Pandemic (H1N1) 2009 FAQs - Vaccine-Related

Who should get the H1N1 vaccine and why? Learn more about H1N1 and seasonal influenza vaccines, how they are administered, what to do if you have allergies, vaccine reactions and why the H1N1 vaccine is safe.

About the H1N1 vaccine - who should get it and why

About the H1N1 vaccine - who should not get it

About H1N1 and seasonal vaccines

Adjuvanted vaccine

Allergies

Antivirals

Drug and other vaccine interactions

Effectiveness

Illness and vaccinations (previous flu-like symptoms)

Pregnancy and breastfeeding

Reactions

Safety

Squalene

Thimerosal

Vaccine composition

Miscellaneous

About the H1N1 vaccine - who should get it and why

Who should get the H1N1 flu vaccine and when?

All Albertans 6 months of age and older will be eligible to receive H1N1 influenza vaccine in sequencing of high risk groups.

The H1N1 flu vaccine is particularly important for people at risk of complications from the flu. People greater then 65 years have not been as vulnerable to H1N1 as they have been to seasonal influenza. Pandemic H1N1 virus does not seem to be as much of a risk to seniors as the seasonal strains are.  This may be because seniors have some immunity to this new H1N1 virus because of exposure to many different types of H1N1 influenza virus in the years prior to 1957.

Those who will benefit most from immunization include:

  • Children six months to less than five years of age and their caregivers.
  • Pregnant women.
    • NOTE: if you are pregnant or think you could be pregnant, tell your health care provider as this may affect the vaccine recommended for you. See Adjuvanted Vaccine
  • People under 65 with chronic health conditions and their caregivers.
  • People living in remote and isolated settings or communities
  • Health care workers involved in pandemic response or the delivery of essential health care services.
  • Household contacts and care providers of persons at high risk who cannot be immunized or may not respond to vaccines.

Are Aboriginal people included in the priority list?

At risk Aboriginal people are captured in the priority groups listed above. For example, many Aboriginal populations have higher numbers of pregnant women, 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 to have access to the H1N1 vaccine as soon as it becomes available wherever they reside, especially those who would benefit most from immunization.

What is vaccine sequencing or prioritization?

While there will be enough H1N1 vaccine for all Albertans who need and want protection, not everyone can be immunized at the same time. Vaccine will be released in lots and in the initial stage of the immunization program there may be a need to determine who should receive these first lots of vaccine. Vaccine sequencing refers to the advice that has been developed on which groups will benefit most from immunization so that the timing and location ofimmunization clinics can be targeted appropriately.

Is a third wave of the H1N1 virus expected and should I still get my family vaccinated?

Yes, there is a possibility that there will be a third wave. In past pandemics, there have been more than two waves of influenza activity. The impact of the H1N1 virus will decrease now and in a future wave as more people get vaccinated for H1N1 influenza. Immunization is the best way to reduce severe illness and deaths from the H1N1 influenza virus.

Even after a large second wave, many people will not yet have been infected and will remain at risk for infection unless they are vaccinated. Getting the H1N1 vaccine is the single best way to protect yourself and those around you from the H1N1 influenza virus.

About the H1N1 vaccine - who should not get it

If I have had H1N1 should I get the vaccine?

The H1N1 vaccine is not required for persons who have had laboratory-confirmed H1N1 infection.

People who have been infected with H1N1 will have developed a protective immune response to this virus and will not get additional benefit from H1N1 vaccine.

H1N1 vaccine is recommended for persons who have experienced an influenza-like illness or have had a clinical diagnosis of H1N1 since March 2009 that was not a laboratory-confirmed case of H1N1.

What is the minimum age that can have the vaccine?

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

You shouldn’t get the H1N1 flu vaccine if: you have had a previous anaphylactic (severe allergic reaction) to any element of the vaccine or:

  • If you currently have a high fever, you should defer receiving the vaccine until you have recovered
  • You have a hypersensitivity to eggs (e.g. hives, swelling of mouth and/or throat, breathing difficulty)
  • You have experienced Guillian Barre Syndrome(GBS) within eight weeks of receiving a seasonal flu vaccine
  • If you have a mild egg allergy, consult a health care provider before immunization. You may be able to be immunized with some additional precautions.

About H1N1 and seasonal vaccines

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. People who have recently had influenza vaccination can go at any point for H1N1.

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.

Is H1N1 a "live" or "killed" vaccine?

