What is Bexsero? How common is meningococcal disease serogroup B?
With the eighth case of meningococcal meningitis confirmed at Princeton University yesterday, and at least seven confirmed as Neisseria meningitis serotype B (MenB) with the most recent still pending, health officials will allow the “not-FDA-approved” Bexsero to be used at the University to vaccinate the student population.
Earlier this year, the Novartis Bexsero vaccine was approved for use in the European Union and in Australia. The vaccine is the first to protect against MenB.
Meningococcal disease is a leading cause of bacterial meningitis. Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world.
According to the European Medicines Agency, approximately 1.2 million cases of invasive meningococcal disease are recorded worldwide annually; of which 7,000 occur in Europe. Over 90% of cases of meningococcal meningitis and septicemia are caused by five of the 13 meningococcal serogroups, specifically groups A, B, C, W135 and Y.
In Europe, group B is the most prevalent meningococcal serogroup, with 3,406-4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Prevention and Control.
Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen, according to the Australian Meningococcal Surveillance Program Annual Report 2011.
Currently, there are two vaccines in the United States ,meningococcal polysaccharide vaccine (Menomune®), and meningococcal conjugate vaccine (Menactra® and Menveo®), that protect against Neisseria meningitidis.
However, they only protect against Neisseria meningitidis Serogroups A, C, Y and W-135.
According to the Centers for Disease Control and Prevention (CDC), the most common ones that cause disease in the United States are B, C, and Y. In 2012 there were about 500 total cases of meningococcal disease, and 160 of those cases were caused by serogroup B.
The US Food and Drug Administration (FDA) is allowing the use of the vaccine at Princeton University under an Investigational New Drug application.
The vaccine would be recommended for all Princeton University undergraduate students (those who live in dormitories or off-campus) as well as graduate students who live in dormitories. Although New Jersey regulation requires that all students who enter a four-year university and reside in a campus dormitory get the shot against the four serogroups, serogroup B is not covered and even if students have been vaccinated, Bexsero would be required to protect against the outbreak strain of meningitis serogroup B. The vaccine would be voluntary.
The CDC says based on studies of serogroup B meningococcus that cause disease in the United States, this vaccine would cover 91% of circulating strains. Lab testing has been done to confirm that the vaccine would help protect against the exact strain of meningococcal bacteria that is causing the outbreak at the University. The outbreak strain at Princeton University is ST409.
On the CDC web page, Serogroup B Meningococcal Vaccine Questions and Answers, the agency answers the question, “Why is the vaccine not approved for use in the United States?” by directing it to Novartis and their plans to seek licensure in the United States.
Will a serogroup B meningococcal vaccine eventually be licensed for use in the United States?
The CDC says it is possible that manufacturers will get this type of vaccine licensed in the United States in the future. In April, 2011, an FDA advisory committee discussed the data available at that time about serogroup B meningococcal vaccines and approaches for getting those vaccines licensed in the United States.
For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page