:
I call this meeting to order.
Welcome, everyone, to meeting number 20 of the House of Commons Standing Committee on Health.
The committee is meeting today to study the emergency situation facing Canadians in light of the second wave of the COVID-19 pandemic.
Before we get going, I wish to emphasize that everyone has the right to participate fully in these proceedings in the official language of their choice. If, at any time, there is an interruption or problem with the translation services, I urge affected members to advise the chair or the clerk without delay. We will do our best to correct the situation.
At this time, I'd like to welcome our witnesses.
We have, as an individual, Dr. Gary Kobinger, professor, Université Laval. From the National Research Council of Canada, we have Mr. Mitch Davies, president. From the University of Alberta and Entos Pharmaceuticals, we have Dr. John Lewis, professor.
With that, I will invite the witnesses to make a six-minute statement.
Dr. Kobinger, please go ahead for six minutes, please.
:
Good morning, everyone.
I was not expecting to start with a six-minute statement, so I will start by telling you that I'm a professor at Université Laval. Before that, I was in Winnipeg as the chief of the special pathogens program at the National Microbiology Laboratory, NML, which I headed for eight years. My expertise is in vaccine development.
Being from the NML, I led the group that developed the VSV vaccine the year after Heinz Feldmann left. The vaccine has now been licensed by the FDA and the EMA in Europe.
I believe I'm here to talk about vaccine manufacturing. I'm actually not too sure; I'm so sorry. I did agree to this with having little information, but I'm pleased to be with you. I'd be very happy to answer your questions.
Since I'm probably still within my six minutes, I will say that we have been facing many challenges, which I, personally, have seen on the international level. In full disclosure, I'm also a member of the advisory group STAG-IH. It is the main advisory group that advises the WHO at the executive director level in emergency operations. At that level, I have seen that there are challenges for many regions in the world, starting with southeast Asia when the first report of the virus emerged December 31, and then going throughout the world with all the different challenges that were faced and are still being faced at the world level.
In Canada, I was part of the vaccine task force, which I stepped out of voluntarily due to concern over transparency. I think it was, more widely, a public decision at the end. Most recently, following a discussion with journalists, I made a few public statements indicating my position that I strongly believe in Canadian capacity—as much in intellectual capacity as in manufacturing capacity. It's not like everything is available, but everything can be built. We have the knowledge here in Canada to develop those vaccines and bring them all the way to a completed phase three and licensure, and, ultimately, in good time, with improved manufacturing in Canada as well.
Part of my expertise also is in the development of therapeutics mainly based on medical antibodies, which touches a bit on the same technology as that of AbCellera, which you may have heard of, as well, as it received important funding from the Canadian government.
I think that will be it. I'm happy to talk about any of those subjects at the more regional, national or international levels.
Thank you so much.
:
Thank you, Mr. Chair, for the invitation to speak to you today about the National Research Council's role as part of the Government of Canada's response to the COVID-19 pandemic.
I'd like to begin by acknowledging that NRC facilities are on the traditional unceded territories of many first nations, Inuit and Métis people. Their ancestral footsteps and rights extend beyond the boundaries that exist today, and we respectfully honour these peoples' rights, history and relationships with this land.
On the specific topic that's the subject of the committee's current study, I would like to address the NRC's role in the government's efforts to develop vaccines and therapeutics for Canadians, and to increase our country's domestic biomanufacturing capacity in the near and medium term.
The NRC is working with partners across government to advance research and development for vaccines and therapies to prevent and treat the spread of COVID-19 in line with the best advice provided by the Government of Canada's vaccine and therapeutics task forces. This includes the NRC's collaboration with VBI Vaccines, first announced in March 2020, to develop a vaccine targeting COVID-19 and related respiratory viruses.
The NRC is also supporting VIDO-InterVac at the University of Saskatchewan in the development and production of its COVID-19 vaccine candidate. Canada's support for VIDO-InterVac was among the first decisions made to support made-in-Canada vaccine projects.
Through the National Research Council's industrial research assistance program, we are working closely with made-in-Canada vaccine and therapeutics developers and providing more than $32 million to finance six of the most promising domestic vaccine candidates and four domestic therapeutics candidates to prevent and treat COVID-19.
In support of the government's effort to expand Canada's biomanufacturing capacity, the NRC is preparing to manufacture COVID-19 vaccines through the construction of a new "good manufacturing practices compliant" biologics manufacturing centre at our Royalmount site in Montreal. Once complete, the new biologics manufacturing centre will be capable of large quantity end-to-end production of vaccines, approximately two million doses per month, depending on the vaccine candidate.
I'm pleased to report construction of the new facility is on track for completion by the end of July 2021. The completion of technology transfer for specific vaccine and Health Canada approvals of both the facility and the vaccine and related manufacturing processes will then be the steps remaining to achieve production for use in Canada. To this end on February 2, the announced the signing of an MOU with Novavax to pursue the production of its COVID-19 vaccine at the NRC's biologics manufacturing centre. This is a significant milestone in this project, to be working with a vaccine producer with a product well advanced in the development process.