The H1N1 vaccine is an inactivated (killed) vaccine.

Is there anything I should do to prepare for the vaccine?

Yes, you should:

  • bring your Alberta Health Care card(s) or some documentation of Alberta residence (i.e. phone bill)
  • wear a short sleeved shirt to assist the nurse in administering the vaccination
  • eat your regular meals prior to immunization to reduce the likelihood of fainting or dizziness

Adjuvanted vaccine

What is an adjuvanted vaccine?

  • There are two parts to an adjuvanted vaccine: the antigen and the adjuvant. Antigen is the active ingredient in the vaccine that provides protection against the virus.
  • Adjuvant is an ingredient made of naturally occurring squalene oil, water and vitamin E that boosts the body's immune response and increases the vaccine effectiveness.
  • Adding an "adjuvant" to the vaccine allows for a larger amount of vaccine to be produced (dose-sparing) and still be effective.
  • Adjuvant-based vaccine also has the potential to provide better cross-protection against mutating flu virus strains. The adjuvant boosts the immune response of an individual.

The World Health Organization (WHO) urges the use of dose-sparing formulations that use adjuvant to maximize antigen-sparing, permitting more vaccine to be available.

If I receive the non-adjuvanted vaccine will I get one or two shots? Will I only get one shot with the adjuvanted vaccine?

Study results indicate that most people will likely need only one dose of either adjuvanted or unadjuvanted vaccine. Children will likely need two doses.

Can I choose to have the non-adjuvanted vaccine rather than the adjuvanted vaccine?

No, non-adjuvanted vaccine will only be available in limited supply, intended primarily for pregnant women. The non-adjuvanted vaccine will be available near the beginning of November 2009.

Is the government ordering non-adjuvanted vaccine? Who will it be recommended for and why?

The Government of Canada plans to purchase a small quantity of non-adjuvanted H1N1 vaccine (approx. 1.2 million doses) as part of its total order of 50.4 million doses.

The purchase of a small quantity of non-adjuvanted vaccine is for pregnant women. This is just a precaution because there is no clinical data about the safety of adjuvanted vaccine in pregnant women.

According to WHO there are no special concerns about the safety of adjuvanted H1N1 vaccines in general. The WHO has also strongly recommended that pregnant women be immunized against the H1N1 flu virus, even if no non-adjuvanted vaccine is available.

Non-Adjuvanted Vaccine for Pregnant Women:

  • The recommended vaccine for ALL pregnant women is the non-adjuvanted vaccine.
  • Beginning Fri, Nov 6, non-adjuvanted vaccine will be available for ALL pregnant women.
  • Both adjuvant and non-adjuvant contain thimerosal and are not a safety risk. See Thimerosal.

NOTE: In cases where non-adjuvanted vaccine is unavailable and H1N1 influenza rates are high or increasing in the community, all pregnant women should be offered one dose of the adjuvanted vaccine. The World Health Organization has indicated that it has no special concerns about the safety of adjuvanted H1N1 vaccine.

  • Even if a non-adjuvanted vaccine is unavailable, the World Health Organization has strongly recommended that pregnant women be immunized against H1N1 influenza.
  • Therefore, pregnant women in a high risk category, or those planning a pregnancy who are in a high risk category, may be offered adjuvanted pandemic (H1N1) vaccine.

Why is there an adjuvant included in the Pandemic (H1N1) 2009 vaccine that will be used in Canada?

For the purposes of controlling an influenza pandemic and having enough vaccine for the entire world, the World Health Organization has recommended that 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.Clinical data to date shows that an adjuvanted vaccine can help mount a robust response against pandemic influenza viruses.

Experts believe that use of the adjuvant:

  • will help to induce protection quicker
  • will give some cross protection from different strains if the virus changes slightly (virus drift) from the strain used to make the vaccine (also known as cross-clade protection)
  • is generally well tolerated and has an acceptable safety profile in the populations that have been studied (based on use of the same adjuvant in seasonal and pandemic influenza vaccine development and trials in other countries).

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 (i.e. Adacel, Boostrix, Pediacel, Neisvac-C™, Prevnar are a few examples). However, they have not previously been approved for use with influenza vaccines in Canada.

The adjuvant chosen for the Pandemic (H1N1) 2009 influenza vaccine is AS03. It is already being used in certain design protocols for the H5N1 pre-pandemic influenza vaccine, and for a vaccine against malaria. It is also similar to another adjuvant, MF59, used by Novartis to produce the seasonal influenza vaccine Fluad®, licensed and used in many countries other than Canada since 1997; more than 40 million doses have been administered.

