Frequently Asked Questions - H1N1 Flu Virus

Updated: November 18, 2009

• About H1N1 Flu Virus
• H1N1 Flu Virus in Canada
• Protecting  yourself and others
• H1N1 Flu Virus Vaccine
  • Vaccine Sequencing
  • Adjuvanted vaccine
  • Vaccine Recommendations for Use
    • General Vaccine Recommendations
    • Vaccine Recommendations for Children
  • Monitoring Vaccine Safety
  • Regulation of H1N1 flu vaccine
  • Seasonal Influenza Vaccine
  • Guillain-Barré Syndrome
• Antivirals
  • Use of Tamiflu for children under the age of one
• Schools, Daycares and Postsecondary Institutions
• H1N1 in First Nation and Inuit Communities
• H1N1 Aboriginal Populations
• International Actions
• Pigs and Pork Products

About H1N1 Flu Virus

H1N1 Flu Virus has been reported around the world, and the World Health Organization (WHO) has declared it a pandemic influenza virus. H1N1 is a strain of the influenza virus that in the past, usually only affected pigs. In spring 2009, it emerged in people in North America. This is a new strain of influenza and because humans have little to no natural immunity to this virus, it can cause serious and widespread illness.

Q1. Is H1N1 Flu Virus contagious? How does it spread between people?

The H1N1 flu virus is contagious and is spread the same way as regular seasonal influenza.  This happens when an infected person coughs or sneezes and their germs enter the nose, eyes, or throat of another person.  The germs can also rest on hard surfaces like counters and doorknobs, and can be picked up on hands and transmitted to the respiratory system when someone touches their mouth and/or nose.  It is not possible to catch it by eating pork or pork products or through blood transfusions.

H1N1 Flu Virus in Canada

Q1. Why does your information about H1N1 keep changing?

Since the H1N1 Flu Virus first appeared in Canada, we have said that the Public Health Agency of Canada’s advice would evolve as information became available. As new, credible information becomes available, we update our messages to the public.

Q2. Does the Government of Canada expect to see more cases of H1N1 Flu Virus in Canada? Or a second wave of illness?

The Second Wave arrived in late October. Second Wave simply means there was an increase in H1N1 flu activity in several parts of the country; in other words an increasing number of Canadians being infected with the virus. This was expected. Although some cases have been severe, including some deaths, most of the cases continue to be mild. We continue to work with our international partners to learn more about this virus and to prepare for additional waves of illness and/or changes to the nature of the virus.

Q3. I understand Canada has experienced deaths related to the H1N1 Flu Virus. Does this mean the virus has grown in strength?

There is no evidence to suggest that the virus has become stronger.

It is important to realize that different strains of influenza result in about 2,000 to 8,000 Canadian deaths a year. We must take all influenza – not just the current strain – seriously, and take measures to protect ourselves.

Q4. How many people in Canada have died from H1N1 Flu Virus?

Reports of H1N1 Flu Virus Deaths in Canada

Q5. Why are only the number of deaths reported and not the numbers of cases of illness?

At first, it was important to understand how the virus was spreading, and what kind of illness it was causing. This is why we did individual testing to laboratory-confirm cases of H1N1 Flu Virus. We know now that the virus has spread to all provinces and territories and is spreading like regular seasonal flu.

Protecting yourself and others

Q1. What can I do to protect myself from infection?

The Public Health Agency advises Canadians to:

• Wash hands often with soap and warm water for at least 20 seconds, or use hand sanitizer.
• Keep your hands away from your face.
• Cough and sneeze into your arm, not your hand. If you use a tissue, dispose of it as soon as possible and wash your hands.
• Get immunized.
• Keep common surface areas—for example, doorknobs, light switches, telephones and keyboards—clean and disinfected.
• Eat healthy foods and stay physically active to keep your immune system strong.
• Keep doing what you normally do, but if you get sick, stay home.
• Check www.fightflu.ca for more information.
• Visit our H1N1 preparedness guide.
• Check www.voyage.gc.ca for travel notices and advisories.
• Talk to a health professional if you experience severe flu-like symptoms.

Talk to your health care provider if you are at risk for complications and you experience even mild flu symptoms. People at risk are

• Children under five years
• Women who are pregnant
• People with chronic conditions such as heart or kidney disease, diabetes, asthma and chronic lung disease, suppressed immune systems, neurological disorders, liver disease, blood disorders and severe obesity

Q2. Should people who are at risk for complications take special precautions such as avoiding crowds?

It's important that people continue their daily lives during the pandemic. PHAC doesn't recommend that anyone avoid going to work or community social events if they are healthy. In other crowded situations that cannot be avoided, extra precautions should be taken such as frequent handwashing, to avoid picking up the virus. Pregnant women or others who are at risk for complications might consider carrying hand sanitizer for the same purpose.

Q3. Should Canadians take any extra measures like wearing surgical masks to avoid catching H1N1 Flu Virus?

Canadians should continue to take normal precautions to protect themselves as they would from a regular flu. While we are investigating to learn more about how this virus spreads, our best advice is for Canadians to wash their hands frequently and thoroughly, cough and sneeze into their arms, rather than their hands, get immunized and stay home when ill.

