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Pfizer reaches safety milestone for COVID vaccine, CEO says – BNN

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Pfizer Inc. Chief Executive Officer Albert Bourla said that a key safety milestone had been reached in the study of its COVID-19 vaccine, and the drugmaker is now preparing to seek an emergency-use authorization from U.S. regulators.

Speaking at a virtual conference hosted by the New York Times on Tuesday, Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration. Last week, Pfizer and its partner BioNTech SE reported that an interim analysis showed their experimental vaccine was more than 90 per cent effective in preventing symptomatic cases of COVID-19.

“We are preparing now for submissions,” Bourla said at the conference without specifying when it anticipated to file for an emergency use authorization.

Nonetheless, Bourla added, important questions about the vaccine still remain to be answered. “When it comes to how durable the protection could be, this is something we don’t know yet,” he said.

Bourla added that Pfizer would soon release more detailed efficacy results.

Pfizer shares were up 1.6 per cent at 3:22 p.m. in New York.

Safety Data

Pfizer and BioNTech had been working to accumulate two months of follow-up safety data on volunteers who had received the full two-dose regimen of their vaccine. The FDA requires the information for emergency clearance.

The safety data is one of the last hurdles needed before Pfizer and BioNTech can apply for emergency authorization. The New York-based drug giant will continue to monitor trial participants well after any authorization or approval in order to assure that safety concerns don’t crop up later, Bourla said.

Also See: Azar says Biden transition delay won’t hamper vaccination plan

The Pfizer-BioNTech vaccine is slightly ahead of one from Moderna Inc. in the race to the finish line. Moderna announced Monday that its own candidate was 94.5 per cent effective. Moderna expects to get the safety data it needs by the end of the month, allowing it to file for emergency clearance in the coming weeks.

Bourla said at the New York Times conference that Pfizer had not been overly specific when it reported “more than 90 per cent efficacy” because that number was likely to fluctuate as the trial gained more cases. The company will report out an additional number once it publishes fuller data, he said.

mRNA Platform

The drug industry executive spoke alongside Bill Gates and Heidi J. Larson, director of the Vaccine Confidence Project, in a discussion about vaccine development, distribution and uptake.

The most recent trial results are “a glorious confirmation of the power of the technology,” Bourla said, referring the the novel messenger RNA used in Pfizer and BioNTech’s vaccine.

Bourla’s tenure at Pfizer spans more than 27 years. He said at a later conference held Tuesday by the online media publication STAT that it was one of the best days of his life when he learned of the vaccine’s success.

“You’re relieved because the news that you’re expecting to hear will not only determine the future of the company, but the future of your world,” Bourla said. “I felt that I was living a dream.”

Tumult, Scrutiny

At other times throughout the pandemic, the company has faced political tumult and scrutiny, Bourla said.

The Pfizer chief rebutted concerns that he sought to report the effectiveness of the vaccine before Election Day, potentially influencing the outcome of the U.S. presidential vote.

“I did not have any political or any artificial timelines in my mind,” Bourla said. Instead, at the start of the company’s work on the vaccine, he set an October goal after his scientists said the product would only be ready by mid-2021.

He pushed for the earlier date, he said, to have a vaccine ready for a possible winter surge of infections.

“I said, ‘Go back and see how many people would die’” if there were a new spike in cases. But the October timeline became publicly conflated with President Donald Trump’s political ambitions.

Bourla said he didn’t take U.S. taxpayer dollars for the vaccine’s research and development in order to avoid politics that might be attached to the effort. “When you want to go from the middle of next year to the middle of October, you need to remove any bureaucracy,” he said. “And I knew this would become very political.”

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Conservatives push for parliamentary committee study into failed vaccine deal – CTV News

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OTTAWA —
The federal Conservatives are calling for a parliamentary committee to probe the Liberal government’s plan to refit a National Research Council facility in Montreal to start producing a COVID-19 vaccine.

The government announced the $44-million project in May as part of a partnership between the NRC and a Chinese company to develop a made-in-Canada vaccine.

By August, the Liberals confirmed the partnership with CanSino Biologics had fallen apart, after the Chinese government had blocked shipments of vaccine samples meant to be used in clinical trials in Canada.