To date, tens of thousands of people have received vaccines containing AS03 in experimental protocols and no major safety issues have surfaced.

Allergies

Can I have the H1N1 vaccine if I have a serious allergic reaction to eggs?

The H1N1 vaccine is grown in eggs, just like the seasonal influenza vaccine. There is no vaccine alternative for clients who have severe egg allergies. There is no product licensed for use in Canada that is guaranteed to be egg free. If you can eat foods with egg in them, then you can be vaccinated. You should NOT get the vaccine if you have a severe allergic reaction to eggs.

Should I get the H1N1 immunization if I have allergies?

You should NOT get the vaccine if you have:

  • a severe allergic reaction to eggs (see egg content)
  • had a severe allergic reaction (anaphylaxis) to this vaccine in the past.

Talk to a public health nurse or a physician before getting this vaccine if you:

  • have severe allergies to any part of the vaccine
  • are severely allergic to any foods, drugs, bee stings, etc.

Can I have the H1N1 adjuvanted vaccine if I have a severe allergy to fish or shell fish?

Yes, you can have the H1N1 adjuvanted vaccine. The Public Health Agency of Canada has stated that the process used to purify squalene oil involves high heat which would break down any proteins in the oil. Therefore, fish or shell fish allergy is not a concern for receiving the H1N1 vaccine.

Antivirals

After a person is started on Tamiflu, is it still recommended that they stay home for seven days from the start of symptoms?

Regardless of the use of antiviral medication, people with influenza symptoms need to stay home until the symptoms of fever and cough are gone. This might be shorter for a person taking antiviral medication, but it is not based on the medication, it based on whether or not the symptoms are still present.

How long will it take for the antiviral medications to start making me feel better?

This varies from person to person. The medication reduces the severity and sometimes the length of the illness by interfering with the reproduction of the virus but you still may have some symptoms for 5-7 days.

What is the lower age limit for antivirals?

Antivirals can be given at any age (including young infants).The dosage will be determined by the prescribing physician.

I am currently taking or have been treated in the past with an antiviral. Can I still have the H1N1 vaccine?

  • Yes, it is safe to have either vaccine while taking an antiviral medication. There is no contraindication to seasonal influenza or H1N1 vaccine in those taking antiviral medications.
  • Antivirals should not replace H1N1 immunization. Immunization remains our primary tool for the prevention of influenza infection and illness.

If I am still sick after finishing tamiflu, is this a concern?

The medication reduces the severity and sometimes the length of the illness by interfering with the reproduction of the virus but you still may have some symptoms for 5-7 days. You may not be back to 100% but should be slowly improving. If your symptoms are not improving or are getting worse you should talk to a health care provider.

If I am taking  Tamiflu can I take Tylenol or Ibuprofen for my symptoms? If my Doctor has ordered antibiotics can I take them at the same time as Tamiflu or should I wait until I have finished the Tamiflu?

Yes, there are no reported drug interactions between Tamiflu and:

  • acetaminophen (Tylenol) - take as directed on the bottle
  • ibuprofen (Advil, Motrin) - take as directed on the bottle
  • or antibiotics such as penicillin or amoxicillin - take as directed by your doctor

It is always important to tell your doctor about every medication you are taking when you are getting a new prescription. Your doctor will know if the medications are compatible.

What can I do to reduce the nausea/vomiting when I take the antiviral medication (Tamiflu)? 

Tamiflu can be taken with food or on an empty stomach. Taking it with food may reduce stomach upset.You must complete the entire treatment of antiviral medication.

When should I expect Tamiflu to take effect? How will I know if it is working?

When taken as recommended by patients symptomatic for no more than 2 days, Tamiflu helps symptoms and shortens their duration.  You will know the medication is working if your symptoms improve. We have no information about how long it will take to have an effect.

Drug and other vaccine interactions

Is H1N1 safe to be administered with other medications or along with other vaccines?

Yes, the vaccine can be given with other medications and vaccines safely.

Is it safe to have the H1N1 vaccine with any childhood immunizations?

Yes, the H1N1 vaccine is not an active virus vaccine (not live) and therefore is safe to have with childhood vaccinations. If the H1N1 vaccine is given at the same time as other vaccines, the other vaccines should be given in a different limb than that used for the H1N1 vaccine because of the higher frequency of local reaction to the adjuvanted H1N1 vaccine.

