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FDA to Discuss Pfizer’s Coronavirus Vaccine Authorization Request in December



The rollout of potential new coronavirus vaccines have a more concrete timeline following the FDA’s latest update regarding Pfizer‘s (NYSE:PFE) recent authorization request. Late on Friday afternoon, the FDA announced a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be held on Dec. 10. The group of independent experts will discuss Pfizer’s request for emergency use authorization (EUA) of BNT162b2, a coronavirus vaccine candidate the big pharmaceutical company is developing in partnership with BioNTech (NASDAQ:BNTX).

Meeting between physicians.

Image source: Getty Images.

Pfizer submitted its request to the FDA following positive results from a clinical trial with over 43,000 participants. At an interim analysis, there were 162 confirmed cases of COVID-19 among volunteers that received a placebo and just eight confirmed cases among patients that received the vaccine. Efficacy appears consistent regardless of volunteers’ age, gender, race, or ethnicity but with just eight positive cases there’s only so much that can be inferred.

The VRBPAC is comprised of independent experts that will pick apart details in clinical trial data Pfizer submitted and whether it proves BNT162b2 is safe and effective enough to authorize for emergency usage. The FDA doesn’t have to follow the advice of its independent experts, but the agency and experts from the broader medical community usually land on the same page when it comes to interpreting clinical trial results.

To date, the results we’ve seen from Pfizer have been from the company itself, but that will change roughly two days before the VRBPAC convenes. As is customary with independent advisory committee meetings, the FDA will release briefing documents to the public that highlight all of the agency’s concerns in an unfiltered format roughly 48 hours ahead of the meeting itself.

Source: – The Motley Fool

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‘Massive undertaking’: Roadmap of Canada’s coronavirus vaccine roll-out – Global News



If all goes according to plan, Canadians will start getting vaccinated for the novel coronavirus early next year.

And one of the people spearheading those efforts is a Canadian from Sherbrooke, Que. — Nicolas Chornet, senior vice-president of international manufacturing at Moderna.

Read more:
Canada will have vaccine infrastructure in place around ‘Christmas,’ 1st doses in January

He moved to Switzerland in August to set up the U.S. drugmaker’s European office and has not seen his extended family in almost a year. But they, too, ask him for constant updates.

“Hey, how fast can we get this? Because we want to see you and we want you to travel and come and see us again,’” his family asks him about the vaccine, he says.

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According to deals signed so far, Canada could have access to up to 414 million doses of COVID-19 vaccines from seven different manufacturers.

The shipment and distribution of the vaccine — once approved — will, however, be a Herculean effort involving a lot of manpower, a web of logistical challenges and scientific constraints.

Click to play video 'Coronavirus: Majority of Canadians concerned vaccine will come too late, Ipsos poll finds'

Coronavirus: Majority of Canadians concerned vaccine will come too late, Ipsos poll finds

Coronavirus: Majority of Canadians concerned vaccine will come too late, Ipsos poll finds

Promising candidates from U.S. pharmaceutical companies Pfizer, Moderna and Johnson & Johnson as well as the U.K.’s AstraZeneca, are all currently under a rolling review process, which means vaccine data is being submitted for regulatory approval to Health Canada as it becomes available.

“Canada is one of the countries that moved very, very fast in securing a vaccine with us. It’s one of the first countries or one of the top countries to receive our supply also,” Chornet said.

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Canada is not manufacturing any COVID-19 vaccines because it has a limited production capacity, especially for the vaccine candidates that are currently proving to be the most promising.

This means it will need to import the vaccines, adding another layer to the logistical labyrinth that has also set off political turmoil.

Read more:
Will Canada lag behind on coronavirus vaccines? It’s complicated, experts say

Last week, members of the opposition slammed Prime Minister Justin Trudeau over his comments that countries like the United States, Germany and the U.K. — some of which have domestic pharmaceutical facilities — will get vaccines before Canada.

Moderna’s supplies to Canada will come all the way from the Swiss city of Visp — home to some 8,000 people — where the company has set up a secondary production plant, in addition to its U.S. headquarters, to meet the global demand.

“Of course, our level of production or inventory will be lower than in the United States,” Chornet said, before adding: “In our distribution here (in Europe), we’ve optimized the supply chain so we can distribute as fast as possible to all the countries.”

Click to play video 'Moderna says COVID-19 vaccine 94.5% effective'

Moderna says COVID-19 vaccine 94.5% effective

Moderna says COVID-19 vaccine 94.5% effective – Nov 16, 2020

The U.S. will receive approximately 20 million doses from Moderna by the end of the year.

