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Health Canada has final data needed from Moderna to make a decision on vaccine – Nelson Star

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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.

READ MORE: Canada to receive early shipment of Moderna’s COVID-19 vaccine before year’s end

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.

Mia Rabson, The Canadian Press


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5 British Columbians under 20 years old battled COVID-19 in ICU in recent weeks – Comox Valley Record

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B.C.’s demographic makeup of those contracting COVID-19 is changing – infecting younger people than at the height of the pandemic – as the second wave drags on across the country.

That’s according to the latest B.C. Centre for Disease Control COVID-19 situation report, released weekly, which shows a breakdown of various aspects of how the infection is taking hold in the province.

The report shows that while overall hospitalizations have fallen in the past few weeks, young people battling the virus in hospital has increased.

In the week of Jan. 3 to 9, two children from birth to age 10 were admitted into the intensive care unit due to COVID-19. Three youth between 10 and 19 years of age were also admitted into the ICU. In the same time period, 36 children under the age of 10 were hospitalized, as well as 31 more who are between 10 and 19 years old.

Meanwhile, adults aged 20 to 39 makeup a disproportionate percentage of COVID-19 cases – 41 per cent of all cases but 28 per cent of the population, the report shows. Of those infected with the respiratory disease, 285 landed in hospital, a further 62 in ICU.

The increase in cases among young people has had an impact on the median age for reported cases, dropping from 56 years old in the first wave to 37 years old as of Jan. 9.

Median age of hospitalizations has stayed relatively stable, at 66 years old and 86 years old, respectively.

No deaths of anyone under the age of 30 have been reported in B.C. since the coronavirus touched down in the province almost a year ago. Four people aged 30 to 39 have died, while 90 per cent of all deaths are of those aged 70 and older – many connected to long-term care homes.

Roughly 65 per cent of total deaths have happened in November and December.


@ashwadhwani
ashley.wadhwani@bpdigital.ca

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TABIB discusses side effects of COVID-19 vaccine – MENAFN.COM

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(MENAFN – AzerNews) By Trend

Each vaccine has side effects including headache, mild fever, and sometimes weakness. Initially selected inactivated COVID-19 vaccine has fewer side effects, said Chairman of the Board of the Azerbaijani Management Union of Medical Territorial Units (TABIB) Ramin Bayramli in an interview with “Khazar” TV channel, Trend  reports.

Bayramli added that the vaccines used in Azerbaijan have been administered to more than one million doctors in Turkey, with no side effects found

“Each vaccine brought to our country is accepted only after laboratory tests, namely, it undergoes a two-week analysis in the laboratories of the pharmaceutical institution of the Turkish Ministry of Health. We have official information about the successful completion of all tests. As agreed, other lots of vaccine will be delivered in the same way”, he said.

According to him, each person is monitored for 30 minutes after vaccination.

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Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.

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Pfizer vaccine delay expected to cause 60000-dose shortfall in B.C., but only temporarily – CTV News Vancouver

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VANCOUVER —
Health officials in British Columbia are expecting a shortfall of about 60,000 doses of Pfizer’s COVID-19 vaccine over the coming weeks as a result of the company’s previously announced delays.

That’s about half of the doses the province was expecting to receive over that period.

But provincial health officer Dr. Bonnie Henry confirmed Monday that B.C. expects increased shipments in March to make up for those missed doses, and that the province is “still on track” to vaccinate its most vulnerable residents before April.

What the delay means for now is that a “higher proportion” of the province’s vaccine will be going to second doses, Henry added.

“We spent quite a lot of time over this past weekend working through how we could make it work, and then stay true to our commitment to getting those second doses into people as soon as logistically possible,” she said.

The provincial health officer also noted that B.C. was expecting potential delays, and was prepared to pivot as necessary.

“The program continues. Our focus continues to be on immunizing all people who are at the greatest risk, and that includes residents and staff who work in long-term care homes around the province,” Henry said.

As of Monday, 87,346 people have received either the Pfizer or Moderna vaccine across British Columbia. The province received 46,675 doses over the past week, including 28,275 Pfizer doses and 18,400 Moderna doses, but is expecting decreased shipments into February.

Henry described the Pfizer issues as a “slight delay,” but stressed that the province still intends to dramatically expand the scope of its immunization program in April to include new demographics.

In the meantime, she urged residents to do their best to stop the spread of COVID-19 by following the same precautions and rules they have been for months.

“We have the tools and it is in our control,” Henry added. “Let’s show each other that we remain committed to doing our part to protect our seniors and elders who have not yet had the vaccine.”

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