Immunisation Information on the HPV Vaccine
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What is in the GARDASIL® vaccine? How safe is the vaccine? How effective is the vaccine? How cost-effective is the vaccine? What is in the GARDASIL® vaccine? The vaccine contains HPV virus-like particles (VLPs) of HPV types 16, 18, 6 and 11. These particles are proteins from the outer shell of the virus. They are a part of the virus but are not live and cannot cause infection. The particles mimic the HPV structure so that the immune system makes antibodies against it. The vaccine does not contain thiomersal. These recombinant types of vaccine have been used around the world for about 20 years. More information Medsafe data sheet - GARDASIL® Back to top How safe is the vaccine? The vaccine was shown to have an excellent safety profile during large clinical trials in which more than 20,000 people from 30 countries took part. GARDASIL® has been licensed for use in more than 100 countries, including New Zealand, Australia, the United States, and the 27 countries in the European Union including the U.K. In New Zealand, as in other countries, there is ongoing monitoring of vaccine safety. All applications for consent to distribute a medicine in New Zealand are evaluated by Medsafe. This evaluation is performed to internationally defined standards and requirements. GARDASIL® was evaluated by Medsafe and formal approval of the vaccine was notified in the New Zealand Gazette on 20 July 2006. The reactions reported from GARDASIL® are similar to other vaccinations. The most common are injection site pain, redness, and swelling. Nausea and fainting have also been reported. Very rarely people have more serious allergic reactions to vaccinations (such as anaphylaxis). All the clinical trials and ongoing safety monitoring worldwide report no deaths have been caused by the vaccine. More information Information on the trials- Quadrivalent Human Papillomavirus Vaccine - Recommendations of the Advisory Committee on Immunization Practices (ACIP) Medsafe data sheet - GARDASIL® Back to top How effective is the vaccine? GARDASIL® vaccine targets the types of HPV responsible for most cases of cervical cancer and genital warts. Clinical trials show GARDASIL® is highly effective in preventing these types of HPV in young women who have not previously been exposed to them. So far, ongoing studies show three doses of the vaccine protects against HPV infection for five years after immunisation, and suggest protection will last much longer. The vaccine was effective at preventing persistent infection with HPV in 96 per cent of women. At present it is expected that booster doses will not be required. Research is continuing to find out how long protection will last. Back to top How cost-effective is the vaccine? Every year in New Zealand about 160 women will be diagnosed with cervical cancer and 60 will die from it. An ongoing programme will cost about $16 million per year, and it is estimated that in the future it will save around 30 lives each year. On top of that there will be savings in diagnosis and treatment costs from a reduction in abnormal smear results. The benefits will not happen immediately as the vaccine is given in early adolescence to prevent potential consequences in later life. The HPV programme is a significant contribution to women’s health. Back to top Back to the Human Papillomavirus (HPV) Immunisation Programme page Website feedback We welcome your feedback on this page. Page last updated: 28 August 2008