Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

A Case Series Seen in General Practice

Authors: Deirdre Therese Little, MBBS, DRANZCOG, FACRRM1Harvey Rodrick Grenville Ward, Bsc(Med), MBChB, DMCOG, FCOG(SA), MMed (O&G), FRANZCOG2

Abstract

Three young women who developed premature ovarian insufficiency following quadrivalent human papillomavirus (HPV) vaccination presented to a general practitioner in rural New South Wales, Australia. The unrelated girls were aged 16, 16, and 18 years at diagnosis. Each had received HPV vaccinations prior to the onset of ovarian decline. Vaccinations had been administered in different regions of the state of New South Wales and the 3 girls lived in different towns in that state. Each had been prescribed the oral contraceptive pill to treat menstrual cycle abnormalities prior to investigation and diagnosis. Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence.

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Comments

  1. This information presented by Dr.Little and co-workers is extremely important.

    Information from the Gardasil package insert regarding congenital anomalies includes:
    “For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 1 case of congenital anomaly in the group that received AAHS control or saline placebo”.

    https://www.michigan.gov/documents/mdch/AcipMinJun06_FB100506_174608_7.pdf
    Page 22:
    “A panel of four teratologists from around the world examined these data in a blinded fashion and unanimously agreed that the congenital anomalies were highly unlikely to be associated with the administration of GARDASIL”.

    I contacted the European Medicines Agency (EMA) for access to the teratologists’ study.
    Their reply included this link:
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001779.jsp&mid=WC0b01ac058004d5c1

    Quote: “The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune”.
    It may well be questioned whether pharmaceutical companies sometimes actually cooperate in helping each other to delay or even to prevent revelation of information

  2. Thank you for that input Sandy. The likelihood of collusion is an ever present concern for many physicians. See ” HPV Gardasil and Safety Concerns”,
    http://www.drnevillewilson.com

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