Finally, in support of Canada's biologics manufacturing capacity for research, the NRC is also building a permanent clinical trial material facility at our Royalmount site in Montreal. Once complete, this facility will be able to produce 500 litres of clinical trial materials per month to support future vaccine research and development in Canada.
Further to the work under way to assist in bringing vaccines and therapeutics to Canadians, I'd like to share specifics about the broader NRC contribution to deliver many other measures as part of the science, innovation and industry response to COVID-19, supported by close to $800 million in new funding.
Significant among these measures was doubling funding available to Canada's innovative companies through NRC's industrial research assistance program. This increased funding supported jobs and preserved value through the business and operational challenges caused by the COVID-19 economic downturn. In addition, the NRC leveraged its experience to build a made-in-Canada system to test lots of new-to-market critical PPE, representing over 120 million products that were made available to the Canadian marketplace to meet the needs of frontline health workers. We provided over 3,000 COVID-related advisory services to innovative firms, created close to 900 youth job placements and post-graduate employment opportunities, and supported over 2,200 firms and more than 26,000 jobs through the innovation assistance program.
In closing, I want to assure Canadians that the NRC has pursued many avenues to secure solutions to the many challenges brought on by COVID-19. We leveraged our long-standing relationships from labs to factory floors. I want to recognize the work of NRC employees across the entire organization who have worked tirelessly to deliver so many critical initiatives to support Canadians during this challenging time.
I thank you for the opportunity to speak with you today and I would be pleased to take your questions.
:
Thank you, Chair. Good morning, ladies and gentlemen. I appreciate the opportunity to share our perspective today.
My name is John Lewis. I'm the founder and CEO of a Canadian company called Entos Pharmaceuticals. It's located in Edmonton, Alberta. I'm also a professor at the faculty of medicine and dentistry at the University of Alberta.
I've worked for many years as both an academic scientist and an entrepreneur, developing novel diagnostics for treatments for cancer, age-related diseases, and now COVID-19.
Entos Pharmaceuticals is an innovative Alberta-based biotechnology company with a track record in the development of state-of-the-art treatments for a wide range of diseases, using a platform we call “fusogenix”. It's a genetic medicines platform. Entos, in the context of the current pandemic, has developed a single-dose, fridge-stable, pan-coronavirus vaccine against COVID-19 that is about to start human clinical trials.
The fusogenix platform that underpins our COVID vaccine candidates was developed as a result of years of Canadian academic research, and our COVID-19 vaccine is manufactured in Canada for the benefit of Canadians and hopefully, potentially, the world.
We are rapidly approaching one year since the coronavirus outbreak was declared a pandemic. It's taken an incredible toll, domestically and worldwide, in terms of mortality and death, as well as having a staggering economic impact. Having access to a safe and effective vaccine remains our best hope for returning to normal, and I'm happy to say that the biopharma industry has risen to the occasion. Companies from around the world have worked faster than we ever thought possible on the development, evaluation, manufacture and deployment of COVID-19 vaccines. Remarkably, today there are two highly effective vaccines rolling out globally, with emergency use authorization in Canada, and there are several more under consideration. I'll repeat. This is astonishing speed, and I think the reason for this astonishing speed is twofold.
First, we've recently seen key innovations in genetic medicines. It's not by luck that the first two approved vaccines are both genetic-based, and genetic vaccines use RNA or DNA to safely teach our immune system to recognize and effectively defend against the novel coronavirus that causes COVID-19.
These new-generation vaccines are much faster to develop, test and manufacture compared to traditional vaccines. They're also more effective. We've also learned that traditional vaccine development and manufacturing has moved at a significantly slower pace. Vaccines developed using traditional technologies haven't performed as well as the genetic-based vaccine against COVID-19, although obviously there's a lot of research and clinical trials yet to complete.
Importantly—and I'll come back to this—genetic vaccines can quickly adapt to a changing virus and its new, more dangerous variants.
I think the second reason that effective vaccines are available within a year was the rapid, decisive and significant upfront investment in vaccine development and manufacturing made by countries such as the U.S. and the U.K. This approach of investing substantially in multiple vaccine platforms and efforts really recognizes the risk in pharmaceutical development that only some efforts will be successful. Most importantly, it allowed these companies to move quickly and boldly without financial risk. This is a key difference between these efforts and Canada's domestic vaccine response. It's one that I'm going to be talking about because it directly impacted Entos.
This brings me to the question on many people's minds. Why has Canada lagged behind other countries such as the United States and how do we get back on track?
From my vantage point as a small but dedicated biopharma company working literally 24 hours a day, seven days a week since last March on a COVID-19 vaccine, the answer is pretty obvious. Canada was slow to make the initial decisions for domestic vaccine development and manufacturing. Despite having internationally recognized expertise in vaccine development and manufacturing in Canada's innovative companies—we have Nobel prizewinners in infectious disease, we have vaccine pharmaceutical manufacturing capacity—we took a careful, risk-averse and committee-based decision approach that led to a relatively modest amount of scattered funding for companies in Canada to develop domestic vaccine. This put the financial risk of vaccine development and our country's national security on them, which I think was a mistake.
