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
Delta variant of COVID-19 now makes up nearly 4 in 10 cases in B.C., data shows – Global News
New data from the BC Centre for Disease control shows that the highly-transmissible Delta variant of COVID-19 has grown to nearly four in 10 cases in the province, up from fewer than one in 10 just two weeks before.
The data comes as the province reported more than 100 new cases in a 24-hour period for the first time in five weeks.
The BCCDC released the data Friday, which covers the week of July 11 to July 15.
B.C. reports 112 new COVID-19 cases, four new deaths
Out of 376 cases recorded that week, the Delta variant, first identified in India, made up 39 per cent of cases, while the Gamma variant, first identified in Brazil, made up 40 per cent. The Alpha variant, first identified in the U.K., made up 17 per cent of cases.
Last week, the BCCDC reported the Delta variant made up 33 per cent of cases, while the week before it was just eight per cent.
Research has found that the Pfizer and AstraZeneca COVID-19 vaccines are highly effective against the Delta variant, but only when people receive both doses.
Partially vaccinated people remain at a much greater risk of contracting it or becoming seriously ill.
B.C. Health Minister Adrian Dix said Friday that 96 per cent of new cases reported in B.C. between June15 and July 15 were among people who weren’t fully vaccinated.
As of Friday, more than 2.68 million people — 58.1 per cent of those eligible and 52.2 per cent of the population — have been fully vaccinated.
Could Canada’s COVID-19 vaccination drive slowdown fuel another surge?
There were strong regional variances in the prevalence of Delta.
In the Vancouver Island Health Region, all of the 14 cases reported over the week in question were found to be the Delta variant.
In the Interior Health Region, which has seen growing case numbers and lagging vaccination rates, Delta made up a whopping 74 per cent of the 122 cases over the week reported.
More than half of the new cases reported on Friday were in the Interior Health region.
Vancouver Coastal Health had the second highest prevalence of Delta, at 33 per cent, followed by the Fraser Health region at 15 per cent.
Officials said 97 per cent of all samples tested were at least one of the known variants of concern.
The BCCDC cautions that the data reported on Friday is subject to change due to a lag in sequencing some samples.
© 2021 Global News, a division of Corus Entertainment Inc.
COVID-19 in Ottawa: Fast Facts for July 24, 2021 – CTV Edmonton
Good morning. Here is the latest news on COVID-19 and its impact on Ottawa.
- The number of active COVID-19 cases in Ottawa continues to creep up as vaccination slows
- A new outbreak in Barry’s Bay has led to nearly two-dozen close contacts and forced businesses to close
- Ontario reported 192 new cases on Friday as the seven-day average jumped slightly
COVID-19 by the numbers in Ottawa (Ottawa Public Health data):
- New COVID-19 cases: Seven new cases on Friday
- Total COVID-19 cases: 27,768
- COVID-19 cases per 100,000 (previous seven days): 3.9
- Positivity rate in Ottawa: 0.5 per cent (seven day average)
- Reproduction Number: 1.28 (seven day average)
Who should get a test?
Ottawa Public Health says you can get a COVID-19 test at an assessment centre, care clinic, or community testing site if any of the following apply to you:
- You are showing COVID-19 symptoms;
- You have been exposed to a confirmed case of the virus, as informed by Ottawa Public Health or exposure notification through the COVID Alert app;
- You are a resident or work in a setting that has a COVID-19 outbreak, as identified and informed by Ottawa Public Health;
- You are a resident, a worker or a visitor to long-term care, retirement homes, homeless shelters or other congregate settings (for example: group homes, community supported living, disability-specific communities or congregate settings, short-term rehab, hospices and other shelters);
- You are a person who identifies as First Nations, Inuit or Métis;
- You are a person travelling to work in a remote First Nations, Inuit or Métis community;
- You received a preliminary positive result through rapid testing;
- You require testing 72 hours before a scheduled (non-urgent or emergent) surgery (as recommended by your health care provider);
- You are a patient and/or their 1 accompanying escort travelling out of country for medical treatment;
- You are an international student that has passed their 14-day quarantine period;
- You are a farm worker;
- You are an educator who cannot access pharmacy-testing; or
- You are in a targeted testing group as outlined in guidance from the Chief Medical Officer of Health.
Where to get tested for COVID-19 in Ottawa:
There are several sites for COVID-19 testing in Ottawa. To book an appointment, visit https://www.ottawapublichealth.ca/en/shared-content/assessment-centres.aspx
- The Brewer Ottawa Hospital/CHEO Assessment Centre: Open Monday to Friday 10 a.m. to 5:30 p.m. Saturday and Sunday 8:30 a.m. to 3:30 p.m.
- COVID-19 Drive-Thru Assessment Centre at 300 Coventry Road: Open seven days a week from 10 a.m. to 2 p.m.
- The Moodie Care and Testing Centre: Open Monday to Friday from 8 a.m. to 3:30 p.m.
- The Ray Friel Care and Testing Centre: Open Monday to Friday from 8 a.m. to 3 p.m.
- North Grenville COVID-19 Assessment Centre (Kemptville) – 15 Campus Drive: Open Monday to Friday 9 a.m. to 5 p.m. Sunday from 9 a.m. to 1 p.m.
- Centretown Community Health Centre: Open Monday, Tuesday, Wednesday, Friday from 9 a.m. to 4 p.m.
- Sandy Hill Community Health Centre: Open Monday to Friday from 9 a.m. to 3 pm.
- Somerset West Community Health Centre: Open from 9 a.m. to 4 p.m. Monday to Wednesday, 1 p.m. to 4 p.m. Thursday and 9 a.m. to 2:30 p.m. on Friday
COVID-19 screening tool:
The COVID-19 screening tool for summer camp children and staff. All campers and staff must complete the COVID-19 School and Childcare screening tool daily.
Classic Symptoms: fever, new or worsening cough, shortness of breath
Other symptoms: sore throat, difficulty swallowing, new loss of taste or smell, nausea, vomiting, diarrhea, abdominal pain, pneumonia, new or unexplained runny nose or nasal congestion
Less common symptoms: unexplained fatigue, muscle aches, headache, delirium, chills, red/inflamed eyes, croup
The number of active COVID-19 cases in Ottawa is back above 40 for the first time in two weeks, as the city’s vaccine administration pace slows down.
Ottawa Public Health reported seven new cases of the virus in Ottawa on Friday. There were no new resolved cases for the second straight day, so the number of active cases has climbed to 41.
It’s the most since July 9, when there were 43 active cases in the city.
A new outbreak of COVID-19 in Barry’s Bay, Ont. has resulted in two closed businesses and nearly two-dozen high-risk contacts.
The Renfrew County health unit is reporting three new confirmed cases that started with a visit from southern Ontario.
Twenty-one high-risk contacts now have to isolate, a fresh example that Canada is not yet out of the pandemic.
Ontario is reporting another jump in the number of new COVID-19 cases as health officials log just over 190 new infections and the seven-day average rises.
The province confirmed 192 new cases of the novel coronavirus on Friday, which comes after officials logged 185 new infections on Thursday.
Before that, the province reported case numbers below the 150 mark for three days.
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