Health
The need for speed: How Canada approved five vaccines for COVID-19 in under a year – NewmarketToday.ca
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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NEWS RELEASE
SOUTHLAKE REGIONAL HEALTH CENTRE
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This Cancer Awareness Month, Southlake is adding advanced technologies to detect and treat breast cancer and other women’s cancers thanks to generous community donor support, most recently through the HERE is Where Cancer Meets its Match campaign. New cancer care technology, including new mammography machines, the MyoSure System and the MOLLI 2® System will make a measurable impact in diagnosing and treating women’s cancers in the communities Southlake serves.
Southlake is installing three new mammography machines to expand its breast cancer screening program to 1,500 more women each year. Two of these machines have new biopsy capabilities that will reduce the number of cancelled exams due to equipment failure, ensuring timely care for women. Women ages 40 to 49 years old will be able to self-refer for publicly funded mammograms through the Ontario Breast Screening Program starting this fall.
“Early detection is critical when treating breast cancer and other women’s cancers,” said Lorrie Reynolds, Director, Regional Cancer Program at Southlake. “We treat more than 1,700 breast cancer patients at Southlake every year. By adding advanced technology, like the new mammography machines, we’re ensuring women have the best experience at Southlake.”
Southlake is also introducing the MyoSure System, an innovative technology that can help detect female reproductive cancers. Damaged tissue in a woman’s uterus such as fibroids and polyps can now be removed in a precise, minimally invasive procedure that leaves the rest of the uterus intact. This will improve the overall patient experience by supporting faster recovery, reducing the risk of infection and giving more women the option to have children. An estimated 200 women per year will benefit from the MyoSure System.
The new mammography machines and the MyoSure System build on Southlake’s recent investment in the MOLLI 2® System, a made-in-Canada wire-free breast localization technology. This technology is considerably less invasive and more accurate when compared to wire-guided localization, resulting in a better patient experience and improved cosmetic outcomes. More than 200 women each year will benefit from this innovative medical device as they are treated for breast cancer at Southlake.
“As a clinician caring for women with cancer in our community, I’m incredibly proud of the work Southlake is doing to advance women’s health and improve patient experiences,” said Sara Temple, MD, Surgical Oncologist and Chief of Surgery at Southlake. “Women who visit Southlake can be confident that they are receiving leading edge care, close to home when they need it most.”
The World Health Organization anticipates a 77 per cent increase in cancer diagnoses by 2050. Southlake serves some of the fastest growing communities in Canada and anticipates that the number of patients requiring cancer care will grow. By investing in new technology, Southlake is ensuring that women in the communities it serves have access to leading edge cancer care. All of these investments were funded with support from community donors who generously gave to Southlake to support investments into women’s health at the hospital.
“The generosity of our donor community and the impact they have made for women receiving cancer diagnosis and treatment at Southlake is something we can all take great pride in,” said Jennifer Ritter, President and CEO of Southlake Foundation. “From our Women’s Health Initiative donors supporting new mammography machines, to the Ladies in Philanthropy for Southlake funding the MOLLI 2 System, to our long-standing partners The Edge Benefits and Pheasant Run Golf Club enabling the introduction of MyoSure System through their joint annual charity golf tournament, we are incredibly lucky to share a vision of access to exceptional care for everyone who depends on Southlake when they need us most. Thank you, to every donor who contributed to these important upgrades to care for women.”
Southlake Foundation’s HERE is Where Cancer Meets its Match campaign supports the Stronach Regional Cancer Centre at Southlake. For more information or to make a donation, visit: southlake.ca/HERE.
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The U.S. Food and Drug Administration says that samples of pasteurized milk have tested positive for remnants of the bird flu virus that has infected dairy cows.
The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.
“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement on Tuesday.
The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department (USDA) says 33 herds have been affected to date.
FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”
WATCH | Bird flu spread in U.S. cows:
For the first time ever, avian influenza, or H5N1 bird flu, was detected in roughly a dozen dairy cow herds across the U.S. About That producer Lauren Bird explores why scientists and public health officials are concerned about the cross-species transmission and whether humans are now at higher risk.
The polymerase chain reaction (PCR) lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University
“There is no evidence to date that this is infectious virus, and the FDA is following up on that,” Jaykus said.
Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.
Tests for viable virus underway, agency says
Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.
The agency said it has been evaluating milk from affected animals, in the processing system and on the shelves. It said it is completing a large, representative national sample to understand the extent of the findings.
Matt Herrick, a spokesperson for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.
Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.
To date, two people in the U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.
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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.
The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.
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