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
What is the Delta variant of coronavirus with K417N mutation?
India said on Wednesday it has found around 40 cases of the Delta coronavirus variant carrying a mutation that appears to make it more transmissible, and advised states to increase testing.
Below is what we know about the variant.
WHAT IS DELTA PLUS?
The variant, called “Delta Plus” in India, was first reported in a Public Health England bulletin on June 11.
It is a sub-lineage of the Delta variant first detected in India and has acquired the spike protein mutation called K417N which is also found in the Beta variant first identified in South Africa.
Some scientists worry that the mutation, coupled with other existing features of the Delta variant, could make it more transmissible.
“The mutation K417N has been of interest as it is present in the Beta variant (B.1.351 lineage), which was reported to have immune evasion property,” India’s health ministry said in a statement.
Shahid Jameel, a top Indian virologist, said the K417N was known to reduce the effectiveness of a cocktail of therapeutic monoclonal antibodies.
WHERE ALL IT HAS BEEN FOUND?
As of June 16 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/994839/Variants_of_Concern_VOC_Technical_Briefing_16.pdf, at least 197 cases has been found from 11 countries – Britain (36), Canada (1), India (8), Japan (15), Nepal (3), Poland (9), Portugal (22), Russia (1), Switzerland (18), Turkey (1), the United States (83).
India said on Wednesday around 40 cases of the variant have been observed in the states of Maharashtra, Kerala and Madhya Pradesh, with “no significant increase in prevalence”. The earliest case in India is from a sample taken on April 5.
Britain said its first 5 cases were sequenced on April 26 and they were contacts of individuals who had travelled from, or transited through, Nepal and Turkey.
No deaths were reported among the UK and Indian cases.
WHAT ARE THE WORRIES?
Studies are ongoing in India and globally to test the effectiveness of vaccines against this mutation.
“WHO is tracking this variant as part of the Delta variant, as we are doing for other Variants of Concern with additional mutations,” the World Health Organization (WHO) said in a statement sent to Reuters.
“For the moment, this variant does not seem to be common, currently accounting for only a small fraction of the Delta sequences … Delta and other circulating Variants of Concern remain a higher public health risk as they have demonstrated increases in transmission,” it said.
But India’s health ministry warned that regions where it has been found “may need to enhance their public health response by focusing on surveillance, enhanced testing, quick contact-tracing and priority vaccination.”
There are worries Delta Plus would inflict another wave of infections on India after it emerged from the world’s worst surge in cases only recently.
“The mutation itself may not lead to a third wave in India – that also depends on COVID-appropriate behaviour, but it could be one of the reasons,” said Tarun Bhatnagar, a scientist with the state-run Indian Council for Medical Research.
(Reporting by Shilpa Jamkhandikar in Pune, Bhargav Acharya and Ankur Banerjee in Bengaluru and Alistair Smout in London; Editing by Miyoung Kim and Giles Elgood)
Colon Cancer Rates Have Increased: How Can You Improve Your Gut Health?
The majority of colon cancer cases are more common among older citizens. However, research has found that colorectal cancer rates have been rising in healthy people under 50. The rate has increased over the ten years. Medical professionals recommend screening from age 45. A colorectal screening test is done to ensure that the individual does not have any signs of cancer.
A study found that there has been a surge in colorectal cancer in younger generations and could become the dominant cause of cancer-related deaths by 2030. Since the risk is alarming, everyone needs to take their gut health seriously. Here are some things that people can do to improve their well-being.
Hydrotherapy is a type of colon cleanse that treats digestive issues such as constipation and bloating. Chronic constipation can lead to colon cancer, so it is vital to deal with the issue before it worsens. Colon hydrotherapy is offered at a few places, including a wellness colonic clinic in Toronto where the staff is committed to providing solutions for their clients’ digestive health.
Cleansing your colon can help improve digestion, relieve constipation, reduce gas, rejuvenate skin, and increase energy. The process involves flushing the colon with a large volume of water. It can be beneficial to speak to the professionals at the clinic and discuss your concerns with them. They will educate you about the process and answer any concerns you may have. The treatment can seem overwhelming but can also be helpful for your gut health.