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Last week, Trudeau said a majority of Canadians should be vaccinated against the coronavirus by next September. That means roughly 75 million doses for the country’s entire population if two shots are given.

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Since the start of the pandemic, more than 400,000 people in Canada have been infected and at least 12,400 have succumbed to the virus.

Long-term care homes have borne the brunt of the pandemic, with outbreaks reported at several hundred nursing homes.

More recently, hospitalizations are soaring across provinces. Quebec, Alberta and Ontario are among the worst affected.

Read more:
Canadians worry vaccine won’t come fast enough to stop coronavirus surge, Ipsos finds

A vaccine will come as a relief for lockdown-weary Canadians – 65 per cent of whom say they intend to get a vaccine when it’s approved by Health Canada and available for free, according to a new poll this week. Meanwhile, an Ipsos poll conducted exclusively for Global News found that 74 per cent of respondents are worried that the public distribution of a vaccine would be too slow to stop a greater spread of COVID-19.

The National Advisory Committee on Immunization (NACI), has identified key populations that should get immunized first, including the elderly and those with underlying health conditions, as well as health-care workers, according to its preliminary recommendations.

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“This will probably be the most complex deployment of vaccines that we’re attempting in Canada, or I would suggest even around the world,” Daniel Chiasson, president and CEO of the Canadian Association for Pharmacy Distribution Management, told Global News.

So how will it work?

Cold storage

Both Pfizer and Moderna’s vaccines need to be kept in cold storage and have specific temperature requirements.

Pfizer’s vaccine must be shipped and stored at -70 C, while Moderna’s can be stored for up to six months at -20 C.

This requires a certain level of infrastructure that Canada may not have if vaccines are deployed in a short time frame, Chiasson said.

“The bottleneck for me is likely to be at the warehouse level,” he said.

“Do we actually have sufficient capacity with the right equipment in terms of refrigeration or frozen capacity to do it? … The infrastructure exists today. Do we have enough of it?”

Click to play video 'Pfizer-BioNTech coronavirus vaccine: The refrigeration problem no one is talking about'

Pfizer-BioNTech coronavirus vaccine: The refrigeration problem no one is talking about

Pfizer-BioNTech coronavirus vaccine: The refrigeration problem no one is talking about – Nov 10, 2020

In anticipation of a vaccine’s arrival, the federal government has ordered 26 ultra-cold freezers required for Pfizer’s vaccine and another 100 needed for Moderna’s. So far, 34 freezers have arrived, according to Public Services and Procurement Canada.

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U.S.-based Thermo Fisher Scientific is among those companies supplying the cold storage to Canada.

Read more:
Two shots. A waiting period. Why the coronavirus vaccine won’t be a quick fix

“The criticality of this is huge, being able to manage the temperature from the point of manufacturing through distribution and ultimately to preparation for injection. It just can’t be overstated,” Dr. Alex Esman, general manager and senior director for cold storage at Thermo Fisher Scientific, told Global News.

“Typically, these freezers are used today in research… but now these freezers are going to be just in slightly different places … like in the pharmacy or in a doctor’s office or a clinical office.”

ESBE Scientific, a distribution company in Markham, Ont., told Global News it has already supplied stocks to the federal government, and the provinces of Ontario and Alberta.


While the federal government is overseeing the procurement and authorization of the vaccines at the national level, provincial health authorities are currently working on their individual plans to decide where the vaccines will be deployed and administered and who will get them in what order.

The Canadian military has also said it is preparing to help with the country’s vaccine roll-out more broadly.

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Read more:
Vaccine advisory committee recommends new ranked roll-out, with long-term care at top

Retired general Rick Hillier, who led the NATO forces in Afghanistan, was recently tapped to lead the vaccine roll-out for the province of Ontario.

“We’re talking to the IT professionals, they’re talking about building a system that is already in progress on iPads to use at those sites to log where the vaccines are, where they’re going to connect that to health cards to make sure that we have a record that somebody has been vaccinated,” Hillier told Global News.

Click to play video 'Coronavirus: Initial supply of COVID-19 vaccine in Canada to be around 3 million vaccinations'

Coronavirus: Initial supply of COVID-19 vaccine in Canada to be around 3 million vaccinations

Coronavirus: Initial supply of COVID-19 vaccine in Canada to be around 3 million vaccinations

At the city level, immunization teams will then be responsible for making sure the vaccines get delivered to the identified priority groups, and for carrying out the immunizations in the community.

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Matthew Pegg, the head of Toronto’s COVID-19 Immunization Task Force, says the roll-out will be a “massive undertaking” that will require a lot of planning and co-ordination.

The “biggest hurdle,” he said, is identifying facilities that can store vaccines and serve as a location for people to get vaccinated.

