November 5, 2015

expert reaction to assessment concluding no causal link between HPV vaccine in young women and complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)

The European Medicines Agency has announced that the Pharmacovigilance Risk Assessment Committee (PRAC) has completed its scientific review of evidence on complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given the HPV vaccine, and has concluded that the evidence does not support a causal link between the vaccine and the conditions.

Dr Heidi Larson, Senior Lecturer, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, said:

“The new EMA risk assessment report on the safety of the HPV vaccine should build confidence among those who have expressed safety concerns about this vaccine, as well as those administering the vaccines and making policy decisions.

“The news, of course, does not alleviate the stress and anxieties that young girls and their parents went through, but hopefully the de-linking of the reported symptoms with the vaccine will help focus attention on other causes that might have prompted the reported adverse events to ensure an appropriate response.”

Prof. Margaret Stanley, Director of Research and Professor of Epithelial Biology, University of Cambridge, said:

“This review is in accord with the large post licensure active surveillance studies that have been carried out in the Nordic countries (registry based data) and in the USA (large managed care patient groups. These studies covered more than a million individuals and no increased incidence of autoimmune or neurological conditions was associated with HPV vaccination. It is worth noting that the side effect of the HPV vaccine is a sore arm, the side effect of cervical cancer is death.”

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2015/11/WC500196352.pdf

Declared interests

Dr Heidi Larson: “We have received research funding from the organisations below. We do have funding from some pharmaceutical companies, but they do not have any editorial control over what we write or say:

European Commission

NIHR

Novartis

Bill&Melinda Gates Foundation

Merck

MRC

Center for Strategic and International Studies

GSK

World Health Organization.”

Prof. Margaret Stanley: “I have acted as a consultant to GSK, SPMSD and Merck.”