E-DRUG: Human papillomavirus vaccines: review of regulatory evidence from EMA
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Dear colleagues,
The Indian Journal of Medical Ethics recently published a review of the regulatory evidence from the European Medicines Agency on human papillomavirus vaccines, complex regional pain syndrome, postural orthostatic tachycardia syndrome, and autonomic dysfunction.
The full paper is available at
http://ijme.in/articles/human-papillomavirus-vaccines-complex-regional-pain-syndrome-postural-orthostatic-tachycardia-syndrome-and-autonomic-dysfunction-a-review-of-the-regulatory-evidence-from-the-european-medi/?galley=html
while the text of the abstract is here below:
"Recent concerns about a possible association between exposure of young women to human papillomavirus (HPV) vaccines and two "dysautonomic syndromes" (a collection of signs and symptoms thought to be caused by autoimmunity) - complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) - led the European Medicines Agency (EMA) to review existing evidence. The review was announced by the EMA on July 13, 2015, and was completed on November 4, 2015.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) carried out the review. The PRAC's review process was confidential. It concluded that there was no evidence of an association between the HPV vaccines and CRPS and POTS despite the existence of independently clustered reports or "signals".
Against the background of the public health importance of HPV vaccines and the secrecy surrounding the EMA's review process, this paper brings together relevant hitherto unseen and uncensored procedural review documents from both the manufacturers and the EMA to assess the process behind the EMA review and expose it to public view by making the documents available.
The PRAC review was carried out in close collaboration with the HPV vaccines' three manufacturers: GlaxoSmithKline Biologicals, Merck Sharp & Dohme Limited, and Sanofi Pasteur MSD. The documentation assembled raises several questions about the quality of the EMA review".
Raffaella Ravinetto
Institute Tropical Medicine, Belgium
Raffaella Ravinetto <rravinetto@itg.be>