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When could Canada approve Moderna’s COVID-19 vaccine? Here’s what we know – Global News

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EDITOR’S NOTE: A press release issued Monday morning said Health Canada was still awaiting data from Moderna and that authorization of its vaccine candidate was likely to take several more weeks. Officials later said that press release was from Friday and it was unclear why it had been re-issued on Monday morning.

It remains unclear when Canadians could see the highly anticipated Moderna vaccine approved for use in this country, even as the U.S. begins moving forward following authorization for the vaccine on Friday.

Health Canada faced questions on Monday about a press release it issued that morning saying Moderna still needed to submit more data to the health agency and that approval was likely still weeks away in Canada.

But officials said later in the morning, when pressed for more details, that the press release was actually from Friday and were unclear why it appears to have been re-issued to reporters again on Monday morning.

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Read more:
U.S. gets 2nd coronavirus vaccine after FDA gives Moderna green light

The United States approved the emergency use of the Moderna vaccine on Friday as cases continue to soar within the country’s borders. Health Canada said it is “working closely” with international regulators, including the U.S. Food and Drug Administration, to exchange information on the vaccine candidates undergoing review.


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Coronavirus: U.S. gets 2nd COVID-19 vaccine after FDA gives Moderna green light


Coronavirus: U.S. gets 2nd COVID-19 vaccine after FDA gives Moderna green light

Last Tuesday, the chief medical adviser at Health Canada said things “look positive” with respect to the Moderna vaccine, and that Canada was on track to make its decision about the vaccine very soon. She noted that the only outstanding information Canada needed was the data on manufacturing plants – documents that were supposed to be delivered by the end of last week.

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However, as of Monday morning, it appears Canada may still be waiting for some information.

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“There is still information and data to be provided by Moderna for review,” read the Friday press release, which was sent to reporters again on Monday morning.

“Health Canada cannot provide a definite timeline for the completion of the review at this time, although it is expected to be completed in the coming weeks.”

When Health Canada obtained all the data from Pfizer on its vaccine candidate, it took just five days for the vaccine to be approved. But Canada was more familiar with Pfizer’s manufacturing facilities, so a review of Moderna’s facilities – which Canada has never reviewed before – may take a bit longer.

Once that approval comes down, Trudeau said doses will begin to arrive within 48 hours – and Canada has inked a deal that would see 168,000 Moderna vaccine doses arriving before the end of the month.


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Coronavirus: Canada secures 2nd agreement with Moderna for early vaccine doses


Coronavirus: Canada secures 2nd agreement with Moderna for early vaccine doses

Moderna doesn’t require the same level of ultra-cold storage as the Pfizer vaccine, making its approval all the more important for Canadians living in remote regions. Because of these logistical struggles, Canada’s three territories have been promised enough Moderna vaccine doses to inoculate 75 per cent of their residents.

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As they await the vaccine’s approval and arrival, however, the virus continues to spread. And while Nunavut had remained untouched by the virus until November, the territory reported its first coronavirus deaths on Sunday.


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Coronavirus: Trudeau says majority of Canadians could be vaccinated by next September


Coronavirus: Trudeau says majority of Canadians could be vaccinated by next September – Nov 27, 2020

Once the Moderna vaccine is approved, Canada will be firmly placed on a track towards attaining its projected vaccination timeline. While Canada has signed purchase agreements with multiple vaccine manufacturers, the agreements with Moderna and Pfizer alone should see 60 million doses arrive in Canada by September.

That’s enough to vaccine 30 million Canadians, just eight million shy of the entire population.

Meanwhile, Health Canada says it’s working as fast as it can to ensure the Moderna vaccine doses – and any other vaccine candidates – are safe for use in Canada.

“Health Canada is working hard to give Canadians access to COVID-19 vaccines as quickly as possible and will not compromise its safety, efficacy and quality standards,” Health Canada wrote in its press release.

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“Protecting the health and safety of Canadians is a top priority.”

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

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Ottawa to delay second doses of COVID-19 vaccine as supply dwindles

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The City of Ottawa says it has to delay second doses of the Pfizer-BioNTech vaccine for some people who have already received their first shot due to a temporary shortage of vaccines.

Anthony Di Monte, general manager of emergency and protective services, said Wednesday some long-term care home and retirement home staff, residents and essential caregivers will have to wait up to 27 days, or nearly a week longer than the 21-day period that’s recommended.

For others who received their first vaccine, they may have to wait up to 42 days, he said.