When the pandemic hit, we at Entos recognized that our fusogenix DNA technology could address key limitations in genetic RNA vaccines, namely the limitations in storage and stability, and rapidly scalable manufacturing. We completely pivoted our research and development operations, from developing gene therapies for cancers and rare childhood disease to developing COVID-19 vaccines.
Using our own internal funds, and at considerable financial risk, we developed a couple of lead COVID-19 vaccine candidates that, on the science side, induced strong, neutralizing antibody response and durable, cell-based T cell response against the COVID-19 virus in animal models. We've invested heavily over the past year in good, clinical manufacturing, established a clinical production pipeline, and performed all the clinical, regulatory and toxicology assessments that we needed.
Unfortunately, this pandemic is not ending anytime soon. Vaccine manufacturing and deployment is going slower than expected, and not just in Canada. I think Canada missed the opportunity to get on top of the first wave, but there is still time to act and catch the second wave. I think with bold leadership and a swift commitment on the vaccine manufacturing industry to bring it up to world-leading standards right now, we can still make a difference to Canadians in this pandemic and we can prepare for the next pandemic. I think the time to do this is now. It's not too late for Canada to invest in the development and manufacture of Canadian-based genetic vaccine technologies.
I have three recommendations I'd like to put forward to the committee.
First, provide substantially increased funding for private Canadian biotechnology companies to remove the financial risk to rapidly develop and manufacture made-in-Canada COVID-19 vaccines. Second, financially support the expansion of genetic vaccine manufacturing capacity across Canada. Third, support an innovative procurement agreement for Canadian pharmaceutical companies that will make these innovations available to Canadians.
I hope these recommendations will provide an opportunity for the Canadian biopharma industry to raise more capital and take their successful Canadian products through the clinical trials, positioning Canada as a world leader in biological and genetic-based medicines.
Thank you so much for your attention, and I'm happy to answer questions over the hour.
There are a lot of billions of dollars being lost in Canada, and a lot of people still losing their lives. We're way behind almost any comparable country, and every day we keep losing dollars, but more particularly, the lives of individuals.
The Liberals kept touting a robust vaccine portfolio, but to date there hasn't been a large number of needles being put in arms. We're getting another 400,000 or 500,000 today for this week, which gives us about 1.6 million to two million vaccines in the next month. The Americans are doing 1.6 million arms per day.
I'm just wondering if you can talk to that part about the portfolio being big, but there is nothing being developed, nothing going into arms.
:
Yes, I will add that actually I did appreciate everything that Dr. Lewis said. I think he's spot on.
What you can see after just a few minutes in this discussion is that there is a disconnect between, for example, what was stated by NRC, that everything is done and that the best six vaccines are advancing, and the reality that the vaccines are not being made available to Canadians.
Just to add to this, we are the first and only team as of now that has brought the vaccine from the lab all the way to licensure. Of course, Merck did help, of course Merck did a lot of projects, but this vaccine was born here in Canada. We have the experience in how to do this. We have prepared for this. We had a Zika vaccine in six months in the clinic, using a DNA platform. This was published. This was public.
Before that we did others, and we got to COVID and we had a vaccine against COVID, which is the same platform that we knew worked against SARS. In early 2001, I was at NML. It was ready in mid-February 2020, and we couldn't find funding.
It was my fault also because I did participate in the task force, and that was excluding me from the only real funding track that could have brought this vaccine to the clinic. I did it knowing that it would hamper my team, and it would be an end to that, but I was really hoping that, above all, these people would find a solution that—
:
Thank you, Mr. Chair; and thank you to the witnesses for being here today.
Folks, access to vaccines is top of mind for all Canadians. I believe in our strategy when it comes to domestic vaccines and therapies and our decision-making process and the supports that have been put in place to help Canadian companies working to find solutions to COVID-19.
Our government's objectives from the early days of the pandemic were actually threefold: to secure access to the leading international vaccine candidates; to invest in the most promising Canadian vaccine and therapies; and to make strategic investments to rebuild Canada's domestic biomanufacturing capacity.
Mr. Mitch Davies, my questions will be directed to you.
Our government invested over $23 million through the NRC industrial research assistance program to support Canadian companies responding to COVID-19. The NRC indicated that it was using this funding to provide advisory services and research and development funding to six companies for their COVID-19 vaccine candidates.
I have three questions, and please feel free to do a deep dive on the three of them. Number one, can you comment on the development status of any of these vaccine candidates? Number two, can you describe Canada's past and present pharmaceutical and bioproduction landscape? Number three, in your opinion, what does Canada need to do to rebuild, or build up, its pharmaceutical sector and bioproduction capacity to manage future variants and pathogens?
:
I'll start with the question of the long-term biomanufacturing capacity in Canada. It's a matter of great importance, and in fact, the government recognized in the fall economic statement that a full plan and full engagement with Canadians, which is now under way under the leadership of Innovation, Science and Economic Development to build that capability out in terms of productive capacities, was necessary. In fact, it's necessary because we have all of the intellectual leadership, the scientific leadership and the capability in terms of research and breakthroughs, which is demonstrated by the candidates that we're supporting through NRC IRAP and other vaccine projects that are under way in Canada, that we can deliver the end-to-end solution to Canadians.
