immediately elaborate.

The regulator said its review will determine whether benefits of using the drug outweigh risks and ensure it meets “stringent safety, efficacy and quality requirements.”

Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.

The company also didn’t disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.

Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University in Atlanta, Ga., decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck.

The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumours.

Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans.

Dr. Sumon Chakrabarti, an infectious disease expert in Mississauga, Ont., said molnupiravir is intriguing because the errors it inserts into the genetic code aren’t recognized as errors by the SARS-CoV-2 virus.

“So that lead to massive mutations and the virus dies,” he said. “It’s kind of cool, actually.”

Merck Canada said Thursday that Health Canada will decide on authorization after reviewing “all necessary evidence.”

The company added that a supply agreement was not yet in place but that conversations with the Canadian government were ongoing.

“We remain committed to working with the government to ensure Canadians will have access to our medicine should it receive market authorization by Health Canada,” Merck said in an email from its media centre.

Chakrabarti said the current context of COVID-19’s circulation in the United Kingdom, where there’s been a “slow burn of a ton of hospitalizations,” may have provided more urgency for regulators there to authorize the drug on a conditional basis.

He said Health Canada will consider use of the drug “in the Canadian context.”

“They’ve been pretty good about not rushing things,” he said of the Canadian regulator. “They look at the data and when they make a recommendation, you can trust it.”

Molnupiravir is also pending review with regulators in the United States, the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization.

The pill, a take-home treatment, was licensed in Britain for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug twice a day for five days.

Chakrabarti, who hasn’t seen the clinical trial data, said the caveat with the drug is that it has to be taken early — either shortly after exposure or in the first days of infection.

“The absolute risk reduction doesn’t seem to be that high, but at least it’s another tool in the box,” he said. “Anything we can use to to prevent hospitalization is good.”

With files from The Associated Press

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Protecting Prince Harry cost Canadians more than $334,000 – CBC News

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Protecting Prince Harry and his family during visits to Canada cost Canadian taxpayers more than $334,000 over a period of less than four years, CBC News has learned.

Records obtained by CBC News from the Royal Canadian Mounted Police under the Access to Information Act show that security related to Harry’s visits between April 1, 2017 and March 31, 2018 cost taxpayers $182,430. That sum covered things like overtime and travel costs but not the salaries of police officers.

In January 2020 — as the Duke and Duchess of Sussex publicly contemplated living in Canada part of the year — the RCMP estimated that protecting them and their son while in this country could cost taxpayers nearly $33,000 a month.

According to the Court Circular, which outlines the public activities of members of the Royal Family, Prince Harry had one public visit to Canada during 2017 and 2018 — a week-long trip to attend events in Toronto. The events included the Invictus Games — which Harry founded — a WE Day celebration and a reception for young people who received Duke of Edinburgh gold awards.

Prince Harry spoke at a We Day Toronto event in September 2017 during a week-long visit to Canada to attend the Invictus Games. (Nathan Denette/Canadian Press)

Prince Harry’s appearance at the Invictus Games drew widespread media attention because it was one of the first times he was seen in public with Meghan Markle, an American actress living in Toronto.

The pair, who met in July 2016 in London, were engaged in November 2017 and married in May 2018, when Prince Harry was granted the title of Duke of Sussex.

That wasn’t Prince Harry’s only visit to Toronto during that period. In April 2017, paparazzi photographers waiting outside Markle’s home in Toronto’s Seaton Village neighbourhood captured images of Prince Harry arriving at her home during a private, unannounced trip.

People watch the Royal Wedding between Prince Harry and Meghan Markle at the Princess of Wales Theatre in Toronto on Saturday, May 19, 2018. (Marta Iwanek/Canadian Press)

It’s not known how many times Prince Harry came to Canada to visit Markle. The RCMP refused to provide a breakdown to explain how it spent $182,430 to protect him during 2017 and 2018. Public Safety Minister Marco Mendicino’s office referred questions to the RCMP.

Spokespeople for the Duke and Duchess of Sussex’s Archewell organization did not respond to questions and interview requests from CBC News.

Pursued by the press

Alastair MacPherson, a photographer who has done freelance work for Splash News, said photographers started hanging out around Markle’s house when news came out in the fall of 2016 that she and Harry were dating.