The Public Health Agency of Canada does not recommend that members of the general public wear surgical masks to protect against contracting H1N1 Flu Virus. Evidence shows that this is not effective in preventing transmission of influenza in the general public. People often use masks incorrectly, or contaminate themselves when putting masks on and taking them off, which could actually increase the risk of infection.

The exception is people who are ill with H1N1 Flu Virus or people who are exhibiting flu-like symptoms. In order to protect those in close contact, like doctors, nurses, and caregivers at home, these people may be asked to wear a face mask.

Q4. What protection will the Government of Canada offer to healthcare workers to protect against H1N1 Flu Virus?

As per normal infection control practices, healthcare workers will need to practice frequent hand washing. When in close contact with affected patients, healthcare workers will use added safeguards such as wearing masks and eye protection.

For more information on protective measures for healthcare workers, visit the Health Professionals section.

H1N1 Flu Vaccine

Q1. How much vaccine is the government ordering?

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 GSK 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.

Vaccine Sequencing

Q1. What is vaccine sequencing?

While there will be enough H1N1 flu virus vaccine for all Canadians who need and want protection, not everyone can be immunized at the same time. Vaccine sequencing refers to the Government of Canada advice to provinces and territories on which groups and populations will benefit most from vaccination so that the timing and location of immunization clinics can be targeted appropriately.

Q2. What are the GoC recommendations on who should get the vaccine first?

Keeping in mind that we have ordered enough vaccine for every Canadian that needs and wants to be immunized, our basic approach is to ensure those that need it most get it first.

 Those who will benefit most from immunization and those who care for them include:

• 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 workersinvolved in pandemic response or the delivery of essential health care services
• Household contacts and care providers of persons at high risk who cannot be immunizedor 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 are expected to use the guidance for planning purposes and will interpret it based on local circumstances and realities.

Recognizing that many Aboriginal populations are younger; may be more socio-economically disadvantaged compared to Canadians as a whole; have higher numbers of pregnant women; have higher rates of diagnosed and possibly un-diagnosed chronic disease; and may live in remote and isolated communities, all efforts will be made to enable those Aboriginal people who would benefit most from immunization, wherever they reside, to have access to H1N1 flu vaccine as soon as possible.

Q3.  What is the rationale for the primary groups?

People under 65 with chronic conditions: This group is at higher risk of complications. When evaluating the Canadian situation, it was observed that immunizing this group early would have the biggest impact on minimizing severe illness and death, even more so than those groups with a higher rate of infection, like school children.

Pregnant women: Pregnant women are at highest risk for severe disease if they do contract the virus. Additionally maternal immunization while pregnant may help to protect the infant after birth.

Children six months to less than five years of age:  This group captures all pre-school age children who have a higher risk of severe disease than other children. Healthy children between six and 23 months of age are at particular risk of severe disease and hospitalization and are the primary focus of this target group. Healthy children aged two and less than five years of age are at higher risk of severe disease and hospitalization than older children.

Persons residing in remote and isolated settings or communities:  People living in remote and isolated communities have limited access to medical care, so it is important to take all available measures to prevent illness. Immunizing these whole communities also creates the potential for developing mass immunity, which means once a significant proportion of the population is immunized, their immunity will protect the rest of the community.  Additionally, given the high concentration of persons with chronic conditions in some remote Aboriginal Communities, priority immunization in these communities will help to lessen the risk of severe disease and deaths.

Health care workersinvolved in pandemic response or the delivery of essential health care services:  Society has a responsibility to protect health care workers that will be exposed to the H1N1 virus in the course of their daily work.  This also helps prevent the virus spreading to vulnerable patients.  Protecting health care workers involved in the delivery of essential health services, from hospitals to laboratories, to pharmacies to those involved in vaccine production, helps protect essential health infrastructure.

Household contacts and care providers of persons at high risk who cannot be immunizedor may not respond to vaccines:  Some high-risk groups, like children under six months and those with weakened immune systems, cannot be immunized, so those around them should be immunized to reduce the risk of spreading the virus to these groups.

Populations otherwise identified as high risk:  As the delivery of vaccines is a provincial/territorial responsibility, jurisdictions may identify other groups as priority recipients for the vaccine based on local conditions and disease spread.

Q4. What is the rationale for the other groups?
 
Children 5 to 18 years of age:  Flu outbreaks are most common in school aged children.  Although they are not at a high risk of severe disease or death, immunizing school aged children could contribute to reducing the spread of the virus to other more vulnerable groups.

First responders:  Police and firefighters often respond to medical emergencies alongside healthcare workers and should also be offered protection as their jobs expose them to a risk of transmission.

Poultry and swine workers:  Immunizing this group can help to protect against re-assortment of the flu virus -- this can occur when people with the H1N1 flu mix with sick animals, which could lead to co-infection with both human and animal flu viruses. This could result in changes in the H1N1 flu virus that could make it more difficult to prevent and/or treat.

Adults 19 to 64 years of age:  As compared to adults over 65, this group has an increased rate of infection and a higher risk of severe outcomes.

Adults 65 and older:  Immunization is one of the most effective ways to protect all members of our communities.  Although healthy adults 65 and older are less likely to contract the virus, by encouraging all age groups to be immunized, we can reduce the chance of exposing vulnerable populations to the virus.

Q5. Are Aboriginal people included in the primary targets list?

