Vaccine Safety Information

HPV Doodle blue

HPV vaccines have been shown to be very safe.

What vaccines are available to protect against HPV?
There are two vaccines currently licensed 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 will be used in the HSE HPV vaccination programme?
Gardasil ® the vaccine produced by Sanofi Pasteur has been chosen for the HSE's HPV vaccination programme. Gardasil ® protects against the types of HPV that cause 7 out of 10 of all cervical cancers .The pdf document on the right gives full details for Gardasil ® in the manufacturer's Patient Information leaflet or PIL - read or download the Updated Gardasil PIL here.

How does the Gardasil ® vaccine work?
The vaccine works in the same way as other vaccines. The body reacts by making antibodies which will help the immune system fight HPV infection

How does the HPV vaccine work?
The vaccine works in the same way as other vaccines. The body reacts by making antibodies which will help the immune system fight HPV infection

Gardasil ®

is not a live vaccine,
is not infectious
cannot cause HPV infection.
cannot cause cancer.

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.

Click here for more information from the European Medicines Agency about Gardasil's safety profile

Click here to read a letter issued by the HSE to Schools and Parents in September 2011 about Gardasil's Safety Profile

What does the vaccine contain?
Gardasil ® constituents are outlined in the Summary of Product Characteristics (SPC).

These are

- Protein in the form of HPV virus like particles
- Aluminium hydroxyphosphate sulphate which is a component of several of the childhood vaccines
- L-histidine which is a component of some hepatitis vaccines
- Polysorbate 80 - a component of several of the childhood vaccines and other medication e.g. mycostatin used for oral thrush, feldene gel used as an anti-inflammatory medication
- Sodium borate a component of some vaccines and medicinal compounds such as Optrex eye drops
The vaccine is manufactured using yeast cells and anybody with a severe allergic reaction to yeast should not receive the vaccine

Who can be protected with Gardasil ® vaccine?
Gardasil ® is licensed for use for adolescents from 9 to 15 years and females from 16 years onwards.

How do we know that the Gardasil ® vaccine is safe?
All vaccines including Gardasil ®, the vaccine used in the HSE's immunisation programme undergo a series of trials before they can be licensed for use in Europe by the European Medicines Agency [hyperlink] and in Ireland by the Irish Medicines Board and these trials can take several years. These trials assess vaccine safety and effectiveness.

After vaccines receive a licence their safety and effectiveness profile continues to be assessed. Internationally, the World Health Organization monitors and reviews the safety of HPV vaccines.

Over 64 million doses of Gardasil ® have been distributed either as part of national immunisation programmes or by private doctors. Gardasil ® has a good safety record. It has been tried and tested in large clinical studies which lasted more than a decade and which included over 25,000 subjects in 33 countries. These studies are outlined in section 4.8 of and 5 of the Summary of Product Characteristics.

The World Health Organisation conducted a review of HPV vaccine safety in 2009 and stated "no concerns with the safety profile were identified.

Gardasil ® is currently used in several European countries, the United States, Canada, Australia and New Zealand. The most frequently reported side effects are local redness and /or swelling at the point of injection, and fever. These are typical and usually mild and temporary reactions to any kind of vaccination

How effective is Gardasil ®?
Gardasil ® is very effective at preventing infection with the HPV types covered by the vaccine.

over 99% effective in preventing pre-cancerous lesions associated with HPV types 16 and 18 in young women
and
99% effective in preventing genital warts associated with HPV types 6 and 11
the vaccine also gives some protection against infection from other HPV types not included in the vaccine.
Vaccination is less effective in females who have already been infected with one or more of the HPV vaccine types.

How long does protection last?
It is expected that the vaccine will provide long term protection. Studies so far show that protection lasts for at least 5 years after a full course. More studies will indicate if a booster dose is necessary.

How is Gardasil ® given?
Gardasil ® vaccine is given by intramuscular injection usually in the upper arm.

How many doses are needed?
Three doses of the vaccine are needed to give full protection.
The three doses are usually given over 6 months; at 0, 2 and 6 months.

What side effects might be expected after vaccination?
There may be some mild side effects, including:

pain, redness or swelling in the arm where the vaccine was given
and/or
a mild fever or headache

These can be treated with paracetamol or ibuprofen.
Rarer side effects include an itchy rash or hives.
Like most vaccines, severe allergic reactions are extremely rare.
As usual, seek medical advice if you are concerned.

Before the next dose of your vaccine you should tell the vaccinator if there has been a serious reaction to a previous dose of vaccine.
Fainting has been reported after vaccination with Gardasil ®. This can happen after any vaccination. Girls will be advised to sit down for 15 minutes after vaccination which can help to prevent fainting.

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: amorphous aluminium hydroxyphosphate sulphate, yeast, sodium chloride, L-histidine, polysorbate and sodium borate.
are pregnant.

Are there any precautions for vaccination?
If a girl has a high fever and is unwell, the vaccination will be postponed.
Vaccine should be administered with caution to people with bleeding disorders. 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.
Parents / guardians should discuss this with their daughter before they sign the consent form

Can the vaccine be given if someone is already sexually active?
Yes.
The vaccine should still be administered as it protects against four HPV types. However, vaccination will not alter or treat any pre-existing HPV infection or the development of any consequences of the infection.

Can the vaccine be given to someone who is breastfeeding?
Yes.
Clinical trials have indicated that it is safe to administer Gardasil ® to breastfeeding females.

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.

Can the vaccine be given to boys?
HPV vaccines have also been shown to be effective in preventing infection in men.
Studies are now being done to see if the vaccines should be routinely recommended for boys/men as well

Do girls get a record of vaccination?
Girls will receive a record booklet after their first vaccination. This is an important document. They must bring this booklet with them when they are getting their second and third doses.

Do girls who have been vaccinated still need to attend for cervical screening?
The HPV vaccines only protect against cervical cancers caused by the HPV types included in the vaccine so it is important that girls vaccinated in the HPV programme avail of smear testing offered by the Cervical Check, the National Cervical Screening Programme when they are older. This will detect problems resulting from infection with other types of HPV that are not prevented by the vaccine, which can be identified and treated before they develop into invasive cancer. Countries which have cervical cancer screening programmes in place have seen a marked decrease in cervical cancer due to this measure.

Protect your daughter from 7 in every 10 cervical cancers