Conservative Leader Erin O’Toole has criticized the Liberals for putting too much faith in Beijing, and blamed the failed deal for Canada being late to order vaccines from other foreign companies.

The proposed committee probe would look at the investment intended to upgrade the NRC facility and how the deal impacted Canada’s efforts to ensure the country has timely access to vaccines.

Prime Minister Justin Trudeau admitted last week that Canada might have to wait for other countries to get access to vaccines, though the government and vaccine-makers have since downplayed any delay.

This report by The Canadian Press was first published Dec. 1, 2020.

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Conservatives press Trudeau government over COVID-19 vaccine after U.K. approval – News 1130

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OTTAWA – The Trudeau government is facing increasing pressure to give a clear timeline for COVID-19 vaccine distribution, after news the U.K. approved on Wednesday the Pfizer candidate for emergency use.

The U.K. is the first western country to approve a COVID-19 vaccine, a move that has prompted the federal opposition to once again ask why Canada didn’t move faster.

A statement from Conservative Leader Erin O’Toole says our allies have plans to get vaccines to their people in days or weeks, and yet the prime minister has no timeline and no plan.

“The U.K. has approved Pfizer’s vaccine and are ready to begin vaccinating people next week, yet Canadians still have no idea when they’ll get vaccines,” he says. “Our allies around the world have plans to get vaccines to their people while Prime Minister Trudeau has no timeline, no plan for distribution, and no plan on who will get vaccines first. Canadians deserve certainty.”

His point is being echoed by Tory MPs, with Marilyn Gladu saying, “It’s too bad that the Liberals’ lack of planning has resulted in Canadians going to be delayed months.”

Conservative MP Michael Barrett claims Canada didn’t act fast enough to ensure we had access to immunizations when our allies do.

“They’re going to start vaccinating their population. We’re seeing that by the end of the first quarter, the promise from the Liberals is that we’ll have six-million doses, which is about three-million vaccinations,” he says.

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The latest on the coronavirus outbreak for Dec. 2 – CBC.ca

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  • Coronavirus tracker: Follow the spread of COVID-19 as case numbers remain high in most of Canada.
  • Quebec hospitalization rates have doctors there concerned that allowing Christmas gatherings could lead to untenable January scenario.
  • Sask. corrections minister under fire because of COVID-19 outbreak at Saskatoon jail. .
  • U.S. advisory panel makes near-unanimous recommendations on priority groups to first receive a COVID-19 vaccine.
  • Read more: Neskantaga First Nation residents deal with evacuation, pandemic stressors because of water crisis; some of Canada’s biggest retailers say Ontario lockdown rules ‘might actually be making things worse.’

Bob Underhill, 84, and his wife Patricia, 82, who is suffering from Alzheimer’s, kiss through a face mask as they are allowed to resume visits with physical contact in London, U.K. at The Chiswick Nursing Centre, which introduced a coronavirus disease (COVID-19) test with results ready in 30 minutes. (Kevin Coombs/Reuters)

Vaccine public opinion polling reflects polarization seen throughout pandemic

Since attention has turned to vaccines and what appears to be the likelihood in the near future that at least one will be authorized as safe to use for most Canadians, the Conservatives in Ottawa have focused their attacks on the federal government’s plan to acquire and distribute the doses, writes CBC’s Éric Grenier.

Conservative Leader Erin O’Toole has claimed that Canada will be “near the back of the line” for vaccines because of the country’s dependence on companies with production facilities outside the country. But this week’s Léger poll suggests a minority of Canadians share O’Toole’s concern — while 37 per cent of Canadians are worried Canada might not get the vaccine at the same time as the United States and the United Kingdom, 48 per cent said they are “not that concerned” and feel “a few months won’t make much of a difference.”

The Léger poll suggests Conservative voters are the ones most likely to be concerned about delays — and the ones least likely to say they would take the first vaccine made available to the public. According to Léger, about half of Conservative voters believe that the current federal government is withholding information about vaccines, with only 15 per cent of Liberal voters holding a similar view.