Do any other childhood vaccines contain the same or similar adjuvant as the H1N1 vaccine? How much adjuvant is too much and is this a concern?

This adjuvant (AS03) has not been used before in any vaccines in Canada. The amount of adjuvant used in the vaccine has been carefully studied by the manufacturer in order to balance the desired level of immune response with the level of local reactions that are expected to occur.

Effectiveness

How well will the vaccine protect against the H1N1 flu virus?

Most people will develop immunity in about 10 days after the H1N1 flu shot. Clinical trials have shown 85 per cent to 98 per cent of healthy adults developed an immune response strong enough to offer protection against the virus.

The vaccine may not work as well in people who have problems with their immune systems or who are taking medication that affects their immune systems, however it is still very important for these people to be vaccinated.

Illness and vaccinations (previous flu-like symptoms)

If I was ill with influenza-like symptoms, but was not tested for Pandemic (H1N1) 2009 should I get the H1N1 vaccine?

Yes. There are many viruses other than H1N1 influenza that can cause influenza-like illness. Anyone who has had influenza-like symptoms but was not tested for H1N1 should still get the H1N1 vaccine when it becomes available in Canada. The Public Health Agency of Canada will be providing more information about the vaccine in the fall.

If I had a confirmed case of H1N1 earlier in the year should I have the immunization for H1N1?

The H1N1 vaccine is not required for persons who have had laboratory-confirmed H1N1 infection. People who have been infected with H1N1 will have developed a protective immune response to the virus and will not get additional benefit from the H1N1 vaccine.

The H1N1 vaccine is recommended for persons who have experienced an influenza-like illness or have had a clinical diagnosis of H1N1 since March 2009 that was not a laboratory-confirmed case of H1N1. The infection may have been due to other respiratory viruses.

People who get the H1N1 vaccine who have had prior H1N1 infection are not expected to have any adverse reactions.

If I am unwell (with transient illness) should I still have the H1N1 vaccine?

  • Yes, if mildly ill.
  • If you are sick now with something more serious than a cold talk to a public health nurse or doctor before getting the vaccine.

Mild illness - A mild acute illness (such as a simple sore throat or runny nose) without a fever (temperature less than 38C).
If an individual or child has minor symptoms, but is doing regular levels of activity, eating normally (and in the case of children behaving normally), then immunization can be given.
Moderate or severe illness (with or without a fever)
If an individual or child has moderate to severe symptoms of illness, immunization of most vaccines including influenza should be postponed until symptoms have resolved.
Individuals with Influenza-like illness: are being told to stay home and are encouraged NOT to attend mass vaccination clinics while they are ill.
People who are ill can spread illness by being in contact with large numbers of people at the clinics. People with illness may be turned away from the clinics.

Pregnancy and breastfeeding

Will pregnant women be able to get the H1N1 vaccine when it comes out?

Yes. The H1N1 vaccine will be recommended for pregnant women because the risk of serious influenza illness increases throughout the pregnancy. There will be enough H1N1 vaccine for all Canadians who wish to have it. The Public Health Agency of Canada has said that those who need the vaccine the most will get it first.

In cases where unadjuvanted vaccine is not available and H1N1 influenza rates are high or increasing in the community, women more than 20 weeks pregnant should be offered one dose of the adjuvanted vaccine.

The World Health Organization has indicated that it has no concerns about the safety of adjuvanted H1N1 vaccines in general. They have also strongly recommended that pregnant women be immunized against the H1N1 influenza, even if a non-adjuvanted vaccine is unavailable. Therefore, pregnant women in a high risk category or those planning a pregnancy who are in a high risk category may be offered the adjuvanted pandemic (H1N1) vaccine if they are < 20 weeks of gestation or planning to become pregnant in the next month.

If I am pregnant, am I at increased risk?

Pregnant women are at increased risk of influenza related complications. Immunity can be decreased during pregnancy. The risk for pregnant women to develop severe complications from H1N1 is small. However it is estimated that pregnancy increases the risk of hospitalization and of severe outcomes (ICU admissions or deaths) from H1N1 by four to five times. More than two-thirds of hospitalized cases occur in the third trimester

If I am breastfeeding can I still have the H1N1 immunization?

