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The need for speed: How Canada approved five vaccines for COVID-19 in under a year – ThinkPol

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OTTAWA — 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. 

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.

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.

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.

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.

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.

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.

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.

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.”

This report by The Canadian Press was first published March 28, 2021.

Mia Rabson, The Canadian Press

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Ontario hospitals may have to withhold care as COVID-19 fills ICUs

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By Allison Martell and Anna Mehler Paperny

TORONTO (Reuters) – Doctors in the Canadian province of Ontario may soon have to decide who can and cannot receive treatment in intensive care as the number of coronavirus infections sets records and patients are packed into hospitals still stretched from a December wave.

Canada‘s most populous province is canceling elective surgeries, admitting adults to a major children’s hospital and preparing field hospitals after the number of COVID-19 patients in ICUs jumped 31% to 612 in the week leading up to Sunday, according to data from the Ontario Hospital Association.

The sharp increase in Ontario hospital admissions is also straining supplies of tocilizumab, a drug often given to people seriously ill with COVID-19.

Hospital care is publicly funded in Canada, generally free at the point of care for residents. But new hospital beds have not kept pace with population growth, and shortages of staff and space often emerge during bad flu seasons.

Ontario’s hospitals fared relatively well during the first wave of the pandemic last year, in part because the province quickly canceled elective surgeries.

The College of Physicians and Surgeons of Ontario told doctors last Thursday that the province was considering “enacting the critical care triage protocol,” something that was not done during earlier waves of the virus. Triage protocols help doctors decide who to treat in a crisis.

“Everybody’s under extreme stress,” said Eddy Fan, an ICU doctor at Toronto’s University Health Network. He said no doctor wants to contemplate a triage protocol but there are only so many staff.

“There’s going to be a breaking point, a point at which we can’t fill those gaps any longer.”

In a statement, the health ministry said Ontario has not activated the protocol. A September draft suggested doctors could withhold life-sustaining care from patients with a less than 20% chance of surviving 12 months. A final version has not been made public.

Ontario’s Science Advisory Table had been forecasting the surge for months, said member and critical care physician Laveena Munshi. During a recent shift she wanted to call the son of a patient only to discover he was in an ICU across the street.

“The horror stories that we’re seeing in the hospital are like ones out of apocalyptic movies,” she said. “They’re not supposed to be the reality we’re seeing one year into a pandemic.”

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In COVID-19 vaccination pivot, Canada targets frontline workers

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By Anna Mehler Paperny

TORONTO (Reuters) – Canada is shifting its vaccination campaign to target frontline workers, moving away from a largely age-based rollout as the country tries to get a handle on the raging third wave of the pandemic.

Canada‘s approach thus far has left unvaccinated many so-called “essential workers,” like daycare providers, bus drivers and meatpackers, all of whom are among those at higher risk of COVID-19 transmission. Provinces are now trying to adjust their strategy to tackle the surge driven by new variants.

Targeting frontline workers and addressing occupation risk is vital if Canada wants to get its third wave under control, says Simon Fraser University mathematician and epidemiologist Caroline Colijn, who has modelled Canadian immunization strategies and found “the sooner you put essential workers [in the vaccine rollout plan], the better.”

Initially, Canada prioritized long-term care residents and staff for the vaccines, as well as the very elderly, health workers, residents of remote communities and Indigenous people.

Targeting vaccinations by age made sense early on in a pandemic that ravaged Canada‘s long-term care homes, Colijn said. But now, immunizing those at highest risk of transmission brings the greatest benefit.

“If you protect these individuals you also protect someone in their 60s whose only risk is when they go to the store. … The variants are here now. So if we pivot now, but it takes us two months to do it, then we will lose that race.”

Data released on Tuesday from the Institute of Clinical and Evaluative Sciences showed that Toronto’s neighbourhoods with the highest rates of COVID-19 infections had the lowest vaccination rates, underscoring the disparities in vaccination.

‘IT’S A JUGGERNAUT’

On Wednesday, Ontario Premier Doug Ford announced a plan to have mobile vaccine clinics target COVID-19 “hotspots” and high-risk worksites, although he stopped short of giving people paid time off to get the shot.

Karim Kurji, medical officer of health in York Region north of Toronto, characterizes the shift in vaccination priority from age to transmission risk as moving from defence to offence.

“It’s a juggernaut in terms of the immunization machinery, and turning it around takes a lot of effort,” Kurji said.

Meanwhile, officials in the western province of Alberta say they are offering vaccines to more than 2,000 workers at Cargill’s meatpacking plant in High River, site of one of Canada‘s largest workplace COVID-19 outbreaks. Provincial officials said in a statement they are looking to expand the pilot to other plants.

Quebec will start vaccinating essential workers such as those in education, childcare and public safety in Montreal, where neighbourhoods with the highest vaccination rates have been among those with the lowest recorded infection rates.

The people doing the highest-risk jobs, from an infectious disease perspective, are more likely to be poor, non-white and new Canadians, health experts say. They are less likely to have paid leave to get tested or vaccinated or stay home when sick and are more likely to live in crowded or multi-unit housing. They need to be prioritized for vaccination and their vaccination barriers addressed, experts say.

Naheed Dosani, a Toronto palliative care physician and health justice activist, said making vaccines available to high-risk communities is not enough without addressing barriers to access.

“The face of COVID-19 and who was being impacted changed dramatically. The variants seemed to take hold in communities where essential workers live. … This [pivot] is a step in the right direction and will hopefully save lives.”

 

(Reporting by Anna Mehler Paperny; Editing by Denny Thomas and Aurora Ellis)

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Canada finance minister: Pandemic an opportunity to bring in national childcare

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OTTAWA (Reuters) – The COVID-19 pandemic and its damaging impact on women has underlined the need for a national childcare plan, which would also help the economic recovery, Finance Minister Chrystia Freeland said on Thursday.

Since taking up her job in August, Freeland has repeatedly spoken about a “feminist agenda,” and has said childcare will be part of a stimulus package worth up to C$100 billion ($79.6 billion) over three years. She will unveil details in her April 19 budget.

“I really believe COVID-19 has created a window of political opportunity and maybe an epiphany … on the importance of early learning and childcare,” Freeland told a online convention of Canada‘s ruling Liberal Party.

The budget is set to be a springboard for an election that Liberal insiders say is likely in the second half of the year.

Canadian governments of various stripes have mused about a national childcare program for decades but never acted, thanks in part to the cost and also the need to negotiate with the 10 provinces, which deliver many social programs.

Freeland said a childcare program would help counter “an incredibly dangerous drop” in female employment since the start of the pandemic.

“It is a surefire way to drive jobs and economic growth … you have higher participation of women in the labor force,” Freeland said. “My hope … is that being able to make that economic argument as well is going be to one of the ways that we get this done.”

Freeland, who is taking part this week in meetings of the Group of Seven leading industrialized nations and the International Monetary Fund, said U.S. Vice President Kamala Harris and Treasury Secretary Janet Yellen had told her they saw early learning and child care as a driver for economic recovery.

($1=1.2560 Canadian dollars)

 

(Reporting by David Ljunggren; Editing by Leslie Adler)

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