Our basic approach is to ensure those that will benefit from the vaccine most, get it first. At risk Aboriginal people are captured in the priority groups outlined in the guidance.  For example, we recognize that many Aboriginal populations are younger compared to Canadians as a whole and as such, have higher numbers of pregnant women, have higher rates of diagnosed and possibly un-diagnosed chronic disease, and may live in remote and isolated communities. All efforts will be made to enable those Aboriginal people who would benefit most from immunization, wherever they reside, to have access to the H1N1 flu vaccine as soon as it becomes available.

Q6. What other groups were considered but not selected and why?
 
Critical Infrastructure Workers:  As disease in Canada continues to be relatively mild, there is no evidence that H1N1 flu virus will cause significant societal disruption to merit immunizing critical infrastructure workers on a priority basis.

Correctional facilities:  The most at-risk groups within correctional facilities (i.e. those with underlying medical conditions) will be immunized as part of the priority groups.

Olympics workers, volunteers and athletes:  In Canada we have enough vaccine to immunize everyone who needs and wants protection a prior to the Olympics.  Given the relative mildness of the virus in Canada, there is not enough evidence to show that it is necessary to immunize this group early.

Household contacts and caregivers of individual with chronic conditions:  This group was considered but is too large to target effectively. The majority of this group will be covered off by the priority groups listed above.

Obese individuals:  There is currently not enough evidence to suggest that this group should be immunized on a priority basis.  Evidence will continue to be evaluated.

Q7. Are these recommendations consistent with those in other countries?

Our recommendations take account of WHO recommendations as well as those of other countries.  These recommendations reflect Canada's needs and realities and the fortunate situation we have of knowing we will have enough vaccine available for every Canadian that needs and wants to be immunized.

Q8. If I have been diagnosed with the H1N1 flu virus, do I have immunity and will I still need a vaccine?

In most cases, when a person is infected with an influenza virus and recovers, they develop antibodies that provide them with immunity to that particular virus. Therefore, in the case of the H1N1 flu virus, the vaccine will be recommended to everyone, but is not necessary for people who have had a laboratory confirmed H1N1 flu virus infection.

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 GSK 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 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 WHO'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:

1. People with weakened immune systems
2. Children between 6 months and 9 years of age
3. 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 WHO 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 WHO 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.

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:

1. People with weakened immune systems
2. Children between 6 months and 9 years of age
3. 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.

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

Q1. 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.

Monitoring Vaccine Safety

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.

Q1. What is an adverse event following immunization (AEFI)?

An 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.

Q2. What is a serious adverse event (SAE)?

A serious adverse event 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.

Q3. 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.

Q4. 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 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.

Q5. 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 (link to QA), 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.
• In order to determine the risk, if any, for Guillan-Barré Syndrome following H1N1 vaccine, PHAC is working with a network of neurologists across the country, to collect data on every case of GBS that occurs during and following the H1N1 flu vaccine immunization campaign. By monitoring every case of GBS, PHAC will be able to compare the number of cases reported with the expected background rates of about 12-14 new cases of GBS that occur every week in Canada. A weekly report of GBS cases will be produced. 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.  

Q6. 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.

PHAC 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.

Q7. 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.

PHAC 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.

Q8. Should children and adults expect the same type of side effects, if any?

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.

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

Q9. 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.

Q10. 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.

Q11. 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.

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 (GSK), 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 (PHAC) 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 WHO 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 GSK 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 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 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 PHAC 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 GSK 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 WHO 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 this Fall.

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 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.

Seasonal Influenza Vaccine

Q1. I’ve heard of a Canadian study that says I’ll be at greater risk for getting the H1N1 virus if I received a seasonal flu shot last year. Should I avoid getting a seasonal flu shot this year?

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. PHAC 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, 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 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.

Q6. Does the NACI recommendation mean that provinces and territories which delayed or cancelled their seasonal flu immunization campaigns will have to reinstate them?

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.

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.

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 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 GBS?

Symptoms of GBS 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 GBS/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 GBS usually affect?

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 GBS?

In most cases, hospitalization with supportive care and monitoring of all vital functions is required. Most patients with GBS 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 GBS in Canada?

Each year in Canada there are about 600 to 700 new cases of 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 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 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.  There has not been a difinitive link made between the flu shot and GBS.    

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

Since 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 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.  

PHAC is working with a network of neurologists across the country to collect data on every case of GBS that occurs during and following the H1N1 flu vaccine immunization campaign. By monitoring every case of GBS, PHAC will be able to compare the number of cases reported with the expected background rates of about 12-14 new cases of GBS that occur every week in Canada.

A weekly report of GBS cases will be produced. 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. 

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 to surveillance by the neurology network, active hospital-based surveillance for GBS cases will be conducted by the IMPACT network in 12 paediatric tertiary care hospitals, and the 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 AEFIs on a weekly basis. The total number of GBS cases for Canada will be part of a weekly 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 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 GBS 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.

Antivirals

Q1. Are there drugs that can treat H1N1 Flu Virus?

Yes. Early research indicates that there are two prescription antiviral drugs, oseltamivir (Tamiflu) and zanamivir (Relenza) that are effective in treating the H1N1 Flu Virus.

Q2. What are PHAC's recommendations for the use of antivirals?

