EMA to further clarify safety profile of HPV vaccines

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

These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV. Cervical cancer is the fourth most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early. The review does not question that the benefits of HPV vaccines outweigh their risks.

As for all licensed medicines the safety of these vaccines is monitored by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The current 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).