The government has purchased 50.4 million doses of H1N1 flu vaccine on behalf of the provinces, territories and federal populations. Most of the order is for adjuvanted vaccine; 1.8 million of the doses are for unadjuvanted vaccine.

The Government of Canada has a longstanding contract with GlaxoSmithKline (GSK) to maintain vaccine production capacity in Canada in order to meet Canada's pandemic vaccine needs promptly and effectively.

The order of unadjuvanted vaccine from GSK will be available by mid-November.

In order for pregnant women across the country to have access to the unadjuvanted vaccine as early as possible, the Government of Canada has purchased 200,000 doses of unadjuvanted H1N1 vaccine from CSL Australia, which is now being administered across the country.

Q2. How will the government pay for the vaccine?

Although the delivery of immunization is a provincial and territorial responsibility, given the exceptional circumstances of a pandemic, the Government of Canada intends to cover 60 per cent of this purchase on a one-time basis.

This investment reflects the seriousness of the situation and our commitment to showing leadership, along with the provinces and territories, on this issue. This investment will be made through a newly allocated federal fund for the H1N1 flu vaccine purchase.

Q3. How did the government decide on the amount of vaccine to order?

While we would aim to vaccinate 100 per cent of the population, from observing seasonal flu shot campaigns, we know that even in provinces with free universal access vaccination programs, usually less than 50 per cent of the population will choose to be immunized.

Ordering 50.4 million doses of pandemic vaccine amounts to ordering 50 per cent more than we would expect to use for a normal seasonal vaccination campaign.

The Government of Canada is confident that 50.4 million vaccine doses will be sufficient to meet the needs of every Canadian likely to need and want protection.

Q4. What if we end up needing more than 50 million doses of vaccine? Will the government be able to buy more and who will pay for it?

Through our contract with GlaxoSmithKline we have the opportunity to place further orders at a later date if we feel that there is a requirement for more vaccine to meet the needs of the Canadian people. The cost sharing of additional purchases would be negotiated at the time.

Q5. Will the vaccine be free for all Canadians, even those in provinces and territories that do not provide free seasonal influenza vaccine programs?

Decision on vaccine delivery and the administration of flu clinics is a provincial/territorial responsibility. The Government of Canada intends to pay 60 per cent of the cost of the vaccine purchase. Each province and territory will have to assess its capacity to deliver immunization clinics and will have to make decisions around cost based on a number of logistical and ethical criteria.

Q6. Since there is now experience in making the H1N1 Flu Vaccine, does this mean it will be easier to make a seasonal flu vaccine that includes the H1N1 Flu Virus?

Yes. Now that experts know what to expect with producing the H1N1 flu vaccine, developing further vaccines should be less challenging.

Q7. How much protection will the H1N1 flu shot provide for next year’s flu season?

Research is currently being conducted to determine how long immunity will last following use of the adjuvanted vaccine. Real-time vaccine effectiveness will be evaluated using the same surveillance methodologies as for seasonal flu vaccine effectiveness.

Since the H1N1 Flu Virus is only one of three flu viruses that may circulate next year, it will be important that people receive next season’s vaccine to ensure good protection next year.

Q8. If a pregnant woman gets immunized against the H1N1 flu virus, will the antibodies be passed to the fetus?

Yes, antibodies from the mother are passed to the fetus via placental circulation. However, immunity passed to a fetus or infant in this way decreases over time; by the time the infant is 6 to 12 months old, he or she would no longer have immunity to the H1N1 flu virus.

Q9. Generally, over how long a time does an infant (who didn’t receive antibodies as a fetus) need to be breast fed for in order to receive protection?

Breastfeeding is strongly encouraged with infants up to age 6-12 months old. In addition to its nutritional value, protective antibodies are passed along to the infant. While these antibodies can provide partial protection, it is still recommended that all Canadians over 6 months old receive the H1N1 vaccine.

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Vaccine Sequencing

Q1. What is vaccine sequencing?

There is enough H1N1 Flu Virus vaccine for all Canadians who need and want protection, not everyone could be immunized at the same time. Vaccine sequencing refers to the Government of Canada advice to provinces and territories on which groups and populations would benefit most from vaccination so that the timing and location of immunization clinics could be targeted appropriately.

Q2. What were the Government of Canada recommendations on who should get the vaccine first?

Canada has enough vaccine for every Canadian that needs and wants to be immunized.

At the beginning of the immunization campaign, the Public Health Agency of Canada recommended that the following groups and populations would benefit most from immunization:

People under 65 with chronic health conditions
Pregnant women
Children 6 months to less than 5 years of age
People living in remote and isolated settings or communities
Health care workers involved in pandemic response or the delivery of essential health care services
Household contacts and care providers of persons at high risk who cannot be immunized or may not respond to vaccines
Populations otherwise identified as high risk

Others who would benefit from immunization include:

Children 5 to 18 years of age
First responders
Poultry and swine workers
Adults 19 to 64 years of age
Adults 65 and older

The groups in each of the two categories are not listed in priority sequence. Provinces and territories were expected to use the guidance for planning purposes and interpreted it based on local circumstances and realities.

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Adjuvanted vaccine and Unadjuvanted Vaccine

Q1. What is the difference between an adjuvanted and unadjuvanted vaccine?

An adjuvanted vaccine is a vaccine that includes a substance that boosts an individual's immune system and increases their response to a vaccine. An unadjuvanted vaccine has no “booster” element.