Certainly it's something that this COVID-19 pandemic has illustrated for us, the need to catch up and make significant investments, which, of course, the government has indicated it's prepared to follow through on and is doing. For example, the biologics manufacturing centre the NRC is currently constructing will be a long-term facility that will be available for pandemic use and be a reserve capacity for the country.
I would say that, concerning the vaccine candidates that we're working with through the NRC IRAP, we're in close contact with each of them, following their clinical progress and following their pursuit of their study, and again, we'll be prepared to follow up and work with them on an ongoing basis to support their needs going forward as they have success in their development programs. Obviously, this will establish a strong group of made-in-Canada candidates with Canadian IP with the ability to pursue those projects for Canadians.
:
Thank you very much, Mr. Chair.
I thank the witnesses for coming to enlighten us today.
The important thing in the crisis we are going through is not to make the same mistakes again. It's not a question of pointing out mistakes complacently, but rather of pointing them out so that we can improve and ensure that we can get through this crisis and never find ourselves in such a situation again—which I anticipate, by the way.
Dr. Kobinger and Dr. Lewis, in connection with what you said, I deduced that this situation could have been very different in terms of research and life sciences. We were talking about a $23-million investment. Is that enough to deal with a pandemic like the one we're experiencing? In my opinion, to ask the question is to answer it.
Dr. Lewis, you were talking about substantial investments. In order to really have a strike force to deal with such a pandemic and to work with the dynamic forces in the field, how large should these investments be?
:
You point out opportunities where we could have done better, and this will be helpful in the future.
I think this indicates that a connection between the funded projects under development has been missing from the beginning. I am referring here to the models in Great Britain and the United States. It's no secret that in the case of projects that received a modest $1 million grant, for example, no one imagined that it would be possible to reach phase 3 of the study.
At present, there is no structure in place to provide more scientific support to particularly promising funded projects during their development and, if necessary, to put projects with more difficulties on hold. We know that funding is always limited, in the end. That's why Britain has decided to target the three most promising projects and to provide significant funding for each, in excess of $300 million if necessary. One of these projects produced a vaccine that is now licensed in more than 50 countries.
In Canada, the approach has been different. The money was kind of sprinkled around and there was no follow-up. I should point out that in our case, we are trying to develop a vaccine in a non-profit organization and 90% of the costs are cut. This vaccine is meant to be owned by Canadians, but there has been no follow-up. We also didn't have the same competitive opportunities because I was on the selection committee for the largest federal competition.
:
The human health therapeutics research centre in Royalmount has a pilot plant facility and has had that facility for many years. We can produce a vaccine product, but it requires a good manufacturing practices approval, Health Canada approval, for the facility. In the case of a specific vaccine candidate, it would have required an emergency authorization for the production of that candidate for human use.
In the case of the commitments and the statements made—the pilot-production level of production, which is the 200,000 doses—it was certainly the goal of the NRC to put in place the necessary procedures, processes and changes in our facility in order to accomplish that. Of course, we were targeting an international vaccine candidate. It's well known. It did not come into the facility. Therefore, without the product, you can't produce.
The facility is capable of a level of production that is in line with what's been said, but of course, by the time we reached the fall, we were dealing with a scenario where we had approved vaccines coming online. We had them starting to be distributed in December in Canada from approved vaccines that had, of course, advanced very rapidly internationally and that Canada, of course, had acquired—
:
My questions are to Mr. Davies, at least to begin with. I'm interested in your existing capacity to manufacture vaccines.
The other Mr. Davies stated that the or you have said that we have the capacity to make 200,000 doses per month, and it could be ramped up by the end of 2020, the last year, to two million doses per month.
In your reply to Mr. Davies, you seemed to suggest that you could make an AstraZeneca kind of vaccine. I would assume, similarly, you could do the same thing for Johnson & Johnson, because again, its an adenovirus-based vaccine. However, you said AstraZeneca didn't seem interested in contracting with you.
If you were to have either a voluntary license to produce one of these adenovirus-based vaccines, or contract with one of those companies, or if you were to receive a compulsory license, say via the government, could your facility start producing vaccines? How fast could you start, and how many could you make?
:
Thank you for your question.
There have, however, been some major investments, notably in AbCellera. The National Research Council of Canada, NRC, received $56 million for the vaccine from CanSino Biologics, which went nowhere. There have been other major investments.
One of the main challenges is not the investment itself, but rather how investments are sent to the right places and how they are monitored.
There's a lot of talk about NRC having to build capacity. This model does not exist in any other country. One federal department waits for approval from another federal department to produce vaccines that, in very few cases, cause serious side effects. There needs to be compensation for people who have these side effects. To my knowledge, the federal government cannot be sued.
I don't know how this model will work. However, it didn't work for ZMapp, by the way.
I hope it will work this time, but we seem, once again, to have put all our eggs in one basket to solve the current crisis.
:
Thank you very much, Mr. Chair. It's always great to hear Mr. Thériault.
I want to thank the witnesses for being here.
Dr. Lewis, I want to thank you as well for all the work you've done on cancer research. I've read up a bit on you, and it's quite astounding what you've accomplished. Thank you for that.
