Abstract
Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11-14 year-old vaccinees with AEFIs, using the number of qHPV doses distributed within the school-based vaccination programme as the denominator. Between September 2009 and August 2013, 211 AEFIs that occurred in 89 vaccinees were reported, a rate of 149.5 vaccinees with AEFI per 100,000 qHPV doses distributed. For five vaccinees, serious AEFIs (8.4 per 100,000 doses distributed) were reported. The highest reporting rates were for fatigue, headache, and fever (≥38.0⁰) (53.8, 40.3, and 35.3 per 100,000 qHPV doses distributed, respectively). As no AEFI resulted in permanent sequelae and they all were categorised as serious only due to the criterion of a minimum of one day of hospitalisation, this provides reassurance for the safety of our school-based HPV vaccination programme. Further AEFI surveillance is warranted to provide data for HPV vaccination programme monitoring and evaluation of its safety.
Highlights
Two vaccines against human papillomavirus (HPV) infection are currently licensed in Europe
In February 2015, the nine-valent HPV vaccine (Gardasil 9), containing four HPV virus-like particles (VLPs) that are in the quadrivalent HPV vaccine (qHPV) (6, 11, 16, and 18) plus five additional HPV VLP types (31, 33, 45, 52, and 58), was recommended for approval in Europe for use in the prevention of cervical, vulvar, vaginal, and anal cancer, genital warts and precancerous lesions of the cervix, vulva, vagina, and anus [3]
One of the authors (MS) coded all reported Adverse events following immunisation (AEFIs) according to the system organ class, using the Medical Dictionary for Regulatory Activities (MedDRA) used by the European Medicines Agency (EMA) and assessed reported AEFIs for seriousness using the World Health Organization (WHO) surveillance definitions [16,17]
Summary
Two vaccines against human papillomavirus (HPV) infection are currently licensed in Europe. In September 2006: the quadrivalent HPV vaccine (qHPV) (Silgard/ Gardasil), containing virus-like particles (VLPs) of the recombinant major capsid L1 protein of HPV types 6, 11, 16 and 18, was licensed for the prevention of cervical, vaginal, and vulvar precancerous lesions, cervical cancer and genital warts (condyloma acuminata). In February 2015, the nine-valent HPV vaccine (Gardasil 9), containing four HPV VLPs that are in the qHPV (6, 11, 16, and 18) plus five additional HPV VLP types (31, 33, 45, 52, and 58), was recommended for approval in Europe for use in the prevention of cervical, vulvar, vaginal, and anal cancer, genital warts and precancerous lesions of the cervix, vulva, vagina, and anus [3]. HPV vaccination programmes in 25 European countries are currently being conducted for adolescent girls with full or partial funding [5]
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