Adjuvanted vaccines are included in common vaccines such as tetanus and hepatitis B. The adjuvant in Canada’s H1N1 flu vaccine is made up of natural ingredients such as water, squalene oil and vitamin E.

Q2. When was the last time Canada used an adjuvant in a vaccine?

Adjuvants are not new. They have been used for several decades to boost immune response to vaccines. Many of the commonly used vaccines in Canada contain an adjuvant. However, they have not previously been approved for use with influenza vaccines in Canada.

Q3. Are adjuvanted influenza vaccines safe for use?

The adjuvant used by GlaxoSmithKline has been tested in approximately 45,000 people around the world and has been evaluated by Health Canada and other regulatory authorities as part of the review of the H5N1 vaccine in the pre-pandemic period. No significant safety concerns regarding the use of the adjuvanted vaccine were detected.

In June 2009, the World Health Organization (WHO) held consultations on the safety of adjuvanted influenza vaccines to review and discuss known and theoretical safety concerns and prospective vaccine safety evaluation. The outcome of the WHO consultation was that no significant safety concerns or barriers to evaluating or using adjuvanted vaccines for the current H1N1 virus were raised.

Clinical studies have been designed to study the risks and benefits of using both adjuvanted and unadjuvanted vaccine against the H1N1 Flu Virus, and Health Canada and the Public Health Agency of Canada are working closely with other national agencies to implement appropriate post-market monitoring.

Q4. Is it true that adjuvanted vaccine gives a stronger immunity? If so, why isn’t everyone receiving the adjuvanted version?

Both the adjuvanted and unadjuvanted H1N1 flu vaccines are safe and effective. The latest research shows both the adjuvanted and unadjuvanted H1N1 flu vaccines provide a strong immune response on average in over 90 per cent of the people who received them in clinical trials.

By comparison, seasonal flu vaccine, which is unadjuvanted, provides between 60 and 80 per cent immunity to people who receive it, depending on the year. This level of immunity is considered to be very good.

There is some evidence that adjuvanted vaccine may provide protection against virus drift and may offer better immunogenicity for certain at risk populations

Unadjuvanted vaccine is recommended for pregnant women since adjuvanted vaccine has not been tested in this group. In cases where the unadjuvanted vaccine is unavailable and H1N1 flu rates are high or increasing in the community, women more than 20 weeks pregnant should be offered one dose of the adjuvanted vaccine.

All data to date indicates that adjuvanted vaccine is as safe and effective as unadjuvated vaccine. The unadjuvanted H1N1 flu vaccine has a similar formula to the seasonal flu vaccine which has long been recommended for pregnant women.

Q5. Does an adjuvanted vaccine pose a risk to pregnant women?

All evidence suggests that adjuvanted vaccines are just as safe as unadjuvanted vaccines; however there is no safety data for the use of adjuvanted vaccine in pregnant women. The World Health Organization's Strategic Advisory Group of Experts (SAGE) recommended in July that pregnant women should receive unadjuvanted vaccine where possible, but that an adjuvanted vaccine could be used if necessary.

Q6. What is the most recent recommendation for who should get the adjuvanted and who should get the unadjuvanted H1N1 flu vaccine?

The Government of Canada has monitored vaccine use internationally and has found that both types of vaccine, adjuvanted and unadjuvanted, offer safe and effective protection from the H1N1 Flu Virus. For healthy people between 10 and 64 years of age, both the adjuvanted and unadjuvanted vaccines provide an excellent immune response.

In order to keep immunizing people and ensure that there is a good amount of immunity in communities, we are making the unadjuvanted supply available so priority groups and healthy people between 10 and 64 years of age can be vaccinated as soon as possible.

However, for some particular groups, the unadjuvanted vaccine may not provide as strong an immune response. For this reason, it is recommended that the following groups do not receive unadjuvanted vaccine:

People with weakened immune systems
Children between 6 months and 9 years of age
People 65 years of age and older

For everyone else, the unadjuvanted vaccine also induces a strong immune response. Both the unadjuvanted and adjuvanted vaccines are safe and effective.

Q7. By buying an unadjuvanted vaccine for pregnant women, isn't the government basically admitting there are serious risks with the adjuvanted vaccine?

No. There is no evidence to suggest that the adjuvanted vaccine is unsafe. Both vaccines have gone through extensive testing and review before being approved for use. However, there is no evidence available from clinical trials using adjuvanted vaccine in pregnant women or in children aged six months to three years.

The Government of Canada ordered unadjuvanted vaccine to offer pregnant women, since adjuvanted vaccine has not been tested in this group. The decision to purchase unadjuvanted vaccine for pregnant women was based on a desire to err on the side of caution.

Q8. Why didn't the government just buy enough unadjuvanted vaccine for everyone?

The World Health Organization recommended countries use dose-sparing vaccines whenever possible. By developing an adjuvanted vaccine, we use less of the virus material (antigen), allowing us to immunize more people in a timely manner. The use of an adjuvant may also provide cross-protection against virus drift, which is common in influenza viruses. Virus drift occurs when the flu virus begins to change. Adjuvanted vaccine provides a broader spectrum of immunity as it protects against infection and severe disease even when the virus begins to change.

The Government of Canada has ordered enough adjuvanted vaccine to vaccinate all Canadians who need and want it, and it remains the recommended formulation for most people.

Since we also ordered 2 million doses of unadjuvanted vaccine for pregnant women– more than we need for all pregnant women who need and want it – we are recommending the “extra” doses be made available to those priority groups who would benefit from being vaccinated as soon as possible. Like the adjuvanted vaccine, the unadjuvanted vaccine is safe and effective for many people.

