Regulators in Europe are undertaking a review of HPV vaccines to “further clarify” elements of their safety profile.
The European Medicines Agency said it is taking a closer look into rare reports of two conditions following their administration, but was quick to stress that whether their benefits outweighs their risks is not being questioned.
The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review data relating to 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.
Reports of these conditions in young women who have received an HPV vaccine have already been considered during routine safety monitoring by the PRAC, which did not establish a causal link between them and the vaccines.
However, it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected to determine whether updates to product information are necessary, the regulator noted.
HPV vaccines currently available in the European Union are Sanofi Pasteur MSD’s Gardasil/Silgard and Gardasil 9, and GlaxoSmithKline’s Cervarix.