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OTTAWA –
Health Canada has approved the Pfizer-BioNTech COVID-19 vaccine for use in that country The first doses could be given as early as next week

It is a critical moment in Canada’s fight against the novel coronavirus as it becomes the first vaccine to receive the green light

The Federal Health Department has rated the vaccine as effective and safe for Canadians, which means the team responsible for introducing vaccines can now start giving it

We expect vaccines to arrive maybe by Monday it will take time to prepare the vaccine said Maj-Gen Dany Fortin, the chief military general who led the rollout of the Canadian health department, said the first shots could be fired by mid-next week

The approval comes with an update to the timeline for the national mass vaccination effort, with plans now to start vaccinating the general population in April 2021 and to have all Canadians vaccinated with any of the various vaccines under consideration by the end of next year

“This is a big deal,” Prime Minister Justin Trudeau said in the House of Commons on Wednesday afternoon, thanking doctors, researchers and scientists who worked on approving the first COVID-19 vaccine we will see next week000 vaccines arrive, many more are on the horizon But we are not finished yet, we have a hard winter ahead of us and I know that together we will make itâ ????

“Health Canada has determined that the Pfizer BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada”Health Canada said in a statement along with a number of documents related to the decision with a promise to receive more information about the clinical trial in the coming weeks

In a press conference, Health Canada Senior Medical Advisor Dr Supriya Sharma called the approval a “critical milestone in our fight against COVID-19 and in our efforts to give every Canadian access to a vaccine” and said that extensive work by a number of scientific experts went into the granting of this permit

“We concluded that there was strong evidence that the benefits of the vaccine outweighed the risks”Sharma said we know that even the best vaccines are only effective if people trust them and ultimately agree to receive them. An important part of building trust is openness and transparency to ensure people have as much information as possible so that they can make informed decisions for themselves and those who are important to them She said

Pfizer studies concluded that the vaccine was effective at preventing COVID-19 in 95 percent of patients one week after the second dose, and is still under investigation in terms of the long-term immunity the vaccine can provide

The vaccine is an mRNA vaccine, which means it teaches cells how to make a protein that will trigger an immune response without using the live virus that causes COVID-19.As soon as that immune response is triggered, it will produce antibodies that humans do protect against infection in case the virus invades your system in the future

In an interview with CTV National News medical correspondent, Avis Favaro, Pfizer Canada’s Vaccines Medical Lead Dr Jelena Vojicic said she was “very satisfied” with the decision of Health Canada

This is certainly a historic moment for science and for Canadians, and it is the result of a tremendous effort from the international scientific community to the dedicated work of the Pfizer and BioNTech staff, the clinical trial sites, the participants in the clinical trials, the volunteers Said Vojicic

And of course I have to acknowledge the tremendous work that Health Canada is doing to quickly review our file while maintaining the really golden standards of review and keeping an eye on the dataâ ????

The first doses of the Pfizer vaccine are expected to arrive in Canada next week It is already planned to deliver the recordings to 14 delivery locations in major cities in Canada within a day or two of the arrival of the deliveries

Vojicic said Pfizer is ready to ship to Canada and it expects shipping to be imminent ???? She expects that most of the vaccines for Canada will come from Belgium

Fortin said he expects the cans to be shipped out by the end of the week, likely on Friday

By the end of December, Canada is expected to have up to 249Received 000 doses of this vaccine or enough to make 124Vaccinate 500 people as it requires two 0.3 ml shots in the arm muscle 21 days apart. In total, the federal government has bought 20 million doses of the vaccine and has an option to buy an additional 56 million

Fortin expects a “constant flow” from there by the end of March 2021 – up to four million doses of Pfizer and potentially two million of the Moderna vaccine candidate next up for approval Moderna’s candidate is now the most advanced in the Canadian regulatory process, but there is no date or estimate yet When it Could Be Approved This vaccine also requires cold storage, but not as cold as Pfizer, which means the logistical rollout of Moderna doses is expected to be less difficult

This means that Canada plans to immunize three million Canadians, or eight percent of the population, by the end of March.From April to June, between 15 and 19 million Canadians will be vaccinated, which corresponds to 40 to 50 percent of the population Millions of Canadians to be Vaccinated These latest projections are based on projected delivery schedules and are subject to regulatory approvals for additional vaccines

Prioritized groups will be the first to receive the vaccine as quantities are initially limited.The earliest people to receive these shots include long-term care workers and residents, as well as other senior housing and healthcare workers at high exposure risk.Each province may use national recommendations for prioritization accordingly change their regional situation For example, Ontario decided to use the first small series in the Toronto and Peel area, where the heaviest bans exist due to weeks of increasing case numbers

In response to Wednesday’s news, Ontario Prime Minister Doug Ford said the lights at the end of the tunnel are getting brighter “

The vaccine is currently recommended for use in people aged 16 and over Further clinical studies are being carried out on children of all ages Therefore, it is possible that Health Canada’s approval in the EU may be revised in the future to include children if the data from these studies support it

Because the vaccine must be stored at temperatures below -70 ° C, Pfizer supplies batches in special thermal shipping boxes that can keep the vaccine stable for days

These thermal senders are also equipped with GPS-enabled data loggers that record the temperature and the location of these senders.This means that we can track these consignments at any time between the production site and the place of use and prevent undesired temperature fluctuations said Vojicic, who added she doesn’t think the security of these broadcasts will be an issue

The vaccine is thawed, decanted and mixed before injection, but it can only last a few hours at room temperature Therefore, Pfizer is calling for the first doses to be given on-site in these 14 medical facilities that have ultra-cold freezers in place to avoid as much waste as possible in moving the vials to another location, meaning Canadians who are in Areas and other remote areas are likely to wait for Moderna vaccine to be approved to receive COVID-19 vaccine

Bahrain approved it first, followed by the UK, which began vaccinating its citizens with this vaccine on Tuesday, although the medical and health products regulator is now warning that people with a history of serious allergic reactions should not be given the vaccine this way, as they are Investigate two cases of side effects experienced by health workers when they received the vaccine

In general, the side effects reported during clinical trials are similar to other vaccines and are considered to be mild or moderate. These include pain at the injection site, chills, fatigue, and fever

The U.S. Food and Drug Administration will give the Pfizer BioNTech vaccine the go-ahead to be available to Americans this week

Questions have been raised about Canada’s place for vaccines versus other countries for weeks, in part due to our inability to produce primary vaccines domestically. But Pfizer said Wednesday that “you can see what’s happening today that we’re definitely not at the bottom of the line stand”We are at the forefront when it comes to vaccine approvals and vaccine rolloutâ ????

Asked how Canada beat the U S. When the FDA found the vaccine safe, Sharma jokingly said, “We’re just better”â ????

“We’re not in a race with another regulator, we’re not trying to beat another regulator We try this Defeat virus and work against this virus”??? she said

“It just so happened that we got the latest information late at night People worked on it They were up early this morning to finish them off That’s why we’re announcing today”? Sharma added that Canadian officials will be attending the US Meet in the next few days to discuss Pfizer approval

Typically, the vaccine submission review process can take up to a year to complete However, thanks to an emergency mandate, Health Canada was able to speed up the approval process.The agency began regulatory reviews of the Pfizer vaccine in October and has been evaluating ongoing information from the drug company’s studies since then, rather than waiting until the end of their work to review the Review the vaccine to begin results

Canadians can rest assured that the review process has been rigorous and that we have strong surveillance systems in place. Health Canada and the Canadian Health Department will closely monitor the safety of the vaccine after its launch and will not hesitate to take action if safety concerns are identified Health Canada said on Tuesday

The pharmaceutical company is also routinely required to provide additional quality, efficacy and safety information. Pfizer has agreed to follow participants in clinical trials for two years after their second dose and will be released before December 31 Publish a complete risk management plan on March 23rd, covering the known and potential safety issues, plans to collect additional safety and efficacy information, and appropriate actions to be taken to minimize the risks associated with the product

For each province and territory, there are plans to track who is receiving doses, and the federal government is considering an additional level of national surveillance, both for overall immunization levels and side effects

Pfizer was one of four vaccine candidates that Health Canada evaluated Assessment of Moderna, AstraZeneca and Johnson & Johnson vaccines is ongoing. Overall, Canada has signed contracts guaranteeing access to 194 million doses of potential COVID-19 vaccines, with the option to purchase an additional 220 million If all studies are successful, we would have access to 414 million doses

Six of the seven vaccines require two doses, with the Johnson & Johnson vaccine candidate being the exception.For those who require two doses, all doses except Moderna and Astra Zeneca must be given 21 days apart, and these two vaccines are said to be 28 days apart administered

It’s an extraordinary day for Canada It’s a step along the way, it’s a tool in terms of our fight against COVID-19, along with all the other measures, “Sharma said.” We have other vaccines that are likely to come too but I think in a year that we haven’t had a lot of good news, this is some good news. And I think we should take a moment to acknowledge that and then we’ll all get back to work “

Supriya Sharma, Chief Medical Advisor of Health Canada, smiles before announcing the approval of a COVID-19 vaccine at a press conference in Ottawa on Wednesday December 9, 2020 THE CANADIAN PRESS / Adrian Wyld

Maj. Gen. Dany Fortin answers a question during a press conference on Tuesday, Jan. December 2020 in Ottawa THE CANADIAN PRESS / Adrian Wyld

This Nov 9, 2020, file photo, a general view of Pfizer Manufacturing Belgium in Puurs, Belgium (AP Photo / Virginia Mayo, file)

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Source: https://www.ctvnews.ca/health/coronavirus/historic-moment-health-canada-approves-pfizer-covid-19-vaccine-1.5223477