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
Exclusive-Canada’s Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages
By Allison Martell
TORONTO (Reuters) – The Canadian province of Ontario will begin offering AstraZeneca’s COVID-19 vaccine on Tuesday to people turning 40 or older this year, according to a government source.
The change will broaden access to vaccines as a third wave of infections threatens to overwhelm hospitals in Canada‘s most-populous province, and should make it easier to use doses that in some cases have been accumulating at pharmacies.
The change will be announced on Monday and go into effect across the province on Tuesday, according to the source. The vaccine has already been distributed to pharmacies but currently can only be given to people turning 55 or older this year.
Ontario announced new public health measures on Friday, promising checkpoints at provincial borders, new police powers and closing outdoor amenities, while leaving many workplaces open. The measures were widely criticized by doctors and public health experts, and the province quickly reopened playgrounds and modified the new police powers.
On March 29, Health Canada said it would review reports of serious blood clots and bleeding in a small number of people who had received the AstraZeneca vaccine in other countries, and an independent panel called the National Advisory Council on Immunization (NACI) recommended that it only be given to people 55 and older. All provinces followed that advice.
But NACI’s recommendations are not binding. Last week, Health Canada, the country’s drug regulator, said it had reviewed all available evidence and would not restrict the use of the vaccine, because its benefits outweigh its potential risks. Health Canada said at the time that NACI was reviewing its recommendations.
On Sunday, NACI’s chair told Reuters that the panel would make a new recommendation on Tuesday.
Health Canada said regulators in the UK had estimated the risk of clots to be very small, roughly four in a million people who receive the vaccine. It also said the complication was treatable. Two people have developed it in Canada, and both are recovering.
Several other countries have limited the use of the vaccine to older people. Denmark has withdrawn the shot, and Norway said on Thursday it would take more time to decide whether to resume use.
Ontario reported 4,250 new cases of COVID-19 on Sunday. The Ontario Hospital Association said 59 patients were admitted to intensive care on Saturday, bringing the number of COVID-19 patients in ICUs to 737.
Health Canada says those who receive the vaccine should seek medical attention immediately if they experience shortness of breath, chest pain, leg swelling, persistent belly pain, neurological symptoms like severe headaches or blurred vision, or skin bruising or tiny blood spots under the skin beyond the site of the injection.
(Reporting by Allison Martell; Editing by Diane Craft and Peter Cooney)
Trudeau mobilizes federal workers to battle COVID-19 in Toronto and rest of Ontario
OTTAWA (Reuters) – Canadian Prime Minister Justin Trudeau said on Sunday he would send federal healthcare workers to help Toronto and the province of Ontario battle a third wave of COVID-19 infections that has forced shutdowns of schools and businesses.
“We are mobilizing federal healthcare workers from across government departments to deploy on the front lines in Ontario and specifically the Greater Toronto area where the situation is most critical,” Trudeau said in a video posted on Twitter.
Other provinces, especially on the Atlantic coast, are working “to determine what human resources and equipment they could free up over the coming days,” Trudeau said, adding that the federal government would cover the costs of that help.
The government will also seek to boost rapid testing, especially for essential workers, Trudeau said.
The government of Ontario, Canada‘s most-populous province and industrial powerhouse, has moved schools online and announced more stringent public health measures on Friday, including shutting the provincial borders to non-essential travel.
On Saturday, federal Public Safety Minister Bill Blair deployed two mobile health units to set up more hospital beds in Toronto and Hamilton, Ontario, and the prime minister said he stood ready to send the Red Cross to staff mobile vaccination clinics in Ontario if help is requested.
Canada‘s seven-day average of new infections was 8,669, the chief medical officer said on Sunday, a 26% increase compared with the previous seven days. Ontario reported 4,250 new cases on Sunday.
Canada has been ramping up its vaccination campaign but still has a smaller percentage of its population inoculated than dozens of other countries, including the United States and Britain.
More than 48 million doses are to be delivered by the end of June, which is enough for all of Canada‘s population of some 38 million to receive at least one shot, with a total of 100 million doses expected by the end of September.
(Reporting by Steve Scherer; Editing by Peter Cooney)
Canada has second case of rare blood clots after AstraZeneca vaccin
(Reuters) – Canada on Saturday reported a second case of rare blood clots with low platelets after immunization with AstraZeneca’s COVID-19 vaccine in a week, while it said it still recommended the use of the shot.
The person who experienced the very rare event has been treated and is recovering, Canada‘s health ministry said in a statement, adding that the person lives in the province of Alberta.
Based on the evidence available, Canada still maintains that the benefits of the AstraZeneca vaccine outweigh the potential risks, the statement said.
Canada health authorities “will continue to monitor the use of all COVID-19 vaccines closely and examine and assess any new safety concerns,” the statement said.
Canada reported a first blood clotting associated with the vaccine on Tuesday, and a day later, after a review, health authorities said they would not restrict use of the AstraZeneca vaccine.
A separate advisory council had earlier recommended Canada stop offering the vaccine to people under 55. That panel is in the process of reviewing its advice.
Canada has been ramping up its vaccination campaign, but still has a smaller percentage of its population inoculated than dozens of other countries, including the United States and Britain.
Amid a spiking third wave of infections, Ontario, Canada‘s most populous province, announced new public health restrictions on Friday, including closing the provinces borders to domestic travelers.
(Reporting by Kanishka Singh in Bengaluru and Steve Scherer in Ottawa, writing by Steve Scherer; Editing by Cynthia Osterman)
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