Evidence of meeting #39 for Health in the 40th Parliament, 2nd session. (The original version is on Parliament’s site, as are the minutes.) The winning word was vaccines.
A recording is available from Parliament.
Conservative
The Chair Conservative Joy Smith
Good afternoon, everyone. Welcome to the health committee today. I'm so glad everyone could be here.
I would like to welcome the Public Health Agency of Canada. Of course, Dr. Butler-Jones is no stranger to this committee. I understand Robert Pless, program director, is with him as well today.
I understand, Dr. Butler-Jones, you can stay until five o'clock. Is that correct?
Dr. David Butler-Jones Chief Public Health Officer, Public Health Agency of Canada
Shortly before.
Conservative
The Chair Conservative Joy Smith
Thank you.
Then we have the Department of Health, Elwyn Griffiths, director general. Welcome.
We also have from GlaxoSmithKline Canada, Paul Lucas. Welcome, Paul. I'm so glad you could come to our committee.
We also have two more. From Sanofi Pasteur, we have Rob Van Exan, the director of immunization policy; and we're going to have a video conference from Vancouver with Susan Fletcher, who's with the Vaccination Risk Awareness Network. Welcome to all of you.
Having said that, we're going to have five minutes for a presentation from each person, then we'll go into the regular questions and answers for seven minutes. That allows our committee to ask some more questions.
Dr. Butler-Jones, could you begin, please.
Chief Public Health Officer, Public Health Agency of Canada
Certainly. Thank you, Madam Chair.
Good afternoon, Madam Chair and members of the committee.
It's a pleasure to be here today to explain our plans for the H1N1 vaccine campaign for the fall flu season.
The second wave of H1N1 flu is here. We have worked hard together preparing for this wave, but our plans will only succeed if Canadians realize they and their families need to be vaccinated and take steps to do so. It's clear to me that vaccination is the most effective way of preventing the spread of any kind of flu, including this strain.
We know that Canadians have a lot of questions about the vaccine. Here are just a few examples: they want to know whether it's safe, whether it's been properly tested, whether it will work, and if the vaccine can give them the flu.
Those are good questions and we have good answers.
To begin, on Wednesday last week we made a very important announcement: we announced that the H1N1 vaccine has performed as we expected it would in clinical testing and that it is safe and effective. This announcement meant that we can start administering the millions of doses of this vaccine that have already been shipped to every province and territory. Now the provinces and territories can start administering the vaccine according to the plans for their own jurisdictions; in fact, the vast majority of the provinces are starting today.
Even though the H1N1 vaccine has been authorized, we don't expect the questions about its safety to stop. But the more Canadians know, the more they will trust the vaccine and see the merits of being immunized. It isn't easy to get that message across while battling the many myths out there. Over the last two weeks I've travelled with the minister, and we have met with Canadians and heard their concerns about the vaccine, about this disease, and we've answered their questions.
The average Canadian has to be reassured that the vaccine is safe or they won't be in line to be vaccinated when the program starts in their community.
We have ordered enough vaccine for every resident of Canada, but they have to be persuaded they need to get it. They have to understand that a vaccine will not only keep them from getting sick, but it will also prevent them from spreading it someone else, who will then spread it to yet another person.
Because this is a new strain, there's very little immunity to it, and we know that in some people it can be fatal. Already 86 people who have contracted this virus have died from it, and hundreds more have required intensive care.
We've been preparing for a pandemic influenza outbreak for several years. A contract has been in place with GlaxoSmithKline to ensure that every Canadian has access to a safe and effective vaccine. The Government of Canada facilitated the bulk purchase of the vaccine on behalf of the provinces and territories. Production began immediately after seasonal flu production runs were complete. That strategy was recommended by the WHO, the World Health Organization.
A handful of countries may have had access to H1N1 vaccines for some of their citizens before us. However, our bulk purchase means that we will be able to secure enough vaccine for every Canadian who needs and wants it—and few countries can say that. As I mentioned earlier, millions of doses have already been shipped to about 80 locations in the east, west, and northern parts of the country.
As you know, on the recommendation of the WHO, most of the vaccine being produced contains an adjuvant. The adjuvant boosts the immune system's response and makes it more effective, especially if the virus mutates during the fall flu season or into the spring. The adjuvant also allows faster production because it uses less of the antigen, the material that gives us the immunity.
