EMA to Clarify Safety Profile of HPV Vaccines

July 12, 2015

The European Medicines Agency (EMA) has started a review of human papillomavirus (HPV) vaccines to further clarify aspects of their safety profile.HPVvaccines have been used in around 72 million people worldwide to prevent cervical cancer and other cancers and conditions caused by HPV. Cervical cancer is the fourth most common cause of cancer death in women worldwide.

The European Medicines Agency (EMA) has started a review of human papillomavirus (HPV) vaccines to further clarify aspects of their safety profile.

HPVvaccines have been used in around 72 million people worldwide to prevent cervical cancer and other cancers and conditions caused by HPV. Cervical cancer is the fourth most common cause of cancer death in women worldwide.

The review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness).

Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), but a causal link between them and the vaccines was not established. PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. While the review is ongoing there is no change in recommendations for the use of the vaccine.

 

Further information is available here.