MENINGOCOCCAL DISEASE
Meningococcal disease is an aggressive illness that can lead to death within 24 hours of the first symptoms. About 1 in 10 of those with the disease will die despite treatment. One in five survivors suffers from devastating, life-long disabilities such as brain damage, hearing loss, or limb loss7. The highest rates of meningococcal disease occur in the first year of life. Meningococcal infection is a leading cause of bacterial meningitis (an infection of the membrane around the brain and spine) and sepsis. Five main groups of meningococcal bacteria cause the majority of all meningococcal disease cases around the world – A, B, C, W-135 and Y. Licensed vaccines are available to protect against meningococcal disease caused by groups A, C, W-135, and Y; however, MenB, a leading cause of bacterial meningitis in industrialized countries, remains an important unmet public health challenge. The CHMP considered that MebB vaccine had been shown to produce a robust immune response to N. meningitidis group B and the risks were acceptable. Although group B meningococcal disease is relatively uncommon in Europe, the CHMP noted that it is more common in certain regions of Europe. The CHMP noted that young children are most at risk, followed by adolescents, and that there is no other vaccine authorized in the EU for meningitis caused by this group of the bacterium. Therefore, the CHMP decided that MenB vaccine’s benefits are greater than its risks and recommended that it be given marketing authorization.