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'Unprecedented': How Canada approved five vaccines for COVID-19 in under a year – National Post

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The five non-COVID vaccines approved, four for influenza and one for shingles, took an average of 397 days

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In the last four years, Health Canada has approved more than 1,500 new or updated pharmaceuticals.

Ten of them are vaccines.

Five of those are for COVID-19.

Dr. Supriya Sharma, the chief medical adviser at Health Canada helping oversee the review process, has never seen anything like the speed with which the COVID-19 vaccines got approved.

“I mean, unprecedented is the one word that we’ve been overusing, but there’s nothing even close to comparable to this,” she said in an interview.

The five non-COVID vaccines approved, four for influenza and one for shingles, took an average of 397 days from the day the company applied for approval in Canada, until that approval was granted.

The average time for COVID-19 vaccines? 82 days.

That includes 61 days for Pfizer-BioNTech, 72 days for Moderna, 95 days for Johnson & Johnson, 148 days for Oxford-AstraZeneca and 34 days for Covishield, the AstraZeneca vaccine produced by the Serum Institute of India.

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Covishield is a slight outlier because Health Canada mostly just needed to review the manufacturing process, as the vaccine is the same formula as the AstraZeneca doses made elsewhere. Sharma likens it to the same recipe made in a different kitchen, but the kitchen still needs to be up to snuff.

A sixth vaccine from Novavax is still under review, with the results from its big clinical trial not expected until next month. It has been under review by Health Canada for 58 days at this point.

Nurses waiting to administer doses of the Moderna coronavirus disease (COVID-19) vaccine sit at a vaccination centre, as part of the COVID-19 vaccination campaign, in Brampton, Ontario, Canada, March 4, 2021.
Nurses waiting to administer doses of the Moderna coronavirus disease (COVID-19) vaccine sit at a vaccination centre, as part of the COVID-19 vaccination campaign, in Brampton, Ontario, Canada, March 4, 2021. Photo by Carlos Osorio /Reuters

The speed has raised fears among Canadians that everything moved too quickly. Many medical experts worry it is contributing to hesitancy to get the vaccines.

But Sharma says speed did not come at the expense of safety.

“That’s the only priority, the only thought, is what’s best for Canadians,” she said. “There’s no other motivation anywhere.”

Lack of research funds can slow down new drug development, but in this case, as lockdowns shuttered economies worldwide and death tolls mounted, countries poured billions of dollars into getting a vaccine to get us out of the pandemic.

Most of the successful vaccines for COVID-19 so far use existing vaccine technology that was adjusted for the SARS-CoV-2 virus that causes COVID-19.

They start with lab studies to check for safety on animals and see how the vaccine works in a lab setting on blood samples and on samples of the virus.

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Then it is tested on a very small number of humans to look for any glaring safety concerns. Then they test it on a slightly larger number of people — usually fewer than 100 — to look for safety and the development of antibodies.

If that goes well, the trial is expanded to thousands of volunteers, some of whom get the vaccine and some of whom don’t. Then they wait to see how many in each group get infected.

Phase 3 trials usually take between one and four years. For the vaccines approved in Canada so far, phase three trials took about three months.

Sharma said the time a trial takes depends on finding enough patients to participate, and then having enough of their trial participants get sick to know how well the vaccine is or isn’t working.

Shirley Banks, 88, flinches a bit in anticipation of getting her needle, wielded by public health nurse Stephanie McKee as the first COVID-19 vaccine was injected at the North London Optimist Centre on Cheapside Street in London, Ont.
Shirley Banks, 88, flinches a bit in anticipation of getting her needle, wielded by public health nurse Stephanie McKee as the first COVID-19 vaccine was injected at the North London Optimist Centre on Cheapside Street in London, Ont. Photo by Mike Hensen/The London Free Press/Postmedia Network

Fortunately and unfortunately, COVID-19 was spreading so rampantly in so many places, getting enough people exposed did not take very long.

Canada has seen very few vaccines tested here so far, mainly because our infection rates weren’t high enough.

