Kids Vaccine Q&As
We need to protect children | Developing a safe vaccine for young children | Where to get vaccinations | Children’s dosages and safety | Travel and the holiday season
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We need to protect children
Why should my children be vaccinated now against pandemic influenza? Isn’t the outbreak over in Australia?
While the number of cases of pandemic influenza in Australia has waned, the disease is still a major threat to Australia. The virus reappeared in the northern hemisphere earlier than the usual flu season and it is likely, with the influx of overseas visitors to Australia over the summer months, that some arrivals will be infected with the pandemic influenza strain. Therefore it is important that all Australians afford themselves the best possible protection from this virus by being vaccinated now.
In addition it is highly possible that Australia’s 2010 influenza season will begin much earlier than usual, as it did in the northern hemisphere in 2009.
What has been the impact of pandemic H1N1 influenza on children in Australia?
About 7,700 children under 10 years of age have been confirmed with pandemic (H1N1) 2009 influenza. More than 1,000 of these children ended up in hospital – with around 40 needing intensive care. Unfortunately a number of children have died, more than half of whom had no underlying illnesses or conditions that made them more vulnerable to serious outcomes from this disease. Around three quarters of all children who ended-up in hospital had no underlying illness or conditions.
There have been more than 37,000 confirmed cases of pandemic (H1N1) 2009 in Australia to date, including almost 5,000 hospitalisations, more than 750 ICU admissions and 191 deaths. Actual numbers will be higher as testing for H1N1 has focused on more severe cases and those in vulnerable groups since mid June when Australia introduced the Protect Phase of its pandemic management plan.
What is the current situation in the northern hemisphere with children and pandemic influenza?
Surveillance of pandemic influenza activity in the northern hemisphere suggests there is a pressing need to start protecting Australian children from pandemic influenza infection.
In Canada paediatric surveillance data shows children were hospitalised with pandemic (H1N1) 2009 influenza at rates far outpacing previous flu seasons. In October-November 2009, 526 cases were reported by 12 paediatric health centres across Canada, more than Canadian investigators expected to see during an entire northern winter. In a single week in November 2009, 240 children were hospitalised. This is about half the total number of children that were hospitalised during the 2008-2009 Canadian season flu season and three to four times as many flu-related hospitalisations during any week in the past five years.
In the United States, 27 paediatric deaths from pandemic influenza were reported in a single week (15-21 November 2009). The US also experienced hospitalisation rates higher than usual in young children.
How can my child, who is under six months of age, be protected from pandemic influenza?
As a vaccine is not available for children under six months of age, the most important thing you can do is to ensure all other family members and regular close contacts of your child are vaccinated to limit your child’s potential exposure to pandemic influenza virus.
If I think my child has already had swine flu, does he/she still need to get the vaccination?
If your child has definitely had pandemic (H1N1) 2009 influenza then it is likely he/she has immunity and does not need the Panvax® H1N1 vaccine. But, you can only know for certain if your child has had pandemic flu if your child was tested for it and the test was positive. This test would have involved swabbing the back of the nose and throat.
If your child was not tested or you are not certain of the test result, then you should get your child vaccinated anyway – just to be safe. If you child had a confirmed case but was treated with anti viral medication they should also get the vaccine. It is safe for children to have the Panvax® H1N1 vaccine, even if they are already immune to the virus, just as it is safe to get a seasonal flu vaccination for people who have already had seasonal flu.
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Developing a safe vaccine for young children
Why did very young children have wait longer for vaccination against pandemic H1N1 influenza?
The pandemic influenza vaccine, Panvax H1N1, made by CSL, was initially trialled and approved for use in people aged 10 years and over. It was released in Australia on 30 September 2009.
A separate trial was undertaken to determine the number of doses and the strength of the dose needed to ensure protection for children. Based on existing knowledge about the use of seasonal influenza vaccination in children aged under 10 years, a separate trial was considered important to confirm that a lower dose would be effective in very young children and to determine whether a second dose was needed for full protection. The children’s trial started after the adult trial had commenced and took longer to complete because of the need to measure immunity levels after a second dose had been given.
The clinical trial was conducted across five Australian states as well as in the United States of America. The Australian trial included up to 400 volunteers between the ages of six months and nine years.
What did the trial show about the vaccine for children?
The clinical trial data was evaluated by the Therapeutic Goods Administration (TGA) and reviewed by the expert Australian Drug Evaluation Committee (ADEC). The evaluations found the vaccine, delivered in two doses not less than 28 days a part in children aged 6 months to 9 years, to be both safe and to offer good protection.
On December 3 2009 the vaccine was approved for use in children aged 6 months to 9 years.
Is the vaccine for children different to the current adult pandemic influenza vaccine?
Children from six months of age can receive vaccine in appropriate dosages from the multi dose vials used for adult vaccinations. A special Panvax ® Junior vaccine is also provided in pre-filled syringes for use in children under 36 months of age. This junior vaccine does not contain the preservative thiomersal.
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Where to get vaccinations
Where can I get the vaccine for my child?
Vaccinations are available from a range of locations including GP offices, vaccination clinics and health care centres. To check vaccination locations in your State or Territory, go to:
Health department websites and phone numbers
WA: call 1800 186 815 or visit
http://www.health.wa.gov.au/swine_flu/home/
SA: call 1800 022 222 or visit
www.flu.sa.gov.au
VIC: call: 1300 882 008 or visit
www.humanswineflu.health.vic.gov.au
TAS: 1800 358 362 (1800 FLU DOC) or visit
www.pandemic.tas.gov.au
ACT: call 02 6205 2300 or visit
www.health.act.gov.au/flupandemic
NSW: visit
www.emergency.health.nsw.gov.au/swineflu/vaccination/index.asp, or call 180 2007 for your local Public Health Unit contact
QLD: 13HEALTH (13 43 25 84) or vist
www.health.qld.gov.au/swineflu/html/vacc.asp
NT: call 08 8922 8044 or visit
www.swinefluvax.nt.gov.au
Back to school - can I get this vaccine through my child’s school?
At this stage no decision has been made about the need for a school-based program in 2010.
Parents should get their children vaccinated through their GP or usual immunisation service provider (see above) to ensure their children are protected in the event of an early upsurge in pandemic influenza cases in late summer/early autumn.
Do I have to pay for the children’s vaccine?
No, the Panvax® vaccine is free, although there may be a consultation fee from your doctor or immunisation service provider. You may be able to claim your consultation on Medicare.
Do I need to be a Medicare card holder to get the children’s vaccine?
No.
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Children’s dosages and safety
How many doses of vaccine are required for children?
The Therapeutic Goods Administration has recommended two doses of vaccine be given to children aged 6 months to 9 years of age. These doses should be given at least 28 days apart.
| Age | Dose | Formulation | Number of doses |
|---|
| 6 months - 35 months | 0.25ml (7.5µg) | Panvax® H1N1 Junior prefilled syringe or
Panvax® H1N1 multidose vial | 2 doses
at least 28 days apart |
| 36 months – 9 years | 0.5ml (15µg) | Panvax® H1N1 multidose vial | 2 doses
at least 28 days apart |
| 10 years and above | 0.5ml (15µg) | Panvax® H1N1 multidose vial | 1 dose |
I’ve heard reports that one dose is enough to protect children. Is this true?
Information from the clinical trials in children shows that around 90 per cent of children developed sufficient antibody levels to give protection after a single dose. However, this rose to 100 per cent after a second dose.
While the Therapeutic Goods Administration and Australia’s Chief Medical Officer agree that one dose gives initial protection to children, they also agree that because children have not been exposed to many, if any flu strains, children under 10 years of age need a higher level of vaccine to ensure longer term and effective immunity. This approach is in line with the usual Australian seasonal influenza vaccine recommendations, where two injections are given in the first years of the flu vaccination to children under 10 years of age to ensure the best protection.
What happens if I can’t get my child vaccinated with a second dose of the vaccine in four weeks time?
Even one dose of the vaccine for children will give good protection against this disease. A second dose is needed to ensure longer lasting immunity but this can be effectively and safely given later than 28 days after the first. It is important to not delay vaccination with the first dose, particularly if you intend going overseas or will be in contact with people arriving from overseas.
If my child is having other vaccinations, do I need to leave some time before receiving the Panvax vaccine or can they be done at the same time?
Generally there is no problem with getting other vaccinations at the same time as the pandemic influenza vaccination but it is best to consult with your health care provider on this issue.
Should some children not be given the vaccine?
Children aged under 6 months should not get the vaccine as it is not registered for use in children under this age. Very young babies do not develop a good level of immunity after influenza vaccination.
Children should not be given Panvax® H1N1 vaccine or any other influenza vaccines if they:
- have experienced anaphylaxis, a severe form of a generalised allergic reaction, following a previous dose of any influenza vaccine;
- have experienced anaphylaxis following receipt of any vaccine component, including neomycin or polymyxin antibiotics; or
- have a severe allergy to eggs, including children who have experienced swelling of the lips or tongue, or had acute breathing problems or convulsions, after eating eggs.