“We need facilities where we can install whatever the requirements will be for refrigeration or freezers,” Pegg told Global News.

His team is currently looking for facilities to serve as warehouses for all of the expected inventory.

Second dose and followup

Vaccines from Pfizer, Moderna and AstraZeneca will require two doses.

Pfizer’s booster shot will be given three weeks after the first one, while Moderna’s is spaced four weeks later. In AstraZeneca’s clinical trials, the second dose was given a month later.

Read more:
Canada’s coronavirus vaccine roll-out — Who will get it first?

Dr. Michael Finkelstein of the Toronto Public Health says it will be important to report and investigate any adverse effects and make sure patients return for that second dose.

We have a lot of experience with people getting vaccines, but much less experience with people needing two doses,” he told Global News.

“And so it’s going to be very important for us to be able to remind people and making sure that they get the message they have to come back.”

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If both Moderna and Pfizer’s vaccines are approved, the first batch of what’s expected to be six million doses — enough for three million Canadians — will begin arriving in early January.

But the actual work of the roll-out will be far from over.

© 2020 Global News, a division of Corus Entertainment Inc.

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How the COVID-19 vaccines are being approved in Canada –



The approval of a COVID-19 vaccine in Canada could potentially be days away with the initial supply to be limited to about three million Canadians, in the first three months of 2021. But what approval processes have the vaccines gone through? CBC explains:

Is the approval process for the COVID-19 vaccine different than for other vaccines?

Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced to the approval process. Typically, a vaccine manufacturer will do all their clinical trials, gather all their data, prepare a submission package and put that forward for approval, said John Greiss, a Toronto-based intellectual property lawyer with Norton Rose Fulbright, who advises companies in the life sciences sector that are regulated by Health Canada.

“Health Canada will comment on it or ask for additional information and it will go back and forth until they come to a decision, he said.

But with COVID-19, Health Canada has accepted what’s known as a “rolling submission.” 

“The new process allows for a company to start an application process, submit the information that they have available, as of that date and add new data and new information as it becomes available, Greiss said

Supriya Sharma, chief medical adviser to Health Canada, said this enables the organization to start reviewing the potential vaccine and will shorten the overall review process “while still maintaining those same standards for the safety and the efficacy.”

What’s included in the submission?

That really hasn’t changed, Greiss said. Vaccine manufacturers have to submit all of the scientific data that they have, which includes any kind of lab data that demonstrates how the vaccine works, any kind of clinical trial data that they have obtained, along with Phase 1 to Phase 3 clinical trial data.

WATCH | Vaccines are coming soon

Dr. Njoo tells reporters the federal government is expecting 6 million doses of first two vaccines to arrive in Canada after approvals within the first quarter of the new year. 1:35

They also have to submit information about the manufacturing process and standards and procedures that demonstrate they’re meeting good manufacturing processes in their facilities, Greiss said.

How is the vaccine reviewed?

One vaccine submission is hundreds of thousands of pages long and can take, on average around 2,000 person hours to review, Sharma said. For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas like toxicology, infectious diseases, clinical medicine, microbiology and epidemiology to review the vaccine.

“Each vaccine submission has its own team that’s dedicated to it. And they will go through all of that information,” she said.

Reviewers must confirm there are no significant safety concerns, determine that the vaccine is able to prompt an adequate immune response in vaccinated people and show that it can protect against disease, she said.

“We go through all of that to see if it actually meets our standards for safety, efficacy, quality,” Sharma said. 

“We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it’s being made in at a licensed place that’s up to standards and up to code.”

Greiss said that during the review process, Health Canada officials might, for example, ask for further clarification about the clinical trial procedure, or how patients were recruited.

The approval process has been modified to accommodate the pressing need for the COVID-19 vaccine. (Dado Ruvic/Illustration/Reuters)

“Or if they see anomalies in the data, they’ll ask the company to justify or clarify that information,” he said. “So there is still that back and forth in terms of Health Canada sort of digesting and analyzing the data and the company having to provide answers for that before they get an approval.”

Are the vaccine manufacturing facilities inspected?

For manufacturing facilities around the world, not just for vaccines, but for medications as well, Health Canada has entered into mutual recognition agreements with other regulators, Sharma said.

“We actually have sent our inspectors over to their country,” she said. “They’ve sent inspectors over to our country. We make sure that our standards are the same, our processes are the same.”

Every facility that manufactures vaccines needs to have an inspection before it’s licensed. And there are ongoing inspections to make sure standards are maintained, she said.

What are they looking for in these facilities?

They’re looking at key factors, known as the four Ps, Sharma said. 