Q9. If unadjuvanted vaccine is safe and equally effective, and it takes less time to produce, why did you recommend Canadians wait for adjuvanted vaccine only to give them unadjuvanted now?

The World Health Organization recommended countries use dose-sparing vaccines whenever possible. By developing an adjuvanted vaccine, we were able to use less of the virus material (antigen), allowing us to produce more vaccine with an aim to immunize more people in a timely manner. The Government of Canada has ordered enough adjuvanted vaccine to vaccinate all Canadians who need and want it, and remains the recommended formulation for most people.

Since we also ordered 2 million doses of unadjuvanted vaccine for pregnant women – more than we need for all pregnant women who need and want it – we are recommending the “extra” doses be made available to those priority groups who would benefit from being vaccinated as soon as possible. Like the adjuvanted vaccine, the unadjuvanted vaccine is safe and effective for many people.

For healthy people between 10 and 64 years of age, both the adjuvanted and unadjuvanted vaccines provide an excellent immune response.

People with weakened immune systems
Children between 6 months and 9 years of age
People 65 years of age and older

For everyone else, the unadjuvanted vaccine also induces a strong immune response. Both the unadjuvanted and adjuvanted vaccines are safe and effective.

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Vaccine Recommendations for Use

General Vaccine Recommendations

Q1. What are the recommended doses for the use of H1N1 flu vaccine?

The Government of Canada has monitored vaccine use internationally and has found that both types of vaccine, adjuvanted and unadjuvanted, offer safe and effective protection from the H1N1 Flu Virus. Recent evidence has shown that adjuvanted vaccine offers better protection for children than unadjuvanted vaccine, but for most people between 10 and 64 years of age, both the adjuvanted and unadjuvanted vaccines provide an excellent immune response. The recommendations for the use of vaccine have been updated to reflect these findings.

The recommendations include:

Children between 6 months of age and under 3 years of age should receive two half-doses of adjuvanted H1N1 flu vaccine, administered at least 21 days apart. Guidance for children in this age group is unchanged.
Children with chronic health conditions who are between 3 and 9 years of age should receive their first half-dose of the H1N1 flu vaccine as soon as possible. They should also receive a second half-dose of the H1N1 flu vaccine. The interval between the two half-doses should be a minimum of 21 days.
Healthy children between 3 and 9 years of age should only receive a single half-dose of the H1N1 vaccine, and do not need to return for a second vaccine for now.
Healthy people between the ages of 10 and 64 years should receive one dose of either the adjuvanted or unadjuvanted vaccine.
Pregnant women should receive one dose of the unadjuvanted vaccine. In cases where the unadjuvanted vaccine is unavailable and H1N1 flu rates are high or increasing in the community, women more than 20 weeks pregnant and women less than 20 weeks pregnant with serious chronic diseases should be offered one dose of the adjuvanted vaccine.
People over the age of 64 and people with weakened immune systems should receive one dose of the adjuvanted vaccine.

These recommendations may be updated as more information becomes available.

Q2. Who should not receive the vaccine?

The following groups of people should NOT receive the H1N1 flu vaccine:

People who have had a previous anaphylactic (severe allergic reaction) to any element of the vaccine; OR
People with a hypersensitivity to eggs ( e.g. hives, swelling of mouth and/or throat, breathing difficulty); OR
People experiencing a high fever; OR
People who have previously experienced Guillan-Barré Syndrome within 8 weeks of receiving a seasonal flu vaccine.

The H1N1 flu vaccine is not approved for children under six months.

Q3. How long will it take after I receive the vaccine to have immunity against the virus?

After receiving the H1N1 flu vaccine, most people will start to develop immunity within 10 days with just one dose.

Q4. Can the H1N1 flu vaccine be administered at the same time as the seasonal flu shot and/or other vaccines?

The H1N1 flu vaccine can be administered along with seasonal influenza immunization and other vaccines.

Seasonal and H1N1 flu shots should be given in opposite arms. If an individual receives seasonal flu, H1N1 flu and pneumococcal vaccine in the same day, the seasonal flu shot and the pneumococcal vaccine should be given in one arm, and H1N1 flu vaccine in the other.

Vaccine Recommendations for Children

Q5. These recommendations indicate that adjuvanted vaccine is recommended and better for young children. If that’s the case, and the U.S. is only using unadjuvanted vaccine, is Canada’s vaccine safer for children?

Clinical trials have indicated that the unadjuvanted H1N1 flu vaccine does not deliver as strong of an immune response in children as was observed in previous trials with the adjuvanted H5N1 (avian or bird) flu vaccine. This is why Canada chose to use adjuvanted vaccine for children . Canada is confident in the safety and efficacy of this vaccine. Vaccine safety monitoring will continue to be carried out as the vaccine is used.

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Monitoring Vaccine Safety

Q1. What is Canada's Vaccine Safety Surveillance Plan for the H1N1 Flu Vaccine?

All vaccines authorized for use in Canada have been carefully tested for safety. The H1N1 flu vaccine has been authorized for use based on preliminary clinical trial data, and will continue to be monitored and tested as it is administered across the country.

Immunization is one of the most effective ways to prevent the spread of infectious diseases. The benefit of immunization – the prevention of serious illness and death – far outweighs any risk associated with being immunized.

Q2. What is an adverse event following immunization (AEFI)?