“Before everyone knew that they were seeing each other, he was here for some time around Halloween and they went to some Halloween party,” he said. “After that happened, people found out that they might be seeing each other and that’s when the reporters and photographers would have been trying to find him.”

When Prince Harry visited Markle, six black SUVs with members of Prince Harry’s British security detail could be seen on the residential street, said MacPherson.

Pierre-Yves Borduas, a former deputy commissioner of the RCMP who is now president of PY Safety, said RCMP officers would have accompanied the British security officers.

Prince Harry made a private trip to Toronto in December 2016, detouring to visit Markle on his way home from an official visit of seven Caribbean countries. He also travelled to Toronto on a public trip earlier that year in May — two months before he met Markle — to announce that the 2017 Invictus Games would be held there.

The additional costs to the RCMP for Prince Harry’s security during that period totalled $52,978.

The RCMP incurred $5,726 in costs to protect the Duke and Duchess of Sussex between April 1, 2018 and March 31, 2019 and no costs at all from Jan. 1, 2014 to March 31, 2016.

Canada’s image is on the line: security expert

When someone like Prince Harry travels to Canada for official duties or a private visit, the RCMP has to assess the potential threats to their safety and provide them with protection, said Borduas.

“They still have responsibility, because what if something would happen to that very important person in our country?” he said. “The ripple effect … could have a negative reflection on our country and how [seriously] we are taking the security of these types of individuals that are enjoying the hospitality of our country.”

While Borduas said he couldn’t explain how the RCMP spent $182,430 in a single year to protect Prince Harry, he said protecting him during the highly publicized, well-attended Invictus Games would cost more than security for a low-profile, private visit.

Once Harry stepped back from royal duties, the RCMP’s obligation to provide protection during his trips to Canada would have ended and responsibility for his security would have transitioned to other providers, said Borduas.

In the United Kingdom, a committee decides who warrants taxpayer-funded security, and being a member of the Royal Family does not guarantee round-the-clock protection. In March 2021, the Daily Mail reported that while royals like the Queen, Prince Charles and Prince William get 24/7 publicly funded security, others like Princess Anne and Prince Edward only get taxpayer-paid security when performing official duties or engagements. Still others, like Prince Harry’s cousins Princess Beatrice and Princess Eugenie, who have fewer official duties, have to pay for their own security.

‘This has the potential to cost us huge’

In the heavily redacted e-mails obtained by CBC News, the prospect of providing security for a member of the Royal Family living part of the year in Canada loomed large for people like Assistant Commissioner Bernadine Chapman, who headed the national division that provides protection for VIPs.

“Media is on this like a hot potato … so lots of coverage of the potential of the royals to spend half their time in Canada now, as an independent couple,” she wrote on Jan. 10, 2020. “Media spin is about the cost to Canadians … (Redacted) … We are having a greater conversation next week on the go forward on this. This has the potential to cost us huge!”

In the end, protecting the Sussexes during their Christmas in Canada until Feb. 27, 2020 cost the RCMP more than $93,000 — part of the $334,000 total.

In a briefing note to then-minister of public safety Bill Blair to explain its decision to tell the Metropolitan Police in early January of 2020 that it was going to end protective policing services for the Duke and Duchess of Sussex, the RCMP made a distinction between private and official visits by the couple.

“The Sussex family’s stay in Canada is of a private nature and, to date, there have been no official outings wherein the Duke and Duchess are representing the Queen,” the force wrote. “There is no indication of either the Duke or Duchess participating in any official capacity for the Crown in Canada in the next two months. Should this change, however, the RCMP will assess and provide security accordingly.”

Queen Elizabeth II, Meghan the Duchess of Sussex and Prince Harry watch a flypast of Royal Air Force aircraft over Buckingham Palace in London on Tuesday, July 10, 2018. (Matt Dunham/The Associated Press)

The couple’s decision later that month to step back from their roles as senior members of the Royal Family also played a role in the RCMP’s assessment, according to the briefing note.

“Family members on private visits to Canada are eligible to receive RCMP protective policing services in alignment with the RCMP’s assessment of threat/risk, but this is a reflection of their official status within the Royal Family,” said the note. “As per the statement from Buckingham Palace on January 18, 2020, the Duke and Duchess ‘will no longer use their HRH titles as they are no longer working members of the Royal Family.'”

