Without a doubt, COVID-19 has persisted for a lot longer than we had all anticipated. In Canada alone, we have exceeded 300,000 total cases. Globally, we have surpassed an astonishing 59million cases, with over 1.4 million deaths. As we close in on one year since the pandemic began, the question on everyone’s mind is: “When are we getting a vaccine?”
In recent months, we’ve seen encouraging results from vaccine trials conducted by large multinational companies like Pfizer, Astrazeneca, and Moderna. The Canadian government has bought an allotment of vaccines from many of these companies. But will all Canadians be able to access vaccination? Are there any Canadian companies trying to develop vaccines here at home?
The short answer is yes. But, before we dive into the Canadian contenders, let’s take a step back and go through what it actually takes to develop a vaccine and bring it to market in Canada.
It all starts at Stage 1: Research. In Stage 1, scientists look for antigens or agents that could be used in a new vaccine. Once some candidates emerge, tests are done to determine the safety, efficacy, activity, and toxicity of the new agent.
Stage 1 is Pre-clinical trials and often takes a few years to complete. But, luckily for us, we had a head start with COVID-19. The COVID-19 virus’ genetic sequence was identified by Dr. Yong-Zhen Zhang of Shanghai Public Health Clinical Centre & School of Public Health. It was made publicly available in January 2020, which gave clinical researchers everywhere a leg up. The plan for most COVID-19 vaccines has been to use some component of the virus itself - or the virus’ genetic information gained through research - to produce a lasting immune response.
Once a company discovers part of the virus that it can safely use in a vaccine, scientists test the vaccine on clusters of cells or animal test subjects to discover which dose would produce a lasting immune response in humans without causing adverse effects. Once this is known, a Clinical Trial Application (CTA) can be submitted to Health Canada.
Health Canada reviews the CTA and approves or rejects it within one month. Once the CTA is approved, it’s on to Stage 2: Phase I & II Human Clinical Trials.
In the first phase of clinical trials, a few dozen healthy volunteers are recruited and given the vaccine. Here, the primary goal is to ensure that the vaccine is safe, that there are no adverse effects and, of course, that the appropriate immune response is observed and antibodies are detected.
Next up are phase two clinical trials, during which a larger group of 50 to 100 volunteers are recruited. Vaccine effectiveness and safety are still being monitored at this stage, but now doses and dose schedules are also tested to determine the best option for everyone across all age groups.
Once a company has successfully passed the first 2 phases of clinical trials, the final phase of clinical trials, during which anywhere from 300 to 30,000 volunteers are recruited, is Stage 3. During this phase, companies will verify and validate the safety and efficacy of the vaccine in a larger population of people.
Once the clinical trials have been successfully completed, companies move on to Stage 4: Regulatory and Licensing of the Vaccine.
Health Canada will review the company’s clinical trial data and grant approval for the vaccine once they:
•Confirm the vaccine’s safety and efficacy.
•Pass an inspection of the manufacturer’s facilities.
•Conduct an independent analysis of the vaccine.
After receiving Health Canada’s approval, Stage 5 is next: Monitoring. The point of this stage is to continue to get information on the long-term positive and negative effects of a vaccine for years after it’s approved and sold on the market.
Once the vaccine is out on the market and Health Canada requires that companies continue to comply with the terms of market approval and the Food and Drug Regulations.
So, now that we’re familiar with the process of vaccine development, who’s in the race to bring a vaccine to market in Canada?
Luckily, there are many companies and universities working together to make a Canadian vaccine a reality. Let’s highlight some of the frontrunners.
First up is Providence Therapeutics. This Toronto-based company is using a similar vaccine development approach to Pfizer: using the virus’ genetic information. In August, in the midst of their pre-clinical trials, Providence announced some promising results from their animal studies. These initial results showed that the vaccine produced a robust immune response. Specifically, Providence reported that they had observed neutralizing antibodies at much higher levels compared to other companies using the same vaccine development approach.
In October 2020, Providence announced that the Government of Canada would be providing $4.7 million in federal support for phase one clinical trials. Providence aims to submit their plan for clinical trial approval before the end of 2020.
But that’s not all. Providence Therapeutics does not just have one vaccine to test – they have two! Their second vaccine is specially designed to help stop the spread of COVID-19 after someone has already been infected.
Next up is IMV: a Halifax-based company. IMV is taking a different approach to their vaccine development. Unlike traditional vaccines where the whole virus is used to produce immunity, IMV’s vaccine will aim to use only the specific parts of the virus that they believe to be safer and more targeted.
What’s also exciting is that IMV’s therapy is entirely synthetic. This means that there are no biological components used in production. The synthetic nature of IMV’s vaccine could make it easier to manufacture on a large scale, once it’s approved for market.
Like Providence Therapeutics, IMV has received federal funding, ($5.4 million) to support their clinical trials. Currently, they are in the midst of pre clinical studies aimed at trying to better understand the vaccine’s mechanism of action and study its safety in animal models.
Once these studies have been successfully completed, IMV plans to begin a larger, combined phase one and two trial. This was decided after consultation with Health Canada, as a means to expedite the clinical trials process.
Then we have Entos Pharmaceuticals, based in Edmonton, who are also using the virus’ genetic information to develop a vaccine. In October of this year, Entos received $5 million in research funding from the Canadian government to move into phase one clinical trials.
In pre-clinical studies, Entos demonstrated that their DNA vaccine was able to elicit a strong antibody response against the COVID-19 virus with only a single dose. They are now set to begin Phase I Clinical Trials at the Research Center at the Canadian Center for Vaccinology in Nova Scotia this month.
Another noteworthy Canadian company is Immunoprecise Antibodies, located in Victoria. They are taking a traditional approach to developing their COVID-19 vaccine. Their approach is similar to Novavax: the international front runner currently in phase three of clinical trials.
As their company name suggests, Immunoprecise Antibodies specializes in antibody therapies: not vaccine development. While they are developing COVID-19 antibody therapies, Immunoprecise are also collaborating with LiteVax BV to develop a vaccine.
Immunoprecise Antibodies and LiteVax announced in September that they started pre-clinical trials to develop a vaccine against COVID-19. The study is currently being carried out in Catalonia, Spain, where the goal is to test the feasibility of a single, low-dose vaccine. At the same time, they’re conducting parallel studies to figure out subsets of optimal vaccine candidates that could be developed further.
Medicago, in Quebec City, was the first Canadian company to begin vaccine trials in humans. They are currently in phase two - the furthest along of any company in Canada to date.
Originally developed by Agri-Food Canada and Laval University, Medicago has been working on their vaccine technology for the last 20 years. What’s interesting is that they generate their vaccine components from plants. Medicago created a seasonal flu vaccine using this plant-based
technology, which is currently awaiting Health Canada approval. If approved, it would be the world’s first plant-derived vaccine.
Medicago received federal funding, in addition to $7 million from the Quebec government. They published promising results from phase one in early November. Medicago’s results clearly showed that after two doses of their vaccine, there was a favorable antibody response in 100% of participants. There were no severe adverse events and other side effects were mild to moderate.
Medicago received approval from regulatory authorities to begin a combined phase two and three clinical trial this month, together with GSK.
The phase two part of the study will test the vaccine on healthy participants between the ages of 18 to 64, and participants 64 years and older, with 300 participants per age group. The study will follow these subjects for 12 months to evaluate the safety of the vaccine and the robustness of the immune response it elicits.
Medicago and GSK’s phase three trial will test the vaccine’s safety and efficacy in a much larger population of over 30,000 participants all over the world including North America, Latin America, and Europe. Phase three is likely to begin before the end of 2020.
There are some companies that offer non-conventional methods of vaccine delivery.
Mediphage Bioceuticals, a preclinical-stage biotech company based in Toronto, is currently developing a DNA vaccine for COVID-19 in collaboration with the University of Waterloo, as well as international labs.
Mediphage’s vaccine can be administered as a nasal spray or orally. The vaccine will produce viral-like particles, referred to as a synthetic infection. The goal is for the spray to take the same route as the virus: from nose to lungs. A nasal route can also boost immunity in the intranasal cavity.
The goal here is to develop novel DNA vaccine technologies that can be adapted for future pandemic climates, whereby a vaccine can be tailored to tackle various coronavirus types and viral infections.
Then we have Symvivo, based in Burnaby. Symvivo is developing a vaccine that can be taken orally. If it’s successful, it could be conveniently shipped to people’s homes.
Symvivo announced in November 2020 that they have begun phase one trials in Australia, with the support of federal funding ($2.8 million).
As you’ve probably already put together, we’ve definitely got a longer wait before we’ll have a reliable and effective Canada-derived vaccine to offer those who need it. That being said, the overall development process has progressed much quicker than the 10+ years it usually takes.
It’s important to note that vaccine research did not begin when the pandemic started.
COVID-19 belongs to the coronavirus family. Lucky for scientists, we’ve already dealt with two other serious coronaviruses in the last two decades: SARS & MERS.
This means that research scientists were already familiar with how the virus worked. Oxford had already developed a vaccine against MERS, which gave us a huge head start.
Also, there is usually a time lag between trials and considerable wait time to process approvals paperwork. Whereas now, companies are completing clinical trial phases back-to-back and governments are prioritizing approvals for the vaccine due to the greater sense of urgency that the pandemic has generated.
Together, all of these factors have helped expedite COVID-19 vaccine development all over the world.
So, even though Canada won’t have a domestically produced vaccine as soon as other countries will, we should have some peace of mind that eventually we won’t have to rely solely on a global supply of vaccines.
Justin Trudeau reported that Canada will receive a COVID-19 vaccine after many other countries: “One of the things to remember is [that] Canada no longer has any domestic production capacity for vaccines. Countries like the United States, Germany and the U.K. have domestic pharmaceutical facilities, which is why they’re obviously going to prioritize helping their citizens first.”
The big news this week is that Health Canada just approved a COVID-19 vaccine from Pfizer-BioNTech. Approximately 249, 000 doses are expected to roll out in a matter of weeks!
The bulk of our vaccines will still arrive in 2021. Trudeau noted that we will likely have vaccines in the third quarter of 2021. However, the Public Health Agency of Canada has reported that Canada is on track to receive an initial 6 million doses by March from international pharmaceutical companies – 4 million from Pfizer and 2 million from Moderna. Reports are constantly changing, but, nevertheless, there is reason to be hopeful.
Once we do get the vaccine, frontline workers and those most susceptible to the disease will likely be offered COVID-19 vaccination first.
Until then, we’ll have to sit tight and stick to the public health strategies that we know work: social distancing and mask-wearing. Let’s all do our part to keep this virus under control and protect those most vulnerable until a vaccine is ready for us.
Noeline Subramaniam, MSc is a PhD candidate at the University of Toronto and Freelance Medical Writer at MedComms Solutions: a Toronto-based medical communications agency.
Papercurve helps streamline compliance reviews in regulated industries like cannabis and life sciences. Manage approvers, comment, reference attached documents and archive past versions for audit – all in an easy to use interface.Learn more