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Health Canada has final data it needs from Moderna to make a decision on vaccine – CTV News

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OTTAWA —
Health Canada says it will “soon” be ready to announce if it can authorize a second COVID-19 vaccine after receiving final documents from U.S. biotech firm Moderna over the weekend.

Moderna’s new Canadian general manager — hired just three weeks ago to establish a Canadian office for the company — said Moderna’s team and Health Canada are in constant communication.

“Everybody worked really diligently all weekend,” Patricia Gauthier told The Canadian Press in an interview Monday.

She said the process is following the required course and “we’re hoping for a decision when Health Canada is ready.”

Eric Morrissette, a spokesman for Health Canada, said the documents are being reviewed as fast as possible.

The U.S. Food and Drug Administration issued an emergency authorization for the Moderna vaccine late last week, becoming the first country to approve it. The COVID-19 vaccine is also the first Moderna product ever authorized for use.

The company was established about a decade ago specifically to work on messenger RNA technology, or mRNA.

The final documents Health Canada needed included data on manufacturing. The Canadian doses of Moderna’s vaccine are being made in Switzerland and sent to Spain for the “fill and finish” process, where six doses will be filled into each vial and the vials packed into freezers for shipping.

As many as 110,000 doses can be transported on a single pallet. Moderna intends to start shipping its vaccine to Canada within 48 hours of approval, with as many as 168,000 doses anticipated before the end of December and two million by the end of March.

Health Canada initially contracted to buy 20 million doses from Moderna, but exercised an option to buy 20 million more earlier this month, for a total of 40 million.

Gauthier said that is enough to vaccinate two-thirds of the Canadian adult population, and that there are still 16 million doses remaining for Canada to potentially buy as part of the contract. Sources not authorized to speak on the matter tell The Canadian Press a decision on whether to buy those extra doses will likely be announced this week.

The Moderna vaccine is only recommended for use on adults over the age of 18. Gauthier said clinical trials on adolescents began earlier this month and the vaccine will be tested on younger children in 2021.

Health Canada approved a vaccine from Pfizer-BioNTech on Dec. 9 and vaccinations with that product began last week. It was about five days from the time the final documents were received until Pfizer got a green light, but Health Canada’s chief medical adviser Dr. Supriya Sharma has said Moderna’s production facilities are new to Health Canada and may take longer to review.

The vaccines from Pfizer and Moderna both use messenger RNA technology, which sends a genetic code to human cells to train them to create an immune response to COVID-19. Both drugmakers say the vaccines were more than 94 per cent effective at preventing infection.

But Pfizer’s technology requires the vaccine to be kept frozen between -60 C and -80 C until just before use, requiring complex shipping processes, dry ice and ultra-low-temperature freezers.

Moderna’s product can be kept stable at only -20 C and can be at room temperature for almost a month. The company said last week that where it is necessary, the vaccine can be shipped at temperatures between 2 C and 8 C.

It means Moderna’s vaccine can be more easily deployed wherever it is needed, including to the North, remote Indigenous communities and long-term care homes.

Moderna will be picked up by FedEx in Europe and shipped in freezers to Toronto, where logistics company Innomar Strategies will take possession of it.

Innomar president Guy Payette said the company will be the importer of record, run a quality assurance check on the vaccines, and then repackage the shipments into smaller amounts to be forwarded to provincial and territorial governments.

“We’re working on the assumption that it is imminent, and that we need to be ready when the vaccines get approved,” Payette told The Canadian Press.

Gauthier is now helping set up the Canadian division of Moderna, intending to hire a team of people whose first focus will be helping governments in Canada get the vaccine administered.

She says that includes efforts to communicate to Canadians the safety and effectiveness of the vaccine.

This report by The Canadian Press was first published Dec. 21, 2020.

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216 new cases of COVID-19 in Manitoba, including 118 in north – CBC.ca

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There are 216 new cases of COVID-19 and three more deaths from the illness in Manitoba, according to a provincial news release issued on Saturday.

Of the new cases, more than half — 118 — are in the Northern Health Region, which has seen a worrisome spike recently.

The rest of the cases are in the Winnipeg (50), Interlake-Eastern (22), Southern (14) and Prairie Mountain (12) health regions.

The deaths reported Saturday were all in the Winnipeg health region — a man in his 60s, a woman in her 70s and a woman in her 80s.

The provincial five-day test positivity rate — a rolling average of the number of tests that come back positive — is 9.8 per cent, up from 9.3 per cent on Friday. Winnipeg’s rate also rose slightly, to 6.5 per cent from 6.2.

The province’s news release says 1,836 COVID-19 tests were completed Friday, bringing the total number of lab tests completed since early February 2020 to 463,084.

