Media Release

19 August 2009

Gardasil – Article in the Journal of the American Medical Association

The safety of the Gardasil vaccine is continuously monitored in New Zealand by Medsafe and the independent Centre for Adverse Reactions Monitoring (CARM).

The safety profile of Gardasil is well documented and reflects the information contained in the data sheet. Worldwide over 17 million people are estimated to have been vaccinated with Gardasil. In New Zealand 146,955 doses of the HPV vaccine are recorded on the National Immunisation Register as having been administered to 30 June 2009.

Up to 26 June 2009, there are 155 reports of adverse events to the Gardasil vaccine recorded in the CARM database. Of these reports, only one is classified as serious. This report related to the hospitalisation of an individual with epilepsy two weeks after immunisation. It was considered unlikely that this event was caused by the vaccine.

As its June 2009 meeting the independent expert advisory committee, the Medicines Advisory Reactions Committee, reviewed the adverse event reports to 31 May 2009. The Committee considered that the pattern of adverse events following HPV immunisation did not raise any concerns, and noted that reports will continue to be regularly reviewed.

As one part of its routine monitoring activities, Medsafe regularly scans the scientific literature. Medsafe is aware that a paper, co-authored by the US Food and Drug Administration and Communicable Diseases Center, has been published in the Journal of the American Medical Association (JAMA). This article analyses the adverse reaction reports for the Gardasil vaccine made to the Vaccine Adverse Events Reporting System in the US.

Medsafe is currently reviewing the information contained in the article. As part of this review Medsafe will also consider evidence from other sources in order to assess the relevance, if any, of the JAMA findings.

Medsafe considers that the benefits of vaccination with Gardasil in the prevention of cancer outweigh the possible risks of side effects. It is however an individual’s personal decision whether to take any medicine. If any individual has concerns regarding any medicine which they are taking they should discuss these with their doctor.
ENDS

Please attribute this statement to Dr Stewart Jessamine, Group Manager, Medsafe

Additional information

Gardasil is approved for use for the prevention of cervical, vulva and vaginal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18 in females aged 9 through 26 years. Gardasil is also approved for use in males aged 9 through 15 years for the prevention
of infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18.
A summary of the known information about Gardasil is contained in the data sheet and consumer medicine information; copies of which are available from the Medsafe website (www.medsafe.govt.nz).
Medsafe is the New Zealand medicines and medical devices safety authority, and is part of the Ministry of Health.
CARM is an independent centre based at the University of Otago in Dunedin.
The Medicines Advisory Reactions Committee is an independent expert advisory committee established to provide advice to the Minister of Health about adverse reactions to medicines and vaccines and their risk-benefit profile.