While relatively rare, meningococcal disease is a serious cause of morbidity and mortality, even when it is managed with state-of-the-art therapy. Meningococcal disease is often hard to diagnose in its early stages because it typically presents with only fever and malaise. However, the disease can progress very rapidly, with death occurring within 24 hours of symptom onset in some cases. In an outbreak of disease, emergency room physicians or family practice specialists often find themselves on the front lines of caring for meningococcal disease. Unfortunately, they may not have any prior hands-on experience in identifying or treating it.
The Development of Vaccines
Because of the pattern of insidious onset and a high risk of severe sequelae and mortality, prevention of meningococcal disease is viewed as the best option. Vaccines have been developed to address this critical public health need and protect those at risk. Vaccines that offer protection against four of the five serogroups of meningococcal disease—A, C, W, and Y—are currently available in the United States and are recommended for routine use in adolescents as well as other vulnerable populations. While these established vaccination programs have reduced the incidence of meningococcal disease in the U.S., serogroup B still causes approximately one-third of all cases overall. Currently, there is no licensed vaccine for serogroup B meningococcal disease, and vaccine development for this serogroup has been challenging.
Examining Recent Efforts
Meningococcal disease tends to occur in outbreaks. For example, in 2013, outbreaks of serogroup B disease occurred at both Princeton University and the University of California, Santa Barbara. To help thwart the spread of disease, the FDA allowed a broad coverage meningococcal B vaccine to be used under an experimental Investigational New Drug protocol that was administered by the CDC. This approach—while necessary for use of an unlicensed product—is not sustainable in the long run. It places a high burden on the CDC and requires waiting for an outbreak to occur, complete with consequent morbidity and mortality, before vaccines can be initiated.
The Emerging Pipeline
Applications for two serogroup B vaccines were recently filed with the FDA to treat meningococcal disease. We’re now poised to have a more complete solution to help prevent individual cases and future outbreaks of the disease. If and when approved, these meningococcal B vaccines will be a means of preventing this specific type of disease and help clinicians finally realize the potential for controlling this formidable pathogen through established vaccination programs.
TimH