Mr. Davies, I know there have been significant investments in domestic vaccine production, whether we're talking about the National Research Centre's $170 million, the Novavax partnership project at the University of Saskatchewan, Precision, Medicago, AbCellera or Entos, all the different groups that we've invested in. Maybe you can expand on that, but also talk about the importance of those investments and what they might yield down the road.
:
I can highlight three of those investments because they're each very interesting in terms of capability that's possible for Canada in the future.
For example, Medicago is working on a unique virus-like platform based in plants. Obviously it has been supported to build out its productive capacity, which, when it comes online—and obviously presuming there's a successful process to approve the vaccine—would provide a very considerable amount of future biomanufacturing capability for Canada, based on the novel vaccine platform technology that Medicago has been developing for many years.
PNI was mentioned as well as a leader in terms of the lipid nanoparticles, the new type of mRNA vaccine, in an area where there's significant Canadian leadership, in fact, and a long-standing leadership of companies in Canada in this space. It is new and it obviously has been the news of COVID-19 in terms of technological development that these new types of vaccines are very important in terms of responsiveness. That capability will be there in the future for Canada.
VBI Vaccines is working on a platform that they're intending to address a broader spectrum of coronavirus as well, including SARS and MERS. Again, it's another very important Canadian technology developed in Ottawa at their research centre and will be able to be advanced for the future.
These do obviously give a sense of the capability in Canada and, of course, the funding that has been provided will allow those capabilities to be advanced considerably in this time.
Dr. Kobinger, drawing on the advice of the vaccine task force last September, the federal government pre-ordered 72 million doses of the vaccine candidate developed jointly by GlaxoSmithKline and Sanofi. That represents Canada's second-largest vaccine supply agreement. Of course, that vaccine development has suffered from significant delays after failing to produce a strong immune response in trials.
Dr. Joanne Langley, one of the task force's co-chairs, holds a $700,000 research chair at Dalhousie partly funded by GlaxoSmithKline, and she has worked with Sanofi on research and as a consultant. According to the task force's website, there were no “direct, material linkages”, no conflict of interest and no need for her to recuse herself from discussing the company's product.
At the same time, in February we received evidence that the federal vaccine task force determined that co-chair Mark Lievonen, who was the CEO of Sanofi Canada for 17 years until 2016, who still owns shares in Sanofi, who is consulting with drug companies and who remains the director of two other drug companies, also had no direct, material conflict of interest in assessing the Sanofi vaccine.
Is it possible to say with certainty that conflicted members did not provide biased advice with respect to vaccine procurement in these circumstances?
:
This meeting is now resumed.
Welcome back to meeting number 20 of the House of Commons Standing Committee on Health, where we are meeting to study the emergency situation facing Canadians in light of the second wave of the COVID-19 pandemic.
On the panel today, as an individual, we have Dr. Kashif Pirzada, emergency physician and assistant clinical professor at McMaster University. For the Canadian Institute for Advanced Research, we have Dr. Alan Bernstein, president and chief executive officer. From the Department of Health we have Dr. Supriya Sharma, chief medical officer.
We will start with statements from our witnesses.
We will start with Dr. Pirzada. You have six minutes, please.
:
Thank you, Mr. Chair and members of the committee, for taking the time to listen to our comments today.
I am pleased to present on behalf of the Critical Drugs Coalition, a grassroots group of frontline physicians, pharmacists and academics. We do not seek nor receive any kind of funding from any entity—public or private. We want to provide recommendations for how the federal government can further the goals of mass vaccination and improve the overall security of Canadian drug and vaccine supplies.
As an emergency physician in Toronto, I've seen many people unfortunately pass away from COVID. I was also a key member of Conquer COVID-19, a community group that helped source PPE at the start of the crisis, and Masks4Canada, which successfully advocated for mask-wearing bylaws across the country.
My attitude, and that of many of my colleagues, is that we have a mess here, but let's see what we can do to fix it and save lives. That's how we approach our patients and that's how we should approach this crisis.
Drug and vaccine shortages are not a new issue. They've only been made worse now in this pandemic. It has been an ongoing health security issue for over a decade now in Canada.
In August 2020, we sent an open letter to the Prime Minister's Office detailing our concerns and highlighting some realistic and cost-effective solutions to include domestic manufacturing. The letter is co-signed by the Canadian Medical Association, the Ontario Medical Association and many other national bodies.
Our current vaccine shortage shares a common route with drug shortages: the lack of dependable and scalable domestic manufacturing. We have the following three recommendations.
One, Canada needs local production of drugs and vaccines. mRNA is a new technology that has incredible potency in fighting COVID-19, cancers and possibly other viruses. When I was a lab student 20 years ago, this stuff was science fiction, and the advances made are just incredible. With virus variants, we all need periodic boosters, possibly for years, as we do with the flu. We have the expertise, from the testimony we heard earlier, from companies such as Acuitas and Providence Therapeutics that can make it here. It is also the promise of second-generation genetic vaccines that can induce longer immunity, and these companies are working on it, the ones that we spoke to.
It's great that federal funding is flowing to these companies now, but this support needs to continue. This is a nascent industry, and the technology underlying it is going to revolutionize pharmaceuticals, cancer care and agriculture. It's crucial that we get on board now. It's great that it's also in the provinces that are losing other traditional industries. These are thousands of high-quality jobs. Therefore, it's a win-win for the country.