Trust in a vaccine could have an impact on Canadians’ willingness to get in line, and it appears to be taking on a partisan hue, writes Grenier.

On average, recent polls conducted by Abacus, Angus Reid and Léger suggest only 34 per cent of Canadians would get immunized as soon as possible, while 41 per cent said they would wait a little before getting the needle. Between 11 and 15 per cent of those polled said they would not get vaccinated at all.

In the Reid, Abacus and Léger surveys, an average of just 27 per cent of Conservative voters said they would get vaccinated as soon as possible, compared to 43 per cent of Liberals and 39 per cent of New Democrats.

Click below to watch more videos from CBC News

As Canada prepares to distribute millions of doses of COVID-19 vaccines in January, Chair of the National Advisory Committee on Immunization Dr. Caroline Quach-Thanh and David Levine, who managed the H1N1 vaccine rollout for Montreal, say this vaccination campaign won’t be without challenges. 3:56

IN BRIEF

Quebec hospitals filling up, doctors concerned Christmas gatherings could push them over the edge

Quebec hospitals usually see a rise in visits to the emergency room in early January, but as of Wednesday morning, nearly one-third of the province’s emergency rooms are operating at full capacity or greater.

For now, the province plans to allow Quebec residents up to two gatherings between Dec. 24 and Dec. 27, with a maximum of 10 people in attendance and with no limit on the number of households those people would come from.

Dr. Vincent Bouchard-Dechêne, an internal medicine specialist at Notre-Dâme Hospital in Montreal, doesn’t see how hospitals can deal with an increase in COVID-19 patients after the holidays while still providing service to people with other ailments.

“To limit gatherings during Christmastime would be the best gift we could give ourselves,” said Bouchard-Dechêne.

Premier François Legault has said he will make a final call on holiday gathering guidelines by Dec. 11, but Dr. Matthew Oughton, a physician with the Jewish General Hospital’s infectious diseases division, is among those questioning that timeline.

The characteristics of COVID-19, including the time it takes for its symptoms to appear, make it difficult for trends to change much between now and Dec. 11, some doctors say.

“That’s really at the fine cutting edge of where anything that you would do today, you’d really see changes reflected in the numbers by Dec. 11,” said Oughton.

Read more about what’s happening in Quebec 

Sask. minister under fire over COVID-19 outbreak at jail

Some NDP members of the legislature are calling on Saskatchewan’s corrections minister to resign amid an outbreak at the Saskatoon Correctional Centre.

Corrections and Policing Minister Christine Tell says the government is doing all it can to protect the inmates and staff at the jail, but has offered little in the way of specifics. In the past 10 days, the number of staff and inmates testing positive for COVID-19 at the centre has gone from none to 142.

“Why it came into the facility with all the precautions, I can’t answer that,” said Tell.

Advocacy groups are calling for the targeted release of inmates from the centre. Earlier this year, the province’s Public Prosecutions agency moved to reduce the numbers in the province’s jails, instructing prosecutors to review all new arrests with an eye to keeping non-violent accused out of jail.

The order was a response to fears about the coronavirus getting into the jail system, which has been a problem during the pandemic in a number of North American prisons and jails. A CBC News analysis earlier in the year found infection rates among those Canadians imprisoned or jailed were up to nine times higher than in the general population.

According to the government, decisions about releasing inmates at the Saskatoon facility who don’t pose a community risk would be made by Public Prosecutions.

Tell said the jail has been taking precautions to slow the spread, including mandatory masking, no longer charging inmates for soap and banning visitors.

NDP MLA Nicole Sarauer said the province’s handling and response should cost Tell her position.

“This is a minister who shouldn’t be a minister anymore,” Sarauer said.

Read more about the situation in Saskatchewan 

U.S advisory panel sets out priority groups for 1st vaccinations

Health-care workers and nursing home residents should be at the front of the line when the first coronavirus vaccine shots become available in the U.S., an influential government advisory panel said this week in a near-unanimous verdict.

The U.S. Advisory Committee on Immunization Practices voted 13-1 to recommend to the Centers for Disease Control those groups — which comprise about 24 million Americans — get priority in the first days of any coming vaccination program, when doses are expected to be limited.

