HPV-vaksiner er trygge å bruke

Abstract

Background information on the procedureHuman papillomavirus (HPV) vaccines have been authorised in the European Union since 2006 for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), and cervical cancers caused by HPV infection. Gardasil, Silgard and Gardasil 9 are additionally indicated for prevention of premalignant anal lesions, and anal cancers and genital warts (condyloma acuminata) causally related to specific HPV types. Following approval, these vaccines have been introduced in national immunisation programs worldwide, including in most EU Member States.The efficacy and safety of the HPV vaccines have been evaluated in large clinical studies and the benefit of these vaccines in protecting against HPV related diseases is well established. Every year, 34,000 women in Europe are diagnosed with cervical cancer, and 13,000 of them die. The use of HPV vaccines are expected to eventually prevent a large proportion of these cases.Since launch, more than 63 million subjects are estimated to have been vaccinated with Gardasil worldwide. Cumulative marketing exposure to Cervarix is estimated as being more than 19 million subjects worldwide.Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known asComplex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS). The majority of the reported cases do not have a well-defined diagnosis. These syndromes have been reviewed repeatedly since 2013 by the PRAC within routine safety follow-up procedures, and a relationship with HPV vaccines has not been concluded in these previous procedures.Individual case reports and case series of CRPS and POTS suspected to be linked to a HPV vaccine have been published in the literature from several geographically distinct locations. Literature reports of CRPS come from Australia, Germany and Japan and reports of POTS originate from USA, Japan and Denmark.These syndromes have been known for a long time before the introduction of the HPV vaccines. It is recognised that these syndromes can occur in the general non-vaccinated population and it was therefore important to undertake further review to determine whether the number of cases reported with the HPV vaccines is greater than would ordinarily be expected in the absence of vaccination and whether the currently available data supports a causal association with HPV vaccines.The majority of POTS cases that have been reported come from one clinic in Denmark. Furthermore, there has been great media attention regarding potential adverse reactions associated with the HPV vaccine, and concerns regarding the safety of these vaccines have been raised. Therefore, Denmark asked the European Commission to initiate another in depth review. Scientific discussion Introduction HPV infectionHPV infection causes benign and malignant dysplastic disease in both men and women, localized primarily in the anogenital area and ...

HPV-vaksinen ti år – hva er status?

“…Nå er ca. 200 millioner doser distribuert, og den gode sikkerhetsprofilen ble nylig understreket av europeiske myndigheter (18,20).…”

Anogenital HPV

“…[35]. According to the recent 58 studies in nine countries from 2007 to February 2016, it is found that a nearly 90% decrease in HPV infection, anogenital warts and cervical lesions in countries with the highest vaccination rates is seen [36]. Gardasil (quadrivalent) is European Medicines Agency (EMA)-approved for males and females, whereas the EMA-approval for Cervarix (bivalent) is currently limited to females only.…”