IPVS Policy statement on safety of HPV vaccines.

Approximately 250,000 women die every year of cervical cancers caused by human papillomavirus (HPV). Most of these could have been prevented by the currently available prophylactic HPV vaccines. Thousands of men and women also die every year of other HPV-associated cancers, including cancers of the anus, vulva, vagina, penis and oropharynx. Yet there are now HPV vaccines currently approved for the prevention of cancers of the cervix, anus, vulva and vagina and their precursor lesions.

These currently licensed HPV vaccines have been reviewed extensively and scientifically, for efficacy as well as safety. This was first reported from clinical trials that provided evidence supporting licensure of the vaccines. As the vaccines have been incorporated into public health programs in real world situations, they have continued to show excellent safety and effectiveness outcomes.

The safety of these vaccines has been reviewed by multiple medical authorities and regulatory agencies globally, including the World Health Organisation [1] and its Global Advisory Committee on Vaccine Safety (on multiple occasions [2]), Food and Drug Administration (FDA) [3], European Medicines Agency (EMA) [4], and International Federation of Gynaecology & Obstetrics (FIGO) [5]. Vaccine safety has also been reviewed by health authorities in many individual countries such as the Medicines & Healthcare Products Regulatory Agency of the UK [MHRA] [6], the Therapeutic Goods Administration of Australia [7], and Centres for Disease Control, USA [8], [9]. All have endorsed them as safe and effective. Importantly, there is no evidence for neurological or autoimmune diseases caused by the HPV vaccines [10], [11], [12], [13]. To date, there have been no deaths directly attributed to HPV vaccination.

The International Papillomavirus Society (IPVS) is the world’s leading professional society devoted to the study of papillomaviruses and the diseases that they cause [14]. IPVS is comprised of basic scientists, clinical scientists, clinicians, public health experts, epidemiologists, and community advocates. IPVS strongly endorses HPV vaccination of all girls and women per the indications specified by the relevant national regulatory authorities and vaccination of boys and men wherever already approved. IPVS urges national regulatory authorities in countries where HPV vaccination is not currently available to implement HPV vaccination in girls and women as soon as possible and to strongly consider vaccination of boys and men.

IPVS Policy Committee members:

Prof. Suzanne M. Garland, MBBS, MD, FRCPA, FRANZCOG, FAChSHM, FASM, FFSc(RCPA)

Director of Microbiological Research and of Clinical Microbiology and Infectious Diseases, The Royal Women׳s Hospital.

Professor, Department of Obstetrics, Gynaecology, University of Melbourne, Victoria, Australia.

Honorary Research Fellow, Murdoch Childrens Research Institute.

Past and Inaugural President of AOGIN (Asia Oceania research organization on Genital Infections and Neoplasia).

Professor Margaret Stanley, OBE FMedSci HonFRCOG

Department of Pathology, Cambridge, United Kingdom

A/Prof. Julia Brotherton B Med (Hons) MPH (Hons), Grad Dip App Epi, FAFPHM, PhD

Medical Director, National HPV Vaccination Program Register, Victorian Cytology Service, Australia

Honorary Principal Fellow, School of Population and Global Health, University of Melbourne, Victoria, Australia

Professor Anna-Barbara Moscicki, MD

Department of Pediatrics,

Chief, Adolescent & Young Adult Medicine

Professor of Pediatrics

David Geffen School of Medicine

University of California, Los Angeles, USA

Professor Neerja Bhatla, MBBS, MD, FICOG, FIMSA, FAMS, Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi, India

President, AOGIN; President, AGOI

Chairperson, Gynecologic Oncology Committee, FIGO; Board Member, IFCPC

Chairperson, Oncology & Trophoblastic Tumours Committee, FOGSI

PD Dr. Andreas M. Kaufmann, PhD

Gynaekologische Tumorimmunologie, Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany

Prof R. Sankaranarayanan, M.D.

Head, Early Detection & Prevention Section (EDP) and Head, Screening Group (SCR) International Agency for Research on Cancer (WHO-IARC)

Prof Joel Palefsky, Past-President IPV

Professor of Medicine

Division of Infectious Disease

University of California

San Francisco, USA

On behalf of IPVS (This document was approved by the IPVS members on the 19th of September, 2015).