An adverse event following immunization (AEFI) is any unwanted medical event that follows immunization. Any adverse symptoms or signs of disease following immunization are classified as an AEFI. However it’s important to remember that just because a medical event follows vaccination, it may not have been caused by the vaccine. It may have been caused by other factors, such as an existing medical condition.

The most commonly reported reactions after H1N1 immunization with the adjuvanted vaccine were minor and included pain, swelling and redness at the injection site. This is to be expected because the adjuvant helps the body develop a stronger immune response by increasing the inflammatory response.

Other commonly reported reactions were fatigue, muscle and joint pain, and headache. In younger children, a fever, drowsiness, irritability and loss of appetite were also reported in low levels.

Q3. What is a serious adverse event (SAE)?

A serious adverse event (SAE) is defined as any event that is life-threatening (such as anaphylaxis) or considered to be a medical event of special importance (for example neurologic events such as Guillain-Barré Syndrome) or that results in hospitalization, disability, birth defects or death.

Serious adverse events following immunization are rare. In any immunization campaign, from regular childhood vaccines to seasonal flu shots, the average reported rate of serious adverse events is about one for every 100,000 doses of vaccine distributed.

The benefits of being protected against vaccine-preventable diseases, including H1N1 flu infection, far outweigh the theoretical risks of getting the vaccine.

Q4. When should an adverse event following immunization be reported?

All serious adverse events should be reported. Unusual or unexpected adverse events should also be reported, even if they are not serious.

It is important that events be reported since they could be an early signal of a vaccine safety problem. The fact that an adverse event occurs following the vaccine does not necessarily mean that the vaccine was responsible for the event. It may have happened anyway, or it could have been caused by other factors/events than the vaccine. A prompt and thorough investigation should be carried out for all serious adverse events to look for possible causes of the event.

Q5. How do I report an adverse event?

When you receive your H1N1 flu vaccine, the healthcare worker who administers it (it might be a nurse, doctor or pharmacist, depending on your province or territory) will observe you for about 15 minutes afterward. If there is any reaction, he or she will report it then.

If you experience an unexpected adverse event after you leave the immunization clinic, you should call your healthcare provider to discuss it. In the unlikely event you need to seek urgent medical care, your healthcare provider will ask about your recent medical history, including your immunization history. We encourage Canadians and health care providers to report any unexpected adverse events following immunizations. They can do so by accessing the Adverse Events Following Immunization Reporting Form on the Public Health Agency of Canada (PHAC) website.

The healthcare provider should report any serious, unusual or unexpected adverse event to your provincial/territorial public health authority, who in turn will share the information with PHAC. None of your personal information will be released to PHAC, only details about the event itself.

Provincial and territorial governments have expressed their commitment to ensuring adverse event reporting is well-timed and accurate.

Q6. How is Canada’s vaccine safety and surveillance system being ramped up to monitor adverse events for the H1N1 flu vaccine?

The Public Health Agency of Canada (PHAC) is working with provinces and territories to produce weekly reports of all reported adverse events associated with the H1N1 flu vaccine.

This reporting will be done through the existing system -- the Canadian Adverse Events Following Immunization Reporting System (CAEFISS) . CAEFISS is supported by healthcare professionals who report adverse events to their provincial/territorial public health offices, who then share the information with PHAC.

This existing system will be supported by additional projects that will provide more detailed data specifically about the H1N1 flu vaccine. These include:

The Immunization Monitoring Program-Active (IMPACT) IMPACT is made up of a network of nurses who report on serious paediatric immunization adverse events observed at Canada’s major teaching hospitals. This existing system is being enhanced to actively monitor for all cases of Guillan-Barré Syndrome, encephalitis/myelitis (swelling and/or inflammation of the brain or spinal cord) as well as bleeding disorders. This system will be flexible and can monitor for additional symptoms, diseases or disorders if necessary.
A Severe Outcomes Surveillance (SOS) Network will mirror the IMPACT network but will monitor the adult populations. This system can also be adapted to monitor for additional symptoms, diseases or disorders if necessary.This project is being funded by the PHAC/CIHR Influenza Research Network (PCIRN) .
Additional PCIRN projects will monitor vaccine safety in various groups and settings, including children, Aboriginals, people living with HIV, healthcare workers and people with egg allergies.
The Public Health Agency of Canada is collecting data on every case of Guillan-Barré Syndrome (GBS) following H1N1 immunization. Each case that follows immunization will be investigated to determine whether the person was at higher risk for GBS during the six week period following immunization. This will help assess whether the observed rate of GBS is higher than what is expected in the population. An update on reported cases of GBS following H1N1 immunization is included in the weekly vaccine surveillance report of adverse events following immunization.

Q7. How is information on adverse events shared?

In addition to monitoring the rates of adverse events across the country, the Government of Canada will meet and consult regularly with provincial, territorial and international experts to review safety data as it becomes available from ongoing clinical trials around the world.

Public Health Agency of Canada officials will also meet regularly to review any serious adverse event reports from provincial, territorial and international partners. This will help public health experts to identify trends and patterns in adverse events early on, and to actively seek out and investigate any similar reports within Canada.

Q8. How can Canadians stay informed?

The Government of Canada will continue to work with its provincial and territorial partners to ensure that all Canadians have the information they need to make informed decisions about immunization.

The Public Health Agency of Canada will prepare a weekly report on Fightflu.ca that provides a summary of the adverse events reported nationwide.

