The European Medicines Agency has announced the launch of a ‘safety review’ of human papillomavirus (HPV) vaccines (see press release). These vaccines, which involve three shots over six months, have been given to around 72 million people across the world with the aim of preventing many cases of cervical or other cancers. In the UK, HPV vaccination was introduced for girls in 2008, and more than eight million doses of the vaccine have been given.

The move follows reports of rare but serious adverse reactions in some young women. The review will focus on two conditions: complex regional pain syndrome (a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS), a condition in which the heart rate increases abnormally after sitting or standing up, and which is common in people with ME/CFS (see our review). These conditions can occur in non-vaccinated individuals, of course, so the European Medicines Agency has to determine whether the number of cases reported with the HPV vaccine is greater than would be expected otherwise. Overall, the European agency says that its review “does not question that the benefits of vaccination outweighs any risk.”

In the context of ME/CFS, this is an interesting development. Some people with ME/CFS say that their illness started after a vaccination or immunisation, and some research supports this. In 2002, a Belgian research group looking for possible triggers of ME/CFS found a small cluster (about 5% of over 1500 cases) where hepatitis B vaccination could have been involved (read abstract). Also, a study in 2000 examining the appropriateness of flu vaccinations, found reports of ‘CFS-related’ adverse events after flu jabs, though the authors related them to “overlap of common, post-influenza immunisation symptoms and CFS constitutional symptoms.” (read abstract). Furthermore, a review from Mexico City published in 2015 suggested that vaccination against HPV could lead to a range of conditions with overlapping symptoms, such as complex regional pain syndrome, POTS and fibromyalgia. The review brought together case reports from across the world that (taken together) point to a “patterned illness” involving chronic pain, headaches, fatigue, and problems on standing – very like the symptoms suffered by people with ME/CFS. The author’s suggestion was that a group of rare but severe reactions following HPV vaccination may be the cause of longer-term nerve damage in a small number of people.

While HPV vaccination is considered beneficial overall, and there is little evidence of serious adverse effects in most recipients, the safety review by the European Medicines Agency is a welcome step, and may lead to increased pharmacovigilance among healthcare professionals for unusual yet potentially serious adverse effects.

Sources
The European Medicines Agency. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines. Press release. Read more.
The Washington Post. Worries about HPV vaccine: European Union medicines agency investigating reports of rare but severe reactions. 2015 July 13. Read more.
Sleigh KM, et al. Double-blind, randomized study of the effects of influenza vaccination on the specific antibody response and clinical course of patients with chronic fatigue syndrome. Can J Infect Dis, 2000 Sep; 11(5): 267-73. Read more (full text).
De Becker P, et al. Possible Triggers and Mode of Onset of Chronic Fatigue Syndrome. Journal of Chronic Fatigue Syndrome 2002; 10(2): 3-18. Read more (abstract only).
Martínez-Lavín M. Hypothesis: Human papillomavirus vaccination syndrome-small fiber neuropathy and dysautonomia could be its underlying pathogenesis. Clinical Rheumatology, 2015 Jul; 34(7): 1165-9. Read more (abstract only).