The federal government announced on Friday Canada would be getting fewer COVID-19 vaccines from Pfizer-BioNTech over the next few weeks because the company has to make changes to a production line in Belgium to grow its manufacturing capacity.

In Ottawa, that means the city will be getting no new Pfizer-BioNTech vaccines next week, said Di Monte. The supply the city does have will be focused on ensuring that those who are due for a booster will get their second shot as soon as possible.

The first dose of vaccines have already been administered to more than 92 per cent of long-term care home residents in Ottawa at all 28 facilities. Residents at one at-risk retirement home and one congregant living setting have also been vaccinated, said Di Monte.

“Our next step is to administer the second dose to those individuals who have already received their first dose of the vaccine. Depending on the vaccine supply we receive from the province, which we know will be minimal in the next few weeks, we will then shift our focus to the high-risk retirement homes,” said Di Monte.

Ottawa has 36 high-risk retirement homes and so far, only the one has received doses of the vaccine.

Dr. Vera Etches, Ottawa’s medical officer of health, said delays beyond 21-day gap are permitted under guidelines established by the National Advisory Committee on Immunization.

“The recommendation is of course to follow the dosing schedule as much as we can,” she said. “But in the context of limited supply … jurisdictions can maximize the number of individuals that are getting the benefit from the vaccine by going ahead with the first dose and delaying the second dose.”

While there isn’t data to show what effects waiting up to 42 days may have on the COVID-19 vaccine efficacy, typically delays in booster shots do not affect the durability of vaccines, she said.

 

Source:- CBC.ca

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Quebec vaccine plan may be rethought after troubling Israeli data, says provincial advisor – CTV News Montreal

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MONTREAL —
Quebec could change its vaccine strategy based on new data out of Israel about the efficacy of the first dose, on its own, of the Pfizer COVID-19 vaccine, says a top advisor in the province.

Israel just provided the world with its first large-scale, real-world hint of how effective the first dose of the Pfizer vaccine is before the booster, and it doesn’t seem reassuring for places that have delayed the second shot, including Quebec and the United Kingdom.

“We not only monitor the data that comes from Quebec but also what is observed around the world,” said Dr. Gaston De Serres, a chief advisor on Quebec’s vaccine strategy,

“Yes, we are looking at the data from Israel and the [Quebec immunization committee] could make recommendations based on this data if necessary,” he said.

Data on 200,000 elderly Israelis suggests that the first shot alone only lowered infections by 33 per cent—about a third of the roughly 90-per-cent rate that many experts around the world have predicted.

It’s “concerning in terms of the single-dose policy decision,” said a U.K. scientist, John Robertson, who had previously written about his concerns about the U.K.’s decision, like Quebec’s, to delay booster shots.

Importantly, Israel is not delaying boosters. It’s following the timeline set out by Pfizer and giving the second, or “booster,” shot 21 days after the first. 

The data doesn’t call into question how well the two doses together work. The trial data showed that together, both doses are 95 per cent effective.

But the Pfizer trial wasn’t meant to prove the efficacy of the first dose alone, so the estimates on how well it works without the booster have all been just that—estimates—with scientists looking back at the data and trying to gauge whether delaying the second shots will work.

Delaying the boosters, as Quebec is doing for up to 90 days, is meant to give more people a first shot and some heightened, if imperfect, immunity.

Israel’s new numbers suggest that even when giving the shots on schedule, the elderly people in question didn’t have nearly the protection that was predicted in the short time before they got the booster.

The data doesn’t help with a bigger uncertainty in places like Quebec: whether, and how much, that first-dose protection could last after the 21-day mark if the booster isn’t given. Pfizer says its trial provided no data on this, and the Israel numbers don’t fill that gap either.

ISRAEL’S FINDINGS SO FAR

Israel has moved very quickly on vaccination, inoculating 2.2 million Israelis over the last month. It made an agreement to get rapid delivery of the Pfizer-BioNTech vaccine in return for tracking the effects and sending the manufacturer detailed data.

Two Israeli experts have spoken about the results in recent days.

According to Israeli news channel i24 News, the leader of the country’s vaccine drive, Nachman Ash, told Israeli Hebrew-language outlet Army Radio that “many people have been infected between the first and second injections of the vaccine,” and that it was “less effective than we thought.”

Ran Balicer, an Israeli doctor and epidemiologist, and an adviser to the World Health Organization, spoke to the UK outlet Sky News, explaining more about what was found.

“We compared 200,000 people above the age of 60 that were vaccinated,” the outlet quoted Balicer as saying.

“We took a comparison group of 200,000 people, same age, not vaccinated, that were matched to this group on various variables,” he said. 