PHAC's recommendation is that antivirals be used to treat H1N1 Flu Virus when the illness is moderate to severe and the patient is at a great risk for complications. PHAC is not recommending that antivirals be given for a mild disease or on a preventive basis at this time. The reasons for this are:

• We do not have sufficient information to suggest that this influenza virus requires the use of antivirals. Most patients in Canada are recovering well on their own.
• There is a risk that the virus could be resistant to antiviral treatment if antivirals are overused to treat mild illness.
• The antiviral stockpile is a finite resource. We want to be sure not to run out before they are really needed.

Q3. How are antiviral medications made available if needed?

Antiviral medications are prescription drugs. They may be obtained from a pharmacy with a regular prescription.
There is a national stockpile of antiviral medication, and some provinces and territories also have their own stockpiles. Every province and territory has access to the national stockpile and antivirals have been distributed on a per-capita basis.

Q4. What is the difference between an antiviral and a vaccine?

Antivirals are drugs used for the prevention and early treatment of influenza. If taken shortly after getting sick (within 48 hours), they can reduce influenza symptoms, shorten the length of illness and potentially reduce the serious complications of influenza.

Antivirals work by reducing the ability of the virus to reproduce but do not provide immunity against the virus. The H1N1 Flu Virus can be treated with two different antivirals, oseltamivir (Tamiflu) and zanamivir (Relenza).

A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines are the primary means to prevent illness and death from influenza. They stimulate the production of antibodies against the flu virus components included in the vaccine, providing immunity against the virus.

In order to provide the best protection, a vaccine must be tailored to fight off specific strains of influenza.

Use of Tamiflu for children under the age of one

Q1. Why does the government think that Tamiflu is safe for children under 1 now?

Health Canada has reviewed the available safety data with respect to the use of Tamiflu in children under 1 year old. As there are no other products available for this age group, and in the context of the current H1N1 pandemic, Health Canada has concluded that the known and potential benefits of Tamiflu outweigh the known and potential risks for children under 1 year. Treatment decisions remain with a physician, who would consider prescribing Tamiflu after weighing the potential risks and benefits to any individual patient.

We know that Tamiflu thus far is effective in treating the vast majority of people who have H1N1, making their symptoms less severe and the illness lasting fewer days. We now have some evidence that there seems to be less risk in using Tamiflu in young children. By providing guidance to doctors to prescribe Tamiflu for young children, we are filling in a gap in terms of treatment availability, dosing information, and we have the opportunity to monitor its effects on children under 1 and increase our body of knowledge on this drug.

Q2. If I have a child that has been diagnosed with H1N1, should I try to get Tamiflu to try to prevent my other children from catching it?

Public health experts have weighed the risks and benefits in providing recommendations on the use of antivirals to prevent infection. After rigorous research and analysis, their conclusion is that the widespread use of antivirals in the community for prevention is not recommended. The use of antivirals for prevention is recommended only under a limited number of circumstances where the potential benefits outweigh the potential risks. However, these recommendations are not written in stone and decisions have to be made on a case by case basis by the physician involved.

Q3. Why wasn't Tamiflu originally recommended for children under 1?

There were some safety concerns identified previously from the use of Tamiflu in animal studies. At that time, there was no data available to see the effect of Tamiflu use in infants.

Q4. What studies have been done on the safety of Tamiflu for children under the age of one?

At this point, there are no formal completed studies to show the safety or effectiveness of Tamiflu in the treatment or prevention of influenza in infants.

Q5. If there are no studies done, then how can you assure me that it is safe?

Recently, limited data has become available on the use of Tamiflu in infants (not from formal studies but from physicians using Tamiflu in infants in other countries). An analysis of this data suggests that Tamiflu may be used in emergency situations for the treatment or prevention of influenza infection with the new pandemic virus in infants, if the physician considers that the benefits of using Tamiflu are more than the unknown risks associated with its use.

Q6. How long would my child have to take it? Do they really need it? Should they be taking it if their symptoms are mild?

It is very important to use the medicine for as long as your doctor has prescribed it. If you observe any unwanted effects from the use of Tamiflu, talk to your doctor and follow his or her advice to continue or stop taking the drug. If drugs like Tamiflu are stopped before completing the course, there is a danger of developing resistance to the virus, which means that the drug would not work to treat or prevent the infection in the future.

Based on the available data, it is suggested that Tamiflu should be used in a dose as prescribed by your physician. For treatment of influenza infection with the new pandemic virus, Tamiflu should be used twice daily for 5 days. For prevention of infection, it should be used once daily for at least 10 days but your doctor may suggest to use Tamiflu for 14 days.

Q7. What are the treatment recommendations for this age group; for example, if another child in daycare has H1N1, would Tamiflu be recommended for prevention for all the children in daycare or is it just for treatment of those who are sick?

Public health officials across Canada have agreed that treatment is recommended only for those who are ill, unless they are living in a residential facility.

Q8. What would an "adverse reaction" to an antiviral look like? What do I do if my child has one?

The most common unwanted effects are nausea, vomiting, pain in the stomach and headache.

People infected with the influenza virus, particularly children and adolescents may also develop seizures, confusion, delirium, hallucinations, agitation, anxiety or other abnormal behaviour early during their illness. These events may occur shortly after beginning Tamiflu or may occur when flu is not treated. These events are uncommon but may result in self-injury to the patient, sometimes fatal. You should watch for unusual behaviour and contact your doctor immediately if such behaviour develops.