Yes. The H1N1 vaccine will be similar to the seasonal influenza vaccine and will be recommended for breastfeeding mothers to help protect their young infants from getting H1N1.

Influenza immunization is recommended for breastfeeding mothers because they could get influenza and give it to their baby.

Infants less than 6 months are too young to be vaccinated for H1N1 Pandemic 2009.
Since children from 0-23 months of age are at higher risk for hospitalization due to influenza illness, immunizing the mother helps to protect them.

The Public Health Agency of Canada recommends women who are breastfeeding should receive the adjuvanted H1N1 influenza vaccine in order to protect their health and the health of their infant.

Is it safe to have the vaccine containing thimerosal while I am breastfeeding?

Yes, there is no safety reason to avoid using vaccines containing thimerosal. As a multi-dose vaccine, the H1N1 influenza vaccine will contain a mercury-based preservative called thimerosal to prevent contamination of the vaccine from bacteria.

The Public Health Agency of Canada makes the following recommendation: women who are breastfeeding should receive the adjuvanted H1N1 flu vaccine in order to protect their health and the health of their infant.

Where should pregnant women with influenza-like symptoms go for assessment?

Pregnant women with symptoms of ILI should be seen urgently by their family physician if possible (ensuring they call first for specific instructions) or they can go to urgent care. They should receive early antiviral treatment within 48 hours of symptom onset.

Why does Alberta Health and Wellness recommend the non - adjuvanted vaccine for pregnant women?

 It is strongly recommended that pregnant women be immunized with a pH1N1 vaccine. The unadjuvanted pH1N1 vaccine is the preferred option for pregnant women given that there are more safety data on the use of unadjuvanted seasonal vaccines in pregnant women.

What if a pregnant woman received the adjuvanted vaccine because it was available first, is it going to be harmful?

The World Health Organization (WHO) has strongly recommended that pregnant women be immunized against the H1N1 2009 influenza virus, even if a unadjuvanted vaccine is not available. More safety data has been collected on the use of unadjuvanted seasonal vaccines in pregnant women. The recommendation to use the unadjuvanted vaccine is only precautionary.

Which vaccine is recommended for a healthy pregnant woman who is less than 20 weeks gestation in regions with increasing or high pH1N1 activity?

There is not enough evidence to recommend for or against the use of adjuvanted vaccine. The risk of complications from H1N1 infection is lower in the first half than the second half of pregnancy. No pregnant woman should be denied the H1N1 vaccine if they want it. They may decide to wait until an unadjuvanted vaccine is available.

Which vaccine is recommended for pregnant women with a chronic health condition in regions with a lot of H1N1 in the community?

People with chronic health conditions are at higher risk of complications from H1N1 infections. Pregnant women with chronic health conditions have two important risk factors for complications and are a high-priority group for immunization. Although there is less safety data on the use of the adjuvanted vaccine in early pregnancy, the potential for the development of severe H1N1 disease in women with underlying health conditions is significant and outweighs any theoretical risk from the vaccine.

If ther is no non adjuvanted vaccine available, adjuvanted vaccine may be used in women with underlying conditions that place them at higher risk of complications from H1N1 infections.

Reactions

If I had an oculorespiratory reaction to seasonal influenza shot, am I still able to receive the H1N1 vaccine?

There is no evidence to suggest that oculorespiratory syndrome (ORS) will be a concern after immunization with the H1N1 vaccine. Unless a person was hospitalized, people who have had ORS following seasonal influenza vaccine may be immunized with the H1N1 vaccine.

If I have a history of Guillain Barre syndrome (GBS) and cannot have the seasonal influenza vaccine, can I have the pandemic H1N1 vaccine?

It is recommended that anyone known to have developed GBS within eight weeks of a previous influenza vaccination should not receive the H1N1 vaccine. It is not known whether influenza vaccination causes GBS in people who have previously had GBS.

What reactions are expected following H1N1 vaccine?

Most reactions to the vaccine are minor. Canada has a vaccine safety surveillance program to report and investigate any serious or unexpected reactions to the vaccine. Serious adverse events following immunization are rare.

Clinical trials found the most common reactions after getting the adjuvanted vaccine were minor and included pain, swelling at the injection site and redness at the injection site, and mild swelling and pain under the arm on the same side of the body that the shot was given. 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, headache, fever and chills, and in younger childen, fever, drowsiness, irritability and loss of appetite were also reported in low levels.

In younger children a fever, drowsiness, irritability and loss of appetite were also reported in low levels.