While the drug makers were busy getting the trials going, Health Canada was getting ready for their submissions. Sharma said discussions about COVID-19 vaccines began in earnest with international bodies in mid-January 2020, before Canada had even had a single confirmed case.

“I think we knew that … we had a virus that was going to be transmissible, that could be causing significant respiratory disease, and that there would be an interest in therapies and vaccines definitely, very early on,” said Sharma.

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It was determined quickly that this virus was so new there was no existing vaccine that could be adjusted quickly, as had happened with the H1N1 pandemic in 2009.

By March, Health Canada had started putting teams in place to review new therapies and vaccines for COVID-19 as soon as they were ready.

Each team was made up of 12 to 15 people, with varying specialties. There was some overlap between the teams but not a lot because many vaccines were being reviewed at the same time.

The experts on the file included infectious disease specialists, pharmacologists, biostatisticians, and epidemiologists.

Separate from that were teams of people looking at manufacturing facilities. Approving a vaccine isn’t just about making sure the clinical data shows it to be safe and effective, but also about making sure the place it is to be made follows the required safety standards.

People line up at a COVID-19 testing clinic Wednesday, March 24, 2021 in Montreal.
People line up at a COVID-19 testing clinic Wednesday, March 24, 2021 in Montreal. Photo by Ryan Remiorz /The Canadian Press

They needed an emergency order from Health Minister Patty Hajdu to do a rolling review. Normally drug makers can’t apply until they have every piece of data ready but with a rolling review Health Canada scientists can start reviewing the data as it becomes available.

Hajdu granted that on Sept. 16.

Then the vaccine submissions began pouring in — AstraZeneca applied Oct. 1, Pfizer Oct. 9, Moderna on Oct. 12, and J&J on Nov. 30. The Covishield application came Jan. 23 and Novavax submitted on Jan. 29.

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Sharma says the teams were working 15 to 18 hours a day, seven days a week, reviewing data, asking the companies questions, requesting more information or new analyses.

Sometimes they were doing it in the middle of the night. Collaborations with international partners in very different time zones, meant 2 a.m. or 4 a.m. video conference calls were not unusual.

When Pfizer and Moderna were reviewed, it was entirely based on clinical trail and pre-market data because the vaccines hadn’t been approved anywhere else. Canada was the third in the world to authorize Pfizer on Dec. 14th, and second to approve Moderna Dec. 23.

By the time Health Canada authorized AstraZeneca — a review process complicated by some mistakes during the clinical trial in dosing and the number of seniors among its volunteer patients — it was also able to pull data from real-world use of the vaccine in the United Kingdom.

The regulatory work doesn’t end when the authorization is announced. The post-market surveillance data is still non-stop. The recent blood clot concern with the AstraZeneca vaccine took a lot of time, but just monitoring the data submitted by the vaccine makers on adverse events overall is still critical.

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To date, the adverse event reports in Canada have not been different than what was seen in clinical trials.

Companies also adjust their submissions requiring further review. Pfizer has so far asked for two changes, one to the number of doses per vial and another for the temperature at which the vaccine has to be kept.

If anything changes on safety, or if the efficacy seen in a clinical trial doesn’t play out in the real world, Sharma says Canada will not hesitate to make adjustments. But those decisions will be made by Canadian experts, said Sharma, the same ones who have been on the files all along.

“It’s important that if anything comes up, we have people that have reviewed it, have gone through every piece of paper, the 2,000 hours, the hundreds of thousands of pages, and that if anything comes up, it’s like they’ve got a really strong science base, and they can put that stuff in context and we can make decisions really quickly.”

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Dutch Teen Who Went to Space With Jeff Bezos Told Him He’s Never Bought Anything on Amazon – Gizmodo

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New Shepard lifts off from Launch Site One in West Texas with four humans on board. (July 20, 2021)

The award for “Best Small Talk on a Flight to Space” goes to Oliver Daemen, the 18-year-old from the Netherlands who was part of Blue Origin’s inaugural crewed flight to space earlier this week. On the roughly 10-minute flight, Daemon told Amazon founder Jeff Bezos what probably sounded like blasphemy to his billionaire ears: He had never bought anything on Amazon.