Reporting an adverse event does not mean that the vaccine caused harm. Only a medical investigation, including a review of the person’s medical history and an assessment of environmental factors can establish whether or not the vaccine caused the reaction.

If there is any evidence that the H1N1 flu vaccine poses an undue risk to Canadians, the immunization program will be halted.

Q9. Should children and adults expect the same type of side effects, if any?

Other commonly reported reactions were fatigue, muscle and joint pain, and headache. In younger children, a fever, drowsiness, irritability and loss of appetite were also reported in low levels.

Canada has a strong vaccine safety surveillance program in place to report and investigate any serious or unexpected reactions to the vaccine.

Q10. What does the Government of Canada recommend regarding immunization for people with allergies to eggs?

People with a hypersensitivity to eggs, (e.g. hives, swelling of mouth and/or throat, breathing difficulty), should not receive the vaccine.

If you have a mild egg allergy, consult a healthcare provider before immunization. You may be able to be immunized with some additional precautions.

Recently, the Canadian Society of Allergy and Clinical Immunology released a statement advising that both seasonal and H1N1 vaccine can be administered in patients with egg allergies if precautions are taken, such as extra observation time, and if medical treatment for severe allergic reactions are on-hand.

Also, people with egg allergies will be somewhat protected from catching H1N1 Flu Virus as people around them get immunized. The more immunized people there are in the community, the greater the probability that there will be less H1N1 Flu Virus in the community.

Q11. Is it true that there is mercury in the vaccine? How much mercury?

Both vaccines contain a small amount of thimerosal. Thimerosal is a form of mercury used in the H1N1 flu vaccine to stabilize it and maintain its quality during storage. Thimerosal is a different form of mercury than the mercury known to cause health problems. The amount in the H1N1 adjuvanted flu vaccine is much less than the daily limit recommended for environmental exposure to mercury. For example, there is significantly less mercury in the vaccine than you would find in a can of tuna fish.

Q12. Is it true that there is 10 times more mercury in the unadjuvanted vaccine? How can that be safe for pregnant women?

Yes, the unadjuvanted vaccine does contain 50 ug of thimerosal while the adjuvanted vaccine has only 5 ug of thimerosal. The 50 ug remains within the daily limit recommended for environmental exposure to mercury. There’s significantly less mercury in the vaccine than you would find in a can of tuna fish.

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Regulation of H1N1 flu vaccine

Q1. How has the Government of Canada facilitated the development of an H1N1 Flu Virus vaccine?

Vaccines are a key component of the Government of Canada’s pandemic influenza plan. To this end, the Government of Canada signed a long-term contract with a vaccine manufacturer, GlaxoSmithKline, in 2001 to produce and test a mock vaccine to enhance Canada’s preparedness to respond to an influenza pandemic and ensure there is a vaccine for every Canadian who needs and wants one in the event of a pandemic.

Q2. Who is responsible for regulating vaccines in Canada?

Health Canada has the authority for evaluating the safety, efficacy, and quality of vaccines to be used by Canadians to help protect and maintain their health. Health Canada works in collaboration with the Public Health Agency of Canada to fulfill its mandate, which is to protect the health and safety of Canadians. Any pandemic vaccine developed in response to the H1N1 Flu Virus must be evaluated and authorized by Health Canada before it can be used in Canada.

Q3. How are vaccines authorized for use in Canada?

Canada, like many other countries worldwide, exercises tight scrutiny or regulatory oversight over vaccines because they are usually given to a large number of healthy individuals. All vaccines intended for use by Canadians are subject to the provisions of the Food and Drugs Act and the Food and Drug Regulations. Prior to market authorization of a new vaccine, the manufacturer must file a submission with scientific and clinical evidence that demonstrates that the vaccine’s health benefits outweigh the risks and that the vaccine is effective and of suitable quality for Canadians.

As part of the approval process, Health Canada experts conduct an on-site evaluation of the manufacturer’s facilities to assess the quality of the vaccine manufacturing process and to determine that the manufacturer is able to carry out the necessary quality controls for the vaccine. The manufacturer must also provide samples of at least three batches or "lots” of the vaccine for testing in Health Canada laboratories.

After Health Canada’s evaluation, if the conclusion is that the benefits of the vaccine outweigh its risks, then the vaccine is granted market authorization and can be sold in Canada. However the evaluation process for vaccines in Canada continues after authorization has been granted. Systems are in place to monitor vaccine safety and to report any potential adverse events following immunization. Authorized vaccines are also subject to ongoing lot release evaluation by Health Canada before they are released on the Canadian market for use by Canadians.

Q4. What are the key steps in developing a pandemic influenza vaccine?

The production of a pandemic vaccine cannot begin until the pandemic strain has been identified and candidate vaccine viruses are developed and tested by World Health Organization certified laboratories. Candidate vaccine viruses are the starting material for vaccine development. The candidate vaccine viruses are then distributed to vaccine manufacturers for use in vaccine production. Many influenza vaccines, including the GlaxoSmithKline pandemic vaccine, are produced by growing the influenza virus in eggs. For more information on the vaccine development process.

Q5. Why didn’t vaccine development start earlier in Canada?

The World Health Organization (WHO) asked all countries to finish producing their seasonal influenza vaccines before starting production of their H1N1 flu vaccine.

H1N1 flu vaccine production in Canada began immediately after seasonal flu vaccine production was complete – as recommended by the WHO. Each year, seasonal influenza affects tens of thousands of Canadians and costs between 2,000–8,000 of them their lives.

