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.”
Mia Rabson, The Canadian Press
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U.S. will accept mixed doses of vaccines from international travelers
The U.S. Centers for Disease Control and Prevention (CDC) said late on Friday that it will accept mixed-dose coronavirus vaccines from international travelers, a boost to travelers from Canada and other places.
The CDC said last week that it would accept any vaccine authorized for use by U.S. regulators or the World Health Organization. “While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records,” a CDC spokeswoman said.
The White House said Friday the new vaccine requirements for foreign nationals traveling to the United States will begin Nov. 8 for visitors crossing at land borders as well as international air travelers.
Representative Brian Higgins, a New York Democrat representing a district along the Canadian border, had on Friday asked the CDC if it would accept the mixed vaccine doses noting “nearly four million Canadians, equivalent to 10% of their fully vaccinated population, have received mixed doses of the available mRNA COVID-19 vaccines – this includes the AstraZeneca vaccine.”
The CDC said the vaccines approved by the Food and Drug Administration (FDA) for use, as well as those authorized by the WHO, will be accepted for entry into the United States, including the AstraZeneca vaccine.
The CDC said “individuals who have any combination of two doses of an FDA approved/authorized or WHO emergency use listed COVID-19 two-dose series are considered fully vaccinated.”
The CDC plans to answer other questions and release a contact tracing order for international air visitors by Oct. 25.
(Reporting by David Shepardson; Editing by Leslie Adler and Aurora Ellis)
Transplant programs reviewing policy on recipients being vaccinated against COVID-19 – Squamish Chief
Transplant centres in Western Canada have stopped short of requiring organ recipients to be fully vaccinated against COVID-19, but they say conversations about such a policy are ongoing.
Some centres in other parts of the country, including Ontario, are requiring proof of vaccination before a patient is approved for the life-saving surgery.
BC Transplant, located in Vancouver, said COVID-19 vaccination is not required to be eligible for a transplant, but programs in the province are actively reviewing it.
“The transplant programs are strongly encouraging all pre-transplant patients to be vaccinated against COVID-19, as they do with many other vaccine-preventable infections,” the agency said in a statement.
Similarly, Alberta Health Services told The Canadian Press it has long been a requirement that patients preparing for transplant have all vaccines to help maximize their chances of success post-transplant. It notes, however, it’s only a practice guideline at this point.
Saskatchewan has also not made any changes.
“Saskatchewan’s organ transplant teams are strongly supportive of all recipients and donors having COVID vaccinations, and the issue of requiring these vaccinations in recipients is actively being discussed,” Lisa Thomson, a spokeswoman for the Saskatchewan Health Authority, said in a statement.
The Ajmera Transplant Centre at Toronto’s University Health Network recently announced its decision to implement a policy that requires patients who may benefit from receiving a transplant be fully vaccinated against COVID-19 before they are listed for solid organ transplant.
However, there may be exemptions for medical reasons or in cases of urgent need of a transplant.
“We all recognize that (COVID-19) is a massive, massive risk factor. The prudent and ethical thing to do to protect patients and to protect each other, and show fidelity and respect to those organ donors, is to require this (policy) to be a price of pass and go,” UHN president and chief executive officer Kevin Smith said in an interview.
The decision to enact the policy is based on a few factors, according to the organization.
It said transplant patients are severely immunocompromised because of lifelong treatment to prevent rejection of a new organ. If someone who is immunocompromised gets COVID-19, they are at a very high risk of being hospitalized or placed on ventilation.
Unvaccinated recipients could also pose a risk to other patients post-surgery. Transplant recipients have high health needs after their transplants and require frequent visits to a hospital. These individuals may pose a greater risk of spreading illness, should they get infected, to other immunocompromised patients in an inpatient or outpatient setting.
“Thinking about an outbreak in an environment like that would be just a massacre,” Smith said.
Infectious disease experts noted this type of policy isn’t new.
“There’s just requirements pre-transplant in order to be eligible for listing. Some of it is complying with some of the medical measures to see if patients would be eligible,” said Dr. Dima Kabbani, an assistant professor in the division of infectious diseases at the University of Alberta.
Kabbani added pre-transplant vaccine recommendations are already in place for hepatitis B, pneumococcal disease and influenza.
Manitoba’s Shared Health said there is no requirement for Manitobans awaiting a transplant to be vaccinated for COVID-19, but noted patients may be required to show proof of vaccinationif there are requirements elsewhere.Kidney transplants are performed in the province while all other organ transplants take place in other provinces.
Jessica Bailey, 35, is living with stage five kidney disease and awaiting a transplant in Saskatoon.
The government has postponed surgeries as the province deals with a devastating fourth wave of COVID-19.
Bailey said she is not in favour of requiring recipients to be vaccinated against COVID-19. She said she is double vaccinated but believes recipients should still have the choice on whether they want the vaccine.
She does encourage patients who may be on the fence to look at the bigger picture.
“If you can get a transplant just by getting the vaccine, go and do it. Pick and choose your battles,” Bailey said.
This report by The Canadian Press was first published on Oct. 15, 2021.
This story was produced with the financial assistance of the Facebook and Canadian Press News Fellowship.
Brittany Hobson, The Canadian Press
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