In an interview with Reuters on Friday, Daemen recounted his first flight to space, from when he got the call asking him if he was interested to the conversations he had with his crewmates, which included Bezos, his brother Mark Bezos, and 82-year-old pilot Wally Funk. Daemen, whose father is the CEO of a private equity firm in the Netherlands, became the youngest person to ever fly to space, while Funk became the oldest.

The teen also holds the distinction of surprising Bezos, whose Amazon empire has made him one of the richest men in the world.

“I told Jeff, like, I’ve actually never bought something from Amazon,” Daemen told Reuters. “And he was like, ‘oh, wow, it’s [been] a long time [since] I heard someone say that.’”

Considering that Bezos thanked “every Amazon employee and every Amazon customer” for making the flight possible after he and the crew returned to Earth, Daemen’s comments may have been a little awkward. However, it’s nice (and kind of funny) to hear that someone was frank with him. Bezos no doubt has enough people telling him that Amazon is God’s gift to humanity, so it’s cool to see one of the youths set him straight.

Daemen wasn’t originally supposed to go on the flight with Bezos and crew. He was offered the opportunity after the winner of the online auction for the seat, whose identity is still unknown and who paid a whopping $28 million for it, said they couldn’t go because of “scheduling conflicts.” Daemen, who was a participant in the auction and had already secured a spot on the second flight, was then moved up on the list. His father, Joes Daemen, paid for the seat.

According to Daemen, his family didn’t pay anything near what the mysterious bidder paid for the opportunity.

“We didn’t pay even close to $28 million, but they chose me because I was the youngest and I was also a pilot and I also knew quite a lot about it already,” he said.

The teen, who will begin his studies at Utrecht University in September, said he wasn’t sure what he wanted to do professionally, but would consider focusing on space travel. He also told the outlet that his fellow travelers were “super fun and all down to Earth.” Well, considering Daemen’s referring to a man that wants to stupidly move all polluting industry into space, I’m not sure I’m sold on that.

Congratulations on the award for that great small talk, though.

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Several Ontario mass vaccination clinics wind down as focus shifts to smaller sites – CP24 Toronto's Breaking News

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The Canadian Press


Published Friday, July 23, 2021 1:37PM EDT


Last Updated Friday, July 23, 2021 1:37PM EDT

Several mass COVID-19 vaccination clinics across Ontario are winding down as first-dose registrations wane and communities shift their focus to smaller venues.

The large clinics held in local arenas, hospitals and recreation centres across the province have been a key part of the vaccine rollout that began in the winter.

Now that first-dose vaccination coverage has hovered at around 80 per cent for adults provincewide, many health units are beginning the transition to smaller, more targeted vaccination approaches.

“Our large-scale clinics are ending because they are no longer filling up,” the Northwestern Health Unit, which covers the city of Kenora, Ont., and surrounding communities, said in a statement this week as its mass clinics wrapped up operations. “Once they are over, we will provide the vaccine in our offices and at smaller clinics in the community.”

Grey Bruce, a current hot spot for the more infectious Delta COVID-19 variant, is also shutting down its mass clinics at the end of the month to return the large sites for community use.

The health unit is advising people with shots booked for August and beyond to reschedule, and is offering smaller clinics across the region that includes several rural areas.

People living in the Wellington-Dufferin-Guelph region were urged this week to seek out their shots before the local health unit starts closing mass clinics the week of Aug. 6.

“I encourage people to take advantage of the thousands of available appointments at our clinics before we move to the next phase,” Rita Isley, director of community health for the region, said in a statement. “These last few weeks of our mass clinics are the easiest way to get your shot.”

The health unit said it will shift to small clinics and pop-ups “into the fall” after the last of the large clinics close on Aug. 20.

Larger cities are also following the trend, with Mississauga, Ont., aiming to close a convention centre used as a vaccination site on Monday, with another hospital clinic closing the next day.