The adjuvant's safety and efficacy have been proven. It has been used in Canada's H1N1 vaccine and it's made of natural products: oil, vitamin E, and water. This adjuvant has been safely tested on 45,000 people worldwide, and similar adjuvants have been used in millions of people. Adjuvant has been used since the 1920s and is included in such common vaccines as tetanus, hepatitis A and B, and diphtheria vaccines. Adjuvanted vaccine is the type of the vaccine we recommend for the vast majority of our population, and it is the vaccine that's available now.
The unadjuvanted vaccine is what we generally recommend for pregnant women until we have more clinical data. In the meantime, before the unadjuvanted vaccine is available, women more than 20 weeks pregnant and women in earlier stages of pregnancy with risk factors for severe disease should consider getting the adjuvanted vaccine.
While the order for 1.8 million does of unadjuvanted vaccine being produced by GSK is still on target for early November, we felt that given the increase in cases of H1N1 across the country, it would be prudent to offer pregnant women earlier access to an unadjuvanted vaccine. Today the Minister of Health announced that we had secured an additional supply of 200,000 doses of vaccine from Australia.
This vaccine has been approved for use by health regulators in Australia and the United States. Barring any distribution delays, this additional supply that's manufactured by CSL Australia will be available to the provinces and territories next week.
The fact that it comes from the southern hemisphere is an important point. While we in the northern part of the world were dealing with H1N1 over the summer in small amounts, the southern hemisphere was in the midst of its winter flu season. Australia was therefore one of the first countries in the world to offer the vaccine to the general population. We've learned a great deal from their efforts and about this vaccine.
Following the immediate distribution of the vaccine, Health Canada and the Public Health Agency of Canada will monitor the safety and effectiveness of the vaccine on an ongoing basis to help ensure the safety of pregnant women. It's important to note that some 600,000 people have already received this vaccine in Australia.
It is crucial that pregnant women consider the benefits of being immunized. The safety of the vaccine is of the utmost importance. So we will keep monitoring the vaccines for adverse events.
The Public Health Agency of Canada and Health Canada continue to monitor vaccines after they are authorized for use, with an eye to their future use .
We have comprehensive mechanisms in place to allow for rapid reporting of adverse events following immunization. In addition to existing surveillance systems, a pan-Canadian surveillance and risk management plan will be implemented to provide even more accurate reporting of adverse events.
We've also invested in the Pan-Canadian Research Network, a joint initiative between the Public Health Agency and the Canadian Institutes of Health Research, which links some 80 scientists in 30 institutions across Canada. This network will strengthen Canada's capacity to help evaluate the safety and effectiveness of the H1N1 campaign and programs.
Through the national immunization strategy, the Public Health Agency of Canada continues to work with provinces and territories to monitor and evaluate the immunization programs and to assess the need for any actions or additions or changes to the existing national strategy.
This is the largest immunization campaign in Canadian history. So it's important that we maintain our communication with all Canadians. The government has been working with the provinces and territories to assist with their public information campaigns and to ensure consistent delivery of information and resources across Canada. That collaboration also helped us develop the Your H1N1 Preparedness Guide, a comprehensive guide to information about this virus.
The guide is available online and it is being distributed through Canada Post outlets and can be ordered through 1-800-O-Canada.
We have been collaborating with key public health stakeholders, such as the Society of Obstetricians and Gynaecologists of Canada, the Canadian Paediatric Society, and other key stakeholders to develop fact sheets and immunization promotion materials to encourage immunization among at-risk populations. We have often said that knowledge is the best defence against this virus.
One of our most important tasks now is to share that knowledge.
Thank you, Madam Chair.
I look forward to answering all of the questions.
Conservative
The Chair Conservative Joy Smith
Thank you, Dr. Butler-Jones.
Now we'll go to the Department of Health and Elwyn Griffiths, director general.
Dr. Elwyn Griffiths Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health
Thank you very much for this opportunity to speak to the committee.
As you've already heard from Dr. Butler-Jones, Health Canada authorized Arepanrix on October 21. This is the adjuvanted vaccine manufactured by GSK, GlaxoSmithKline, for use against the H1N1 flu virus. This authorization was made under an interim order.
An interim order is issued by the Minister of Health under the authority of the Food and Drugs Act in rare situations when the minister believes that immediate action is required to deal with a significant risk, direct or indirect, to human health, to public safety, or the environment. This interim order enabled Health Canada to authorize the vaccine based on human clinical data available at the current time. Based on Health Canada's review of the available data on quality, safety, and efficacy—in this case, its immunogenicity—and given the World Health Organization's declaration of an influenza pandemic and its risk to human health, Health Canada considers the benefit-risk profile of the vaccine as favourable for immunization against a pandemic strain.
Canada, like many other countries worldwide, exercises tight regulatory oversight over all vaccines, because they're usually given to very large numbers of healthy individuals. All vaccines made available to Canadians are subject to a strict authorization process conducted by Health Canada, the regulatory authority in Canada. In order to fulfill its mandate, Health Canada—which is the regulator, as I said—works in collaboration with the Public Health Agency of Canada, which itself provides health advice to Canadians.
To put the regulatory system into perspective, I'll very briefly describe some of Health Canada's activities on the vaccine side, activities that apply to a whole range of different vaccines, not just to the pandemic one. This is for the child and adult populations.
Prior to the approval of a new vaccine, the manufacturer must file a submission with scientific and clinical evidence demonstrating that the vaccine's health benefits outweigh the risks and that the vaccine is effective and suitable for use in Canadians.
Clinical trials that take place in Canada must also be approved by the regulator before their commencement. However—and I think this is quite important—it is not necessary for trials to be conducted in Canada in order for a vaccine to be eventually authorized here. Adherence to internationally accepted standards of good clinical practice helps ensure that clinical trials conducted in other countries meet the same high standards of evidence needed to support authorization in Canada. With clinical trials, the issue is the quality of the science, not where the science has been done.
All clinical data, regardless of where the trials are conducted, will be evaluated with data from laboratory and animal studies as well. Furthermore, as part of the overall approval processes, Health Canada conducts an evaluation of the manufacturer's facilities to assess the quality of the vaccine manufacturing process and determines the manufacturer's ability to carry out the necessary quality control studies on the vaccine. The manufacturer must also provide samples of the vaccine for testing by Health Canada.
Once the evaluation is completed, and if the conclusion is that the benefits of a vaccine outweigh any potential risks, then the vaccine is granted market authorization and can be sold in Canada. After approval, however, Health Canada continues its regulatory oversight by conducting its own independent testing as part of a lot release program before each lot is released onto the market. An inspection of the manufacturer's facilities is also conducted regularly—at least every two years—to make sure they're following the very best practices for drug manufacturing.
Potential adverse events with the vaccine are also monitored, this time by the Public Health Agency of Canada through active and passive surveillance. However, there are unique challenges associated with the development and regulatory evaluation of influenza vaccines. Each year the influenza vaccine must be remade to reflect the strain of the virus the WHO believes will be circulating that year. The time between the completion of the manufacturing and the need to get the vaccine into the arms of Canadians to provide immediate protection is always short. Health Canada works closely, therefore, with manufacturers to help minimize any delays.
While challenges are the norm in dealing with influenza vaccine regulation, these are magnified in a pandemic situation considerably. Influenza pandemics are actually caused by novel strains that have not previously circulated. A key challenge the regulatory authorities worldwide have had to deal with—this is not peculiar to Canada—is how to conduct clinical evaluation for safety and efficacy of a vaccine in the absence of disease and prior to the start of a pandemic. You cannot just manufacture or test a vaccine against a disease that doesn't yet exist.
For this reason, both Health Canada and the Public Health Agency of Canada have been proactively preparing for a pandemic for several years. The Canadian pandemic influenza plan has built in a balance between the need to provide access to a pandemic vaccine in a timely manner and the need to gather as much information as we can on vaccine quality, safety, and effectiveness.