The number of Manitobans in hospital is 272, up from 268 on Friday. There are also 40 people in intensive care, up from 33 the day prior.

On Friday, the province reported 173 new cases of COVID-19, with more than a third — 64 — in the Northern Health Region.

As well, Fox Lake Cree Nation declared an outbreak of COVID-19 on Friday.

There are 34 active cases in the First Nation, about 700 kilometres northeast of Winnipeg, Chief Morris Beardy said in a news release.

That number includes Beardy himself.

“This is very serious and scary for us all. I also know how resilient and strong our community is, and how we can support each other through difficult times,” he said.

There are 88 Fox Lake households affected by the virus, including 15 in the Bird reserve and 70 in the nearby town of Gillam, according to the release.

The northern region, including the town of Churchill, was excluded from an easing of some of the province’s strict pandemic restrictions, which came into effect for the rest of Manitoba Saturday, following recent drops in case numbers.

Two designated visitors are now allowed for each household, and group of up to five can gather outdoors on private property.

Retailers are allowed to sell non-essential items in-store again, and barbers and hair stylists are able to go back to work.

As well, as of Saturday, all Manitoba teachers, educational support staff and other staff working in schools and directly with students can now make an appointment for rapid COVID-19 testing at the Winnipeg Fast Pass site at 1066 Nairn Ave., provided they meet certain criteria.

To be eligible, people who work in schools must be symptomatic, identified as a close contact because of an exposure at school, or have a symptomatic household member. 

Appointments for the pilot site are now open for eligible staff working in all schools and school divisions, the province says.

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Fewer than 2400 new COVID-19 cases reported in Ontario, another 52 deaths logged – CTV Toronto

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TORONTO —
Health officials in Ontario are reporting fewer than 2,400 new cases of COVID-19 Saturday.

The 2,359 infections mark a drop over Friday’s report when 2,662 cases were added and bring the province’s COVID-19 case total to 252,585, including deaths and recoveries.

Fifty-two of those deaths occurred in the previous day, 25 of which were residents in a long-term care home.

The Ministry of Health now considers 3,025 more cases to be resolved, a number that has been outpacing new infections in Ontario in recent days. Since the beginning of the pandemic, 222,287 people previously diagnosed with COVID-19 have recovered. 

The data released by the government Saturday shows there are currently 24,545 active cases of the novel coronavirus across Ontario.

With 63,453 tests processed in the last 24 hours, the province’s COVID-19 positivity rate stands at 4.5 per cent.

Where are the new COVID-19 cases in Ontario?

Most of the cases reported Saturday were found in Toronto (708), Peel Region (422), York Region (220), Hamilton (107) and Windsor-Essex (100).

Toronto Mayor John Tory commented on the city’s numbers in a tweet published Saturday where he said case counts are heading in the “right direction.”

“Let’s keep it that way. Stay home this weekend, Toronto,” he said.

For context, the province reported 779 cases in Toronto on Friday, 897 (102 of which were attributed to a previous technical issue) on Thursday and 925 on Wednesday.

Toronto has consistently reported the highest daily COVID-19 case numbers in the province since the start of the pandemic.

Several other regions reported case numbers in the high double digits, including Niagara, Waterloo, Halton, Simcoe Muskoka and Durham Region.

Right now, there are 1,501 patients in hospital with COVID-19, down from the 1,512 reported a day earlier.

Of those patients, 395 are being treated in an intensive care unit and 299 are breathing with the assistance of a ventilator.

Update on COVID-19 vaccinations in Ontario

Health Minister Christine Elliott says that 276,146 doses of the COVID-19 vaccine have been administered throughout Ontario since inoculations began last month.

The province said that 11,161 of those shots were administered in the previous day.

At least 57,907 people have received both their first and second shots and are considered to be fully vaccinated.

Ontario is currently operating in Phase 1 of it’s vaccination rollout, which will see shots given to health-care workers in hospitals, long-term care homes and retirement homes, other congregate care settings and remote Indigenous communities

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2 New Deaths, 116 New Cases Of COVID-19 In Windsor Essex On Saturday – windsoriteDOTca News

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  1. 2 New Deaths, 116 New Cases Of COVID-19 In Windsor Essex On Saturday  windsoriteDOTca News
  2. BlackburnNews.com – Overdose alert issued for Windsor area  BlackburnNews.com
  3. Some local leaders fear looming crisis as migrant workers start to arrive in Windsor-Essex  CBC.ca
  4. 8 additional deaths, 99 new COVID-19 cases in Windsor-Essex  CTV News Windsor
  5. Ontario’s enforcement tour coming to Windsor-Essex this weekend  CTV News Windsor
  6. View Full coverage on Google News



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