Mayor Bonnie Crombie said the transition away from mass clinics is part of the city’s focus on bringing vaccines to the least-immunized communities, with more emphasis planned on pop-ups, drive-thru clinics and primary care sites.

“This is a good news story and it shows that our mass vaccination clinics have done their job getting the majority of our people vaccinated,” Crombie told reporters on Thursday.

“We can now look at this period as the home stretch of our initial vaccine rollout to get to that final 10 to 20 per cent of our population and ensure that they, too, are vaccinated.”

​Kingston, Ont.’s health unit announced last week that it would enter a “new phase” of its vaccination effort, with plans to shut down mass clinics beginning in August and shift to pharmacy, mobile and primary care sites.

Mass clinics in the London, Ont., will see reduced hours in the coming weeks amid dwindling demand, the health unit announced this week. It said immunizations have sped up and many people have moved up their second-dose appointments that were scheduled for the fall, meaning the large sites won’t be needed.

“As the health unit turns its focus to individuals in the community, the vaccination effort will rely on mobile and walk-in pop-up clinics, as well as providing opportunities to be vaccinated at community events,” the Middlesex-London Heath Unit said in a statement.

Health Minister Christine Elliott said earlier this month that primary care sites would become more essential to the province’s vaccination plan as mass clinics at hospitals, stadiums and other large venues wind down and resume their old uses.

A spokeswoman for Elliott said targeted vaccination strategies will play a greater role going forward as the province aims to reach vaccine hesitant communities.

“The province is working with the public health units to improve vaccination rates through mobile clinics and community-based pop-ups, dedicated clinic days for people with disabilities, holding townhall meetings in multiple languages, and providing services such as transportation, translation services, and drive-through clinics,” Alexandra Hilkene said in a statement on Friday.

The Grey Bruce health unit noted this week that its local COVID-19 situation is now a “pandemic of the unvaccinated,” a trend documented around the world.

The health unit says 95 per cent of cases reported in the first two weeks of July were among people not fully vaccinated, and encouraged people to get their shots, noting that it’s likely that vaccinated people may be subject to fewer restrictions such as isolation rules in the event of future outbreaks.

“Vaccinating the majority of people sets us on the road to return to normal,” it said.

Ontario reported 192 new COVID-19 cases on Friday and one death from the virus. Sixty-six per cent of Ontario adults are now fully vaccinated.

This report by The Canadian Press was first published July 23, 2021.

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Will Doug Ford’s opposition to vaccine passports survive the fall? – TVO

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The Ontario COVID-19 Science Table issued a brief earlier this week laying out the arguments in favour of some kind of “vaccine certificate” system for domestic use in Ontario: a more rigorous kind of proof of vaccination than the receipts people are currently issued that could be used to exclude the unvaccinated from the highest-risk non-essential places, such as bars, restaurants, gyms, and theatres.

There is one problem — one expressly conceded in the document: the authors note that they can’t say with scientific confidence that such certificates would reduce COVID-19 transmission or increase vaccination uptake. It’s still a novel pandemic, after all.

“You also have to remember this is a new virus, and population-wide coverage of these vaccines is also new,” says co-author Karen Born, an assistant professor at the University of Toronto’s Institute for Health Policy, Management and Evaluation. She acknowledges that the case for certificates — more commonly known as vaccine passports — can’t cite peer-reviewed literature to make the case yet, because it doesn’t exist. But, she says, “just because there’s no evidence to date doesn’t mean we can’t make that pragmatic case.”

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In the absence of iron-clad, gold-standard evidence, we can look to other provinces, such as Quebec and Manitoba, and to other countries — both Italy and France have announced they intend to implement a vaccine-certificate system.

But the most compelling case might be Israel, where the government relied on a form of vaccine certificate, the “Green Pass,” earlier this year to control access to some non-essential places while implementing a comprehensive vaccination of its population. The Green Pass was suspended on June 1. But on Thursday, in the face of a higher rate of new cases, the government announced it would return, terming it a policy of “soft suppression.”