  • Product: What’s being made there.
  • Premises: There are very detailed specifications on the facilities themselves. For example, special flooring and ventilation systems have to be in place.
  • Process: All the processes that go into manufacturing the product.
  • People: The qualifications and training of the people that work there.

All of those things are really important in terms of making sure that standards are met, she said.

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Alberta's COVID-19 testing positivity rate hits 'grim milestone' at more than 10 per cent –



On a day that Alberta reported 18,243 active cases of COVID-19 and 15 additional deaths, the province also reported a record high test positivity rate.

The positivity rate climbed to 10.5 per cent, a “grim milestone and one that should concern us all,” Dr. Deena Hinshaw, Alberta’s chief medical officer of health, told a news conference Friday.

With almost 17,200 people tested, and one of every 10 testing positive, the total number of new cases in Alberta reached 1,828.

To date 590 people have died in Alberta. As of Friday there were a record 533 people in hospital, including 99 in intensive care.

“We are heading into the first weekend of December,” Hinshaw said. “In a difficult year, I know this last month may be the toughest for many. This virus can spread quickly from one to many.

“In a month usually marked by festive gatherings, we feel the restrictions more keenly. But I want to stress the seriousness of the rising case numbers that we’re seeing and how crucial it is that we reduce the spread and bend the curve back down.”

Here is how the active cases break down among the regions:

  • Edmonton zone: 8,578 cases
  • Calgary zone: 6,666 cases
  • Central zone: 1,251 cases
  • North zone: 1,012 cases
  • South zone: 630 cases
  • Unknown: 106 cases

7 deaths at care home in Edmonton’s Chinatown

The 15 deaths reported Friday included seven people linked to an outbreak at the Edmonton Chinatown Care Centre: four men in their 90s, a woman in her 90s, a man in his 80s and a man in his 100s.

Other deaths reported Friday:

  • A woman in her 70s linked to the outbreak at Clifton Manor in Calgary.
  • A man in his 80s linked to the outbreak at Capital Care Lynnwood in Edmonton.
  • A man in his 70s from the Edmonton zone.
  • Two men in their 60s from the Edmonton zone.
  • A man in his 50s from the Edmonton zone.
  • A woman in her 70s from the Central zone.
  • A woman in her 90s from the Calgary zone.

Contact tracing getting help

Dr. Verna Yiu, president and CEO of Alberta Health Services, told the news conference AHS is working to bolster its troubled contact-tracing system.

“As case numbers have increased exponentially in the past six weeks it has become more and more difficult for our teams to keep up with demand,” Yiu said.

“We are rapidly increasing our response to the unprecedented volume of COVID-19 cases in the province.”

WATCH | Alberta to ramp up contact tracing efforts:

A desperate shortfall of COVID-19 contact tracers is one of the staffing challenges plaguing Alberta, says AHS president and CEO Dr. Verna Yiu. 1:29

The province has more than 900 contact tracers in Alberta and is on track to double that number by the end of the year, Yiu said.

“This means that we will have 36 contact tracers per 100,000 people, which will be on par or better compared to other provinces.” 

Bending the curve

Albertans are now one week into the latest round of restrictions aimed at bending the curve of COVID-19 cases in the province.

Last Friday, Premier Jason Kenney ordered junior and senior high schools to close, barred indoor social gatherings and capped capacity for businesses.

Next week Albertans will find out what impact those measures are having on the virus, which is spreading faster in Alberta than anywhere else in the country.

It was the second set of restrictions issued by the premier in November.

Three weeks ago, Kenney suspended indoor group fitness programs, team sports and group performance activities, and reduced operating hours for restaurants, bars and pubs in cities.  

But the curve didn’t bend and the virus has continued to surge since, setting records almost daily as it tightens its grip on the province.

The province’s contact-tracing system is struggling against demand. Alberta’s government continues to resist calls to adopt the federal contact-notification app or order a province-wide mask law.

It is also continuing to spurn calls by physicians for a two-week lockdown, or “circuit-breaker,” to drop the effective reproduction number and allow contact tracing to catch up. 

WATCH | Alberta requests field hospitals from Ottawa:

The Alberta government is in talks with Ottawa and the Canadian Red Cross for help in setting up field hospitals, as the number of COVID-19 patients continues to surge. 2:42

This week, the province acknowledged it is preparing for the worst. Alberta has asked the federal government for two field hospitals, and the Red Cross for two more. 

Alberta hospitals are preparing to double-bunk critically ill patients, revamp operating and recovery rooms and reassign staff to treat an expected surge of COVID-19 patients destined for intensive care units.  

AHS has asked hospitals in Calgary to begin rationing oxygen.

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