EU drug regulator starts safety review of HPV vaccines

The European Medicines Agency (EMA), the EU’s drugs authority, announced on Monday that it would review the safety of the human papilloma virus (HPV) vaccine.

While the review is ongoing, there is no change in recommendations for the use of HPV vaccines.

The agency stresses however that the review does not raise questions about whether the vaccines’ benefits in preventing cervical cancer outweigh their risks and says there should be no change to national HPV vaccination recommendations.

Over 100 Danish girls have thus far applied for financial compensation for their side effects and according to Svenska Dagbladet, three of them have received compensation totaling more than four million kroner ($593,000 or 536,000 euro). In the United States, public health officials have campaigned aggressively over the past few years using everything from birthday card direct mailings to social media campaigns to get children – both boys and girls – to get the vaccine. However, it still remains of concern amid rising side effect speculations, whether or not the vaccine does provide more harm than good to its patients.

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

Instead, it will focus on whether they are linked to two rare conditions: complex regional pain syndrome, a chronic pain condition affecting the limbs, and postural orthostatic tachycardia syndrome, “a condition where the heart rate jumps abnormally after sitting or standing”, The Associated Press reported. Certain HPV strains can cause cancers of the cervix, head, neck and anus.

Human papillomavirus (HPV) is an ordinary, mostly sexually transmitted infection.

Both conditions can occur in non-vaccinated individuals and the EMA wants to discover whether the number of reports of CRPS and POTS among women who receive the vaccines matches the number that would be expected among the general population.

The review of HPV vaccines has been initiated by the European Commission at the request of Denmark, under Article 20 of Regulation (EC) No 726/2004.