Following the complaint of a French patient against the laboratory marketing Gardasil. The European agency does not confirm the link between this vaccine and the occurrence of multiple sclerosis.
While at the end of November the ANSM had confirmed that, in view of all the efficacy and safety data, the benefit / risk ratio of the HPV Gardasil vaccine remained favorable, it is now the turn of the Europe to clarify its opinion. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which met from December 2 to 5, 2013 in London, is in line with the French authorities.
No link between the HPV vaccine and the occurrence of MS
Following the media coverage of Marie-Océane’s case and her decision to take legal action on the occurrence of her multiple sclerosis after her vaccination with the Gardasil vaccine, the PRAC discussed the possibility of a link between the anti-vaccination -HPV and the occurrence of this disease. According to this committee, HPV vaccines are monitored regularly (every 6 months) and attentively at European level when reviewing periodic safety reports. To date, multiple sclerosis is not an effect listed in the summaries of product characteristics. This new point on the available data therefore does not make it possible to establish a link between anti-HPV vaccination and the occurrence of multiple sclerosis. The PRAC stressed, however, that due to the age at vaccination and the average age of onset of MS, it is inevitable that cases of MS are reported following vaccination without this establishing a causal link. This potential risk will continue to be monitored in future vaccine safety reviews.
15 cases of multiple sclerosis in seven years in France
Gardasil is a vaccine indicated for the prevention of precancerous and cancerous lesions of the cervix caused by certain human papillomavirus (HPV) infections. Since its launch on the French market in November 2006, this vaccine has been the subject of reinforced national pharmacovigilance monitoring as part of a national risk management plan (RMP) which complements a European RMP. As a result, out of more than 5 million doses of the Gardasil vaccine distributed in France since its marketing, 435 cases of serious adverse effects including 135 of autoimmune diseases including 15 cases of MS have been reported to the national CRPV network (regional centers for pharmacovigilance) and to the laboratory concerned for this vaccine. Furthermore, data from international and French literature do not show an increase in the incidence of autoimmune diseases or more particularly of MS after vaccination with Gardasil. “Health insurance data, relating to a cohort of nearly 2 million young girls born between 1992 and 1996 and followed over a period from 2008 to 2010, confirm these results” specified the ANSM at the end of November.
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