Adverse events can happen with any vaccine, and we expect we will see primarily mild reactions to the H1N1 flu vaccine. Adverse reactions usually occur within six to 12 hours of immunization and disappear within 24 - 48 hours.

Monitoring for adverse effects from the H1N1 flu vaccine will be aggressive and will seek out any potentially serious adverse events. Any serious events (including those that led to hospitalization or death) will be investigated.

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 people immunized. For the seasonal flu shot, the rate of reported serious adverse events is about one for every million people immunized.

What should you do if you have a reaction to the vaccine?

  • Apply an ice pack or a cool moist cloth where the needle was given to reduce the pain and swelling.
  • Take a medication such as acetaminophen (e.g. Tylenol) to reduce the pain or if a fever develops. Aspirin (ASA) is not recommended for children.
  • Drink extra fluids (water, fruit juice) if you develop a fever.
  • Report any unusual reactions to HEALTHlink Alberta.

Other ways to manage side effects:

  • Provide opportunity for extra rest.
  • Dress in lightweight clothing and cover with a lightweight sheet if experiencing a fever. Losing heat through the skin is an important way to reduce the fever. If you begin shivering, add warmer clothing or a blanket, but remove once the shivering stops. For an infant, a single baby blanket wrapped loosely provides sufficient cover.

If your or your child has a fever:

Acetaminophen (e.g. Panadol, Tempra or Tylenol) is the medication recommended to manage fever (over 38C/100.4F) and/or pain related to immunization. The timeframe of this recommendation is short-term (during the time of the expected reactions). This is usually 24 to 48 hours.

It is not necessary to wake up during the night to give fever or pain medication unless directed by a physician. Tepid baths or sponges do not reduce a fever. Bathing cools the skin, not the core of the body. You can bath in usual temperature bath water if comfortable. If you are shivering or uncomfortable stop bathing, dry off and dress. Do not use alcohol in the bath because it can be absorbed by the skin.

Safety

How safe is the H1N1 flu vaccine?

In Canada, vaccines must undergo laboratory and field-testing. They must pass a rigorous licensing procedure with the federal government before they can be used. Once a vaccine has been approved for use, every lot is tested for safety and quality.

The virus used in the pandemic (H1N1) 2009 vaccine has been killed. Therefore, a person cannot get pandemic (H1N1) influenza disease from the vaccine.

Clinical trials from several countries around the world have shown the H1N1 flu vaccine to be safe and effective in protecting yourself against the H1N1 flu virus. The H1N1 flu vaccine is produced in a similar manner to seasonal flu vaccines, which have been used safely and effectively in Canada for many years.

The H1N1 flu vaccine contains an adjuvant, which is an ingredient made of naturally occurring oil, water and vitamin E that boosts the body’s immune response and increases the vaccine effectiveness. This same adjuvant was tested in 45,000 people and did not identify any safety concerns for healthy adults or children. However, the adjuvant was not tested widely in children under three years and pregnant women.

I heard on the news that someone died from the H1N1 vaccine. Is this true?

  • There are no deaths related to immunization reported in Canada.
  • An Albertan in their 50s died in October due to complications related to H1N1. This death is a reminder that H1N1 and other influenzas can cause serious illness or death, especially in high risk populations. All the more reason to be immunized.
  • Both the seasonal and H1N1 vaccines are safe.

The vaccine was left out on the table at the immunization clinic. Should it be refrigerated?

No. While immunizing the reconsitiuted vaccine should be kept at room temperature and protected from light when not in use.

I have heard on the news that there has been serious allergic reactions to one lot (batch) of H1N1 vaccine?

The Public Health Agency of Canada, is reviewing reports of a higher than expected number of allergic reactions associated with one lot of the H1N1 flu vaccine. The higher incidence of allergic reactions has been reported only in people receiving vaccine from the identified vaccine lot. The Public Health Agency of Canada immediately notified provinces and territories about the increase in reactions. All remaining vaccine from the lot in question was immediately withdrawn from all vaccine programs.

Have there been any adverse reactions from this H1N1 vaccine lot in Alberta?

No. To date (November 20, 2009) there have been no adverse reactions associated with this vaccine lot in Alberta.

How many reactions have been reported from this H1N1 vaccine lot?

The lot being reviewed provides 172,000 doses of vaccine. One to two allergic reactions are expected in a lot this size. There have been six to11 serious adverse reactions associated with this lot of vaccine.

