The European Medicines Agency announced Thursday that evidence "does not support a causal link" between human papillomavirus (HPV) vaccines, such as GlaxoSmithKline's Cervarix and Merck & Co.'s Gardasil, and the development of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women. The agency noted that its Pharmacovigilance Risk Assessment Committee completed a detailed scientific review of the evidence surrounding reports of the two syndromes, adding that "there is no reason to change the way the vaccines are used or amend the current product information."
In its analysis, the EMA evaluated published studies, clinical trial data, reports of suspected side effects from patients and healthcare professionals and data supplied by EU countries. The regulator also indicated that it consulted with leading experts and considered detailed information provided by patient groups concerning the effects CRPS and POTS can have on patients and their families.
The EMA, which noted that the use of HPV vaccines is expected to prevent cases of cervical cancer and other cancers related to HPV infection, stated "the benefits of HPV vaccines therefore continue to outweigh their risks." The agency further indicated that "the safety of these vaccines, as with all medicines, will continue to be carefully monitored."
Commenting on the news, Steve Lockhart, vice president of development at Sanofi Pasteur MSD, remarked "the value of HPV vaccination has been demonstrated through several studies showing significant reductions in the precancerous lesions that lead to cervical cancer." Lockhart continued "this robust, independent scientific review on the safety of the HPV vaccines reaffirms the safety and benefit profile and provides continued reassurance on the role of HPV vaccination in meeting important public health goals."