Parents and health care professionals are encouraged to report serious adverse reactions to Health Canada's Canada Vigilance Program. For more information on what type of adverse reactions to report and how to report them, Health Canada has developed the following Guidelines to Reporting Adverse Reactions to Antiviral Drugs During an Influenza Pandemic .

Schools, Daycares and Postsecondary Institutions

Q1. What actions does PHAC recommend schools, daycares and postsecondary institutions take to address H1N1 flu virus?

The H1N1 flu virus can spread easily among young people, PHAC has developed guidelines for daycares and K-12 schools as well as postsecondary institutions and board schools to help reduce the risk of transmission within school settings.

These guidelines make recommendations on how to teach students and staff about proper handwashing and covering coughs and sneezes, as well as increased measures in isolating the ill, disinfecting common surfaces, and reporting outbreaks to local public health authorities.

Q2. What are PHAC's recommendations regarding school closures?

The Public Health Agency of Canada continues to recommend against the widespread proactive closure of schools. This measure may not be effective in preventing transmission, and the benefits of keeping schools open currently outweighs the risk of transmission in these settings. This recommendation will continue to be reviewed based on the situation in Canada.

Q3. Under what circumstances should schools close?

PHAC does not recommend widespread proactive school closures, but in certain circumstances, the reactive closure of some schools might be necessary. This would be a local decision in accordance with provincial/territorial legislation. One situation where school closure might be considered is if the number of school absenteeism and/or staff shortages impacts the safety of school operations.

Q4. What considerations have been made for students living in dorms?

PHAC recommends that post-secondary institutions and boarding schools consider isolating ill students in a separate section of dorms. Also, all students should be provided with information on how to care for themselves if they have the flu and how to seek medical attention, and consideration should be given to providing support for students who do not have a support network in the area (i.e. students from out of province/territory). This may include providing in-room meals and care.

H1N1 in First Nation and Inuit Communities

The Government of Canada is committed to protecting the health and well-being of individuals living in on reserve First Nation and remote, isolated and Inuit communities and we are working diligently with our partners to manage the outbreak of respiratory illness. 

We recognize the many challenges faced by individuals living in on reserve First Nation and remote and isolated communities and continue to coordinate our efforts with all orders of government and First Nation and Inuit leadership to address these challenges.

Saskatchewan Premier Brad Wall, in his remarks following the conclusion of the Council of Federations held in Regina in early August acknowledged the Government of Canada's leadership on the H1N1 file, saying, "I think every single provincial government is taking action to deal with what's happening today and prepare for what could be perhaps a little bit more serious in the fall and of course we're needing the federal government to be engaged on the issue, as they are, to make sure that we are doing everything possible to ensure the safety and the health of all Canadians, and specifically those who may be more vulnerable..."

As the Honourable Leona Aglukkaq, Minister of Health, told her colleagues during a meeting of the Standing Committee on Health held August 12, 2009, the Government of Canada has made a concerted effort to share information and lessons learned with provincial and territorial counterparts and this collaboration reflects an unprecedented level of cooperation. Experts and decision-makers from all jurisdictions and from the entire spectrum of public health management have come together to ensure an appropriate and timely response to the H1N1 outbreak. Furthermore, from day one, the Government of Canada has been working with First Nations leaders and provinces to ensure that communities have everything they need in a timely manner, based on the best public health advice.

The Government of Canada is committed to maintaining and improving its strong working relationship with the provinces and First Nations leadership to ensure all Canadians receive the care they need, when they need it and that First Nations have the support they need to protect their communities.

Q1. How is Health Canada managing H1N1 in on reserve First Nation communities?

Health Canada is working closely with the provinces, the Public Health Agency of Canada,  Indian and Northern Affairs Canada, other federal departments and First Nation leadership to support a comprehensive and coordinated response to H1N1 in on reserve First Nation communities.

Access to care

Health Canada provides or supports the delivery of community-based health programs in on reserve First Nation communities and nursing staff are following provincial clinical care guidelines for respiratory illness.

Nursing services are available 24 hours a day at nursing stations staffed by qualified healthcare professionals and additional medical staff are being sent to communities as needed. Staffing levels are being closely monitored to ensure that adequate care is available at all times. 

Provision of personal protective equipment (PPEs)

Health Canada has sent personal protective equipment for health care workers to First Nation communities, and is in the process of obtaining additional supplies to meet the long term needs of health care workers on reserve.

Health professionals at nursing stations in First Nation communities are following provincial guidelines for the use of personal protective equipment.

Prepositioning of antivirals

Health Canada has pre-positioned supplies of antivirals in nursing stations and in remote and isolated First Nation communities to be used for treatment if they are needed. 

Epidemiological Research

Health Canada is concerned about the current situation in some reserves which we continue to closely monitor.  We are also doing epidemiology work to better understand the impact of the H1N1 flu virus on this population.  In the meantime, we are doing everything possible to ensure First Nation people have access to quality health care.

On June 23, the Minister of Health announced that the Public Health Agency of Canada's National Microbiology Lab is partnering with intensive care units across the country in a study to determine how and why severe illnesses affect some people after they become infected with the H1N1 Influenza.  The lessons learned from this study will help physicians, intensive care and emergency care specialists prepare for the anticipated wave of pandemic H1N1 in the fall.

Support for developing and implementing pandemic plans

Health Canada provides support to on-reserve First Nations in the development, testing and revision of community-level influenza pandemic plans, integrated wherever possible with provincial efforts.