Has the vaccine been recalled?

The remaining doses of the identified vaccine lot will not be used until the Public health Agency of Canada and Canada’s vaccine regulator have finished their investigation.

How do I know if I had vaccine from that lot? Do I need to be concerned?

No, people that have received the H1N1 flu vaccine from that lot and have not had an allergic reaction have no reason to be concerned. Alberta Health does vaccine reaction reporting and callers who feel they have had a reaction related to the H1N1 vaccine need to report it by calling HealthLink Alberta.

Squalene

What is squalene?

Squalene is a naturally occuring substance found in plants, animals and humans. It is manufactured in the liver of every human body and circulates in our bloodstream. Squalene is also found in a variety of foods, cosmetics, over the counter medications and health supplements. It is also commercially extracted from fish oil, and in particular, shark liver oil. Squalene used in pharmaceautical products and vaccines is purified from this source.

Is there squalene in vaccines?

Since 1997, an influenza vaccine (FLUAD, Chiron) which contains about about 10 mg of squalene per dose, has been approved in health agencies in several European countries. Squalene is present in the form of an emulsion and is added to make the vaccine more immunogenic.

Squalene is being added to improve the efficacy of several experimental vaccines including pandemic flu and malaria vaccines being developed.

Why is squalene added to vaccines?

Squalene is a component of some adjuvants that are added to vaccines to enhance the immune response. MF59, an adjuvant produced by Novartis and added to the FLUAD flu vaccine is an example.

Squalene by itself is not an adjuvant, but emulsions of squalene with surfactants do enahance the immune response.

What is known about the safety of squalene in vaccines?

Twenty two million doses of Chiron's influenza vaccine (FLUAD) have been administered safely since 1997. This vaccine contains about 10 mg of squalene per dose. No severe adverse effects have been associated with the vaccine. Some mild local reactogenicity has been observed.

Clinical studies on squalene-containing vaccines have been done in infants and neonates without evidence of safety concerns.

Why do some people think squalene in vaccines carries a risk?

A few people have tried to link the health problems of Gulf War veterans to the possible presence of squalene in the vaccines these soldiers received. One published report suggested that some veterans who received anthrax vaccines developed antisqualene antibodies and these antibodies caused disabilities. It is now known that squalene was not added to the vaccines administered to these veterans, and technical deficiencies in the report suggesting an association have been published.

Thimerosal

Will there be a thimerosal reduced version of H1N1 for pregnant women, children and breastfeeding clients?

There is no safety reason to avoid using vaccines containing thimerosal. As a multi-dose vaccine, the H1N1 influenza vaccine will contain a minute amount of a mercury-based preservative called thimerosal to prevent contamination of the vaccine from bacteria. Thimerosal also has a stabilizing effect on the vaccine, ensuring its effectiveness.

Studies have demonstrated that there is no association between childhood immunization with thimerosal containing vaccines and neuro-developmental outcomes including autistic spectrum disorders.

Will a single dose, thimerosal-free format for pandemic (H1N1) 2009 influenza vaccine be available?

No. There will not be a thimerosal-free pandemic (H1N1) influenza vaccine available in pre-filled syringes or single dose vials.

Vaccine composition

Australia has been using this vaccine for several weeks now. What kind of adverse reactions have been reported? How many serious adverse reactions have been reported so far?

In Australia, about 3 million doses of this vaccine have been given. There have been 316 adverse events reported. This is within the normal range of adverse events expected with any influenza vaccine. Most were mild reactions such as pain at injection site, headache, nausea and diarrhea. There were six serious adverse events reported which is not more than expected. Four of these were severe allergic reactions.

Does Panvax® vaccine contain antibiotics?

Yes. The vaccine contains Neomycin and Polymyxin B sulphate

Does Panvax® vaccine contain egg product?

Yes. Panvax® vaccine is prepared from influenza virus grown on chicken eggs. The virus is harvested from the eggs, purified, inactivated but may still have microscopic amounts of egg protein.

Does Panvax® vaccine contain latex?

No. The vaccine is closed with a latex-free stopper and seal.

Is the Panvax® vaccine manufactured by CSL Australia vaccine safe?

Yes, Health Canada has been working closely both the U.S. Food and Drug Administration and Australia's Therapeutic Goods Administration. Both of these regulatory agencies have authorized this vaccine and have shared safety and effectiveness information about the vaccine with Health Canada 

The H1N1 vaccine is an inactived (killed) vaccine.

