HPV Vaccines Not a Cause of Two Syndromes, Says EMA

November 9, 2015

A review by the European Medicines Agency shows that the HPV vaccine does not cause complex regional pain syndrome and postural orthostatic tachycardia syndrome.

According to an eagerly awaited scientific review conducted by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee, the human papillomavirus (HPV) vaccination does not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).

The agency concluded that the vaccine, given to teenage girls and boys to protect them from cervical, anal, and/or other HPV-related cancers, as well as genital warts, shows no direct link between the three marketed vaccines-Cervarix, Gardasil/Silgard, and Gardasil-9-and the onset of either CRPS or POTS.

CRPS is a chronic pain syndrome, and POTS is a syndrome in which the heart rate increases to an abnormal level upon sitting or standing up. They both cause dizziness, fainting, headache, nausea, and fatigue, among other symptoms, and affect quality of life.

The committee reviewed published research, clinical trial data, and reports of potential side effects from patients and clinicians. Based on their conclusions from this review, the EMA does not recommend any modification in the way these vaccinations are given.

“The reports of CRPS and POTS after HPV vaccination are consistent with what would be expected in this age group,” they concluded.

The review was initially requested by Denmark in July. The Parliamentary Health Committee of Denmark is conducting their own independent review, having allocated 7 million kroner for the study.

In the United States, HPV vaccination is recommended for girls and boys age 11 to 12 years and through the age of 26 by the American Academy of Pediatrics as of 2012. Women up to the age of 26 and men up to the age of 21 should also be vaccinated if they have not received the full three-dose vaccine. According to the EMA, it is estimated that more than 63 million girls and women worldwide have been vaccinated with Gardasil/Silgard and more than 19 million with Cervarix.

In Europe, Gardasil has been approved since 2006 to protect against HPV-related cancers and genital warts caused by four HPV types (6, 11, 16, and 18) in both boys and girls. Gardasil-9 was approved in June of this year and protects against these four types plus five additional cancer-causing types-31, 33, 45, 52, and 58. Cervarix, available since 2007 in Europe, is approved in women and girls against HPV types 16 and 18. After their approval, the vaccines became part of national immunization programs in many European countries, including Denmark.