Concerned by reports of serious adverse effects in young women receiving human papillomavirus (HPV) vaccines, the European Medicines Agency has , it said early Monday.
"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)," the EMA said in a statement.
Causality has not yet been established yet, the agency stressed, noting that "both conditions can occur in non-vaccinated individuals."
One goal of the review will be to establish whether HPV vaccine recipients have experienced these conditions at rates greater than normally seen in the general target population. It will also examine "possible causes and pathophysiology of CRPS and POTS" with an eye toward determining the biological plausibility of a connection with HPV vaccination.
Some 72 million people worldwide have received HPV vaccines, the EMA said. "The review does not question that the benefits of HPV vaccines outweigh their risks," it stated.
Three HPV vaccines are currently licensed in Europe: Gardasil/Silgard, Gardasil 9, and Cervarix, all of which are approved in the U.S. as well.