Reactions 1282 - 12 Dec 2009

Gardasil vaccination runningsmoothly in Australia

Vaccination against the human papillomavirus withthe human papillomavirus vaccine recombinantquadrivalent [Gardasil] in Australia, has resulted in a"very low" number of suspected adverse events,according to the Australian Therapeutic GoodsAdministration (TGA).

To date, over 6 million doses of Gardasil have beendistributed in Australia and 1476 suspected adversereactions were reported as at 18 November 2009. Themajority of these adverse reactions have been mild andcommon problems, such as injection-site reactions(19.4%) and psychogenic events (e.g. dizziness,syncope and panic attacks; ≈ 20% combined). As of 18November 2009, 13 reports of anaphylaxis (2.2 per1 million doses) and 131 reports of urticaria had beenreported after injection with the vaccine. All reportedcases were either treated appropriately or resolvedwithout treatment.

The TGA has also reported that it is aware of a smallnumber of cases in which neurological symptoms,similar to those expected from demyelinating disorders,have been reported postvaccination. Based on thereported cases, the TGA has stated that the incidence ofdemyelinating disorders amongst recipients of Gardasilis not higher than would be expected by chance. Nodeaths related to administration of the vaccine havebeen reported.TGA - Therapeutic Goods Administration. Human papillomavirus vaccine(GARDASIL): Advice from the Therapeutic Goods Administration. InternetDocument : [3 pages], 7 Dec 2009. Available from: URL: http://www.tga.gov.au 801140263

» Editorial comment: This document updates a previousreport from the TGA. See Reactions 1267 p1; 801108592

1

Reactions 12 Dec 2009 No. 12820114-9954/10/1282-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved