Gardasil (quadrivalent human papillomavirus vaccine), update 1
Gardasil is a vaccine that protects males and females from a range of cancers (including cervical and anal cancers) and other diseases caused by human papillomavirus (HPV). It is administered as three injections over six months.
Gardasil has been offered to females aged 12-13 years through schools, as part of the National Immunisation Program, since 1 April 2007. From February 2013, Gardasil has also been offered to males aged 12-13 years through the National HPV Vaccination Program.
The TGA published a safety update regarding Gardasil on 24 June 2010. Since then, the TGA has continued to monitor the vaccine In that time, the TGA has identified no new safety signals. As with other regulators around the world, the TGA continues to consider Gardasil to be safe and effective.
Adverse events following Gardasil vaccination
Almost 7 million Gardasil doses have been distributed in Australia, while about 97 million doses have been distributed in 120 countries worldwide.
To 9 February 2013, there were 1991 suspected adverse events following vaccination with Gardasil recorded in the Database of Adverse Event Notifications (DAEN). Gardasil was the sole vaccine administered in 1571 of those cases. In many cases, more than one adverse event was reported. See 'Accessing reports' below for further information regarding DAEN and the public availability of adverse event reports.
The adverse event profile for Gardasil is similar to that reported by the TGA in 2010. The majority of reported adverse events are mild, well-recognised and listed in the Gardasil Product Information and Consumer Medicine Information.
|Suspected adverse event||Number of reports (% of total reports for Gardasil)|
|Injection site reaction*||364 (18.3%)|
|Fatigue and lethargy||217 (10.9%)|
|General feeling of being unwell||162 (8.2%)|
|*Injection site reaction includes one or more symptoms occurring at the site of the injection such as pain, redness, swelling, bruising, rash, itchiness, or lump.|
Fainting: Fainting is common after injections, especially in adolescents and young adults. It is one of the reasons that it is recommended that anyone receiving the vaccine should stay under observation for 15 minutes after the injection. Fainting was reported in 171 cases. Some of these cases also reported shaking or stiffening of the limbs.
Allergy: The number of anaphylactic reactions reported to the TGA was 19. The rate of reporting continues to be in keeping with the rates found in international studies for other vaccines given to adolescents and children.1 Other allergic reactions reported included urticaria (hives) in 159 cases and hypersensitivity in 19 cases.
Demyelination disorders: The TGA continues to find no evidence that the incidence of demyelinating disorders, such as multiple sclerosis, after Gardasil vaccination is higher than would occur by chance. This finding is supported by a recently published safety review of HPV vaccines.2
Deaths: No deaths directly linked to the vaccine have been reported in Australia.
Information regarding males
Please note that the above analysis of adverse events only includes reports publically available in the DAEN to 9 February 2013, which is just after the commencement of the extension of the National HPV Vaccination Program, through which vaccination is now offered to males aged 12-13.
The TGA has closely monitored the adverse events reported following HPV vaccination in February 2013 and no new safety concerns have been identified in males or females.
Reports of adverse events received by the TGA are added to the publically available Database of Adverse Event Notifications (DAEN). Any interested person can search the DAEN for reports received between 1971 and three months prior to the date of access. The TGA uses this three month period of time to investigate the adverse event reports.
Gardasil protects against infection with four types of HPV, known as types 6, 11, 16 and 18. Gardasil has been approved by the TGA for the prevention of the following cancers and diseases caused by these HPV types:
- In females aged 9 through 45 years:
- cervical, vulvar, vaginal, and anal cancers;
- abnormal cells and precancerous lesions (changes in cells which have a risk of turning into cancer) of the cervix, vagina, vulva and anus;
- genital warts; and
- HPV infection.
- In males aged 9 through 26 years:
- anal cancer;
- precancerous lesions of the anus;
- external genital lesions, including genital warts and cancers of the penis; and
- HPV infection.
Vaccination with Gardasil is most effective when given to people before they are likely to be exposed to HPV through sexual contact, which is why the vaccine is given to females and males in their first years of secondary school through the National HPV Vaccination Program as part of the National Immunisation Program.
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to our monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.
- Bohlke K, Davis RL, Marcy SM. Braun MM et al., Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics 2003;112: 815-820.
- Macartney K, Chiu C, Georgousakis M, Brotherton J, Safety of human papillomavirus vaccines: a review. Drug Safety 2013: 36(4) online DOI 10.1007/s40264-013-0039-5.