Human Papillomavirus Vaccine and the Ovary: The Need for Research
Proceedings of the 18th World Congress on Controversies in Obstetrics, Gynecology and Infertility. (COGI) October 24-27, 2013 Vienna, Austria
Author and affiliation Deirdre Little dradford@wirefree.net.au Department of General Practice North Bellingen Medical Services, Bellingen, NSW Australia. Visiting Medical Officer Bellinger River District Hospital, NSW, AustraliaThis article published with the permission of the author, Dierdre Little MD
Summary
New onset of menstrual disturbance and oligomenorrhoea commencing four months after quadrivalent human papillomavirus vaccine (HPV4) and proceeding to premature ovarian failure over the next twenty four months occurred in a well 16-year-old girl. Exclusion of metabolic, other endocrine, genetic and overt auto-immune causes left unknown causation as it does in 90% of cases. Enquiry of vaccine animal testing found no research reports were available of ovarian histology or of ongoing ovarian function in vaccine tested rats. Histology reports were available of vaccine tested rat testes and epididymides. Pre-clinical studies did not consider the duration or capacity of the reproductive life-span. Subsequent phase II and phase III clinical studies before vaccine licensing have lacked the capacity to attest to ovarian function due to weaknesses in study design and hormonal contraceptive usage. Studies since licensing lack capacity to evaluate ovarian function due to focus on emergency department presentations, and definitional limitations. Vaccine adverse event notifications of amenorrhoea are poorly investigated and followed up. Other documented published cases of premature menopause following HPV4 vaccination indicate the need for further research of the ovary after HPV4 vaccination. In the interests of women’s reproductive health and egg-bearing capacity, this issue needs to be resolved prior to the implementation of universal vaccination programmes.
Keywords: HPV4 (Gardasil TM) oligomenorrhoea periods ovarian failure menopause