EMA Inspects HPV Vaccines’ Safety Profile
The European Medicines Agency has initiated a review of human papillomavirus vaccines to determine if product information should be updated, following reports of rare but serious conditions that may be associated with their use.
Specifically, the agency is looking into reports of a chronic pain condition known as complex regional pain syndrome and an abnormal heart rate disorder called postural orthostatic tachycardia syndrome in people immunized against HPV.
Current HPV information doesn’t include warnings about these conditions.
The agency’s Pharmacovigilance Risk Assessment Committee previously considered reports of both conditions in vaccinated young women during routine safety monitoring, but did not establish a causal link between them and the vaccines. PRAC is conducting the current review as well.
Merck’s Gardasil/Silgard and Gardasil 9 and GlaxoSmithKline’s Cervarix are available as HPV vaccines in the EU. GSK says it is cooperating with the review.
Approximately 72 million people worldwide have been vaccinated against HPV, which is the major cause of cervical cancer, the EMA says. — Jonathon Shacat