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STIKO publishes interim statement on the new meningococcal serogroup B vaccine, Bexsero®

The German Standing Committee on Vaccination (STIKO) recently published an interim statement on progress in the evaluation of Bexsero® in the National Epidemiological Bulletin (Epidemiologisches Bulletin 2013; 49:495-498; link see below). Here we present a brief summary of the key points.

STIKO concluded that the existent evidence based on results of currently available clinical and strain coverage studies is insufficient to allow a definitive decision regarding a vaccination recommendation to be made at the present time, particularly in the German setting of a low incidence with a decreasing trend in recent years. While no data are available on clinical efficacy of the vaccine, available data suggest that vaccination with Bexsero should protect against a high proportion of strains causing serogroup B (SgB) invasive meningococcal disease (IMD) in Germany, at least in the short term. However, data are insufficient to evaluate the potential strain coverage in different age groups, particularly infants, who have the highest disease risk. Further studies investigating vaccine coverage of strains circulating in Germany are currently underway.

In addition, only limited data are currently available on the persistence of bactericidal antibodies against the four vaccine antigens. These suggest fairly rapid, although differential waning according to vaccine antigen; the significance of this for clinical effectiveness is not yet clear. Furthermore, data on a possible effect of Bexsero on carriage, which could lead to herd effects, are essential for a decision regarding which age groups should be targeted by the vaccine. Thus far, available data are inconclusive on this issue. Additionally, since only about 7,500 individuals have been vaccinated thus far, the risk of possible rare adverse events remains unknown. Finally, data are lacking regarding the feasibility of integrating an additional vaccine requiring 4 doses into the vaccination schedule in the first year of life; a survey of German paediatricians addressing this is currently underway.

Definitive answers to most of these questions will require large-scale epidemiological studies following broad implementation of the vaccine in a high incidence setting.

Nonetheless, vaccination with Bexsero according to the Summary of Product Characteristics may be useful for individuals at increased risk of disease based on individual risk-benefit considerations. This may apply to close contacts of SgB IMD patients, especially household contacts or persons at increased risk due to underlying immunological defects such as asplenia or complement defects.

Date: 09.12.2013