Ombudsman Finds No Fault in EMA’s HPV Vaccine Investigation

An ombudsman cleared the European Medicines Agency of wrongdoing in the EMA’s investigation of claims that administration of human papillomavirus (HPV) vaccines is linked to two specific syndromes.

Complaints were raised that the investigation by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) was scientifically unsound and that committee members had conflicts of interest. The ombudsman rejected both complaints.

PRAC determined the vaccines were not linked to the syndromes: complex regional pain syndrome, a chronic condition affecting the limbs, and postural orthostatic tachycardia syndrome, in which the heart rate increases after sitting or standing up, causing symptoms such as dizziness and fainting.

The ombudsman recommended greater transparency in the activities of PRAC.