A key component of this preparatory work has been close collaboration with the contract vaccine manufacturer GSK to complete as much of the process as necessary for the evaluation of a pandemic vaccine in advance of the declaration of a real pandemic. In this period, what you might call the pre-pandemic period, Health Canada evaluated potential pandemic or mock H5N1 avian vaccine that was produced by the manufacturer, and this enabled Health Canada to inspect the vaccine manufacturing facilities and review results from both animal and human studies with the mock vaccine. These activities were performed to assess the quality, safety, and efficacy of the vaccine, which all contribute, really, to the overall safety of the product. The idea was that the development of a regulatory evaluation of the prototype vaccine would facilitate the approval of a pandemic vaccine once the pandemic stream was identified and production started.
The GSK adjuvanted vaccine consists, as we've already heard, of two components, an antigen and the adjuvant. The antigen is the active component, an ingredient in the vaccine, or the immunizing part, which provides protection against the virus. The adjuvant is a substance added to the vaccine to boost the immune response. Adjuvanted vaccines may also provide broader cross-protection against mutating flu virus strains. Adding the adjuvant contributes also to what is called dose sparing, which allows for larger amounts of the vaccine to be produced because less antigen is used.
During the pre-pandemic period, the safety and effectiveness of the adjuvant to be used with the vaccine was assessed by both Health Canada and other regulatory agencies worldwide. Clinical trials on the adjuvant were conducted in the United States, Canada, Europe, and so on, and included over 13,000 patients. Data from additional trials conducted by GSK in Europe, which combined this same adjuvant with a seasonal influenza vaccine, were also assessed. Now overall, this adjuvant has been evaluated in around 40,000 to 45,000 individuals worldwide. No serious safety concerns regarding the use of the adjuvant have been detected.
A similar adjuvant has been used safely in Europe since 1999 in an influenza vaccine manufactured by the company Novartis, which is a licensed vaccine. Furthermore, the World Health Organization held a consultation early in June, from all the world regulators, on the safety of the adjuvanted vaccine, the conclusion of which was that there were no significant safety concerns or barriers to the use of adjuvanted vaccines in the current H1N1 virus situation.
In Canada, the pandemic vaccine file is what's called a rolling submission, which means that Health Canada has been reviewing data on an ongoing basis--as it becomes available, essentially--and it will continue to do so and review any additional information from the ongoing studies immediately upon receipt.
Quality, which means the chemistry and manufacturing of the vaccine, are the data that are used to indicate that the vaccine is produced with the H1N1 strain and it has been manufactured in accordance with the usual high standards expected of vaccines in Canada. Safety information for the H1N1 vaccine has been reviewed from studies in animals as well as clinical studies in around 900 individuals, to ensure that the vaccine has an acceptable safety profile for use in humans, and that the vaccine produced is an adequate immune response.
Both the safety of the antigen and adjuvant were considered. However, because it was recognized that the vaccine would need to be made available before extensive safety studies could be completed, additional studies and surveillance will continue post-market in order to detect any change in the incidence of adverse events or special interests, such as Guillain-Barré syndrome or any other rare adverse events. GSK's clinical development plan includes trials across Europe, the United States, and Canada, and it will also include resulting safety and effectiveness data in a further 10,000 people, approximately.
Data from clinical trials have become available globally during the authorization process. Using similar or related pandemic vaccines was also considered in this period. Clinical trial results from the United States, Europe, Australia, and China supported vaccine safety and effectiveness, and with no serious adverse events--we looked at all those as well. Canadian clinical trials of the GSK H1N1 pandemic vaccine are under way, and promising early results have already started to come in to us.
As you have already heard, a non-adjuvanted H1N1 pandemic vaccine is also being manufactured by GSK as part of its contract with the Government of Canada. Health Canada is also reviewing available data to support the quality, safety, and efficacy of this non-adjuvanted version as it becomes available.
Now, maximizing the quality, safety, and efficacy of vaccines is well recognized as really an essential component of any successful immunization program. Vaccines have an excellent safety record. However, we all know that rare adverse events cannot be detected until the vaccines are given to very large numbers of individuals. And these occur even when the very best regulatory controls are in place. There are instances where adverse events may occur following immunization. So further investigation is key, really, to determining if the reaction was directly or causally, as we say, related to the vaccine or not. This is an important way of investigating this.