Q2. How do you ensure First Nation communities have the information they need about H1N1?

In April 2009, the Government of Canada launched a public awareness campaign to inform Canadians about the H1N1 flu virus. The campaign consisted of public health notices which were placed in daily and weekly newspapers including print media reaching First Nation and Inuit audiences.

Health Canada also sent the public health notices directly to First Nation and Inuit communities, including Band Council Offices, Chiefs, Hamlets, Co-ops and Northern stores, Inuit organizations, and to more than 1,400 Aboriginal Health Organizations including addiction programs, community health representatives, healing lodges, health access centres, health education programs, hospitals, and nursing stations.

Health Canada Regional Offices continue to provide their health care facilities with provincial guidelines for elevated surveillance and reporting activities, and clinical care guidelines. They continue to work closely with their provincial public health counterparts to ensure that on reserve First Nation communities are obtaining accurate and timely information on the emerging situation, just as other provincial citizens do.

Q3. How is Health Canada currently supporting First Nations and Inuit living in remote and isolated communities?

Health Canada provides primary care services in on-reserve First Nation communities in remote and isolated areas where provincial services are not readily available.  Nursing services are available 24 hours a day at nursing stations staffed by qualified healthcare professionals.   

Budget 2009 provided $305 million over two years to strengthen current health programs for First Nations and Inuit. This included $135 million for the construction and renovation of health services infrastructure in First Nations communities, including health clinics and nurses' residences. These investments, along with others outlined in Canada's Economic Action Plan, reflects the importance this government places on improving the health and well-being of Aboriginal peoples in Canada.

In this current situation, there is a concerted effort with First Nation partners and provinces to help communities update and implement their pandemic plans.

Health Canada is working with provinces, territories, the Assembly of First Nations and other stakeholders to adapt existing clinical care and public health guidelines to better respond to the needs of remote and isolated communities.

Q4. How do you treat H1N1 in residents of fly-in First Nations communities?

In fly-in First Nations communities, if a person falls ill, that person would be assessed at the local nursing station, and if treatment is required, it would be provided according to provincial treatment guidelines. Individuals exhibiting signs of serious illness are transported to nearby hospitals.    

Q5. What should I do if I think I have H1N1?

Information on the H1N1 Flu Virus, including symptoms, who is at risk for complications, when to contact a health professional and when and how to care for someone at home are available in the H1N1 preparedness guide. You can also contact your local nursing station or community health centre.

Q6. Are First Nation communities included in the Government of Canada's pandemic planning process?

The Canadian Pandemic Influenza Plan for the Health Sector provides a framework that guides planning in all jurisdictions, including on reserve First Nation communities.  The information pertaining to influenza pandemic planning considerations in on reserve First Nation communities can be found in Annex B of the Canadian Pandemic Influenza Plan.

Q7. How is Health Canada addressing the incidence of H1N1 in First Nation communities?

Health Canada is closely monitoring the H1N1 situation in on reserve First Nation communities.

A Task Group has been established specifically to review national guidelines for the H1N1 response and adapt them, as required, to better reflect the circumstances in remote and isolated communities.  Members of this task group represent the provinces, territories, Health Canada, the Public Health Agency, Indian and Northern Affairs Canada and First Nations and Inuit. 

Health Canada, in collaboration with the Public Health Agency of Canada, is also doing epidemiological work to better understand the impact of H1N1 on First Nations.  In the meantime, we are doing everything possible to ensure First Nations people have access to quality health care.

Q8. Do First Nation communities have the equipment they need to manage H1N1 cases?

Health Canada, in collaboration with the Public Health Agency of Canada, provinces and First Nation leadership is sharing up-to-date information to the communities about pandemic influenza prevention and infection control.

Efforts have been made to minimize the risk of the H1N1 virus in on-reserve First Nations by providing educational materials and public messaging regarding risks and risk avoidance, universal hygiene behaviours (such as hand washing and respiratory hygiene) and information on self-care, self-monitoring and self-isolation. 

In addition, Health Canada has sent personal protective equipment to on reserve First Nation communities, including remote and isolated communities, and is in the process of obtaining additional supplies to meet the longer-term pandemic related needs of health care workers providing health care services in on reserve First Nation communities.

In collaboration with the provinces antiviral drugs have been pre-positioned in many locations to ensure rapid access and Health Canada continues to assess the needs of each community to determine additional resources required.

Regional offices continue to work closely with their provincial public health counterparts to ensure that on reserve First Nation communities are obtaining accurate and timely information on the emerging situation, just as other provincial citizens do.

H1N1 Aboriginal Populations

Q1. Who is responsible for Aboriginal public health on-reserve and off-reserve?

Public health is an area of shared responsibility, including all levels of government and jurisdictions, and involving non-governmental organizations, other stakeholders, communities and national Aboriginal organizations. 

In the federal government, the Public Health Agency delivers national public health leadership through the Chief Public Health Officer; national management of the emergency supply stockpile; and overseeing contracts for antiviral and vaccine production.

The First Nations and Inuit Health Branch (FNIHB) of Health Canada pays for, and in some cases, delivers a range of programs and services on reserves including health promotion and illness prevention. These also include health services; support to develop, test, and revise pandemic plans; antiviral and vaccine distribution and administration; and Personal Protective Equipment stockpile for community health care workers

For all residents outside reserve communities, including First Nations, Métis and Inuit, the provinces and territories are directly responsible for providing health care and public health programs and services.

