Meningococcal meningitis is swift and often lethal and, for decades, reliable vaccines were out of reach for the African countries that suffer the greatest disease burden. But the 2010 introduction of MenAfriVac®—Serum Institute of India Pvt. Ltd.’s (SIIPL’s) conjugate vaccine that protects against serogroup A meningococcal meningitis and that was designed specifically for use in Africa—changed the game.
MenAfriVac had huge success in eliminating serogroup A meningitis (at the time, the most common form of the disease) but it didn’t protect against the other meningococcal serogroups in circulation.
Then came MenFive®, SIIPL’s multivalent conjugate vaccine that protects against the five predominant causes of meningococcal meningitis in Africa, receiving World Health Organization (WHO) prequalification in 2023. MenFive has immense potential to eliminate all meningococcal meningitis outbreaks and epidemics from Africa’s meningitis belt, but, though introduction has been prioritized for the highest burden countries, full introduction across the entire meningitis belt will likely take several years. Moreover, logistical and economic challenges can occur when all countries are relying on a single supplier and a single supply of vaccines.
To ensure sustainable vaccine access in the African meningitis belt, we need additional, affordable meningococcal meningitis vaccines options—a key tenet of the WHO’s Defeating Meningitis by 2030 initiative.
That’s why, with funding from the Gates Foundation and the RIGHT Foundation, we’re evaluating a new multivalent meningococcal conjugate vaccine developed and manufactured by EuBiologics Co. Ltd. in the Republic of Korea. This new vaccine candidate, which contains all five meningitis serogroups circulating in the meningitis belt, could one day be a new and complementary tool in the meningitis prevention toolkit.
A history of devastation
Meningitis—a serious infection of the thin lining surrounding the brain and spinal cord—has many causes, usually viruses or bacteria. Viral cases typically resolve in their own; bacterial cases can be devastating.
Meningococcal meningitis is a bacterial form of meningitis that has the most potential to cause large epidemics. While it can occur anywhere in the world, it’s most prevalent in Africa’s meningitis belt, a string of 26 countries from Senegal and The Gambia in the west, to Ethiopia in the east with an at-risk population of about 470 million. For people living in the meningitis belt, meningococcal outbreaks and epidemics are a terrifying annual threat that can reach large-scale proportions.
Historically, reactive, emergency mass vaccination campaigns using polysaccharide meningococcal vaccines were the only recourse for African countries suffering meningococcal meningitis epidemics.
Polysaccharide vaccines are typically more affordable than complex conjugate vaccines, but they have substantial limitations. They only provide short-term protection, don’t promote herd protection, are not effective in children younger than two years of age, and don’t provide coverage against all meningococcal serogroups.
This meant communities needed to be vaccinated each time an epidemic struck—an expensive approach that put a high burden on Africa’s already-stretched health system. Moreover, these campaigns were conducted in response to epidemics and so were often implemented after the epidemic had already progressed significantly—offering very limited health impact.
The introduction of affordable meningococcal conjugate vaccines to the African meningitis belt—which can be used not only in one-time mass campaigns in a broad age group, but also in routine infant immunizations—marked a new era, however, and demonstrated that meningococcal meningitis prevention and control in Africa was possible.
The great success of MenAfriVac and the huge potential of MenFive have helped lay the pathway for new meningococcal meningitis vaccines like the one we’re evaluating.
The great success of MenAfriVac and the huge potential of MenFive have helped lay the pathway for new meningococcal meningitis vaccines like the one we’re evaluating.
Building a larger toolkit
A Phase 2/3 study of EuBiologics’ pentavalent meningococcal conjugate vaccine candidate began in September 2024 in Bamako, Mali. A second site in Banjul, The Gambia, will begin enrolling participants in early 2025.
Between the two sites, the study will enroll about 4,200 participants between 9 months and 29 years of age, and will evaluate the vaccine candidate’s safety and immunogenicity and performance when compared to a licensed vaccine.
The vaccine candidate contains meningococcal serogroups A, C, W, Y and X and is designed to provide the same level of protection as MenFive. Notably, it’s packaged in a fully liquid, multi-dose presentation which helps lower costs, reduces storage needs, and makes administration simple for health care workers.
Importantly, because EuBiologics’ pentavalent meningococcal vaccine candidate has already entered Phase 2/3 clinical development, if results are successful, regulatory approval and market availability could happen in the near future—potentially within 3-4 years.
This is crucial for expanding vaccine access as it would make available a second affordable vaccine that is effective against all five serogroups circulating in the meningitis belt. Even though multivalent meningococcal conjugate vaccines have been available and in use for years in higher-income countries, MenFive was the first to offer a lower cost alternative to low- and lower-middle-income countries, and to include protection against serogroup X—which is increasingly implicated in African meningitis outbreaks.
Continued outbreaks of meningococcal meningitis offer a lesson for why we mustn’t take our foot off the gas pedal. For instance, Nigeria faced an outbreak of serogroup C meningitis between October 2023 and March 2024 that was stemmed with the help of a large, reactive MenFive campaign. And in 2023, there was a 50 percent jump in annual meningitis cases reported across Africa from non-meningococcal A serogroups.
There is no doubt the world has made huge strides in the last decade-plus toward preventing meningitis but the work isn’t done. Introduction of the MenFive pentavalent vaccine is just starting and stakeholders are working to make sure the countries that need meningococcal meningitis vaccines the most have access.
This evaluation of EuBiologics’ pentavalent meningococcal conjugate vaccine keeps that momentum going. Along with our partners, PATH is committed to ensuring sustainable vaccine access for all meningitis belt countries and helping to eliminate meningococcal meningitis epidemics in Africa.