Our second point is that science coordination and communication needs to improve in this country. We are losing a head-to-head comparison with the U.K., the U.S., Israel and many other countries. The U.K. was able to mobilize a unified effort across industry, academia and government and had a cabinet-level post of vaccine minister.
I'll give you an example just from my personal history. I, along with half of my U of T class in 2003, was quarantined during SARS after inadvertent exposures. Many of us survivors from that time have been trying to get attention on issues such as PPE, drugs and vaccines, but there's no one to talk to, no network to access and no way to warn the government about what we knew was coming back in 2020. We need to involve grassroots frontline providers, scientists and industry leaders in a regular network of advisory groups like the U.K. does. Get the meetings online, make them public, get the deliberations public and that's how you share information freely.
Our third point is that we have some grave concerns from the front lines on the vaccine scale-up and rollout. The rollout so far to health care workers has been fairly chaotic. Many rural providers have not gotten their doses. If the government can't get this right with a smaller population like that, what are the chances it's going to work for 37 million Canadians?
We should keep things simple, as the U.K. has done. Avoid overly complex criteria and tell the public about plans. Be transparent. Who is getting it, when and where? Focus on the most important thing of all, which is getting vaccines into people's arms as quickly as possible.
Another point we've discovered is that community providers have not been engaged in the vaccine rollout so far. Family physicians and pharmacists can deliver millions of doses a week, but they're not involved. They have access to and good insight into vulnerable patients and communities, unlike others.
Another frontline insight is that some have been able to squeeze extra half doses out the Moderna vials and combine them into a single dose, but they are being discarded right now because there's no approval for unorthodox procedures like that. However, in a crisis such this, we should look at any option.
Our final point on the vaccine rollout is that we should seriously consider giving a single dose of the vaccine to as many Canadians as possible. Just today, we have seen seven schools in B.C. closed because of outbreaks and likely airborne spread of the South African variant, which is widespread in the city of Toronto now, in Mississauga. Variants are spreading quickly: in my own hospital log, a dozen last week and five more today. They're more contagious and likely airborne.
We should take pride that we've vaccinated many long-term care patients. However, we are discounting the long-term consequences of even mild COVID-19 infections on younger populations. We should not assume that if they only get mild or moderate illness they're fine. In fact, 15% of them will get what's called “long COVID syndrome”. They'll have memory issues, chronic pain and chronic fatigue, and this will last possibly for years. They won't be able to go to school or work in their jobs. Normally healthy, able-bodied people will have their quality of life ruined and forced onto long-term disability at extreme cost to themselves and their families, and this might even affect children. Imagine if 15% of our children couldn't taste anything or had chronic pain and were unable to go to school.
In summary, as frontline workers battling this pandemic, we recommend that we build vaccine and drug capacity in Canada, we improve communication with frontline workers, decision-makers, and finally we ensure we have an effective vaccine rollout and protect as many as Canadians as quickly as possible with the first dose of the vaccine.
Thank you very much.
Thank you to all members of the committee for your time and interest in clearly what's a very important matter.
My name is Alan Bernstein. I am president and CEO of CIFAR. We are a Canadian-based global research organization. I believe I have been called as a witness here today because I also serve with honour as a volunteer member of the federal vaccine task force.
As you know, the vaccine task force was formed in June of last year to advise the government on the very best strategy to secure a safe and effective COVID-19 vaccine for Canadians as quickly as possible. In doing so, we were also tasked to look at both domestic and international candidates and to look at the state of biomanufacturing capacity in the country.
The vaccine task force is made up of a distinguished group of immunologists, vaccinologists, vaccine developers, biomanufacturers, ethicists and lawyers. We serve as volunteers, providing our very best possible advice in a timely manner in a very changing and uncertain environment. You will recall there was no vaccine last summer, nor was it clear whether there would ever be a vaccine. I want to stress that. Most vaccine journeys end in failure. We were trying to cover our bases with the vaccines we recommended to government.
Our very first meeting was on June 16. We've now met at least 40 times as a task force, for a total of over 125 hours, plus roughly an equal amount of time devoted to studying the proposals that were put in front of us. Let me stress one thing: our primary objective and the charge we were given by ministers was to recommend those vaccine candidates that were most likely to lead to safe and effective vaccines for Canadians as soon as possible. At our first meeting we quickly decided not to put all our eggs in one basket, to put many shots on goal, which you have to take if you want to win a game. We also decided that, given the uncertainties and the seriousness of the situation, we would hedge our bets by recommending at least two vaccine candidates for each one of the three main scientific platforms that are available: RNA vaccines, a new platform; viral vectors; and protein subunits. Such a diverse portfolio of candidates might also reflect the needs of different target groups in any immunization strategy that government might decide to implement.
We were also very cognizant of two factors. First, the majority of vaccine development journeys end in failure. Second, the successful development of a vaccine, through trials to regulatory approval to scaled-up capacity to rollout, is best characterized as a voyage in very rough seas. We therefore felt that Canada needed an appropriately diverse mix of science platforms and firms within the portfolio of candidates that we would ultimately recommend to ministers, even if that meant recommending that Canada purchase more vaccine doses than we might need.
