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Merck's experimental COVID-19 pill under review by Health Canada – CTV News

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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.”

Virologists out of the University of Alberta (U of A) tested the compound to see its mechanism of action, independently of Merck. Their findings were published in May in the Journal of Biological Chemistry.

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.

With files from The Associated Press

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Biden says United States would come to Taiwan’s defense

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The United States would come to Taiwan‘s defense and has a commitment to defend the island China claims as its own, U.S. President Joe Biden said on Thursday, though the White House said later there was no change in policy towards the island.

“Yes, we have a commitment to do that,” Biden said at a CNN town hall when asked if the United States would come to the defense of Taiwan, which has complained of mounting military and political pressure from Beijing to accept Chinese sovereignty.

While Washington is required by law to provide Taiwan with the means to defend itself, it has long followed a policy of “strategic ambiguity” on whether it would intervene militarily to protect Taiwan in the event of a Chinese attack.

In August, a Biden administration https://www.reuters.com/world/asia-pacific/us-position-taiwan-unchanged-despite-biden-comment-official-2021-08-19 official said U.S. policy on Taiwan had not changed after the president appeared to suggest the United States would defend the island if it were attacked.

A White House spokesperson said Biden at his town hall was not announcing any change in U.S. policy and “there is no change in our policy”.

“The U.S. defense relationship with Taiwan is guided by the Taiwan Relations Act. We will uphold our commitment under the Act, we will continue to support Taiwan’s self-defense, and we will continue to oppose any unilateral changes to the status quo,” the spokesperson said.

Biden said people should not worry about Washington’s military strength because “China, Russia and the rest of the world knows we’re the most powerful military in the history of the world,”

“What you do have to worry about is whether or not they’re going to engage in activities that would put them in a position where they may make a serious mistake,” Biden said.

“I don’t want a cold war with China. I just want China to understand that we’re not going to step back, that we’re not going to change any of our views.”

Military tensions between Taiwan and China are at their worst in more than 40 years, Taiwan’s Defense Minister Chiu Kuo-cheng said this month, adding that China will be capable of mounting a “full-scale” invasion by 2025.

Taiwan says it is an independent country and will defend its freedoms and democracy.

China says Taiwan is the most sensitive and important issue in its ties with the United States and has denounced what it calls “collusion” between Washington and Taipei.

Speaking to reporters earlier on Thursday, China’s United Nations Ambassador Zhang Jun said they are pursuing “peaceful reunification” with Taiwan and responding to “separatist attempts” by its ruling Democratic Progressive Party.

“We are not the troublemaker. On the contrary, some countries – the U.S. in particular – is taking dangerous actions, leading the situation in Taiwan Strait into a dangerous direction,” he said.

“I think at this moment what we should call is that the United States to stop such practice. Dragging Taiwan into a war definitely is in nobody’s interest. I don’t see that the United States will gain anything from that.”

(Reporting by Trevor Hunnicutt; Additional reporting by David Brunnstrom in Washington, Michelle Nichols in New York and Ben Blanchard in Taipei; Writing by Mohammad Zargham; Editing by Stephen Coates)

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Alec Baldwin fires gun on movie set, killing cinematographer, authorities say

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Actor Alec Baldwin fired a prop gun on a movie set in New Mexico on Thursday, killing cinematographer Halyna Hutchins and wounding director Joel Souza, authorities said.

The incident occurred on the set of independent feature film “Rust,” the Santa Fe County Sheriff’s office said in a statement.

“The sheriff’s office confirms that two individuals were shot on the set of Rust. Halyna Hutchins, 42, director of photography, and Joel Souza, 48, director, were shot when a prop  firearms was discharged by Alec Baldwin, 68, producer and actor,” the police said in a statement.

A Variety report https://bit.ly/3nnyldg said the shooting occurred at the Bonanza Creek Ranch, a production location south of Santa Fe in New Mexico.

No charges have yet been filed in regard to the incident, said the police, adding they are investigating the shooting.

Baldwin’s representatives did not immediately respond to Reuters’ request for comment.

 

(Reporting by Bhargav Acharya in Bengaluru; Editing by Karishma Singh)

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Trudeau 'confident' other countries will accept Canadians' proof of vaccination – CBC.ca

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Prime Minister Justin Trudeau said today he’s “very confident” countries around the world will accept Canadians’ proof of vaccination.

Today, the federal government announced that Canadians will be able to use a standardized provincial or territorial proof-of-vaccination documentation to travel internationally — although it will be up to foreign governments to accept them or not.

Government officials, speaking on background during a briefing this morning, said they worked with the provinces to come up with a “pan Canadian” format and are confident it will be widely accepted.

They added the government is working with other countries to ensure acceptance abroad.

“We are very confident this proof-of-vaccination certificate that will be federally approved, issued by the provinces with the health information for Canadians, is going to be accepted at destinations worldwide,” Trudeau told a news conference in Ottawa today.

The standardized COVID-19 proof of vaccination includes the holder’s name and date of birth, the number of doses received, the type of vaccine, lot numbers, dates of vaccination and a QR code that includes the vaccination history. Canadians can also request the proof by mail.

The documentation was designed with what the government calls a “common look” featuring the Government of Canada logo and the Canadian flag.

The official Canada wordmark on the top right of an Ontario vaccination proof document. (Government of Ontario)

The government said that as of today, Ontario, Quebec, Newfoundland and Labrador, Nova Scotia, Saskatchewan, Nunavut, Northwest Territories and Yukon are issuing the standardized proof of vaccination.

Trudeau said all the provinces and territories have agreed to issue the accepted credentials ahead of the holiday season.

“Not every province has yet delivered on that but I know they are all working very quickly and should resolve that in the weeks to come,” he said.

In Ontario, for example, fully vaccinated residents can download a QR code built to the SMART Health Card standard, which includes the Government of Canada “wordmark” or logo.

WATCH |  Canadians will be able to use their provincial vaccine certificates for international travel

Canadians will be able to use their provincial vaccine certificates for international travel, says Trudeau

10 hours ago

Prime Minister Justin Trudeau says that as more provinces and territories require the use of vaccine certificates, he is ‘confident’ that foreign governments will accept these documents from Canadians travelling internationally. 2:01

The SMART Health Card standard is a set of guidelines, approved by the International Organization for Standardization and endorsed by Canada, to store health information and is used by a number of tech companies, including Apple. 

The government said it’s talking to other countries to encourage them to recognize those who have received mixed vaccine doses as being fully vaccinated.

“This includes sharing Canada’s evidence and experience with mixed schedules of Health Canada-authorized vaccines for both AstraZeneca/mRNA and mixed mRNA doses,” says a government release.

“Initial outreach has focused on the ongoing exchange of technical and scientific information to advance this time-sensitive work.”

Proof can be used for domestic travel too

The standardized proof of vaccination can also be used when the requirement for proof of vaccination to travel domestically kicks in at the end of the month, although travellers can continue to use their old provincial proof of vaccination if their province is not yet issuing the standardized credentials.

As of Oct. 30, all travellers aged 12 and older taking flights leaving Canadian airports or travelling on Via Rail and Rocky Mountaineer trains must be fully vaccinated before boarding. Marine passengers on non-essential passenger vessels like cruise ships must also complete the vaccination series before travelling.

Mike McNaney is president of the National Airlines Council of Canada, which represents Canada’s largest air carriers — including Air Canada, Air Transat and WestJet. He said he welcomes the standardized approach and urged the government to ease off on other pandemic measures.

“With aviation becoming one of the only sectors requiring fully vaccinated employees and customers, it is imperative that the government work with us and determine what other travel measures can now be amended in keeping with global practices,” he wrote in a media statement.

“Such as elimination of blanket advisories against travel, elimination of mandatory PCR testing pre-departure for fully vaccinated international travellers coming to Canada, and enabling children under 12 to be exempt from de facto home quarantine.”

Officials said they considered other options, including federally issued credentials, but decided that would have “limited value” given that provinces and territories administered the shots and held the data.

They also said the global health travel advisories will soon adopt a destination-based approach, so that Canadians can better prepare travel plans.

Dispute over mandatory vaccine rule for MPs continues

Trudeau’s announcement comes as a fight brews over making vaccination mandatory for MPs ahead of Parliament’s return next month.

Earlier this week, the House of Commons’ governing body introduced a new mandatory vaccination policy for MPs and anyone else entering the House of Commons.

Conservatives said they oppose the “secret” move by the Board of Internal Economy and object to the idea of more virtual sittings of the chamber.

“While we encourage everyone who can be vaccinated to get vaccinated, we cannot agree to seven MPs, meeting in secret, deciding which of the 338 MPs, just elected by Canadians, can enter the House of Commons to represent their constituents,” said a statement from the party Wednesday.

 WATCH| ‘It’s not too much to ask’ — Trudeau discusses mandatory vaccination rule for MPs

‘It’s not too much to ask’ — Trudeau discusses mandatory vaccination rule for those working in the House of Commons

10 hours ago

Prime Minister Justin Trudeau addresses the COVID-19 vaccine mandate for MPs, which will be in place when Parliament resumes in November. 2:04

While the Conservative Party says that it supports vaccination as the “most important tool to get us out of this pandemic,” it did not require all of its candidates in the federal election to be fully vaccinated. It also didn’t reveal how many of its candidates were vaccinated.

Both the Liberals and NDP required that their candidates be vaccinated during the election campaign, though they did not extend that requirement to staff members. The Bloc Québécois said during the campaign that all of its candidates were vaccinated. The Green Party told CBC that both of its MPs have been fully vaccinated.

“It is puzzling to me that there are people out there that think that just because they are members of Parliament they do not need to keep themselves, their loved ones or their constituents safe, when the vast majority of Canadians have done the right thing,” Trudeau said Wednesday.

“It is on Mr. O’Toole to explain why he thinks people should not be fully vaccinated if they want to serve as members of Parliament, and why indeed he doesn’t even think there should be a hybrid model so those who aren’t fully vaccinated can still speak up for their constituents in the House of Commons.”

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