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Meningococci serogroups B is the cause of septicemia and meningitis with a rapid onset of illness, high morbidity and mortality. In the European Union (EU) and European Economic Area (EEA) countries, in 2005, 1,682 cases of B-type meningococcal disease were registered, with the incidence rate highest among infants below the age of 1, although the burden of disease varies between countries.

The first multi-component meningococcal vaccine B (4CMenB) has been licensed for marketing in the EU in 2013, and since then, 12 countries have issued recommendations for its use. Today, this vaccine is included in the state immunization programs in Ireland, Italy and the United Kingdom. Austria, the Czech Republic and Germany (Saxony) recommend this vaccine without public funding, and 6 countries have included it in the immunization program only for those at risk. Countries that have decided not to introduce a routine vaccination against the meningococcal B group have given various reasons for abandoning it: low morbidity, lack of cost-effectiveness, limitation of data on efficacy, safety, duration of protection against infection, etc.

It has been proven that the CMenB vaccine 4 is effective for inducing the immune response in infants aged 2-5 months at doses given in the "3 + 1" scheme, as well as in infants older than 6 months and in infants 2 to 5 years under the scheme "2 + 1 ". In adolescents and adults, 2 doses of the vaccine allowed to achieve the required immune response. Results from the UK, where immunization with 2 doses of the CMenB vaccine was introduced into the national immunization program in September 2015, shows that the efficacy of 2 doses of the 4cmenb vaccine was 82.9% in relation to all cases of meningococcal B group infection. Number of cases the incidence among infants who were eligible for vaccination, halved in the first 10 months of the program.

In turn, data from Ireland and the UK showed that this vaccine is cost-effective because of a higher incidence of meningococcal B-infection among children under the age of 1 in these countries and taking into account social costs, vaccine costs, schedule of vaccination . In general, the cost effectiveness of the 4cmenb vaccine depends on the specifics of a particular country.

ECDC expert opinion on the introduction of a multicomponent meningococcal vaccine b (4 CMenB) in the EU / EEA provides several options for vaccination schemes for countries considering the inclusion of this vaccine in the immunization program: vaccination of all infants under the age of 1, vaccination of different age groups , vaccination of people at high-risk groups or vaccination of people in an outbreak.

In addition, this expert opinion highlights the importance of communicating with parents and health workers on this vaccine and on collaboration between countries in the process of assessing the feasibility of including it in the schedule of immunization.

The document is intended to support the adoption at national level of decisions on vaccination against meningococcal disease in the EU / EEA countries.

By ecdc.europa.eu


Завідувач кафедри загальної фармації  та безпеки ліків

Lyudmila І. SHULGA

Head of the Department of General Pharmacy and Safety of Drugs IPHPQI NUPh,
Doctor Sciences in Pharmacy, Professor

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