Seasonal flu immunization is an important and successful public health measure. Canada has one of the highest flu vaccination rates in the world which helps prevent the spread of the virus, and lessen the severity of illness among those who do get sick.

Q6. How are seasonal influenza vaccines regulated?

Since influenza viruses undergo continuous mutation and evolution, the influenza vaccine must be re-made each year. Each year, based on global surveillance data, the World Health Organization (WHO) observes what strains of influenza virus are circulation in the world and then recommends the strains that should be included in that year’s vaccine.

Because of this need to remake and reapprove the influenza vaccine every year and because the time between the production of the vaccine and the need to use it to protect the Canadian population is short, a special approval process has been developed for influenza vaccines. The seasonal influenza vaccine is licensed each year via the filing of manufacturing and quality data and revised labelling material together with clinical trial data from a small clinical trial that assesses the tolerance and immune response to the vaccine. Close coordination is needed between the manufacturers and Health Canada. The Health Canada publication, Access to the Seasonal Flu Vaccine in Canada: How the flu shot makes its way from the laboratory to the doctor’s office, describes the pathway for the development, regulation and distribution of the influenza vaccine in Canada.

Q7. Could standard vaccine development and regulatory processes be used to authorize the H1N1 pandemic vaccine?

Development of a pandemic vaccine could not begin until the pandemic strain had been identified and vaccine may be needed almost immediately after it has been manufactured in order to be useful. Unlike the situation with the seasonal influenza vaccine, influenza pandemics are caused by completely novel strains of virus that have not previously circulated in humans; therefore, the human population does not have any immunity against the virus, and there are no historical data that vaccines against the strain are effective. As a result, standard vaccine development and regulatory processes cannot be used in a pandemic situation.

Q8. What is Health Canada doing to ensure there is timely access to a safe and effective pandemic vaccine in Canada?

Health Canada and the Public Health Agency of Canada have been proactively preparing for a potential influenza pandemic for several years and review of a potential pandemic vaccine was initiated in 2007.

The Government of Canada has had a contract in place with GlaxoSmithKline (GSK) since 2001 to secure domestic vaccine production capacity in Canada, to test a pre-pandemic vaccine, and to ensure availability of a vaccine for Canadians in the event of a pandemic.

In the inter-pandemic period, Health Canada focused regulatory activity on review of a "mock” (H5N1) vaccine. This enabled Health Canada to validate the contract manufacturer’s production process and prepare for regulatory evaluation of a pandemic vaccine, if needed.

Q9. Would vaccine be available sooner if Health Canada treated it as a variant to the seasonal flu vaccine?

Due to the extensive evaluation of the mock (H5N1) vaccine during the pre-pandemic period, a lot of the work to support approval of the pandemic vaccine has already been completed. The remaining data requirements necessary for authorization of the H1N1 flu vaccine are similar to what is required each year to support the seasonal flu vaccine in Canada.

In Canada, the file is a "rolling submission”, which means that Health Canada experts have been reviewing data as it becomes available. The evaluation process will continue concurrent with production of the vaccine. Health Canada is working closely with GlaxoSmithKline to review production timelines and will be in a position to make a decision on the authorization of a vaccine as soon as one becomes available, depending on the results of the Health Canada’s review. Canadians can be confident that there will be no delay in getting vaccine to Canadians due to regulatory requirements.

Q10. What if the vaccine is needed before it is authorized by Health Canada?

The decision to authorize a vaccine and the public health decision to start using a vaccine are two separate decisions. Depending on the severity of the situation, public health authorities may decide that vaccine is needed before it has been authorized by Health Canada.

The World Health Organization has urged all countries to ensure that emergency use provisions are in place to provide access to unlicensed vaccines. Health Canada has prepared for this situation and emergency use mechanisms would be available to provide emergency access to the vaccine, if warranted to protect the health and safety of Canadians.

If the public health situation in Canada becomes such that an urgent supply of vaccine is required, Health Canada has the authority it needs to expedite vaccine access without first having to assess all of the clinical trial data that may become available in the Fall 2009.

Q11. Will vaccines being developed now be effective if the strain changes?

Vaccines have been developed based on the circulating strain recommended by the World Health Organization (WHO). While the virus appears to be stable, influenza virus changes are difficult to predict. Based on theoretical considerations, it is expected that the vaccine will have at least partial effectiveness against a modified (drifted) H1N1 strain. The use of an adjuvant is expected to broaden the immune response and provide some cross protection against virus drift. The WHO laboratories around the world continue to monitor the situation. If there is a significant change in the virus, the vaccine may lose efficacy. If this is the case, the WHO would recommend that manufacturers change the composition of the vaccine.

Q12. How is Canada collaborating internationally on vaccine regulatory issues?

As part of its regulatory preparedness activities, Health Canada actively participated in 2006-2007 in the development of the World Health Organization (WHO) Guidelines on Regulatory Preparedness for Human Pandemic Influenza Vaccines. The guidelines promote convergence between National Regulatory Authorities on regulatory evaluations of the quality, safety, and efficacy of vaccines that would be used in a pandemic situation.

Since the pandemic virus emerged in April 2009, Canada has been participating in regular WHO regulatory teleconferences, as well as collaborating with other national regulatory authorities, such as the United States Food and Drug Administration, the European Medicines Agency, and the Australian Therapeutic Goods Administration in regular discussions on clinical development and pharmacovigilance plans for H1N1 flu vaccines. There is a global commitment amongst regulators to share data in real time.