About three million people in the U.S. live in nursing homes, long-term chronic care hospitals and other long-term care facilities. Those patients and the staff members who care for them have accounted for six per cent of U.S. coronavirus cases and a staggering 39 per cent of deaths, CDC officials say.

The recommendations are not binding, but the panel dates back to 1964 and for decades its advice has been widely heeded by doctors. But one potential complication is that it will be governors and state officials who ultimately have final say on the prioritization of specific populations in their jurisdictions.

The panel will meet again at some point to recommend who should be next in line. Among the possibilities: teachers, police, firefighters and workers in other essential fields, such as food production and transportation, could be among those under consideration then.

In Canada, the National Advisory Committee on Immunization, or NACI, has released preliminary recommendations that prioritize the elderly and others at severe risk of illness, including health-care workers, front-line staff and those with lower access to health care, such as Indigenous populations.

Read more about the recommendations 

(CBC News)

Stay informed with the latest COVID-19 data.

THE SCIENCE

U.K. approves Pfizer coronavirus vaccine for emergency use

Britain’s Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the United Kingdom, approved Pfizer’s COVID-19 vaccine for emergency use on Wednesday.

While the U.K. has ordered 40 million doses of the Pfizer vaccine — enough for 20 million people — Conservative Health Minister Matt Hancock said the first shipment will be 800,000 doses and will arrive “within days” to the National Health Service.

China and Russia have offered different vaccinations to their citizens ahead of late-stage testing, but Britain is the first to sign off on a COVID-19 vaccine through a Western-style regulatory process.

The U.S. Food and Drug Administration is set to meet on Dec. 10 to review the Pfizer product. Pfizer’s vaccine is among seven that Canada has pre-ordered, and Health Canada’s chief medical adviser, Supriya Sharma, has said regulators here are expected to make decisions on timelines similar to those followed by the U.S.

Final testing must still be completed for the shots made by U.S.-based Pfizer and its German partner BioNTech, but results appear to be effective at preventing mild to severe COVID-19 disease, with no known serious side-effects so far.

The vaccine itself does come with challenges in terms of deployment. It must be stored and shipped at ultra-cold temperatures of around -70 C, unlike some of the other vaccine candidates, and it will be delivered with a saline solution for dilution purposes.

AND FINALLY…

Nova Scotia study to examine COVID-19 shaming

Motorists go through checkpoints on July 3 leaving the Confederation Bridge in Borden-Carleton, P.E.I., as part of Atlantic Canada’s travel bubble. While the region has generally not seen virus outbreaks as in other parts of the country, shaming of those who test positive occurs, says a Dalhousie professor. (Brian McInnis/The Canadian Press)

A Dalhousie University professor hopes that a study of shaming during the COVID-19 pandemic can be a start to breaking the historical cycle. International development studies professor Robert Huish is looking for people who have been the targets of pandemic shaming to tell their stories.

Huish is starting his study in Nova Scotia, but hopes to expand it across Atlantic Canada and eventually across the country.

“There is always someone who is shunned, someone who is shamed, someone who is made to feel marginalized, and that’s been an unfortunate consequence of quarantine for thousands of years, Huish told Island Morning host Mitch Cormier.

The expected arrival of a vaccine, presented as a “light at the end of the tunnel” scenario, could paradoxically be a difficult time, Huish said. In the beginning there will not be enough vaccine for everyone, and the federal and provincial governments will prioritize groups to first be vaccinated. Many Canadians will have to physically distance and wear masks well into 2021.

“Allowing people to be vaccinated and then suddenly free of any of the ordinances that the rest of society is following, that could build huge resentment, stigmatization and all sorts of weird social complexities that we may not see coming,” he said.

Read more about the study here

Find out more about COVID-19

Still looking for more information on the pandemic? Read more about COVID-19’s impact on life in Canada, or reach out to us at covid@cbc.ca if you have any questions.

If you have symptoms of the illness caused by the coronavirus, here’s what to do in your part of the country.

For full coverage of how your province or territory is responding to COVID-19, visit your local CBC News site.

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