The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer's serogroup B meningococcal vaccination to help protect individuals at increased risk.
Specifically, the ACIP voted to recommend serogroup B meningococcal vaccination for persons aged 10 years and older at increased risk for meningococcal disease, including: Persons with persistent complement component deficiencies; Persons with anatomic or functional asplenia; Microbiologists routinely exposed to isolates of Neisseria meningitidis; and Persons identified to be at increased risk because of a serogroup B meningococcal disease outbreak.
In October 2014, Pfizer’s Trumenba (Meningococcal Group B Vaccine) was granted accelerated approval by the US Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
“We are encouraged by this initial ACIP recommendation,” said Dr. Laura York, Global Medical Lead for Meningococcal Vaccines, Pfizer Vaccines. “However, we believe public health would be best served by broader routine recommendations for adolescents and young adults who are currently only protected against serogroups A, C, W and Y. We look forward to continued dialogue with the CDC on the most appropriate vaccination strategies towards prevention of serogroup B meningococcal disease in adolescents and young adults.”
The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval. Once approved, the recommendations are published in the Morbidity and Mortality Weekly Report (MMWR).
Trumenba was recently selected for use during large-scale vaccination clinics at Providence College and the University of Oregon, following cases of serogroup B meningococcal disease on both campuses.
“While uncommon, meningitis B cases continue to be reported on college campuses,” said Susan Silbermann, president, Pfizer Vaccines. “We believe a recommendation for adolescents and young adults to be vaccinated against serogroup B meningococcal disease can't come early enough. Everyone’s goal should be to allow enough time for students to start their vaccination before they return to school next fall.”
Trumenba (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of Trumenba is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of Trumenba against diverse serogroup B strains has not been confirmed.
Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.