(For those people who insist that we need to “learn to live with the virus”: that’s exactly what Israel says such measures are in service of: we’re allowed to choose how we live, intelligently, with a new endemic virus.)

While Israel has a higher share of its population fully vaccinated than Canada or Ontario, it’s still vulnerable to new pandemic waves. Although Ontario is currently seeing low numbers of cases and falling hospitalizations, it’s not hard to sketch out how a resurgence of COVID-19 could happen here in the next few months: the province will likely enter whatever comes after Step 3 in August, and both public schools and post-secondary education will resume in September. Many employers will start calling their workers back to offices in the fall, and all of these things will lead to increased spread of the disease.

Kieran Moore, the chief medical officer of health, has said he expects a new wave of infections in the fall. That’s in part why he repeatedly urges people to get their shots — to try to minimize the severity of a potential fourth wave.

True, the vaccines mean that cases are far less likely to turn into hospitalizations and deaths. But they haven’t changed one crucial thing: it takes only 300 or so people in Ontario’s intensive-care units to start delaying hospital procedures, and we’ve barely started to dig out from the procedure backlog that built up over the past 18 months. There are more than 4.5 million people currently unvaccinated in Ontario as of today; nearly 275,000 of those are over the age of the 60, according to the province’s daily data release. COVID-19 could still throw a wrench into our hospital system if spread isn’t controlled.

And what would the government do if ICU cases were to start creeping north of 200 again in the fall and show no sign of slowing? (Friday’s number is 136.) Another round of broad-spectrum lockdowns would overwhelmingly punish the large majority of people who’ve done the right thing and gotten their shots. It would also rightly enrage businesses that are just starting to get their customers back after a brutal year. Born cites gyms as an example of the kind of business that could be saved by a vaccine certificate in the event of a fourth wave. Movie theatres, already chafing under what they call “arbitrary and unreasonable” restrictions, are another example.

“This could allow for a faster reopening and also allow for increased capacity in those settings,” Born says. “We’re looking at places where certificates should be used and also where they shouldn’t — lower-risk settings and essential settings.”

It doesn’t make sense to let needed medical care be postponed once again in this pandemic because we didn’t maximize our vaccination coverage, especially given that a vaccine certificate could be implemented relatively quickly — we know that the province did the work to develop a digital pass before deciding to abandon the idea.

“It’s either, let’s do a shutdown, let’s close businesses and schools, or let’s lean into this kind of framework,” says Born. “The alternative is closures that we’re all familiar with at this point.”

Not only has the government failed to implement any kind of rigorous proof-of-vaccination policy; it also hasn’t clarified the legal rights of businesses or employers with respect to unvaccinated customers and employees, creating a fog of confusion that helps nobody (except anti-vaxxers).

Vaccine passes raise legitimate civil-rights concerns, and they should obviously be implemented carefully and thoughtfully; the science table’s brief has important advice on how to do that. When Premier Doug Ford says that it’s a constitutional right to take the vaccine or not, he’s not wrong. But the freedom not to be vaccinated should not require the rest of us — or the province’s hospital system — to be held hostage to people’s refusals. And it’s difficult to believe that a government that has compelled the speech of businesses to attack the federal Liberals and prohibited the speech of unions for its own electoral advantage is making a sincere defence of Ontarian’s Charter rights here. In any event, a vaccine certificate is arguably a less intrusive public-health measure than broader lockdowns.

That, then, is the logic behind calls for a vaccine passport: the government shouldn’t let a fourth wave delay needed medical care in our hospitals, and it shouldn’t use the blunt instrument of new lockdowns again. A vaccine certificate would give the Tories a smarter, more targeted alternative — if they’re willing to use it.

So far, Ford has made his position clear: he isn’t considering a vaccine passport. But events could very well press the issue by October, and then he and his cabinet would have a choice. Since I think they’ll end up flip-flopping on this issue out of simple necessity, it would be best if they’d do that sooner rather than later.

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