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Current recommendations in France on vaccination against hepatitis B virus (HBV) are maintained according to the policy report of the commission public hearing on the subject released Thursday.

A public hearing charged to an inventory between vaccination against HBV and the risk of multiple sclerosis (MS) at the request of the Minister of Health and Social Welfare Minister Philippe Douste-Blazy, after the resumption of the debate on the safety of the vaccine against hepatitis B.

In a report of ten pages available on the websites of the three pre-mentioned instances, the jury "confirms the recommendations of the consensus meeting in September 2003 (...)", arguing that "the data presented in the hearing is not likely to jeopardize the positive relationship between income and risk of vaccination against HBV in infants, children and pre-teens. "

"In adults belonging to a risk group, the benefit of vaccination outweighs the risk seems to remain, even considering more than 3 as measured in the study Hernan risk," he adds.

The jury considers however that there is "no sufficient return to justify the promotion of vaccination in adults who are not part of a risk group."

"All the epidemiological, pathophysiological and immunological global data do not exclude the possibility of a risk in adults, but the evidence available to date are insufficient to demonstrate a causal link between vaccination against HBV and central demyelinating diseases, "he said, adding that young people must be reconciled with the adults in the absence of specific epidemiological data for this age group.

To reach these conclusions, the jury obviously brought attention to Hernan study focused on adults. He believes that "in terms of biological plausibility, immunopathological data presented at the hearing did not provide any new information, nor on the possible mechanisms, nor the time to onset of multiple sclerosis after a causal event, "he adds.

A BENEFIT ASSESSMENT / RISK FAVORABLE FOR ADULTS AT RISK

At the public hearing, Daniel Lévy-Bruhl, the Institute of Health Surveillance (VS), presented an evaluation of the benefit / risk of HBV vaccine in adults and adults at risk from risk factor equal to 3 study Hernan, recalling beforehand that this new study should not be isolated from other studies and it is neither better nor worse than the other from a methodological point of view.

In this worst case assumption HBV vaccine, the risk of acute demyelinating damage attributable to the vaccine is more than 2 per 10,000 vaccinated against a background incidence estimated at 2.7 per 100,000.

These figures should be compared to adults at risk of a carrier rate of HBsAg between 4 and 7% and a frequency history of HBV infection between 20% and 60% data in France in HIV + patients or infected with sexually transmitted diseases (STDs) for the years 1990-1996.

The jury of the public hearing stressed the importance of having data to assess the benefit of HBV vaccination in these groups and risk situations.

Risk levels are indeed different between health professionals, drug users parenteral (intravenous use or per-nasal), those followers of tattooing or piercing, people in contact with a subject carrying the HBsAg within a family or community outreach, people infected with HIV or HCV, hemodialysis and chronic transfusion, patients and personnel structures for the mentally disabled, people with multiple sexual partners and / or recent STD travelers highly endemic countries, prisoners and transplant candidates.

On the French cohort Kidmus on children under the age of 16, "Preliminary analyzes unpublished [but presented at the public hearing] would not show a link between vaccination against HBV in infants, children or pre-teen and the subsequent onset of a first episode of acute demyelinating central achievement, "said the jury.

Finally, it stresses that the promotion of a policy of vaccination "is part of a responsibility of the State" and "regret that the recommendations made in 2003 by the jury of the consensus meeting have not yet been work a year after they were issued. "

He also stressed "the need to develop systems for collecting and monitoring data to assess and if necessary adapt the vaccination policy" and to have additional data to regularly assess the risk / benefit ratio of vaccination against HBV.