Topic: Pandemic (H1N1) 2009 Human Swine Influenza: Frequently asked questions and answers about vaccine safety
Description
This fact sheet provides questions and answers about the Pandemic(H1N1) Human Swine Influenza vaccine.
How safe are influenza vaccines and will this one be any different?
Pandemic influenza vaccines are not entirely "new" vaccines. Pandemic vaccines are made using the same manufacturing process as for seasonal vaccines which have been shown to be safe. CSL has been manufacturing seasonal influenza 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 (swine flu) strain. Interim results in adults show that the safety profile of the pandemic vaccine is comparable to seasonal flu vaccines.
Has the safety of the Pandemic (H1N1) 2009 vaccine been proven?
In Australia, the necessary assessment procedures to ensure any new medicines are safe and effective are conducted by the Therapeutic Goods Administration (TGA). Once the TGA is satisfied of the safety and quality of a medicine, it is registered. The vaccine for Pandemic (H1N1) 2009 was registered by the TGA on Friday 18 September 2009. This registration was for the giving of the vaccine to people over 10 years of age. Registration for giving the vaccine to children under 10 years of age will be dependent on the results of clinical trials due to finish in October.
What kind of reaction could I have to the vaccine?
It is common (around one in 10 people) with influenza vaccines to have some swelling, redness and/or pain where the injection is given. Other symptoms such as fever, tiredness, headaches and muscle aches are less common. These side-effects can start within a few hours of vaccination and may last for one to two days.
Allergic reactions are uncommon after vaccination, but can be severe in some people. These reactions are due to an allergy to egg protein or to other components of the vaccine, including the antibiotics neomycin and polymyxin, which are in the vaccine in small amounts.
Some allergic reactions can happen within 15 minutes of vaccination, so it is important that you wait in the surgery or clinic for this time so that you can be observed.
Serious adverse events after seasonal influenza vaccination are uncommon and it is reasonable to assume they will also be uncommon following vaccination with the Panvax H1N1 vaccine. Early data from the clinical trials supports this assumption.
What do I do if I feel unwell or experience a reaction after the Panvax H1N1 vaccine?
If you have pain at the injection site you can take paracetamol or apply a cold compress to ease the discomfort. If you have fever after vaccination you should drink extra fluids and rest. Paracetamol can also be used to reduce fever. If the fever persists, or you are worried about any reaction you are experiencing, contact your doctor or the healthcare provider that gave you the vaccine as soon as possible, or go to a hospital. A reaction to vaccination should be reported to the health professional who gave you the vaccine.
How are reactions investigated?
All reports of serious adverse events following vaccination will need to be closely investigated to confirm or exclude a causal relationship with the vaccine. This is done by the Therapeutic Goods Administration (TGA) with the assistance of expert advisory panels as required.
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 whether they should receive the vaccine.
An increased risk of developing Guillain-Barre Syndrome (GBS) was reported with the 1976 swine influenza vaccine. Is this new vaccine likely to be associated with the same increase in risk?
There is a background rate of GBS in the population and there are other causal factors which have been shown to be associated with GBS, such as influenza-like illnesses and certain other gastrointestinal and respiratory infections. Studies subsequent to the 1976 swine influenza vaccine have shown no or very minimal increased risk of GBS with seasonal influenza vaccination.
Why is the vaccine supplied in Multi-dose vials?
The vaccine will be supplied primarily in multi-dose vials (MDV) in order to facilitate the distribution and supply of a large number of doses. MDV are also being used in both the U.S. and the UK for roll out of the H1N1 vaccine.
Isn't there a risk of transmitting infectious diseases by using a multi-dose vials (MDV)?
The MDV Panvax H1N1 vaccine contains a preservative to maintain sterility of the vaccine. While there have been cases of use of MDV causing infection in the past, they have been traced to a breakdown in process and/or a failure to follow strict infection-control measures during the process of administration. The risk of transmitting infectious diseases is extremely low if strict infection-control procedures are followed.
Does the vaccine contain thiomersal? Hasn't thiomersal been removed from other vaccines in Australia?
The multi-dose vial contains a small amount of thiomersal to maintain sterility of the vaccine. Thiomersal has been used in very small amounts as a preservative in vaccines for about 60 years. Multi-dose vials of thiomersal-containing seasonal influenza vaccine are routinely used in other countries. The Global Advisory Committee on Vaccine Safety in the USA states that there is no evidence of toxicity in infants, children or adults exposed to thiomersal in vaccines. Nevertheless, a thiomersal-free preparation will be made available to young children.
Thiomersal has been removed from vaccines used in young children, but this was just a precaution to reduce the total exposure to mercury in babies and young children because other environmental sources are difficult to eliminate. There is no evidence that thiomersal has caused any developmental or neurological abnormalities, such as ADHD or autism.
More information
Please go to the Queensland Health Swine Flu Response website: http://www.health.qld.gov.au/swineflu/html/vacc.asp
Last Updated: 29th September, 2009
Date Valid to: 28th February, 2010
