The State of Vaccine Confidence

The State of Vaccine Confidence

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Confidence Commentary: Blog archive

European Medicines Agency releases new report confirming HPV vaccine safety

Heidi Larson | November 6, 2015

EMA Press Release – 05 November 2015
 The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions. This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information.  (See the original EMA press release here)

Immediate comment from Heidi Larson

“The new EMA risk assessment report on the safety of the HPV vaccine should build confidence among those who have expressed safety concerns about this vaccine, as well as those administering the vaccines and making policy decisions. The news, of course, does not alleviate the stress and anxieties that young girls and their parents went through, but hopefully the de-linking of the reported symptoms with the vaccine will help focus attention on other causes that might have prompted the reported adverse events to ensure an appropriate response.”