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EMA launches review of cervical cancer vaccine safety

Regulator assessing possible side effects of pain and arrhythmia in girls using the treatments

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The European Medicines Agency is looking into the safety of two widely-used vaccines that protect against cervical cancer after reports of possible side effects.

The HPV vaccines - GlaxoSmithKline's Cervarix and Sanofi Pasteur MSD's Gardasil/Silgard and just-approved new version Gardasil 9 - have been approved for nearly 10 years with some 165m doses delivered to around 72m people worldwide.

The EMA is responding to reports of two conditions - complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (PoTS) - in girls receiving the human papillomavirus (HPV) vaccines and wants to see if there is a causal link.

CRPS is a poorly understood condition in which a person experiences persistent severe and debilitating pain - generally in the limbs - while PoTS is an abnormal heart rhythm when standing upright that is relieved by lying down.

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.

The EMA said its pharmacovigilance risk assessment committee (PRAC) will now examine the available data on CRPS and PoTS to see whether there may be a causal link with HPV vaccination before deciding whether any change to recommendations or the vaccines' labelling is required.

The investigation has been prompted by a request by Denmark's medicines regulatory authority, which was informed by doctors at Frederiksberg Hospital that an increasing number of girls who received HPV vaccines required treatment for side effects such as fainting and arrhythmia.

According to the Danish Health and Medicines Authority, there have been around 66 reports globally of PoTS as a suspected adverse reaction after HPV vaccination, mainly coming from Denmark and the US. A cluster of 33 cases were reported in Denmark in the third quarter of 2014.

The country has implemented special measures in the form of a new questionnaire that will ensure follow-up on adverse reaction reports of symptoms suggestive of PoTS, said the agency. 

The EMA said: “Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected.”

Article by
Ben Adams

14th July 2015

From: Regulatory



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