Reports after HPV vaccination consistent with what would be expected in this age group
The European Medicines Agency (EMA) has today announced the completion of its review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS), in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions. In line with its initial recommendations, the EMA confirms that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil 9) and development of CRPS or POTS. Therefore, the EMA states, there is no reason to change the way the vaccines are used or to amend the current product information.
The review noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME). Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS. Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) carried out the initial stage of the review. It considered published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States. In reaching its recommendations, it also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.
The findings of the PRAC were passed to the EMA’s Committee for Medicinal Products for Human Use (CHMP), along with further representations from patient groups. The CHMP has concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines. It therefore does not recommend any changes to the terms of licensing or the product information for these medicines.
The CHMP’s position will now be passed to the European Commission for a legally binding decision. The assessment report containing the evidence supporting the review will be published shortly on EMA’s website.
The full EMA statement, including specific information for patients and healthcare professionals, can be viewed on the EMA website.
Update: European Commission Implementing Decision
The Commission's Implementing Decision was subsequently published on 12 January 2016.