Immunization cannot cause influenza because vaccine does not contain live viruses. The vaccine is a split virus inactivated vaccine. The H1N1 flu vaccine is produced in a similar manner to seasonal flu vaccines, which have been used safely and effectively in Canada for many years.

The H1N1 vaccine contains an adjuvant.

The H1N1 flu vaccine contains an adjuvant, which is an ingredient made of naturally occurring oil, water and vitamin E that boosts the body’s immune response and increases the vaccine effectiveness. The adjuvant was tested in 45,000 people and did not identify any safety concerns for healthy adults or children. However, the adjuvant was not tested widely in children under three years and pregnant women.

The H1N1 vaccine contains the following antigenic strains:

Three types of vaccines will be provided by Alberta Health and Wellness for the publicly funded H1N1 influenza immunization program through Alberta Health Services. The H1N1 vaccines provided will be an adjuvanted vaccine (AREPANRIX™ H1N1) and an unadjuvanted vaccine.

1) Adjuvanted – AREPANRIX™ H1N1: Antigen suspension - HA-A/California/7/2009(H1N1) v-like strain (A/California/7/2009, X-179A) AS03 adjuvant emulsion containing:

  • squalene
  • Vitamin E oil
  • polysorbate 80 (Tween 80)
  • antigen suspension vial contains trace residual amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose
  • minute amounts of thimerosal

2) Non-adjuvanted – PANVAX® H1N1 Vaccine - Pandemic (H1N1) 2009 Monovalent Vaccine (Unadjuvant)
Manufacturer: CSL Limited

  • (HA)-A/California/7/2009 (NYMC X- 179A) [A/California/7/2009 (H1N1) v-like]
  • Minute amounts of thimerosal

3) Non adjuvant - Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Unadjuvant)
Manufacturer: GlaxoSmithKline Inc (GSK)

  • 15 μg HA - A/California/7/2009(H1N1)v-like strain (A/California/7/2009, NYMC X-179A (H1N1)v).
  • minute amounts of thimerosal
  • trace residual amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose.
  • vaccine is prepared in eggs
  • antibiotics are not used in the manufacture of this vaccine

Do the H1N1 vaccines contain gluten?

No. None of the three types of vaccine contain gluten.

Miscellaneous

Can I get the H1N1 vaccine at a travel clinic?

Yes, the Public Health Agency of Canada recommends that travelers be vaccinated with H1N1 before leaving Canada. Travelers attending the Public Health Travel Clinics (in Edmonton and Calgary) will be able to receive their H1N1 immunization as part of their scheduled travel visit at no additional cost.

Appointments will not be made for travelers wanting only H1N1 vaccine. Individuals who are travelling but who need or want only the H1N1 immunization should attend the mass immunization clinics to receive the vaccine.

If I am not in Canada during the H1N1 vaccination timeframe, how can I still receive the vaccine?

You will need to contact your local community health centre and ask if you can receive the H1N1 vaccine.

If I am out of the country, can I receive the H1N1 vaccine in that country free of charge (paid for by Alberta Health)?

You will still have to pay for immunizations done outside of Canada. You will not be reimbursed for the immunization.

Will the H1N1 immunization be made legally mandatory for all Albertans?

No. Vaccination in Alberta is voluntary, with the exception of a few vaccines for health care workers in specific settings. It is not expected that the H1N1 vaccination will be any different. It is not expected to be mandatory. It is important that anyone considering any vaccination has the information they need to make an informed decision. They need to know the risks of the disease and the risks and benefits of the vaccine.

Do the ingredients of the vaccine vary between countries?

Vaccines may vary from country to country (for example, the United States will have pandemic vaccine from several different manufacturers; Canada will only have vaccine from one manufacturer (adjuvanted and non-adjuvanted)). All vaccines will contain the pandemic H1N1 influenza strain (inactivated) but the other vaccine components vary depending on the manufacturer.

Should I have the H1N1 vaccine if I am scheduled for surgery?

If you are scheduled for surgery you should contact your surgeon before receiving your H1N1 shot. Although it is usually safe to receive H1N1 vaccine, please check with your surgeon before being vaccinated for influenza to avoid the risk of surgery cancellation.

Will the H1N1 vaccine effect getting blood work?

There is no contradiction to having blood work done before or after receiving the H1N1 vaccine.