About the vaccine

• The free HPV vaccine used in New Zealand is called Gardasil®.

• It protects against infection from four types of HPV – two high-risk types (16 and 18) that cause 7 out of 10 cervical cancers and two low-risk types (6 and 11) that cause 9 out of 10 cases of genital warts.

• The vaccine causes the body's immune system to produce its own protection (antibodies) against these four HPV types.

The vaccine has been shown to be 95% to 100% effective in preventing infection from the four types of HPV it targets.

• Protection is expected to be long lasting.

• As studies are ongoing, the exact period of protection is unknown. So far, they show that five years after immunisation, protection from HPV infection remains high with no sign of weakening.

• These studies show the vaccine is effective in preventing persistent infection with HPV in 96% of women.

• Studies have also shown evidence of “immune memory” which indicates protection may be life-long. Similar results were seen with studies of the hepatitis B vaccine, where long-term immunity is internationally accepted.

• The Ministry of Health is continuing to monitor international research on the duration of protection from the vaccine.

• The vaccine is given as three injections in the upper arm, normally over a six-month period.

• Normally the second dose is given two months after the first dose, followed by a third dose four months after the second dose.

• The vaccine’s safety profile is well documented.

• The safety and effectiveness of the vaccine have been assessed against international guidelines and the requirements of the Medicines Act 1981.

• The decision to approve the vaccine for use in New Zealand took into account evidence from clinical trials involving more than 20,000 people from 33 countries, including clinical trials in New Zealand.

• The vaccine has been approved for use in more than 100 countries, including Australia, the USA, Canada and the European Union. More than 54 million doses of the vaccine have been distributed worldwide.

• Ongoing monitoring of the vaccine’s safety and effectiveness continues to reinforce the results from the clinical trials.

• In June 2007 the World Health Organization’s Global Advisory Committee on Vaccine Safety concluded that both HPV vaccines (Gardasil® and Cervarix®) have good safety profiles. In December 2008 and June 2009, when they reviewed post-marketing surveillance data, WHO found no reports raised sufficient concern to change this conclusion.

• For more information on the vaccine, see the Medsafe Consumer Medicine Information Sheet and Datasheet.

• Reactions experienced following the HPV immunisation are similar to those from other vaccines.

• As with all immunisations, girls may have a sore arm and get redness, pain and swelling at the injection site.

• Other less common reactions include vomiting or fainting. These can follow any immunisation and girls should remain seated for 15 to 20 minutes (to reduce the risk of injury from falling if they faint). 

• It’s also a good idea for girls to eat breakfast and lunch and avoid excessive exercise on the day they receive the immunisation.

• Other possible reactions that can occur, usually within one or two days, include:

  • a fever (feeling hot)

  • headache

  • general discomfort (feeling unwell, aches and pains)

  • skin reaction, rash.

• Very rarely, a serious allergic reaction (like a peanut allergy), called anaphylaxis, occurs, usually within 10 minutes of immunisation.  Anaphylaxis can occur with any medicine or vaccine.

• Based on clinical studies and experience from overseas we can expect around three anaphylatic reactions per one million doses of vaccine administered. This is similar to the rates for other vaccines given to children and adolescents.

• If anaphylaxis does occur, it can be treated. For this reason, girls are asked to wait for 15 to 20 minutes after immunisation. Every vaccinator is trained and equipped to deal with such a reaction.

• If you have concerns about reactions following the immunisation, contact the nurse or your general practice. 

• It is important you tell the nurse or doctor if there have been reactions to any previous immunisations, before having the HPV immunisation.

• It is also important to report any unexpected side effects following immunisation as there is ongoing monitoring of the safety of the vaccine. 

• As vaccines are given to large numbers of people in a population, many events occur around the same time as a vaccine is delivered.  This does not necessarily mean the vaccine was the cause of the events.

• Both international and New Zealand safety monitoring databases record and monitor events to assess whether they are likely to have been caused by the immunisation or whether they were simply chance associations in time. 

• To date the only known very severe side effect associated with the HPV vaccine is immediate allergic reaction (anaphylaxis) in rare cases.  International regulators are continuing to monitor and watch for any very rare possible events following immunisation.

• Reactions that occur after being given a vaccine in New Zealand are reported to the Centre for Adverse Reactions Monitoring (CARM) at the University of Otago by health professionals, or members of the public can report directly.

• If you are unsure whether a symptom is related to the vaccine, discuss this with the nurse or your doctor.

• Anyone who has had a life-threatening reaction (hypersensitivity or anaphylaxis) to any component of the vaccine or if they have had a reaction to the previous dose of the vaccine.

• The vaccine should not be given to pregnant women.

• Anyone who has a bleeding condition or an immune disorder should talk to their doctor or nurse before having the HPV vaccine.

• The link between HPV infection and cervical cancer was recognised in the 1980s.  The doctor who discovered this link was awarded the Nobel Prize for Medicine.

• Scientists have worked since then to develop a vaccine to protect against HPV infection. This work was started in the mid-1980s jointly by the University of Queensland (Australia), Georgetown University Medical Center (USA), the University of Rochester (USA), and the National Cancer Institute (USA). 

• The technology was licensed to two companies – and two vaccines are now available. One of the vaccines (Cervarix®) is not currently available in New Zealand.

• The vaccine selected for New Zealand’s HPV immunisation programme – Gardasil® - was first licensed by the USA in 2006.

• More than 100 countries have now licensed Gardasil® and an estimated 17 million young women around the world (54 million doses) have been immunised with it.

• The clinical trials for the HPV vaccine involved more than 20,000 women aged 16 to 26 from 33 countries, including clinical trials in New Zealand.

• The trials showed the vaccine had almost 100% efficacy in preventing cervical abnormalities caused by high-risk HPV types 16 and 18.

• The trials did not allow cervical cancer to develop as an end-point – it would have been unethical to deny treatment to women in the placebo group.

• For ethical reasons, younger girls were not included in some of the trials as they would have been required to have regular smear tests and other swabs, which would have been inappropriate given their age. 

• Instead immune response studies were used to compare the development of immunity from the vaccine between younger and older girls.  These trials showed that immune responses were up to two-fold higher in girls aged 9 to 15 compared with those aged 16 and over; that is, they responded as well if not better to the vaccine than the older group.

• For more information about the vaccine see Further reading and sources of references.

• The vaccine contains tiny virus-like protein particles that mimic HPV but cannot cause infection.

• There is no virus in this type of vaccine - you cannot become infected with HPV when you have the vaccine.

• Each 0.5ml dose of the vaccine also contains a small amount of aluminium, which stimulates the immune response. Aluminium has been safely and effectively used in vaccines for more than 70 years.

• The vaccine also contains tiny amounts of sodium chloride (salt), L-histidine (an amino acid), Polysorbate 80, sodium borate and sterile water.

• The vaccine does not contain preservatives, antibiotics or any human or animal materials.

• After vaccination, the body quickly starts making antibodies that protect against the four types of HPV the vaccine targets.