While a petition calling for the establishment of a parliamentary mission to assess the advisability of the Gardasil vaccine has just been signed by more than 420 doctors, the National Agency for the Safety of Medicines and Health Products ( ANSM) has once again reiterated its confidence in the vaccine against the human papillomavirus.
“Since Gardasil was marketed in France and until September 20, 2013, 5.5 million doses have been distributed. 2,092 medically confirmed adverse reaction reports, including 503” serious “, have been collected and analyzed. The majority of these notifications (76%) therefore correspond to non-serious cases (pain at the injection site for example). As for the autoimmune manifestations, which were the subject of particular attention in this new assessment, their number remains low in relation to the exposed population: 127 cases notified in France including 17 cases of multiple sclerosis, since the start of marketing “states the ANSM in its update of the safety data for the Gardasil vaccine, published on his site.
No questioning of the benefit / risk ratio
“In addition, the Pharmacovigilance Risk Assessment Committee (PRAC) undertook in July 2013 the study of a signal relating to a complex regional pain syndrome reported in certain young Japanese girls vaccinated. that Japan recently informed the ANSM that it does not question, to date, the benefit / risk ratio of this vaccine “continues the Agency before adding that” the results of French and international studies carried out in the framework of the monitoring of this vaccine did not bring to light any elements calling into question its safety profile.
Also, all the available surveillance data did not highlight any elements calling into question the expected benefit with regard to the risks of this vaccine “concludes the ANSM
ANSM continues to monitor
However, the ANSM decides to continue its reinforced surveillance of Gardasil and the drug agency is launching with the National Health Insurance Fund a study on the risk of the occurrence of autoimmune diseases in vaccinated women.
Remember that Gardasil is a vaccine indicated in the prevention of diseases caused by human papillomaviruses (HPV), such as cancer of the cervix, precancerous lesions of the vagina or genital warts. And that the High Council of Public Health recommends the vaccination of young girls from 11 to 14 years old with a catch-up up to the age of 19.