The Canadian Taxpayers Federation — which first revealed the cost of RCMP security for the Duke and Duchess of Sussex’s Christmas in Canada — says it wants to see more transparency about where taxpayers’ money went.

“This isn’t just a few dollars and cents,” said CTF federal director Franco Terrazanno. “This is thousands and thousands of dollars that are being billed to taxpayers. So certainly we deserve an explanation and certainly we deserve full transparency.”

Elizabeth Thompson can be reached at elizabeth.thompson@cbc.ca

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Tracking omicron: Canadian scientists race to understand new variant – CBC News

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Canadian scientists are racing to understand more about the threat of the omicron variant — how fast it spreads, whether it causes more or less severe illness, and if it can escape previous immunity to COVID-19 — but it could take weeks before a full picture emerges.

There have been dozens of suspected and confirmed cases of omicron reported throughout Canada in recent days, but several have no known link to international travel and have prompted concerns the variant could already be driving outbreaks here.

Health officials in London, Ont., confirmed omicron is now linked to a cluster of at least 40 COVID-19 cases in the city associated with schools, child care centres and a church, with 171 high-risk close contacts identified. 

And countries such as South Africa, Denmark and England are already reporting widespread community transmission of the variant, with growing evidence that omicron was already spreading in Europe before it was identified by researchers in southern Africa. 

Dozens of suspected and confirmed cases of omicron have been reported throughout Canada in recent days, but several have no known link to international travel and have prompted concerns the variant could already be driving outbreaks here. (Evan Mitsui/CBC)

Canadian labs better prepared for omicron 

But the capacity to analyze this new variant and quickly share information about it both in Canada and globally has grown dramatically from a year ago, when the alpha and beta variants of concern first emerged.

“The most important thing for Canadians to know is that we have spent more than a year building the capacity for genomic surveillance,” said Catalina Lopez-Correa, executive director of The Canadian COVID Genomics Network (CanCOGeN). 

“But it’s really early days for us to predict the clinical outcomes, the transmissibility, also we don’t know if this variant will be as fast taking over like delta … all this we can only see with time.”

Marc-André Langlois, a molecular virologist at the University of Ottawa who heads the Coronavirus Variants Rapid Response Network (CoVaRR-Net), says labs across the country are working tirelessly to conduct experiments on omicron. 

“What’s changed is the fact that we’ve managed to bring our academic laboratory assets together,” Langlois said. “We have epidemiologists, we have modellers, we have immunologists, virologists and they’ve all come together.” 

Guillaume Bourque, director of bioinformatics at the McGill Genome Centre in Montreal, says Canada is also now able to act on the data more quickly.

“Now we have the system in place,” Bourque said. “We want to make it available to public health and to the scientific community as fast as possible, so that people can really start working on trying to understand the variant and then give advice to public health in terms of the best approach to try to contain it.”

Langlois says that the early data coming out of southern Africa on omicron is useful — but limited in scope.

“That snapshot is very, very different to the Canadian landscape. So the information we have now is indicative, but it’s not a true reflection of what’s going to happen when this variant spreads in Canada,” he said. “This is why we need a Canadian network to look at the Canadian situation.”

WATCH | Spike in COVID-19 levels in South Africa as omicron variant spreads:

South Africa sees spike in COVID-19 cases as omicron variant spreads

4 days ago

Duration 2:02

The omicron variant is driving a sharp increase in COVID-19 cases across South Africa. Scientists believe the variant is more transmissible, and may even bypass acquired immunity in some people who have recovered from COVID-19. 2:02

Langlois said the first tests will look at whether antibodies from COVID-19 vaccines will still neutralize the virus compared to other variants, but figuring out how much of an impact omicron could have on vaccine effectiveness at a population level will take time. 

“We’re talking about maybe two, three more weeks to get some neutralizing data from the blood of Canadians,” he said. 

Not enough data to ‘speculate’ on omicron impact yet

But Canadian scientists aren’t just looking on Canadian soil for answers — they’re also poring over hints from around the world about the impact omicron could have here. 

Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan, says epidemiologic data from documented omicron cases in Canada and globally will be key.