Although ministers made clear that the first priority was to recommend the very best vaccine candidates, some special attention should be paid to domestic proposals. Twenty-four Canadian proposals were carefully examined and three were recommended: Medicago, Variation Biotechnologies and Precision Nanosystems. These three companies are receiving significant government support for vaccine development through the strategic innovation fund.
Some other domestic candidates showed promise, but for a variety of reasons the vaccine task force felt they were at too early a stage for significant investment at the time we looked at them. Therefore, we recommended that six of these projects be referred to the National Research Council for funding through IRAP, the industrial research assistance program. The six projects that received funding in that way were Biodextris, Entos, Glycovax, Inovio, Providence Therapeutics and IMV. In addition, several companies, such as Entos and Providence, received significant additional funding through grants from the Canadian Institutes of Health Research and the NGen fund respectively.
Thank you, Mr. Chair.
:
Good afternoon, Mr. Chair, and thank you for the opportunity to appear before the committee today.
I appreciate this opportunity to highlight how Health Canada has been using agile regulatory processes to expedite the access to COVID-19 vaccines while maintaining high standards for safety, efficacy and quality.
My name is Dr. Supriya Sharma, and I am the chief medical adviser at Health Canada and also the senior medical adviser at Health Canada's health products and food branch.
I want to begin by saying that, since the beginning of the pandemic, our fundamental priority has been to ensure that nimble and timely processes are in place to review applications for clinical trials as well as submissions for authorizing COVID-19 treatments and vaccines.
[Translation]
In particular, we recognize the vital importance of vaccines in Canada’s pandemic response and our fight against COVID-19. Since the start of the pandemic, Health Canada has worked closely with other departments and the Vaccine Task Force on vaccines against COVID-19—
:
Since the start of the pandemic, Health Canada has worked closely with other departments and the Vaccine Task Force to develop and implement Canada's vaccine strategy. Early on, we recognized the need to facilitate clinical trials of drugs for COVID-19, given that no treatments or vaccines were available for this new virus.
In May 2020, Canada’s approved an interim order to facilitate clinical trials for COVID-19 products. Among its benefits, the Interim Order reduces the administrative burden for sponsors without compromising the safety of participants, and makes it easier to set up trials across Canada.
In September 2020, the Minister of Health introduced another interim order to expedite the review of treatments and vaccines for COVID-19, while maintaining a high level of scientific scrutiny.
[English]
This interim order allows Health Canada to approve a new vaccine based on available evidence with more agile administrative and application requirements and to apply terms and conditions to require the manufacturer to continue providing information on the safety, efficacy and quality of the vaccine once marketed; and permits the Public Health Agency of Canada to arrange for the importation of promising COVID-19 drugs into Canadian facilities prior to approval in Canada.
The interim order also allows for rolling reviews, which lets a vaccine manufacturer submit its request for authorization before it has completed all the clinical trials. This means that it can submit required data as they become available.
Additionally, we have a strong post-market safety surveillance system to monitor the safety of COVID-19 vaccines. Once a vaccine is on the market, Health Canada and the Public Health Agency of Canada monitor for any adverse events after immunization in collaboration with the provinces and territories and the manufacturer. The interim order provides the authority to impose terms and conditions on any authorization at any time, such as conducting additional assessments of safety information.
All of Health Canada's regulatory decisions are independent and based solely on science and evidence.
[Translation]
So far, 10 submissions have been received under the interim order—including four treatments and six vaccines. Two vaccines and one treatment have been authorized, while the others remain under review.
Another key step that we have taken to ensure timely and thorough approvals is hiring additional scientists and establishing dedicated review teams for COVID-19 vaccines, in order to ensure consistency in reviews. These review teams, comprised of experienced regulatory and scientific experts, focus solely on COVID-19 work, and have been working around the clock on the scientific reviews of submissions.
Health Canada reviewers are scientists and physicians with many years of experience reviewing vaccines, and with expertise in different domains including, but not limited to, clinical medicine, toxicology and pharmacology, biochemistry, virology, immunology, microbiology, and other scientific disciplines relevant to the development, testing, manufacture and quality control of vaccines.
[English]
Furthermore, as soon as there was information that vaccines were going to be developed, our department worked closely with other international regulators and the World Health Organization to collaborate on the regulatory requirements for COVID-19 vaccines and to make the regulatory processes as efficient as possible.
These partnerships allow us to share information, support scientific collaboration and align regulatory approaches and requirements for vaccines, while still making independent decisions for Canadians.
Together, these measures have allowed Health Canada to authorize several clinical trials in Canada for COVID-19 vaccines, as well as the two vaccines, Pfizer-BioNTech and Moderna, that are already being administered to Canadians.
[Translation]
Our response to the pandemic is being guided by the latest science and research. We also continue to monitor the emerging viral variants closely, and work with manufacturers and international regulators to assess the impact of the new variants on vaccine efficacy and provide guidance to manufacturers.