Due to seasonal differences in the Northern and Southern hemispheres, countries in the Southern hemisphere, such as Australia were the first to start pandemic vaccine production and to initiate clinical trials. Early data on pandemic vaccine performance and appropriate dosing schedules may help inform vaccine policy decisions.

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Seasonal Influenza Vaccine

No, but you should consult with your provincial or territorial health authority for their plans for the timing of seasonal and H1N1 immunizations.

Q2. There are recent Canadian studies suggesting that people might be more susceptible to the H1N1 virus if they have been vaccinated against the seasonal flu.

Similar studies from other countries have not shown this. The Public Health Agency of Canada asked an international expert panel to review the studies. This panel concluded that the Canadian studies hold merit and are worthy of further research.

At the same time, the Panel also concluded that various vaccine program options remain valid – so in the end, provinces and territories will make their own decisions, based on the impact of the virus in their jurisdiction and their capacity to deliver immunization programs. Canadians should consult the recommendations from their provincial or territorial office of health.

Q3. What recommendations has the National Advisory Committee on Immunization made regarding the 2009-2010 seasonal influenza vaccine?

This year, there has been some concern about previous seasonal flu immunization and a potential increased risk for H1N1 Flu Virus infection, as was observed in Canadian studies. After weighing the evidence, the National Advisory Committee on Immunization (NACI) decided that the benefit of seasonal flu immunization far outweighs any potential increased risk for pH1N1 infection.

NACI recommends the following regarding seasonal and H1N1 flu immunization:

People who have received seasonal influenza vaccine can be immunized with the H1N1 flu vaccine, and vice versa;
People who have received the H1N1 flu vaccine can receive the seasonal flu shot;
The shots can be administered at the same time in opposite arms. If not administered at the same time, there is no specific period of time that must be observed between shots.

Q4. Can I get my H1N1 flu vaccine at the same time as my seasonal flu shot?

Yes. The seasonal flu shot can be administered at the same time as the H1N1 flu vaccine and other vaccines. Seasonal and H1N1 flu vaccine should be administered in opposite limbs.

Q5. Why was there so much conflicting advice coming out of Canada around seasonal and H1N1 flu vaccines?

The Public Health Agency of Canada (PHAC) is responsible for providing recommendations to provinces and territories on immunization.

Provinces and territories are ultimately responsible for vaccination decisions in their respective jurisdictions.

Since the H1N1 Flu Virus first appeared in Canada, we have said that PHAC advice on addressing the virus would evolve as information became available.

The Government of Canada has taken the time to review all the emerging evidence around seasonal flu immunization and a potential link to H1N1 and has remained transparent with the Canadian public throughout this process.

There has never been a one-size fits all approach to seasonal vaccines in Canada and this year is no different. Provinces and territories have not previously had to administer two separate flu immunization programs in a single season and some of the decisions taken on seasonal and H1N1 flu vaccine timing reflect concerns over logistics, capacity and likely vaccine up-take.

Most provinces and territories are adopting similar approaches that focus on people over the age of 65 and people living in long-term care facilities, two of the major at-risk groups for seasonal flu. It should also be noted that current evidence suggests the H1N1 Flu Virus has replaced the seasonal H1N1 Flu Virus this flu season.

The National Advisory Committee on Immunization (NACI) recommends that the seasonal flu vaccine may be offered when it becomes available. Decisions regarding the precise timing of vaccination in a given setting or geographic area should be made according to local epidemiologic factors (influenza activity, timing and intensity), opportune moments for vaccination, as well as programmatic issues (e.g. consideration of the need to deliver the pandemic H1N1 influenza vaccine).

Provincial and territorial Chief Medical Officers of Health know their populations and are best placed to decide how to roll-out vaccine programs in their jurisdictions.

Q7. Is H1N1 Flu Virus likely to be included in next year’s or future season’s seasonal flu vaccines?

Each year, the World Health Organization releases its recommendations on the makeup of the seasonal flu vaccine, which includes three flu virus strains. For the Southern Hemisphere they have already made those recommendations for the upcoming flu season and have recommended H1N1 be one of three strains used.

The WHO will make its recommendations for the Northern Hemisphere seasonal flu vaccine in January. The Government of Canada, in conjunction with the provinces and territories, will examine these recommendations along with considerations such as use of adjuvants in making their decisions on next year’s seasonal flu vaccine.

Guillain-Barré Syndrome

Q1: What is Guillain-Barré Syndrome?

Guillain-Barré Syndrome (GBS) is an acute illness characterized by sudden onset of weakness or paralysis. Most patients recover fully. Why and how GBS develops is not completely understood but it is thought to result from an immune disorder. Usually Guillain-Barré Syndrome occurs a few days or weeks after the patient has had symptoms of a respiratory or gastrointestinal viral infection.

Q2: What are the symptoms of Guillain-Barré Syndrome?

Symptoms of Guillain-Barré Syndrome usually begin with numbness or tingling in the toes and fingers. These symptoms progress over several days with weakness in the arms and legs, and/or a “rubbery” feeling in the legs, which can buckle and may cause difficulty walking. In some people the symptoms do not progress beyond numbness or tingling. Others may experience only mild symptoms, or symptoms on one side of the body.

In some people the disease continues to progress, and can lead to complete paralysis of the arms and legs. In some instances paralysis can extend to the chest, freezing the breathing muscles, leaving the patient dependent on a ventilator.

Q3: What is the frequency of Guillain-Barré Syndrome in Canada?