Due to the uniqueness of the pandemic situation, all of the safety and clinical effectiveness data regularly required were not available at the time of licensure. This is the case in Canada and in all other jurisdictions. Major regulatory agencies, including Health Canada, have developed review processes specifically as part of their pandemic planning. As a result, a carefully designed post-market surveillance plan is a critical component in order for Health Canada and the Public Health Agency to monitor the safety and effectiveness of the vaccine and to communicate any adverse events following immunization in a very timely manner.
Now, a pandemic is a global issue that requires collaborative international response. It's not peculiar to Canada. As noted previously, Health Canada and the Public Health Agency, in close collaboration with other national regulatory and public health authorities, have been preparing for many years to deal with this situation. So between 2006 and 2007, Health Canada initiated and hosted regulatory preparedness workshops with the U.S. Food and Drug Administration and the World Health Organization. These workshops resulted in the development of what is now called the WHO guidelines on regulatory preparedness for human pandemic influenza vaccines and the creation of a global network of about 10 influenza vaccine regulators. These are the key global regulators.
Since the H1N1 virus emerged, the WHO has been hosting biweekly telephone conferences with this vaccine regulators network. In addition, Health Canada has been participating in biweekly multilateral discussions with the USFDA, the European Medicines Agency, the Australian Therapeutic Goods Administration—the regulator in Australia—and Japan to discuss clinical development plans and pharmaco-vigilance of the H1N1 vaccines.
Most importantly, there is a global commitment amongst this group to share clinical and safety data on the H1N1 vaccines in real time. This enables countries to maximize the amount of data available to support vaccine approval and rapidly share information on potential adverse events following immunization. This has already started and will continue to inform vaccine policy decisions worldwide as time progresses.
Vaccines are only authorized if the benefits outweigh any risks, be they real or theoretical. In the case of the H1N1 pandemic vaccine, as part of the authorization the manufacturer is required to submit and adhere to a risk management plan. The plan includes a list of adverse events of special interest, such as Guillain-Barré syndrome, which would develop by consensus between the WHO and major regulatory authorities around the world, and these adverse events will be monitored when the vaccine is rolled out.
The manufacturer will also be required to continue conducting clinical studies and to submit monthly safety reports to the government. The continued clinical trials will focus on assessing vaccine safety and effectiveness especially in specific population groups. And all lots of pandemic vaccine will be tested in Health Canada laboratories before they are released for the Canadian market.
Let me conclude by saying that the regulator has not really cut corners in the regulatory process here to verify the safety and effectiveness of this vaccine. A lot of work has gone into evaluating this vaccine.
Thank you very much.
Conservative
The Chair Conservative Joy Smith
Thank you very much, Dr. Griffiths.
Now we will go to Paul Lucas, who is the president and chief executive officer of GSK.
Mr. Lucas.
Paul Lucas President and Chief Executive Officer, GlaxoSmithKline Canada
Thank you, Madam Chair. Thank you for the opportunity to appear today to share with you GlaxoSmithKline's update on H1N1. I'd like to make two key points.
First, we are fortunate in Canada to be home to a world-class vaccine production facility in Sainte-Foy, Quebec, as it provides a domestic and secure supply of H1N1 vaccine. All vaccines supplied by GSK in Canada will be manufactured here at our facility in Quebec.
Second, as a result, GSK's H1N1 vaccine production is on schedule and will meet the timeline set out in our Government of Canada contract, and Canada will be one of the first countries in the world to secure enough pandemic vaccine to cover its entire population.
Canada will be one of the first countries in the world to have enough vaccine against the flu pandemic to immunize its entire population.
GSK is a long-standing partner with governments across Canada and around the world in delivering life-saving medicines and vaccines. Our presence here goes back more than one hundred years. We are a top 15 contributor to R and D, investing more than $156 million in 2008 alone. We have facilities in several provinces, and we employ more than 3,000 people across the country.
GSK is the largest bio-pharmaceutical employer in Canada and the only company in Canada with a full influenza portfolio of pandemic vaccine, pre-pandemic vaccine, seasonal vaccine, and antivirals.
GSK began planning for pandemic production as far back as the nineties. Today we're applying our extensive global knowledge--again, from years of research, innovation, and investment--to the development of a safe and effective H1N1 vaccine. Over the past four years, GSK has invested globally approximately $5 billion in developing technologies and in increasing the capacity at our manufacturing sites.