[English]
As part of our commitment to openness and transparency, Health Canada has published detailed information about the authorized COVID-19 vaccines on the department's new COVID-19 vaccines and treatments portal. Health Canada and the Public Health Agency of Canada also provide weekly updates on reported adverse events following immunization.
Canadians can feel confident that the review process for vaccines is rigorous and that we have a strong monitoring system in place.
Once again, thank you for this opportunity to speak with the committee today. I'd be happy to answer any follow-up questions you may have regarding Health Canada's vaccine approvals process.
Thank you.
:
Dr. Pirzada, thank you so much for taking time to be here today and for your service in our community.
You might not realize this, but you've had an impact on me and my role as a vice-chair of this committee since I was appointed last fall. Since the pandemic started, I've always been of the opinion that in order to reduce the larger societal impacts of lockdown, we should be looking at ways to undertake more targeted isolation measures supported by rapid testing, so we can prevent the spread of COVID but also reduce the harm of domestic violence, suicide rates, mental health, surgeries being cancelled and all the stuff I'm sure you're seeing.
You wrote an article in the fall, talking about the need to have rapid test deployment, and here we are, six months later, on track to have well under 10% vaccinated by the end of March. Do you think it's time we had a federal strategy on rapid testing deployment?
:
Yes, I've been quoted in an interview in the newspapers that I think mixing and matching has several advantages. One is for the viral vector vaccines like the AstraZeneca Oxford vaccine. The second time you come in with the second shot, the host will have already, perhaps, mounted an immuno-response against the vector itself, and so you'll have diminished effectiveness of the vector or the vaccine the second time around, whereas, if you only give it once and then come in, for example, with the RNA vaccine, you're combining the best of both worlds. That's one reason.
The other reason is that there's evidence that the RNA vaccines are particularly good at mounting one arm of our immune system, making antibodies, whereas the viral vector vaccines are particularly good at activating another arm of our immune system, which is the so-called cellular arm of our immune system. By combining the two, you get, again, the best of both worlds.
The third reason, of course, is that, in terms of vaccine availability, if we find that we have a lot of one and not the other, that's another argument for doing both.
I think the bottom line is that we won't know until we do a trial to really measure the effectiveness of that mix-and-match strategy. That trial's begun in the U.K. Here in Canada, my recommendation is that we should also consider doing such a trial as well, perhaps in partnership with the British.
:
Mr. Chair, I'd have to look at exactly what those other two committees do to give you a complete answer.
I would say that, when the Canadian vaccine task force got started, we were just swamped with the need to identify, as quickly as possible, those vaccine candidates that would yield the very best vaccines for Canadians. Indeed, here we are now, seven months later. I think all of us feel very proud of the fact that the six candidates we identified, the international ones, are exactly the six that everyone in the world now wants. We did our due diligence, I think, absolutely correctly. That was our number one priority.
I think the second priority was, as you said, transparency or making things more open. I certainly think there would be room for us to do that. Part of the issue, of course, was that we were providing advice to ministers, which, as you know, is confidential in the parliamentary system. Second, there are some industry issues. Every company that came in front of us, both Canadian and international, required that we all sign confidentiality agreements with them. Indeed, there were confidential issues from the companies' points of view that we could not release, so there are some issues.
You're absolutely right. There's research coming out of Israel that has been interpreted as potentially being information that would talk to transmissibility. The research in Israel was really around viral shedding. What they found was that there was a decrease in viral load in those people, so they would shed less virus, and then the conclusion was that potentially they would be less transmissible. I think that's an interesting hypothesis. We still don't know exactly how that correlates, the amount of the virus you shed or what type of virus it is, or what phase, and how that directly translates to transmissibility.
Whether it's for the Pfizer-BioNTech vaccine, whether it's for Moderna, that has some data around potential decreasing of asymptomatic spread, as well as AstraZeneca that shows in some studies that potentially it's about a 66% decrease in asymptomatic transmission. I think we'll have some data on the vaccines, but for all of them, it's not yet conclusive. Really, the studies have been designed to look at decreasing and preventing serious illness, moderate illness and death. We know that for the vaccines that we have under review and have authorized, they all have very good outcomes there, but again, the transmission and the effect on the transmission is still an ongoing area of research.
I think it is important that Canada be a major contributor to both COVAX and other mechanisms for vaccines for the developing world. Until the U.S. came in I think we were the largest contributor per capita to the COVAX facility. But it's in our interest to make sure that everyone in the world is vaccinated as quickly as possible. Dr. Sharma alluded to the variants that inevitably have appeared, and those variants will appear anywhere. The number of variants that appear will be directly proportional to the size of the virus pool in the world. So it's in our interests here in Canada to shrink that virus pool as quickly as possible, and the best way to do that is to vaccinate the whole world as quickly as possible.
I think Canada has a moral as well as a practical reason for donating vaccines to the rest of the world, either through COVAX or through other mechanisms: directly to Gavi, the Vaccine Alliance, or through the WHO. I think that is very important.
At least on paper, Canada has purchased more vaccines per capita than any other country. If all those vaccines are eventually approved by Health Canada, we will have the opportunity to donate a lot of doses to COVAX or to the developing world directly. I think the important point is that we step up and donate those vaccines to the developing world. Thank you.