In January 2013 a new vaccine, Bexsero® from Novartis and Diagnostics S.r.l., against invasive meningococcal disease caused by Neisseria meningitidis serogroup B was authorised by the European Commission. This new vaccine is indicated for active immunisation of individuals from 2 months of age and older. With the aim of establishing the use of this vaccine from the public health perspective an assessment has been conducted following the framework described in the document “Assessment criteria to support changes in the immunisation programme in Spain” (Criterios de evaluación para fundamentar modificaciones en el programa de vacunación en España).
The disease burden of invasive disease caused by N. meningitidis serogroup B in Spain and the recently authorised vaccine were assessed fulfilling the assessment of step 1 established in the aforementioned document.
In the 2011‐2012 epidemic season a steady decrease in tendency in the meningococcal disease incidence was observed pertaining to all group ages and in every region in Spain. This decrease in tendency started in the 1999‐2000 season.
The new vaccine is a 4 component‐vaccine, made up of 3 proteins obtained by DNA recombinant techniques and outer membrane vesicles which contain mainly PorA protein. Vaccine efficacy has been inferred by demonstrating the immune response using subrogate markers of protection, having adequate response for every age group in clinical trials. The vaccine effectiveness, the persistence of immune response at short and medium term and clinical importance of its use are not known at this moment. Pertaining to safety a high proportion of local reactions and fever ≥38ºC have been observed in vaccinated infants, mainly when the vaccine is co‐administered with other vaccines. There is no available information about the efficacy and safety of the vaccine in immunodeficient and other vulnerable populations
In order to estimate the potential coverage of the vaccine in Spain a study of meningococcal strains that caused invasive disease during the period from the end of 2008 to mid 2010 was conducted showing a 68.7% coverage.
Taking into account the available information and the epidemiology, the introduction of the vaccine in the immunisation programme is not considered justifiable at this moment. Resuming the assessment of the vaccine is recommended as soon as key information about clinical protection is available in any region or country in our context and a laboratory surveillance system is set out in order to study the effectiveness of the vaccination and evolution of the circulating meningococci population. Health authorities can assess the use of the vaccine in specific outbreak or isolated case situations of invasive meningococcal disease caused by serogroup B strains.
- Recommendation
- Europe
- Spain
- Meningococcal disease