Each year in Canada there are about 2 new cases of Guillain-Barré Syndrome /100,000 population. This amounts to about 600-700 cases each year in Canada. This is quite similar to what is observed in other countries.

Q4: Who does Guillain-Barré Syndrome usually affect?

Guillain-Barré Syndrome (GBS) is most often reported in people over the age of 50 and is very rare in younger populations. Rates of GBS are slightly higher in men than in women.

Q5: What is the treatment for Guillain-Barré Syndrome?

In most cases, hospitalization with supportive care and monitoring of all vital functions is required. Most patients with Guillain-Barré Syndrome are treated with plasmapheresis (blood plasma exchange) or immunoglobulin. About 70% of patients respond to one of these treatments. In some cases, spontaneous improvements may occur. Rehabilitation may be required to regain lost functions.

Q6: What is the prevalence of Guillain-Barré Syndrome in Canada?

Each year in Canada there are about 600 to 700 new cases of Guillain-Barré Syndrome (GBS). While the number of cases may change from month to month there is no significant difference from one season to another. Thus on average, there are about 12 to 14 new cases of GBS every week across Canada.

Q7: What causes Guillain-Barré Syndrome?

One of the strongest proven causes of Guillain-Barré Syndrome (GBS) is Campylobacter jejuni, a type of foodborne bacteria that causes diarrhea. Other triggers that have been linked to GBS include respiratory infections including influenza-like illness, and surgery.

Q8 : How often is Guillain-Barré Syndrome reported in Canada after seasonal influenza vaccine?

Prior to 2009, about 10 to 12 million doses of influenza vaccine were distributed each year in Canada, making it the single largest annual immunization program in the country. Over the last three years, between 250-300 serious adverse events following the flu shot were reported each year.

Since 1997, during 12 annual seasonal influenza vaccine campaigns, a total of 79 cases of Guillain-Barré Syndrome (GBS) have been reported following influenza vaccine. This is an average of 7 cases per year, with a yearly range of 1 to 14 cases.

Given the annual background rate of 600-700 new in Canada, cases reported following influenza vaccine do not exceed the expected rate. The risk of getting GBS after getting the flu shot is, at most, one extra case per 1 million doses administered. The fact is you are at far greater risk of developing GBS after getting the flu than you are after getting a flu shot.

Q9: Is there a danger of getting Guillain-Barré Syndrome from the H1N1 flu vaccine?

Since Guillain-Barré Syndrome (GBS) is so rare, it is usually not seen as an adverse event following immunization in the clinical trial stage. In order to assess the potential risk, if any, of GBS following H1N1 flu vaccine, we need to observe a larger population. The risk of getting GBS after any flu vaccine is about one case for every million doses distributed. The benefit of the vaccine outweighs this theoretical risk.

Q10: How will Canada conduct surveillance for Guillain-Barré Syndrome?

The objective of surveillance for Guillain-Barré Syndrome (GBS) during the pandemic H1N1 campaign is to characterize, as quickly as possible, the risk, if any, of GBS following vaccine. In order to do this, a system has been developed to detect every case of GBS, regardless of whether the person has received the H1N1 flu vaccine.

The Public Health Agency of Canada is collecting data on every case of Guillan-Barré Syndrome (GBS) following H1N1 immunization. Each case that follows immunization will be investigated to determine whether the person was at higher risk for GBS during the six week period following immunization. This will help assess whether the observed rate of GBS is higher than what is expected in the population. An update on reported cases of GBS following H1N1 immunization is included in the weekly vaccine surveillance report of adverse events following immunization.

This research will ultimately inform not only the vaccine safety of the H1N1 flu vaccine, but other vaccines and may help to establish risk factors for GBS that could lead to better treatment and prevention.

In addition, active hospital-based surveillance for GBS cases will be conducted by the Immunization Monitoring Program-Active (IMPACT) network in 12 paediatric tertiary care hospitals, and the PHAC/CIHR Influenza Research Network (PCIRN) Severe Outcomes Surveillance network in 10 adult acute care hospitals. These three networks will work together to ensure cases are not counted twice. All provinces and territories will be reporting the total GBS reported to them as adverse event following immunization (AEFI) on a weekly basis. The total number of GBS cases for Canada will be part of a weekly vaccine surveillance report prepared by PHAC.

Q11: If someone develops Guillain-Barré Syndrome after getting their H1N1 flu shot, will the vaccine be pulled?

Based on the background rates, about 12 to 14 new cases of Guillain-Barré Syndrome (GBS) occur every week in Canada. These cases would happen regardless of the immunization campaign. A single case of GBS will not be a reason to halt the campaign.

The efforts to monitor every case of GBS that occurs from the time the pandemic vaccine campaign starts, until several months after it is over will allow an assessment of whether the observed rate of disease is higher than what is expected in the population.

Should the observed rate exceed what is expected then the public health response will be rapid and intense with a thorough investigation and consideration given to changing recommendations for immunization.

Q12: Will injury compensation be available for individuals who develop Guillain-Barré Syndrome within 6 weeks after H1N1 vaccine?

The administration and delivery of immunization programs and associated compensation schemes in Canada are a provincial/territorial responsibility.

Currently, Quebec is the only province with a no-fault vaccine injury compensation program in place in Canada.

Through the National Immunization Strategy, the Public Health Agency of Canada continues to work with provinces and territories to monitor and evaluate immunization programs and to assess the need for any additions or changes to the existing national strategy.

Get all the facts on the H1N1 Flu Virus