Naar aanleiding van de uitzending van Zorg.nu op 15 november 2016, over het HPV-vaccin, heeft European Medicines Agency (EMA) onderstaande reacties gegeven.
'EMA did indeed conduct a review of HPV vaccines in 2015. The review confirmed the safety of HPV vaccines in relation to two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS). The final EU position is that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS.
You can read more on the outcome of our review on our website here (see the assessment report under the 'all documents' tab).
The review process in place at EMA is robust and multifaceted and it brings together scientific experts from across Europe ensuring a comprehensive, transparent and independent review. Highly experienced regulators and experts in medicines from all Member States take part in this process and any outcome is the result of a collective approach which minimises the risk of bias.
The review of HPV vaccines was carried out by EMA’s scientific committees, the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP). PRAC and CHMP have carried out a detailed scientific review of all available evidence. In addition, they have heard from independent leading experts on vaccination, cardiology, neurology and POTS/CRPS, as well as from patient groups, patients and families.
The decision taken by the PRAC was unanimous, which means that all members and experts of the Committee agreed with the overall conclusion. The PRAC assessment report and conclusions were also unanimously adopted by EMA’s CHMP.
The review took into account various scenarios on reporting rates, diagnostic criteria and risk period. The scientific grounds for the conclusions are detailed in the assessment report mentioned above. Based on this review, we are able to give a strong and reassuring message on the safety of HPV vaccines. EMA continuously monitors the safety of these vaccines, and routine on-going pharmacovigilance activities are in place to review any new safety signal, should they arise from the EudraVigilance database of adverse reactions or from any other source of information.
EMA understands the difficulties faced by young women affected by CRPS and POTS. While there is no evidence of a causal association of these syndromes with the HPV vaccine, it is important that they get the best treatment possible.
I hope this helps. Please do get in touch should you need further clarification.'