Author: Dr. D. Little
Abstract:
The quadrivalent virus-like particle vaccine against human papillomavirus (QHPV) is a population vaccine targeting peri-pubertal girls and boys. Focus on evaluation of adolescent ovarian safety arises from cases in primary care and published case series describing the development of menstrual dysfunction and idiopathic premature ovarian insufficiency (POI) following QHPV vaccination. A structured review of QHPV vaccine safety studies was performed to answer the question ‘has the ongoing ovarian safety of this vaccine in adolescents been assessed?’ The design, size, and process of pre-licensing safety trials in relation to their capacity to assess ovarian function were reviewed. A structured literature search and review of post-licensing QHPV vaccine safety studies was conducted to September 2015. Post-licensing safety studies were hand searched for adolescent enrolment. These studies were further searched for documentation of menstrual function and ability to detect abnormal menstrual function. Vaccine adverse event notifications and regulatory safety statements were sought. Pre-licensing controlled safety trials did not investigate ovarian function. Capacity to observe ovarian function was impeded by safety trials’ design, size and reporting process. Both placebo controls were comprised of vaccine constituents. Both were incorrectly identified. No controlled safety studies post-marketing reported on ovarian function or had the capacity to do so due to their design and pre-specified objectives. One small observational research finding from a syncope unit suggests new menstrual dysfunction in 48% of vaccinated young women. The ongoing ovarian safety of this vaccine in adolescents has not been assessed.