“We’re looking at the number of breakthrough infections that occur, looking at the number of people who’ve been vaccinated, who end up not only with infection with the omicron variant but also in the hospital,” she said. 

“We are reliant on these studies to determine really whether the vaccines will remain effective — including protecting against severe disease caused by omicron.” 

Another way scientists are understanding more about how omicron spreads is by experimenting with the virus in other species using challenge studies, where animal models are vaccinated and then infected with the variant to determine how severe their illness is. 

“We’re looking to see what type of clinical manifestations this variant causes in laboratory animals and if in laboratory animals this particular variant can transmit easily,” said Alyson Kelvin, a virologist at the Canadian Center for Vaccinology and VIDO in Saskatoon.

“Those are key evaluations that need to occur before we can really speculate anything about this variant.” 

People travel at Pearson International Airport during the COVID-19 pandemic in Toronto on Friday. New travel testing and restrictions have been put in place due to the omicron variant. (Nathan Denette/The Canadian Press)

Could omicron overtake delta in Canada?  

Delta remains the dominant variant in Canada, but if early speculation about omicron being more transmissible and causing less severe disease holds true, experts say we could be looking at a very different epidemic picture in Canada in the coming weeks and months. 

“To be honest, I wouldn’t be surprised if it does take off because if it’s like delta, the main thing we can do is slow down progression,” said Bourque. 

“We need to learn as much as we can from experiments that we’ll be doing here on those samples, but also from other colleagues from all over the world.” 

Bourque says Canadian scientists can piece together a better picture of omicron in the coming days, which will help  “buy ourselves a few weeks” to make the most educated decision possible going forward on how best to mitigate potential spread.

“What concerns I think a lot of scientists, including myself, is that we’re seeing omicron slowly overtaking delta in southern parts of Africa. So at least over there, it looks like it is more transmissible than delta,” Langlois said. 

“Will that hold true for Canada and the northern hemisphere? We don’t know. But it is likely to be more transmissible.” 

Delta remains the dominant variant in Canada, but if premature speculation about omicron being more transmissible and causing less severe disease holds true, experts say we could be looking at a very different epidemic picture in Canada soon. (Ben Nelms/CBC)

‘Concerning’ mutations don’t tell whole story

Omicron contains more than 30 mutations in the spike protein alone, the part of the coronavirus which helps it enter human cells, some of which are associated with resistance to neutralization from antibodies. 

But scientists are urging caution before drawing too much from the limited data on the real world impact of omicron to date.

“Those mutations are concerning, but we had several different variants across this pandemic that had mutations in very concerning sites and they didn’t end up being highly transmissible or more pathogenic,” said Lopez-Correa. 

Kelvin says just because a variant has concerning mutations, does not mean it will necessarily take off — especially in the face of other variants like delta.

“The beta variant, which was first identified in South Africa, had probably the lowest amount of neutralization from either vaccine antibodies or antibodies from people who’ve recovered from COVID-19,” she said. 

“But that’s not the variant that we saw that spread around the world.” 

Until we know more from laboratory tests and real world data in highly vaccinated populations, speculation about the impact omicron could have in Canada and around the world should be weighed carefully. 

“Yes, this variant is concerning. Yes it will likely be more resistant to neutralization. But is this variant a monster? Probably not. ​​The vaccines will work against this variant,” said Langlois. 

“To what extent? That’s the question.” 

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Could surge in COVID-19 cases mean more restrictions? – CTV News

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BARRIE —
As Canada’s two most populous provinces grapple with a surge in COVID-19 cases, concerns are swirling over whether new restrictions could be imposed before the holidays.

On Saturday, 1,512 new COVID-19 cases were detected in Quebec, marking the highest single-day tally in the province since April.

A total of 1,234 new cases were reportedin the provinceon Tuesday.

Meanwhile, in Ontario, 1,184 new cases were detected on Sunday, marking the province’s highest daily increase in six months.

On Tuesday, Ont.officials said 928 more people had tested positive for the virus.

Dr. Doug Manuel is a senior scientist in the Ottawa Hospital Research Institute’s clinical epidemiology program.

He told CTV’s Your Morning that in some places, the increase in case counts has already resulted in additional restrictions.

