A new AAP policy statement makes recommendations on the use of two recently licensed meningococcal B (MenB) vaccines. MenB-FHbp (Trumenba) and MenB-4C (Bexsero) are approved for use in individuals 10 through 25 years of age.
The AAP recommendations are based on whether an individual is at increased risk for serogroup B meningococcal disease and are similar to those of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The statement Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older, from the AAP Committee on Infectious Diseases, is available at http://dx.doi.org/10.1542/peds.2016-1890 and will be published in the September issue of Pediatrics.
New vaccines target serogroup B
Neisseria meningitides causes serious and life-threatening infections in individuals of all ages. There are 12 different serogroups of N. meningitides, of which serogroups B, C and Y cause nearly all of the disease in the U.S. Serogroup B is the predominant serogroup causing disease in infants and young children; serogroups C and Y cause the majority of disease in adolescents.
A polysaccharide vaccine and two conjugated-polysaccharide vaccines have been available for prevention of A, C, W and Y meningococcal disease. However, since the polysaccharide of serogroup B meningococcus is not immunogenic, an alternate approach to vaccine development relying on antibodies directed against proteins of serogroup B meningococcus was needed in order to have an effective MenB vaccine.
MenB-4C is licensed as a two-dose series, with the second dose given more than one month after the first dose.
Since each vaccine uses very different protein antigens, the entire vaccine series must be completed with the same vaccine. If an adolescent receives one dose of each of the two MenB vaccines without completing the full series of either vaccine, seroprotection requires that he or she complete the full vaccine series for one of the vaccines. Pediatricians need to communicate to the patient/family which vaccine has been given so that subsequent doses will be with the same vaccine.
Recommendations concerning the need for booster doses will require additional efficacy, safety and antibody persistence data.
Determining increased risk for disease
Individuals 10 years of age and older who are at increased risk for meningococcal B disease are recommended to routinely receive a MenB series (ACIP Category A recommendation).
Individuals at increased risk for serogroup B meningococcal disease include those with persistent complement component deficiencies (C3, C5-C9, properdin, factor D, factor H or receiving eculizumab); anatomic or functional asplenia, including sickle cell disease; and those residing in a community with a serogroup B meningococcal disease outbreak as defined by the local health department on the basis of CDC criteria.
College students are not considered to be at increased risk for serogroup B meningococcal disease since the incidence of meningococcal B disease in college students is not greater than that of the general population of the same age.
MenB vaccine is not routinely recommended for healthy individuals who are not at increased risk for serogroup B meningococcal disease. However, a MenB series may be administered to healthy adolescents and young adults if they wish to obtain short-term protection against diverse strains of serogroup B meningococcal disease (ACIP Category B recommendation).
Based on current epidemiologic data on serogroup B meningococcal disease and antibody persistence for MenB vaccines, the preferred age for MenB vaccination is 16 through 18 years.
MenB vaccine is routinely recommended only for those at increased risk for meningococcal B disease because 1) meningococcal B disease is at historically low levels and 2) some important data are preliminary or not yet available even though both vaccines were approved by the Food and Drug Administration. The pending data include long-term side effects profile; duration of immunity (preliminary data suggest approximately 60% of recipients still have protective levels of antibody two years post-vaccine); efficacy of MenB vaccine in preventing meningococcal disease due to serogroup B meningococcus strains whose proteins differ from the protein antigens contained in the vaccine; and the impact on nasopharyngeal carriage.
In addition, vaccine efficacy was based on a serologic response that is a presumed measure of protection, i.e., based on the ability of vaccine-induced antibodies to kill meningococcal strains selected as representative strains in the U.S. In vitro killing of meningococcal B strains may not be a true indication of protection. Since the protein antigens used in both vaccines vary among different serogroup B meningococcal, neither MenB vaccine is expected to protect against all strains of serogroup B meningococcal disease in the U.S.
Dr. Brady is an ex officio member of the AAP Committee on Infectious Diseases and associate editor of the AAP Red Book.See related Q&A on MenB at http://www.aappublications.org/news/2016/08/29/MenBSide082916.