Expert opinion on the introduction of the meningococcal B (4CMenB) vaccine in the EU/EEA
The multicomponent meningococcal B (4CMenB) vaccine Bexsero for the prevention of serogroup B invasive meningococcal disease (SgB IMD) has been available in the European Union/European Economic Area (EU/EEA) since 2013. Meningococcal serogroup B (SgB) is the most common cause of IMD in all age groups at the aggregated EU/EEA level. SgB IMD predominantly affects infants and young children and is the leading cause of mortality and morbidity related to IMD in children under five years of age.
The aim of this document is to provide an ECDC expert opinion on the introduction of the 4CMenB vaccine in the Member States of the EU/EEA. This expert opinion document is intended to support national decision-making by summarising the considerations and concerns of some EU/EEA countries when they discussed whether to introduce the 4CMenB vaccine into their national immunisation programmes. It also summarises the reasons behind national recommendations for the 4CMenB vaccine, points out data gaps, and presents options on how to introduce the vaccine.
Serogroup B invasive meningococcal disease (SgB IMD) is a significant cause of septicaemia and meningitis in EU/EEA countries due to rapid onset, high morbidity and high case–fatality, which makes prevention essential. ECDC has published an expert opinion on the introduction of the multicomponent meningococcal B vaccine (4CMenB) in the EU/EEA, which is intended to support national decision-making in Member States. The ECDC expert opinion provides information on the burden of serogroup B invasive meningococcal disease in the EU/EEA, includes general considerations for 4CMenB introduction such as vaccine immunogenicity, safety, cost-effectiveness, ease of implementation and areas for country collaboration, and highlights different options for vaccine introduction.
In 2015, 1 682 cases of SgB IMD were reported in the EU/EEA through the EU surveillance system (TESSy), with cases highest among infants younger than one year of age although the burden of disease varies between countries.
The first meningococcal B vaccine (4CMenB) was licensed in 2013 in the EU and since then 12 countries have issued recommendations about its use. To date, the vaccine has been introduced into publicly funded national routine immunisation programmes in Ireland, Italy and the UK. Austria, the Czech Republic and Germany (in the state of Saxony) have recommended the vaccine without funding and six countries have introduced the vaccine for risk groups only. Countries which decided not to implement routine vaccination against SgB IMD cited reasons such as low incidence of SgB IMD, unfavourable cost-effectiveness, limited data on efficacy, duration of protection and carriage as well as the need for more safety data.
The 4CMenB vaccine has been shown to be effective in inducing immune response in infants between two and five months on a 3+1 dose schedule, as well as in infants over six months and in children from two to ten years on a 2+1 schedule. In adolescents and adults, two doses led to protective antibodies against the vaccine antigens. Results from the UK, where the vaccine was introduced in the national immunisation programme in a two-dose priming schedule in September 2015, show that two-dose 4CMenB vaccine effectiveness was 82.9% against all SgB IMD cases. Cases in vaccine-eligible infants halved in the first 10 months of the programme.
Economic assessments from Ireland and the UK showed the vaccine to be cost-effective due to the higher incidence of SgB IMD in infants below one year in these countries, and taking into account societal costs, a vaccine price lower than the manufacturer’s list price and a reduced two-dose infant priming schedule. On a general level, the calculation of cost-effectiveness of introducing the 4CMenB vaccine is dependent on the country-specific context.
The expert opinion highlights the importance of communicating with parents and healthcare workers about the vaccine and of collaboration among countries in the assessment process. A series of options are suggested for countries that are considering the introduction of the 4CMenB vaccine; these include universal vaccination of infants below one year of age, vaccination of different age groups, vaccination of individuals at risk or vaccination of individuals in an outbreak setting based on country-specific evaluations and analyses.
 Parikh SR, Andrews NJ, Beebeejaun K, Campbell H, Ribeiro S, Ward C, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016 Dec 03;388(10061):2775-82