Your food intake plays a significant role in your gut health. If you have gut problems, it may be worthwhile to speak to a doctor and change your diet. You should also consider finding out if you have any food intolerance. There may be trigger foods such as oil or dairy that could be causing discomfort.
Even if you do not have any problems with your food consumption, it is never wrong to watch what you eat. Foods with probiotics or high fibre content can be good for you. Eating the right foods can improve your overall health too.
Water almost seems like a magical drink sometimes. From skin problems to digestive issues, it can improve many situations. Consuming a good amount of water every day can balance good bacteria in the gut and promote your health. Hydration can also help your organs function properly and improve cognitive function.
Say Goodbye to Extreme Stress
It can be challenging to bid farewell to stress forever. However, chronic high levels of stress can impact your abdomen and your overall health. There is a connection between the brain and gut, and stress can cause your stomach to become anxious.
Long-term stress can trigger several gut problems such as indigestion, constipation, or diarrhea. Look for ways to reduce stress levels so that your gut can remain healthy.
Some health problems are inevitable with age, but you can do your best to stay healthy and deal with any issues you face. Prepare yourself to fight any disease beforehand, and your body will thank you.
Biden’s vaccine pledge ups pressure on rich countries to give more
The United States on Thursday raised the pressure on other Group of Seven leaders to share their vaccine hoards to bring an end to the pandemic by pledging to donate 500 million doses of the Pfizer coronavirus vaccine to the world’s poorest countries.
The largest ever vaccine donation by a single country will cost the United States $3.5 billion but Washington expects no quid pro quo or favours for the gift, a senior Biden administration official told reporters.
U.S. President Joe Biden‘s move, on the eve of a summit of the world’s richest democracies, is likely to prompt other leaders to stump up more vaccines, though even vast numbers of vaccines would still not be enough to inoculate all of the world’s poor.
G7 leaders want to vaccinate the world by the end of 2022 to try to halt the COVID-19 pandemic that has killed more than 3.9 million people and devastated the global economy.
A senior Biden administration official described the gesture as a “major step forward that will supercharge the global effort” with the aim of “bringing hope to every corner of the world.” “We really want to underscore that this is fundamentally about a singular objective of saving lives,” the official said, adding that Washington was not seeking favours in exchange for the doses.
Vaccination efforts so far are heavily correlated with wealth: the United States, Europe, Israel and Bahrain are far ahead of other countries. A total of 2.2 billion people have been vaccinated so far out of a world population of nearly 8 billion, based on Johns Hopkins University data.
U.S. drugmaker Pfizer and its German partner BioNTech have agreed to supply the U.S. with the vaccines, delivering 200 million doses in 2021 and 300 million doses in the first half of 2022.
The shots, which will be produced at Pfizer’s U.S. sites, will be supplied at a not-for-profit price.
“Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible,” said Pfizer Chief Executive Albert Bourla.
‘DROP IN THE BUCKET’
Anti-poverty campaign group Oxfam called for more to be done to increase global production of vaccines.
“Surely, these 500 million vaccine doses are welcome as they will help more than 250 million people, but that’s still a drop in the bucket compared to the need across the world,” said Niko Lusiani, Oxfam America’s vaccine lead.
“We need a transformation toward more distributed vaccine manufacturing so that qualified producers worldwide can produce billions more low-cost doses on their own terms, without intellectual property constraints,” he said in a statement.
Another issue, especially in some poor countries, is the infrastructure for transporting the vaccines which often have to be stored at very cold temperatures.
Biden has also backed calls for a waiver of some vaccine intellectual property rights but there is no international consensus yet on how to proceed.
The new vaccine donations come on top of 80 million doses Washington has already pledged to donate by the end of June. There is also $2 billion in funding earmarked for the COVAX programme led by the World Health Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI), the White House said.
GAVI and the WHO welcomed the initiative.
Washington is also taking steps to support local production of COVID-19 vaccines in other countries, including through its Quad initiative with Japan, India and Australia.
(Reporting by Steve Holland in St. Ives, England, Andrea Shalal in Washington and Caroline Copley in Berlin; Writing by Guy Faulconbridge and Keith Weir;Editing by Leslie Adler, David Evans, Emelia Sithole-Matarise, Giles Elgood and Jane Merriman)
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