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Hum Vaccin Immunother. 2016 Oct 2;12(10):2662-2665. doi: 10.1080/21645515.2016.1192737. Epub 2016 Jun 13.

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

Author information

1
a Department of General Medicine , Royal Children's Hospital (RCH) , Melbourne , Australia.
2
b SAEFVIC, Murdoch Childrens Research Institute (MCRI) , Melbourne , Australia.
3
c Department of Paediatrics , The University of Melbourne , Melbourne , Australia.
4
d Discipline of Paediatrics, University of Adelaide , Adelaide , Australia.
5
e Monash Health & Monash University , Melbourne , Australia.
6
f Westmead Children's Hospital , Sydney , Australia.

Abstract

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.

KEYWORDS:

HPV; clinical network; safety; vaccine

PMID:
27295585
PMCID:
PMC5084979
DOI:
10.1080/21645515.2016.1192737
[Indexed for MEDLINE]
Free PMC Article

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