Scientists then compared the daily rate of positive COVID-19 cases between the two groups. They found at first, unsurprisingly, there was no difference in the first two weeks after the shot—the vaccine takes about two weeks to kick in.

After that, starting at 14 days post-vaccination, “a drop of 33 per cent in [positive cases] was witnessed in the vaccinated group and not in the unvaccinated,” Balicer told Sky News.

He called it “really good news,” considering the group did have much more protection than their unvaccinated peers. 

SHORT OF ESTIMATES, THOUGH MANY QUESTIONS

However, that number fell far short of the estimate in recent weeks: Dr. De Serres in Quebec, as well as the UK vaccine advisory committee and many other experts, had all said they believed the first shot would be about 90 per cent effective, at least for several weeks, allowing them to delay the booster.

Pfizer has maintained that its trial data only showed a rate of 52.4 per cent efficacity before the second shot and that it knows nothing about what would happen past 21 days.

One question remains around how well the single dose worked to help people fight off serious infections, even if they tested positive for the virus—a key measure. On Wednesday afternoon, Israel’s Minister of Health said Ash’s comments had been taken “out of context” on this.

The minister clarified that Ash had been discussing how Israel “[has] yet to see a decrease in the number of severely ill patients,” not infections, according to the BBC.

And Balicer suggested the surprise in Israel’s data may have come partly from the fact that those studied so far have all been elderly, whereas Pfizer’s trial subjects were a mix of ages. The immune systems of the elderly aren’t as strong as those of younger people.

Balicer said he expects the Israeli numbers to rise once more young people are included in the group studied.  

He also said that real-world data is not the same as trial data—and on the upside, Israel’s data proves beyond a doubt that the vaccine does work, and on the same kind of timeline the Pfizer trial showed.

“This is not the ideal setting of a randomized controlled trial where everything from coaching maintenance to selection of the population of interest is done in a very meticulous way,” he said.

“This is the real world. And so by seeing the real-world impact so early on in the same direction and in the same timing as we’ve seen in the clinical trials is something that makes us very hopeful.”

According to the BBC, Balicer also said that after the first 33-per-cent drop in infections, the rate of cases continued to drop—meaning immunity appeared to keep growing stronger, in those vaccinated with the first dose—but it was too soon to know more.

QUEBEC URGED TO TAKE A SECOND LOOK

Robertson, a professor of surgery at the University of Nottingham, said Wednesday that he thinks the Israeli results provide strong evidence for Quebec and similar jurisdictions to change course if they’ve delayed second doses.

Earlier this month, Robertson co-published an opinion piece for the BMJ British medical journal arguing that delaying the second dose wasn’t based in firm science.

“The personal and population risks have even greater relevance and urgency for Quebec given the real-life data reported from Israel,” he said Wednesday.

“The second dose should be given on Day 22 as in the Phase 3 trials and approved by regulatory agencies worldwide.”

Pfizer said it has no comment yet on the new data and can only speak about the results of its Phase 3 trial.

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Hinshaw assures vaccine safety as frustrations mount amid Alberta's shrinking supply – Calgary Herald

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Article content continued

During a job interview with a private company Tuesday, Jeffries said she was asked if she had received the vaccine and was denied immediate employment when she said she hadn’t.

“I can’t compete in a job right now because their preference is for people who have had at least the first dose, so that’s upsetting, and to be told that there’s no estimated date for first doses to be supplied . . . it’s all starting to feel a little heavy,” Jeffries said.

“Not knowing when I’m going to get the first dose, I feel like I’m not only at health risk, I’m at job risk.”

Hinshaw said she understood the frustrations from health-care workers, especially in the wake of a public call-out for staff to sign up for open vaccination spots less than a week earlier, before the Pfizer delay was announced.

She said there’s no timeline for when first doses may resume, saying there is not enough vaccine in stock to do so while covering off second doses.

“I would ask health-care workers and others to be patient and to assure them that we are doing everything we can to plan forward, to ensure that when we do have enough supply, hopefully the experience of booking and receiving vaccine will be as smooth as possible for them.”

The 95,243 vaccinations administered in Alberta break down to 88,240 first doses and 7,003 second doses. On a per-capita basis, Alberta outpaces all provinces except for Prince Edward Island and Saskatchewan for vaccinations.

Also Wednesday, Alberta reported 669 new cases of COVID-19 from 14,888 tests, about a 4.5 per cent positivity rate. It’s the lowest positivity rate logged in Alberta since Oct. 31, but still far exceeds the one-to-three per cent rate seen during the summer and through early fall.

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