Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance

Australia was one of the first countries to licence a quadrivalent human papillomavirus (HPV) vaccine, rapidly followed by a federally funded program of universal vaccination of a broad age group of females through schools (12 to 18 years) and primary care (19 to 26 years). As of August 2009, more than 5.8 million doses of Gardasil((R)) (quadrivalent; Merck, New Jersey, USA) have been distributed in Australia and a total of 1394 suspected adverse events following immunisation (AEFI) have been reported to the passive surveillance system. Most reports are of common and expected reactions. Case series of more uncommon and serious AEFI, both known to be potentially vaccine related (anaphylaxis, conversion disorders and lipoatrophy) and otherwise (multiple sclerosis and pancreatitis) have been published.