Since acquiring ID Biomedical in 2005, GSK continued investing here in Canada and it invested $200 million in the centre at Sainte-Foy to triple production capacity and almost double the filling capacity, and nearly $50 million at Laval for research and development for North America.
As Canadians, we're fortunate to be assured this domestic security of supply, which, as I said earlier, will come from GSK's Quebec facility. Let me assure you that we take this responsibility seriously. Dedicated people across our Canadian and global organizations are collaborating with the Canadian government to provide a safe and effective supply of H1N1 vaccine in Canada and around the world.
While our initial focus is on the Canadian population, GSK has also allocated 20% of production in Canada to developing countries, including an intended donation of 50 million doses to the WHO. GSK's dedicated pursuit of innovation in this area put us on the leading edge when the H1N1 virus emerged. An example is GSK's ASO3 adjuvant technology.
Adjuvants enhance protection against challenging pathogens like H1N1. An adjuvanted vaccine can help to protect against the risk of a virus changing during a pandemic. It is also possible to produce more doses of vaccine faster, which ensures that more people around the world get access, all key elements to a successful global pandemic response.
In short, influenza is our business and our expertise. GSK's H1N1 vaccine production is on schedule, and Canada will be one of the first countries in the world to secure enough pandemic vaccine to cover its entire population.
GSK has been working closely with industry experts and government since the WHO first identified in late April the pandemic potential of the H1N1 virus. We began H1N1 vaccine development in late May upon receipt of the seed strain from the WHO. Production of H1N1 began following completion of our seasonal vaccine, as per guidance issued by the WHO and SAGE. Since then, GSK has initiated clinical trials at more than 150 sites around the world. To date, more than 2,600 people have received GSK's H1N1 vaccine in global clinical trials.
Canada's program began this month. More than 2,000 Canadian volunteers will be vaccinated, including healthy adults, the elderly, and children, including infants.
The adjuvant system in our influenza vaccine has been tested in more than 40,000 people globally in pandemic and seasonal influenza programs. GSK strongly supports the WHO's call for post-marketing surveillance of the highest quality, and we are sharing information from safety and effectiveness studies with the appropriate regulatory authorities on a regular basis.
Now that regulatory approval is achieved, dissemination of the H1N1 vaccine to Canadians will require continued collaboration. GSK will continue to support governments, public health, and health care providers who will administer the vaccine to ensure the success of the largest mass vaccination program in our history. I'd like to acknowledge the challenging and excellent work done by all involved, including the planning by the Canadian government as far back as 2001.
In closing, I want to assure members that GSK has embraced the responsibility entrusted in it. We take it very seriously and are committed to delivering to Canadians through their governments.
Thank you. I welcome your questions.
Conservative
The Chair Conservative Joy Smith
Thank you very much, Mr. Lucas.
We'll now go to Sanofi Pasteur, Mr. Rob Van Exan, on immunization policy.
Please proceed.
Rob Van Exan Director, Immunization Policy, Sanofi Pasteur
Thank you, Madam Chair and members of the committee, for your invitation to Sanofi Pasteur to be at your proceedings today. I am honoured to represent the 1,100 employees of Sanofi Pasteur who research, develop, and manufacture vaccines in Canada.
Our company's commitment to public health dates back to 1914 in this country. As Connaught Laboratories, a name many of you may remember, our company has played an integral role in many Canadian breakthroughs, including the first production of insulin in 1921, a significant role in the development of Salk vaccine during the outbreaks and epidemics of the mid-1950s, and in the global eradication of smallpox.
Our experience over the years with public health threats suggests the key to dealing with infectious disease threats is collaboration, and it's collaboration among governments, industry, non-governmental organizations, and academia. And having world-class facilities located in this country enhances the ability of this government to collaborate.
We are now part of the sanofi-aventis Group, a global pharmaceutical company with leadership in vaccines. Our Connaught campus in Toronto develops and manufactures vaccines for Canadians and the world. Each year we invest approximately $100 million in vaccine R and D alone, and a total of $200 million in research in Canada, making us one of the largest investors in research in this country.
Sanofi Pasteur's Connaught campus in Toronto currently manufactures 10 vaccines, all of which were researched and developed right here in this country. The Toronto site has a global mandate for these products and exports close to half a billion dollars' worth of vaccine each year. Sanofi Pasteur has invested over $350 million dollars in its production and R and D facilities at the Toronto campus in the last decade, and this includes a new $100 million R and D facility, which is under construction as we speak.
I appreciate your calling on Sanofi Pasteur's knowledge of immunization and vaccines in your committee's research and I would like to acknowledge, on behalf of Sanofi Pasteur, the successful milestone announced last week by the Canadian government and GlaxoSmithKline. The successful regulatory release in Canada of the first lots of pandemic H1N1 vaccine is a significant step forward in providing Canadians with protection from the H1N1 virus, which is currently circulating in this country.
Sanofi Pasteur is the world's largest influenza vaccine manufacturer, producing an estimated 40% of the total world demand for seasonal flu vaccine at our facilities in the U.S. and in France. We are playing a lead role as a pandemic supplier in the U.S. and many European countries and have committed to donating 100 million doses of H1N1 vaccine to the WHO for emergency use in developing countries. Our company is not currently supplying pandemic vaccine in Canada, although we have supplied annual inter-pandemic vaccines for decades.
Influenza vaccine is unlike other products our company makes. It is the only vaccine that changes every year in response to changes in the circulating virus. Some influenza strains are much harder to produce than others. Unpredictability in both the capacity and the timing of influenza vaccine supply from year to year and manufacturer to manufacturer is part of the nature of making influenza vaccine.
Because new vaccine production adaptations and strain formulation must be undertaken each year to meet the needs of regular annual influenza programs, influenza vaccine supply has a greater degree of unpredictability than the supply of any other vaccine. For this reason, our company has always advocated having two sources of supply of influenza vaccine to ensure production back-up capacity should one supplier experience production delays or difficulties and to ensure delivery of initial doses of vaccine in a timely manner to maximize program effectiveness.
Having access to more than one source of supply can likewise be important in a pandemic situation. Canada has chosen to focus on a single Canadian supplier of pandemic vaccine as a means of enhancing security of vaccine supply during a pandemic. Canada should also consider having a second supplier, with global expertise and capacity for influenza vaccine manufacturing outside of Canada, with a strong manufacturing, filling and packaging capacity inside Canada. This would provide Canada with the best of both worlds and would maximize pandemic vaccine security of supply. Strong public health policy for immunization in general should recognize the critical strategic importance of its Canadian-based manufacturers to the safety and security of its people when it comes to disease prevention and secure access to vaccines.
According to the WHO, existing and emerging infectious diseases are a threat to national and global security. Canadian policies that foster an environment that strengthens Canadian vaccine innovation and encourages investment in vaccine manufacturing capacity in Canada will go a long way to increasing the safety and security of its people by ensuring timely access to vaccines against existing and emerging diseases.
Thank you very much. I'd be pleased to respond to any questions you may have about Sanofi Pasteur's operations.
Conservative
The Chair Conservative Joy Smith
Thank you very much for your presentation, Mr. Van Exan.
We'll now go to video conference via Vancouver. We're presenting now Ms. Susan Fletcher from the Vaccination Risk Awareness Network.
Good afternoon, Susan. Can you hear me?
Susan Fletcher Researcher and Board Member, Vaccination Risk Awareness Network Inc.
Can you hear me now?
Conservative
The Chair Conservative Joy Smith
My greetings to you. Please start with your presentation.
Susan, you must have muted your microphone.
Researcher and Board Member, Vaccination Risk Awareness Network Inc.
Hello? Can you hear me now?
Conservative
The Chair Conservative Joy Smith
We can hear you now.
Welcome to the committee. We're so glad you're alive and well; just don't press any buttons.
Thank you.
October 26th, 2009 / 4:05 p.m.
Researcher and Board Member, Vaccination Risk Awareness Network Inc.
I'm new to this, as you might imagine.
Conservative
The Chair Conservative Joy Smith
Susan, we have five minutes for your presentation, then you'll be a part of our question and answer session. It's a seven-minute round, and people can direct questions to you after your presentation. First, give us a five-minute presentation, and then we'll go into our round.
Can you start now?
Researcher and Board Member, Vaccination Risk Awareness Network Inc.
Thank you for the invitation.
