Safety of the vaccine

How safe are flu vaccines and will this one be any different?
Pandemic vaccines are not regarded by regulatory authorities as entirely “new” vaccines. Pandemic vaccines are made using the same manufacturing process as for seasonal vaccines which have an extensive body of safety data. 

CSL has been manufacturing seasonal flu vaccines for over 40 years and the safety profile is well established. The key difference is that seasonal vaccines protect against three strains of influenza, whereas Panvax^®H1N1 vaccine protects against only one, the Pandemic H1N1 2009 strain. 


Additional Safety Information
What side-effects can I expect following getting vaccinated with Panvax^®H1N1 vaccine?
What should I do if I (or a member of my family) experience side-effects after using Panvax^®H1N1 vaccine?
Will there be further monitoring of the safety of Panvax^®H1N1 vaccine?
Who should not be given the Panvax^®H1N1 vaccine?
I have a severe allergy to eggs – am I able to receive the pandemic vaccine?
What is Guillain-Barré Syndrome and is it linked to flu vaccines?
Can having the Panvax^®H1N1 vaccine give me the pandemic flu?






What side-effects can I expect following getting vaccinated with Panvax^®H1N1 vaccine?
Results from a study in healthy adults showed that the vaccine was generally well tolerated with a safety and tolerability profile consistent with that seen with seasonal flu.The most commonly reported side effects were injection site tenderness, headache and injection site pain. The majority were mild to moderate in intensity.

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What should I do if I (or a member of my family) experience side effects after using Panvax^®H1N1 vaccine?
Tell your doctor or pharmacist as soon as possible if you or someone in your family feels unwell after having Panvax^®H1N1 vaccine. The vaccine may have caused you to feel unwell, or it may have happened by coincidence. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. Medical treatment may be needed for some side effects.

Suspected side effects to Panvax^®H1N1 vaccine can be reported to CSL by phoning 1800 024 204.


Will there be further monitoring of the safety of Panvax^®H1N1 vaccine?
Yes. CSL will continue to work with the Australian Government to monitor the safety of the vaccine and investigate any reports of adverse events after vaccination. CSL has a system in place for monitoring the safety of all of its products which complies with Australian and international regulations.

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Who should not be given the Panvax^®H1N1 vaccine?
People with a history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of the vaccine should not be given the vaccine.  

If you have a fever, or acute infection, then you should postpone getting vaccinated if the pandemic situation allows it. Discuss with your doctor. 


I have a severe allergy to eggs – am I able to receive the pandemic vaccine?
The vaccine is made from virus grown in chicken eggs. People with egg allergies should talk to their doctor about the nature of their allergies and immunisation with the pandemic vaccine. There are varying degrees of allergic reactions, and medical advice should be sought about the most appropriate way to manage these. 

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What is Guillain-Barré Syndrome and is it linked to flu vaccines?
Guillain-Barré Syndrome (GBS) is a very rare but sometimes severe condition affecting the body’s nerves. The cause of GBS is not always clear but it is thought to result in the immune system mistakenly attacking its own nerves. 

There is a back ground rate of GBS in the population and there are several factors which have been shown to be associated with GBS, such as influenza-like illnesses and certain other gastrointestinal and respiratory infections. Studies have shown no or very minimal increased risk of GBS with seasonal influenza vaccination. The risk of GBS with Panvax^®H1N1 vaccine is not considered to be greater or less than any ordinary seasonal influenza vaccine. 


Can having the Panvax^®H1N1 vaccine give me the pandemic flu?
No. Panvax^®H1N1 vaccine does not contain any live virus, and so it is not possible for the vaccine to cause the flu.

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