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

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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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Key COVID-19 numbers in the Ottawa area today – CBC.ca

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  • Ottawa is reporting 136 new cases of COVID-19 on Saturday.
  • Western Quebec has confirmed 43 new infections today.

Today’s Ottawa update

Ottawa Public Health (OPH) recorded 136 new cases of COVID-19 on Saturday. OPH also declared 111 more cases resolved and reported no new deaths.

The infection rate in Ottawa has risen to record levels since around Christmas, prompting OPH to declare the city is once again in a COVID-19 crisis.

The current lockdown in eastern Ontario went into effect Dec. 26, and is now scheduled to last until Feb. 11.

A provincial stay-at-home order is also in effect. 

Numbers to watch

88.9: The number of new COVID-19 cases per 100,000 Ottawa residents, down from Friday.

1.01: The average number of people infected by a single COVID-19 case, or R(t), has been in gradual decline this month but remains unchanged since Friday. OPH aims to keep the number below one.

4.1%: Ottawa’s average test positivity percentage, down from 4.5 per cent.

Across the region

Health authorities in western Quebec are reporting 43 new cases of COVID-19 but no more deaths.

Quebec’s lockdown lasts until Feb. 8. It includes an 8 p.m. curfew that went into effect last weekend.

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Ontario reports 3056 new COVID-19 infections, 51 more deaths – CP24 Toronto's Breaking News

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Ontario is reporting more than 3,000 new COVID-19 cases and a slight decrease in hospitalizations on Saturday.

The province logged 3,056 new infections and 51 additional deaths.

Twenty-five of the latest fatalities were among long-term care home residents, according to the Ministry of Health’s latest epidemiological summary.

To date, 3,162 long-term care residents have died from the disease caused by the novel coronavirus, representing 59 per cent of all virus-related deaths in the province. A total of 5,340 people have died from the virus in Ontario.

Provincial health officials said 3,212 more people have recovered from the virus on Saturday, bringing the number of active cases to 28,618.

Ontario recorded 2,998 new cases on Friday, 3,326 on Thursday and 2,961 on Wednesday.

A record 3,945 new cases were recorded on Jan. 10.

The seven-day rolling average now stands at 3,218, compared to 3,341 a week ago. Last week’s average does not include the approximately 450 additional cases that were reported by Toronto Public Health on Jan. 8 due to a data backlog.

In the past 24 hours, the province processed more than 73,800 tests, down from the record 76,472 tests conducted a day ago.

The testing positivity rate now stands at 4.9 per cent, up from 4.6 per cent a day ago, according to the Ministry of Health. The positivity rate was 5.3 per cent a week ago.

Most of the cases continue to be throughout the Greater Toronto Area.

“Locally, there are 903 new cases in Toronto, 639 in Peel, 283 in York Region, 162 in Durham and 152 in Ottawa,” Health Minister Christine Elliott tweeted.

Toronto, Peel Region and York Region saw a decrease in new cases compared to a day ago, while Durham and Ottawa saw an increase.

Halton Region logged 61 new infections, down 20 from Friday, and Hamilton reported 53 new cases, a notable decrease from 138 cases logged a day ago.

Only three of Ontario’s 34 public health units reported zero new cases on Saturday, and 16 logged 10 or less new infections.

Patients hospitalized with the virus decreased slightly on Saturday as the province’s health care system remains overwhelmed with COVID-19 cases.

According to the government, 1,632 were hospitalized with the virus in the past 24 hours, down from 1,647 a day ago. On Tuesday, 1,701 people were in hospitals across the province with the virus but hospitalizations have been decreasing slightly ever since.

Of the latest hospitalizations, 397 are in intensive care units, up from 387 on Friday, and 281 are breathing with the help of a ventilator.

There have been more than 234,300 cases of the novel coronavirus in the province since the virus emerged almost a year ago. More than 200,400 people have recovered from COVID-19.

More than 19,000 completed vaccinations

As of 8 p.m. on Saturday, the government has administered more than 189,000 doses of COVID-19 vaccines across the province.

In the past 24 hours, more than 14,400 doses were administered to Ontarians.

Since Dec. 14, more than 19,300 vaccinations have been completed across the province, as two doses of either the Pfizer-BioNTech or Moderna COVID-19 vaccines are required for full immunization.

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No change to Canada's Pfizer vaccine shipments as company restores European supply – Calgary Herald

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Article content continued

Alberta Health said the ministry would not be able to provide an update on the topic before Monday.

On Friday, Health Minister Tyler Shandro said he was “disappointed” in the delay, saying it meant the current phase of vaccinations in Alberta, which includes priority groups of health-care workers, would take longer to complete.

The start of the following phase, allowing seniors over 75 and Indigenous seniors over 65 to get the jab, will be consequently pushed back.

As well, Shandro said the province will be forced to delay some second doses of vaccination due to the news.

Pfizer shipments to Canada are expected to continue, but will contain fewer doses. There is no change to scheduled shipments of the Moderna vaccine.

Through end-of-day Friday, 81,561 Albertans have received their first dose of COVID-19 vaccine, an increase of 7,451 from the previous day. Among all provinces, Alberta ranks second for immunizations per capita, behind only Prince Edward Island.

The province is slated to administer at least 16,000 more jabs over the weekend, after Alberta Health Services said all previously advertised appointments had been booked.

Also Saturday, Alberta reported it had detected another 717 cases of the novel coronavirus.

The new infections came from 12,439 tests, a 5.8 per cent positivity rate, consistent with rates over the previous two days and below the seven-day average positivity rate of 6.2 per cent.

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