In six months, 80 Canadian deaths have been linked to swine flu, also known as H1N1. During that time, almost 20,000 have been linked to diabetes. Immunologist Bart Classen, MD, MBA, provides evidence that vaccines may cause or contribute to both type 1 and type 2 diabetes. Even if vaccines were the source of only 1% of all diabetes cases, they would be much more lethal than H1N1 has been. Unsurprisingly, most of those who have been seriously ill or died from the swine flu have had underlying conditions like diabetes. VRAN contends that it would have been logical to focus most resources on the underlying conditions rather than the virus.
Categories of people highly recommended to have the vaccine include infants, pregnant women, and those with immune-suppressing health conditions. In his article, “Swine Flu: To Vaccinate or Not?”, Marc Girard, MSc, MD, consultant in drug monitoring and pharmaco-epidemiology, declares this to be criminal nonsense. Those are exactly the categories that are most likely to experience vaccine adverse events.
The Public Health Agency of Canada has reassured the public that the vaccine will be safe, when it cannot possibly know that this is true. This summer Dr. Elwyn Griffiths, director general of the biologies and genetic therapies directorate, revealed that a vaccine trial of a mere 100 to 200 Canadians would be enough to allow approval of the vaccine. I don't care what Dr. Griffiths says; I think Canadians need to be trialed, not somebody from Europe, Australia, or wherever. In fact, the trials had just begun the week the vaccine was approved, the week immediately before the first dose might be injected.
The GSK adjuvant ASO3 is the most worrisome ingredient in the vaccine. The book Vaccine-A, by award-winning journalist Gary Matsumoto, discusses oil-based adjuvants, especially squalene. Referring to 1970s UCLA research, he reveals that “rats injected with either squalene or squalane all developed experimental encephalomyelitis, an MS-like disease”.
ASO3 contains squalene. This month physicians and advisers of the German military have nixed the approved H1N1 vaccines containing squalene and thimerosal, which is also a concern. Perhaps the powerful immune stimulation from squalene was on the mind of microbiologist Karl Weiss when he was interviewed for an article in the September 25th edition of the Montreal Gazette. Aaron Derfel reported that Weiss was certain that “For those who have been confirmed to have been infected by H1N1, getting the vaccine would not be a good idea. That's because their immune systems could overreact horribly.” This raises the question of how many Canadians would be at risk from the vaccine because they've already become infected with the virus, many without confirmation by testing or without realizing that they had an infection.
In his article, “How Vaccines Can Damage Your Brain”, retired neurosurgeon Russell Blaylock, M.D., CCN, declares same-day multiple injections criminal. He warns of research showing that a priming effect on brain immune cells by an initial vaccination may be followed by an extreme overreaction of these cells if a second vaccination is administered up to a year later. How much more overreaction will Canadians' brain cells suffer with the addition of yet another vaccine to the recommended schedules?
The aims of VRAN are threefold: fully informed consent to vaccination, an easily accessible and unbiased vaccine adverse event monitoring or event reporting system, and a national no-fault compensation plan. IMPACT, Immunization Monitoring Program ACTive, is conflicted by its sponsorship from a profession that earns wages through administration of vaccines and by its monitoring of opportunities to introduce new vaccines.
To Canada's shame, it's one of only a few developed countries without a national compensation plan. The excellent no-fault compensation report drafted many years ago by the Manitoba Law Reform Commission serves only to gather dust.
Conservative
The Chair Conservative Joy Smith
Thank you very much, Susan.
Now we're going to go to our first round of seven minutes of questions and answers.
We'll ask Dr. Duncan to begin.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you, Madam Chair.
Good afternoon, everyone. Thank you for being here and for your time and effort.
I don't know whether I'm allowed to ask this, but on what date was the vaccine ordered? Am I allowed to ask that?
Chief Public Health Officer, Public Health Agency of Canada
We signed the contract with the predecessor to GSK some eight or nine years ago.
Chief Public Health Officer, Public Health Agency of Canada
That was for any pandemic vaccine.
As soon as the seed strain was available and the seasonal was done, GSK started producing vaccine. It didn't matter when we ordered it; we already had a contract for all of the first doses.
I can't remember what the date was, but it doesn't matter. It was August or--