EMA’s PRAC conducted a referral procedure to examine whether there is any evidence of a causal link between HPV vaccination and two syndromes, complex regional pain syndrome (CRPS), a chronic pain condition affecting the limbs, and postural orthostatic tachycardia syndrome (POTS), a condition where the heart rate increases after sitting or standing up. PRAC concluded that the evidence did not support a finding that HPV vaccines cause CRPS or POTS.
The complaint, submitted by three researchers, a medical doctor, and a Member of the European Parliament, expressed concerns about the handling of the referral procedure, its transparency and openness, and its impartiality. They mainly disagreed with the nature of PRAC’s scientific work.
The Ombudsman’s review followed a complaint which expressed concerns about aspects of the PRAC’s handling of the referral procedure.
The Ombudsman concluded that there were no procedural findings that could have negatively impacted the work and the conclusions of the PRAC referral procedures.
The Ombudsman concluded that the available evidence does not support that two specific syndromes, CRPS and POTS in young women and girls are caused by HPV vaccines.
The Ombudsman found there was no conflict of interest by EMA.