EMA says no evidence of link between HPV vaccines and chronic pain syndrome, heart rate increases

The European Medicines Agency said that there is no proof to support a causal link between human papillomavirus (HPV) vaccines, such as GlaxoSmithKline's (LSE: GSK)  Cervarix (HPV bivalent [types 16 and 18] vaccine, recombinant) and Merck & Co's (NYSE: MRK) Gardasil (quadrivalent human papilloma virus [types 6, 11, 16, 18] recombinant vaccine), and the development of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women.

The regulatory agency said that there is no reason to change the way the vaccines are used or amend the current product information after a detailed scientific review from its Pharmacovigilance Risk Assessment Committee seeking evidence surrounding reports of the two syndromes.

Sanofi Pasteur MSD UK (a joint venture between France’s Sanofi and Merck) welcomed the evaluation of the safety profile of these vaccines that has included published research, clinical trial data, adverse event reports and input from leading experts and patient groups.