“You’re already seeing it in say Windsor-Essex – they’ve reduced their capacity in restaurants by 50 per cent,” Manuel said Tuesday.

He said in Ontario, a lot of the places hardest-hit are rural communities outside of the greater Toronto area.

“In many places across Canada, we’re getting cases above 100 cases per million per day,” Manuel said. “That’s often when public health can’t keep up anymore with contact tracing and starts to think about more restrictions.”

To date, 76 per cent of the Canadian population are vaccinated against the virus.

Asked whether the vaccination rate means Canada could see less extreme measures, should they be reintroduced, Manuel said it “helps tremendously.”

 

Dr. Doug Manuel on restrictions amid case surge

“We’re following Europe,” he said. “Europe has about the same vaccination rate as us and many countries, they opened up quite quickly later in the summer or in the fall, and their cases went up quickly, and now they’re imposing restrictions and some of those countries are imposing more severe restrictions than we have in Canada.”

Manuel said he “hasn’t seen” a country or jurisdiction “successfully make that transition with current vaccination rates.”

“But that doesn’t mean that we have to have full restriction like we’ve seen in the past,” he said.

Ultimately, Manuel said things are dependent on what happens with the Omicron variant.

The variant — first detected in South Africa — has caused global panic. Several countries, including Canada, have imposed more stringent travel restrictions in a bid to keep the disease outside of their borders.

However, by Monday, at least 23 cases of the Omicron variant had already been detected in Canada.

Manuel said he expects Omicron will “take over as the dominant strain worldwide, sooner than later.”

He said researchers are waiting for more data from South Africa, to determine whether those who have been infected with the Omicron variant experience more severe symptoms.

“The hospitalization rates are starting to go up there quite quickly,” he said. “But we’re still hearing that people in hospital are less severe than they’ve seen in the past.”

He said “for sure it’s more transmissible.”

“It will likely take over very quickly, and the only question is as it comes in quickly, will that result in increase hospitalizations and deaths?” he continued. “That will dictate what we do moving forward.”

WHAT HAVE PROVINCIAL AUTHORITIES SAID?

Health officials in both Ontario and Quebec have suggested new restrictions are not in the immediate plans.

Last week, Ontario’s Chief Medical Officer of Health Dr. Kieran Moore said he doesn’t expect the province will re-impose restrictions due to the Omicron variant.

“If we see widespread presence of Omicron across Ontario, which is not the case at present, then we could review any measures that we need to take at a provincial level.”

He said, though that he doesn’t have a “crystal ball.”

Moore said if it’s a “less lethal virus,” has less impact on the province’s hospital sector and vaccines continue to work against it, “we will continue our current strategy and not have to have any further public health restrictions.”

However, on Tuesday, officials in Ontario did announce the pause on moving to the next step of reopening plans would continue indefinitely.

Next week, capacity limits were supposed to be lifted in some high-risk settings where proof of COVID-19 vaccination is required.

However, that was delayed last month due to a surge in cases. 

In new modelling released by the Science Table COVID-19 advisory for Ontario on Tuesday, researchers said cases are rising in “most public health units” across the province due to the Delta variant.

“Testing has not increased, but positivity is rising,” the updated projection document reads. “This is a real rise in cases.”

The scientists said modelling shows that, even without the Omicron variant, occupancy in intensive care units at hospitals in Ontario is expected to climb to between 250 and 400 by January, putting hospitals under strain once again.

“We can’t predict Omicron precisely, but it will almost certainly hit us hard and fast,” the scientists said in a series of tweets on Tuesday. “Cases are rising, even without much Omicron yet. Our hospitals and ICUs are feeling pressure again. We need to increase vaccination and we can’t let up on public health measures.”

Meanwhile in Quebec, officials announced Tuesday that gatherings of up to 20 vaccinated people will be allowed in private homes beginning on Dec. 23.

Currently only 10 people from no more than three households are allowed to gather in homes.

Premier Francois Legault said last week that the province was not planning to add additional public health measures.

“I know Quebecers well enough to know that there are many people fed up with the current measures,” he said. “We don’t like the trend, but it’s under control.”

Legault said as long as hospitalizations “stay at low levels, it remains under control.”

With files from CTV’s Katharine DeClerq and Sean Davidson, and The Canadian Press 

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