Adverse events following HPV immunization in Australia: Establishment of a clinical network.

OBJECTIVE: To formalise a collaborative national Adverse Events Following Immunisation Clinical Assessment Network (AEFI-CAN) following the expansion of the Australian Human Papillomavirus (HPV) immunisation program to boys in 2013. METHODS: AEFI-CAN linked state-based vaccine safety clinics and the Department of Health including the Therapeutic Goods Administration (TGA). Monthly teleconferences held to discuss HPV related cases. AEFI conditions of interest recorded in a centralised database. RESULTS: Between 1st January 2013 - 31st October 2014, 118 HPV AEFI were documented, 56% in males. The median age was 13 y (range 12-16 years). The majority of AEFI reports were after dose 1 (59%). 76 of 118 (64%) AEFI were seen in a vaccine safety clinic: 62% in Victoria, NSW (16%), South Australia (9%) and Western Australia (8%). Eight TeleHealth consultations were undertaken. AEFI were categorised as: rash 24% of reports (n = 28), urticaria/angioedema 23% (n = 27), anaphylaxis 3% (n = 4). Syncope was also reported (n = 12, 10%) and other neurological events (n = 22, 19%). CONCLUSIONS: We demonstrated the advantages of a national network, providing a collaborative approach to AEFI review and management. The vaccine safety network has applicability to any vaccination program, and has potential to collaborate more broadly with regional pharmacovigilance partners such as New Zealand.

Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.

Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.

Anaphylaxis following quadrivalent human papillomavirus vaccination.

BACKGROUND: In 2007, Australia implemented the National human papillomavirus (HPV) Vaccination Program, which provides quadrivalent HPV vaccine free to all women aged 12-26 years. Following notification of 7 presumptive cases of anaphylaxis in the state of New South Wales, Australia, we verified cases and compared the incidence of anaphylaxis following HPV vaccination to other vaccines in comparable settings. METHODS: We contacted all patients with suspected anaphylaxis and obtained detailed histories from telephone interviews and a review of medical records. A multidisciplinary team determined whether each suspected case met the standardized Brighton definition. Some participants also received skin-prick allergy testing for common antigens and components of the HPV vaccine. RESULTS: Of 12 suspected cases, 8 were classified as anaphylaxis. Of these, 4 participants had negative skin-prick test results for intradermal Gardasil. From the 269 680 HPV vaccine doses administered in schools, 7 cases of anaphylaxis were identified, which represents an incidence rate of 2.6 per 100 000 doses (95% CI 1.0-5.3 per 100 000). In comparison, the rate of identified anaphylaxis was 0.1 per 100 000 doses (95% CI 0.003-0.7) for conjugated meningococcal C vaccination in a 2003 school-based program. INTERPRETATION: Based on the number of confirmed cases, the estimated rate of anaphylaxis following quadrivalent HPV vaccine was significantly higher than identified in comparable school-based delivery of other vaccines. However, overall rates were very low and managed appropriately with no serious sequelae.

Childhood tetanus in Australia: ethical issues for a should-be-forgotten preventable disease.

Refusal of a parent to have a child vaccinated against tetanus raised ethical issues for the treating clinicians. The clinicians felt their duty to the child was compromised, but recognised that our society leaves the authority for such decisions with the parents. As there was no reason, other than different beliefs about vaccination, to doubt the parent's care for the child, the clinicians limited their response to providing strong recommendations in favour of vaccination. Other issues raised by this case include community protection, and the costs to the community of treating a vaccine-preventable disease.