Children with milder forms of egg allergy may be able to be vaccinated and should talk to their health care provider about the vaccine.
Children who are moderately or severely ill with a fever should usually wait until they recover before getting the vaccine. Children with a mild illness can usually get the vaccine.
Will the seasonal flu shot protect against the pandemic virus
Yes, but supplies of the 2010 seasonal flu vaccine are primarily targeted at risk groups, including pregnant women, Aboriginal and Torres Strait Islander people aged 15 to 64 years, people aged six months to 64 years with chronic medical conditions such as cardiac disease and respiratory conditions and people aged 65 years and over.
The free Panvax®H1N1 will continue to be provided to all Australians six months and older during the 2010 flu season.
People not in identified risk groups for seasonal influenza will be required to pay for seasonal flu vaccine as well as any vaccine provider consultation costs.
What are the expected side effects from the children’s vaccine?
The expected level of side effects from the children’s vaccine is the same as for the adult vaccine. The vast majority of vaccinations occur without any side effects. Every year in Australia millions of influenza vaccines are administered, yet in the five years from 2004 to 2008, of the 655 suspected adverse reactions reported to the TGA the vast majority of these reactions were minor.
All medicines and vaccines can have unwanted side-effects. 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. Some people may get side effects like nausea or occasionally, vomiting.
The most common side effects are easily treated at home, such as a cold compress to relieve soreness at the injection site or paracetamol for a mild fever or headache. Do not give children under 16 years of age medicines containing aspirin.
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.
The vaccine will continue to be monitored for safety. Any reports of adverse events (side effects) will be investigated.
Reports of the number and severity of suspected adverse reactions to Pandemic influenza vaccine in Australia are being placed on the TGA website at
www.tga.gov.au
Why are pre-filled syringes being made available for use in children aged under 3 years?
The Australian Government used the time available during trials of the vaccine in young children to purchase pre-filled syringes specifically for children under 36 months of age. Each of the two doses provided for children under 36 months is half of that given to older children and adults, and can be safely drawn-up from the multi-dose vials or conveniently provided from a pre-filled syringe.
Pre-filled syringes do not contain the preservative thiomersal used in the multi-dose vials. This gives parents a choice of getting a thiomersal-free product should they so desire – an important step to ensure no very young children are potentially left unvaccinated because of any parental concerns about thiomersal.
The removal of thiomersal is simply a precautionary measure. Thiomersal, which contains a small amount of mercury, was removed from all vaccines given to young children in Australia simply as a precaution. A number of vaccines are given in the first two years of life and the decision to remove thiomersal was made to reduce the theoretical risk of exposure to mercury in babies, particularly those of very low birth weight.
Can children under 3 years be safely given the vaccine from multi-dose vials?
Yes. There is no reason why a child cannot receive vaccine from a multi-dose vial.
Why does Panvax® H1N1 vaccine contain thiomersal?
Most doses of Panvax® H1N1 vaccine are provided in multi-dose vials that also contain a small amount of thiomersal – a preservative, which keeps the vaccine safe in the vial. Thiomersal is an antibacterial and anti fungal, meaning it stops bacteria and fungi growing in a medicine and has been used in many medical products and vaccines for more than 60 years.
Is thiomersal in vaccines safe?
Thiomersal has been used in medical products and vaccines for more than 60 years and is the most commonly used preservative in multi-dose vials. It has a very long safety record.
There is no evidence anywhere in the world that thiomersal in vaccines has caused any developmental or neurological abnormalities, such as Attention Deficit Hyperactivity Disorder (ADHD), autism or any other health problem.
The Australian Technical Advisory Group on Immunisation (ATAGI) has looked at this issue and has advised that influenza vaccines containing thiomersal are safe for infants, children, adolescents and adults (including pregnant women). The ATAGI advice regarding the use of influenza vaccines containing thiomersal is available from
www.healthemergency.gov.au
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travel and the holiday season
If I am travelling overseas soon, should I and my children be vaccinated before we leave Australia?
Absolutely. It is important that you and your children be vaccinated before travelling overseas, particularly to the northern hemisphere. Even getting one dose of vaccine for you and your children provides good protection. Ideally both doses should be received before travel.
See your doctor or immunisation provider for specific advice.
Where can I get more information?
Information on the vaccination program is available through local pharmacies and GP surgeries as well as via
www.healthemergency.gov.au.
You can also call the Pandemic Hotline on 180 2007 for information about the program and where to get vaccinated.
