HPV vaccines have been shown to be very safe.
What vaccines are available to protect against HPV?
In Ireland there are two vaccines currently licensed and available for the prevention of HPV infection .
Cervarix®, manufactured by GSK, protects against infection with two HPV types (16 and 18).
Gardasil®, manufactured by Sanofi Pasteur MSD, protects against infection with four HPV types (6, 11, 16 and 18).
What vaccine is used in the HSE HPV vaccination programme?
Gardasil® the vaccine produced by Sanofi Pasteur MSD is used in the HSE's HPV vaccination programme. Gardasil® protects against the types of HPV that cause 7 out of 10 of all cervical cancers .
You can read the licensed documentation about Gardasil called the Summary of Product Characteristics (SPC) here and the - Patient Information Leaflet (PIL) here for more detailed information about the vaccine.
How does Gardasil® vaccine work?
The vaccine works in the same way as other vaccines. The body reacts by making special proteins, called antibodies, which help the immune system fight HPV infection.
Key points about the vaccine
- is not infectious
- cannot cause HPV infection
- cannot cause cancer
- is not a live vaccine
What does the vaccine contain?
Gardasil® constituents are outlined in the Summary of Product Characteristics (SPC).
- Protein, in the form of HPV virus like particles, which causes the bodys immune system to produce special proteins, called antibodies, which protects you from HPV disease.
- Aluminium hydroxyphosphate sulphate, aluminium salts have been used in many vaccines for 70 years The quantity of aluminium in the vaccine is very small (most adults will get approximately 35x more aluminium in their diet each day, than exists in the vaccine).
- L-histidine is an essential part of proteins which our body needs, and that we get mostly from the food we eat. A small amount is required in the vaccine
- Polysorbate 80 is commonly used in many products ranging from vaccines and medications to ice cream
- Sodium borate, a component of some vaccines and medicinal compounds such as Optrex eye drops, is present in very small amounts.
The vaccine is manufactured using yeast cells . However as no yeast remains in the vaccine, allergy to yeast is not a contraindication to the vaccine.
The vaccine does not contain preservatives, antibiotics or any human or animal materials.
How is Gardasil® made?
Gardasil is made in the same way as many other vaccines, by using DNA to make proteins. Very small amounts of DNA may be found in any vaccine made in this way. Many studies have shown that there is no link between these very small amounts of DNA and any side effects from Gardasil or any other vaccine.
How effective is Gardasil®?
Gardasil® is very effective at preventing disease occurring from the HPV types that are included in the vaccine.
The vaccine is over 99% effective in preventing pre-cancers associated with HPV types 16 and 18 in young women and 99% effective in preventing genital warts associated with HPV types 6 and 11
In Australia, Denmark, Sweden, the US, Canada and the UK the HPV vaccine has dramatically reduced the number of cases of pre-cancers of the cervix in young women. In countries where Gardasil is used the number of cases of genital warts has decreased dramatically, in both young women and men.
How long does protection last?
Studies so far show that protection lasts for at least 9 years after a full course of the vaccine.
It is expected that the vaccine will provide long term protection, through the body's ‘immune memory’.
How is Gardasil® given?
Gardasil® vaccine is given by intramuscular injection usually in the upper arm.
How many doses are needed?
All girls less than 15 years of age at the first dose require two doses of the HPV vaccine given at least 6 months apart.
All girls aged 15 years and older at the first dose require three doses of the HPV vaccine given at least 6 months apart and the third dose given at least three months after the second dose.
Why is the vaccine being given to 1st year girls at second level school?
We are offering the vaccine to this age group, so that girls are protected before adulthood and likely exposure to HPV. The vaccine has been shown to provide the best protection when given at this age.
Who should not receive Gardasil® HPV vaccine?
Girls should not receive the vaccine if they:
- have had a severe allergic reaction (anaphylaxis) to a previous HPV vaccine or any of its ingredients
- are pregnant
Are there any precautions for vaccination?
- Fever - If a girl has a high fever and is unwell, the vaccination will be postponed.
- Bleeding disorders – If you suffer from any bleeding disorder please let us know
Can the vaccine be given if you have an impaired immune system?
Yes – vaccination is safe for people with impaired immune systems, whether due to treatment or illness, but they may not respond as well to the vaccine.
Can the vaccine be given during pregnancy?
No - This is because no studies have been done to recommend vaccination during pregnancy.
Can other vaccines be given at or around the same time?
Yes - Gardasil® vaccine is not a live vaccine and can be administered either at the same time or at any time before or after another vaccine.
What side effects might be expected after vaccination?
These are outlined in the vaccine Patient Information Leaflet (PIL) The known side-effects are presented in the PIL by how commonly they occur.
About 1 girl in 10 will get pain, swelling and redness at the injection site and/ or headache.
About 1 girl in 100 will get nausea, pain in the vaccinated arm and mild fever.
About 1 girl in 1000 to 1 girl in 10,000 will get an itchy rash or hives.
If you are concerned that you may have developed a side effect after vaccination, seek medical advice.
Severe allergic reactions with difficulty breathing are very rare (about 1 in 1 million patients). However, the school vaccination team are trained to treat any severe allergic reaction.
Occasionally girls faint after getting an injection. The girls are advised to sit down for 15 minutes after the vaccination. This helps prevent fainting.
There are no known long-term side effects of Gardasil.
For more information, please see the PIL.
Can the vaccine be given to boys?
Yes - HPV vaccines have also been shown to be effective in preventing infection in men. Some countries for example Australia and the United States, recommend routine vaccination for boys. This is not recommended as part of the school programme in Ireland at present. If you wish to get your son vaccinated you will need to pay for the vaccine and the administration of the vaccine privately.
The HPV vaccine will protect girls from developing cervical cancer when they are adults and is available free of charge from the HSE.
Copies of the information materials are available to download for parents of girls in 1st year of second level schools or equivalent in special schools.
How do we know the HPV vaccine is safe and effective?
Since HPV vaccine was licensed in 2006, research has been conducted all over the world that shows that the vaccine is safe and prevents cancer. The evidence has been steadily growing since 2006 and now a large bank of research proves the safety and effectiveness of this vaccine. Studies have been conducted worldwide showing that HPV vaccination is the right way to protect girls from cervical cancer. This map shows the countries which have conducted the most research on HPV vaccine.
Click here to read more about the evidence for HPV vaccine safety and effectiveness
This page was updated on 10 January 2017