There is no evidence to support a causal link between human papillomavirus vaccines and the development of two conditions - complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS), European regulators have confirmed.
The finding comes from a European Medicines Agency’s Pharmacovigilance Risk Assessment Committee review of evidence surrounding rare reports of CRPS and POTS in young women given the vaccines - GlaxoSmithKline’s Cervarix and Sanofi Pasteur MSD’s Gardasil/Silgard and Gardasil-9 - for protection against cervical cancer and other HPV-related cancers and pre-cancerous conditions.
CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue. In some patients they can severely affect the quality of life.
After looking at the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as consulting with leading experts in the field and a number of patient groups, the PRAC concluded that there was no difference in the overall rates of these syndromes in vaccinated girls and expected rates in these age groups.
Its conclusions echo earlier findings from routine safety monitoring which also failed to find a causal link between these conditions and the vaccines and, as such, their safety information will not be updated.