Q2. How are federal public health officials communicating with First Nations, Inuit and Métis about the H1N1 outbreak?

We want to ensure that First Nations, Inuit and Métis have access to accurate, timely information to help make informed decisions to protect their health and the health of their families.

The Government of Canada is working closely with the provinces and territories, First Nations and Inuit leadership and other Aboriginal organizations to ensure a comprehensive and coordinated response to public health emergencies.

We are working with First Nations, Inuit and other partners to manage the current outbreak and support the completion of pandemic plans for communities.   We keep the lines of communication open to ensure that concerns specific to First Nations, Métis and Inuit are heard throughout the planning and the response to the H1N1 outbreak.

For example, the Public Health Agency regularly conducts meetings with eleven (11) national Aboriginal organizations to deliver updates on H1N1 and to listen to concerns.  These organizations include the Assembly of First Nations, Inuit Tapiriit Kanatami, Metis National Council, Native Women's Association of Canada, and the Congress of Aboriginal Peoples.

Q3. How is the Government of Canada informing First Nations, Métis and Inuit in Canada?

Our goal is to make sure that First Nations, Métis and Inuit have access to accurate, timely information to help make informed decisions to protect their health.  We are doing this in a variety of ways such as tailoring culturally-relevant information and making it available through a variety of ways. 

For example, PHAC collaborated with First Nations and Inuit Health Branch, the Assembly of First Nations and Inuit Tapiriit Kanatami to develop culturally-appropriate posters on influenza prevention for use in community health centres and other public venues.

We have sent public notices and posters to Band council offices, Chiefs, Hamlets, Co-ops, Northern stores, Friendship Centres and Inuit organizations.  We have also sent information to 1,400 Aboriginal health-related organizations (addiction programs, community health representatives, healing lodges, health access centres, education programs, nursing stations)

For those with Internet access, the Fight Flu website (Fightflu.ca) has a special First Nations, Métis and Inuit section established to provide information. There is also a section with similar information related to Remote and Isolated Communities.

Our communications efforts over the next months will include:

• Print ads appearing in Aboriginal weeklies, biweeklies and monthlies
• Radio advertisement ‘calls to action' being translated in select languages and dialects, placed  with Aboriginal community radio stations
• H1N1 instruction and information materials being created
  • Delivery to individuals via Canada Post Northern Mail Service
• Information kits recommended to all Aboriginal media and leadership leading-up to vaccine deployment
• Engaging Aboriginal advertising agency to identify:
  • Web sites on which to place banner ads; and
  • Popular FN/I/M-themed social media pages (Facebook pages, blogs, business and youth sites) to be provided info

Q4. What is PHAC doing to understand the needs and concerns of the First Nations population?

We have been working with the Assembly of First Nations and others to find ways of learning of on-reserve First Nations' attitudes and awareness of H1N1.  Through a confidential telephone survey, people will be asked how much they know about H1N1 and what they plan to do to protect themselves and their families.  Based on what we learn, we will make adjustments if we need to on how we deliver information and how we say it.  What people tell us will go into a report and we will make it available to the public.

Q5. Who looks after the H1N1 outbreaks in remote or isolated communities?

The Government of Canada is working closely with the provinces and territories, First Nations and Inuit leadership and other organizations to ensure a comprehensive and coordinated response to public health emergencies.

In preparation for the fall flu season, we have formed a Task Group to identify any limitations to national guidelines and issues related to the H1N1 response for remote and isolated communities.  Membership includes provinces and territories, and First Nations and Inuit health representatives.

The Remote and Isolated Communities Task Group has 25 members from across the country. The Task Group is responsible for building on existing guidelines to address the gaps that relate to remote and isolated communities as follows:

• The group has reviewed approximately 15 existing documents for relevance for Remote and Isolated communities in response to H1N1, including antivirals (prescribing by nurses, storage and security) vaccines, community based surveillance such as school-based ILI, public health measures including social distancing, clinical care and health services.
• When gaps were identified the document was adapted accordingly or if required, a new document is being produced. Some new documents being developed include clinical care and use of antivirals in these communities, and hand washing in communities where there are water issues.
• A stand alone document is also in development, which compiles all identified issues for these communities.
• The group is also mandated to identify relevant research needs for this audience.

PHAC and Health Canada are assisting the Assembly of First Nations (AFN) on the development of a school based Influenza Like Illness monitoring tool with a view of readiness for the fall.

Two different culturally appropriate First Nations and Inuit specific community infection  control posters which highlight key public health messages (hand washing, get a flu shot, keep common surfaces clean and stay home if sick), have been completed and distributed to every FN community and Inuit hamlet. The FN poster is in English and French and there are two Inuit posters with English, French and 5 Inuit dialects.

Q6. What is being done to protect Inuit during the H1N1 outbreak?

Under the Canadian Pandemic Influenza Plan (CPIP), the provinces and territories are responsible for surveillance, preparedness and response activities and pandemic preparedness.

The majority of Inuit who reside in Nunavut and the northern parts of the Northwest Territories, Quebec and Newfoundland and Labrador are part of this provincial/territorial planning.

The Public Health Agency is working closely with the relevant provinces and territories in areas including monitoring of outbreaks in Inuit communities and the distribution of vaccines, antivirals and other key supplies.

The Public Health Agency is also working with Health Canada, provinces and territories, and other federal departments and Inuit health representatives to address the unique circumstances of remote and isolated communities during the H1N1 outbreak.

At the request of the Government of Nunavut, the Public Health Agency of Canada provided epidemiology support to the territory early in the outbreak to assist with assessing the impact of H1N1 in Nunavut.

PHAC also has been providing financial and technical assistance to develop a template for pandemic planning in community health centres in Nunavut. PHAC's Ontario and Nunavut Region will send staff into communities, in collaboration with Government of Nunavut staff, to assist health centre staff in completion of their individual plans. The original 18 month timeline for this project has been shortened in response to H1N1, with anticipated completion in fall, 2009.

PHAC collaborated with First Nations and Inuit Health Branch and Inuit Tapiriit Kanatami to develop culturally-appropriate posters on influenza prevention for use in community health centres and other public venues. We have sent public notices and infection prevention posters to Hamlets, Co-ops, Northern stores, Friendship Centres and Inuit organizations.

International Actions

Q1. The World Health Organization (WHO) has raised the pandemic alert level to Phase Six. What are these phases?

WHO currently identifies six stages of Pandemic Preparedness and Response.

Phase 1: Influenza viruses are circulating in animals, especially birds. No reports of animal viruses infecting humans.

Phase 2: Human infection by an animal influenza virus. Potential pandemic threat.

Phase 3: An animal or animal-human influenza virus has caused limited disease in people. Isolated human to human transmission may occur – but not widespread.

Phase 4: Verified human to human transmission of an animal or human-animal virus causing widespread or "community-level" outbreaks. Risk of pandemic is considered much higher but not a foregone conclusion.

Phase 5: Human to human spread of the virus is confirmed in at least two countries in one WHO region. It is likely that a pandemic is imminent. Time to finalize organization, communication, and implementation of planned mitigation strategies is short.

Phase 6: The Pandemic Phase. Community outbreaks in at least one country from a second WHO region – indicating that a global pandemic is underway. The Director-General of the WHO makes the decision about an elevation of pandemic phases based on reports from countries of the impact of disease.

Q2. The WHO has indicated that the overall level of severity of the pandemic to be moderate. What does this mean?

At this time, the WHO considers the overall severity of the pandemic to be moderate. This assessment is based on the clinical and epidemiological information available to WHO to date, as well as input from its Member States on the pandemic's impact on their health systems and more generally on their social and economic functioning. Essentially, this assessment reflects that:

• The overwhelming majority of patients experience mild symptoms and make a rapid and full recovery without the need for hospitalization or medical care.
• Overall, national levels of clinically severe or fatal cases of respiratory illness appear similar to levels seen during local seasonal influenza periods-- although in some local areas and institutions, high levels of disease have occurred.
• Overall, hospitals and health care systems in most countries generally have been able to cope with the numbers of people seeking care -- although in some localities, some facilities and systems have been stressed.

Q3. What other recommendations is the WHO making related to Phase Six?

The WHO is also recommending:

• No border closure. It will not be possible to stop the virus at the border, at ports or at airports. There is no evidence that these measures stop the spread of the disease, and they may be very disruptive for international traffic and trade.
• No restriction of travel. People who are infected with the virus and are capable of infecting others, may not show symptoms when travelling, so they cannot be identified from others who are not infected.
• Greater emphasis on providing care with a decreased emphasis on stopping the spread of the virus. Now that a pandemic has been declared,all governments will need to focus its resources on caring for those who fall ill.

Q4. Are all pandemics severe?

No. An influenza pandemic may be mild, moderate or severe. An influenza pandemic means the virus is spread easily between humans, and affects a wide geographic area. An influenza pandemic does not necessarily cause more severe illness than seasonal influenza.

Pigs and Pork Products

Q1. How can an influenza virus spread from pigs to people?

Different strains of influenza are commonly circulating in our environment, including strains that can cause illness in humans, birds and pigs.

Sometimes, humans and animals can pass strains of flu back and forth to one another through direct close contact - such as in pig production barns and livestock exhibits at fairs.

When a swine influenza virus does affect a human, there is also a risk that the animal influenza can mutate and then spread directly between humans.

Q2. Should people be avoiding exposure to pigs?

Influenza viruses can be transmitted from pigs to people and vice versa via coughs and sneezes, but there are not many documented cases of this actually happening. This H1N1 Flu Virus is spreading between humans – not directly from pigs to people. As a result, there is no risk from proximity to healthy pigs.

Because humans can also spread the disease to pigs, individuals with influenza symptoms should avoid close contact with pigs to reduce the risk of introducing a new influenza virus into domestic swine populations.

Government officials are conducting investigations to find out more about how this particular strain of H1N1 Flu Virus spreads.

Q3. Can I catch H1N1 Flu Virus from eating pork?

No. H1N1 Flu Virus is not transmitted through pork meat. Continue to follow proper handling and cooking procedures to reduce the risk of foodborne illnesses.

Q4. Can the H1N1 Flu Virus be transmitted from humans to other animals, other than pigs, such as farm animals and household pets?

Scientists are currently conducting a range of studies to learn more about the H1N1 Flu Virus. Part of this work is focusing on the susceptibility of various species.