Pfizer Inc., a research-based global pharmaceutical company, announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers.
Specifically, the ACIP voted that a serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age.
Pfizer’s Trumenba (meningococcal group B vaccine) is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
“Healthcare providers should understand the importance of today’s ACIP recommendation to help protect adolescents and young adults,” said Dr. Laura York, global medical lead for meningococcal vaccines, Pfizer Vaccines. “This recommendation is an important step forward that provides guidance that serogroup B meningococcal disease vaccination may be administered between the ages of 16 through 23, with preferred timing for vaccination between ages 16 through 18.”
The ACIP recommendation 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). The Affordable Care Act (ACA) and Vaccines for Children (VFC) program ensure coverage for all vaccines administered in accordance with ACIP recommendations. Healthcare providers should contact their individual plan to determine specific coverage and reimbursement requirements.
“Serogroup B meningococcal disease is an uncommon but serious illness that attacks without warning and may become life-threatening within 24 hours,” said Susan Silbermann, president, Pfizer Vaccines. “Parents and healthcare providers should take action now and consider vaccination particularly for those aged 16 through 23. No one in this age group should lack access to potentially life-saving vaccines.”
This recommendation expands the CDC’s ACIP February 2015 recommendation for serogroup B meningococcal vaccination.
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.
As with any vaccine, Trumenba may not prevent disease in all vaccinated individuals. The frequency of meningococcal disease caused by serogroup B varies geographically, and could influence the ability to evaluate effectiveness of the vaccine in any given country. Based on the low incidence of meningococcal disease, placebo-controlled clinical trials for Trumenba were considered unfeasible due to the size of the study that would be required and were not performed. Licensure of Trumenba was based on demonstration of immune responses measured using a serum bactericidal assay with human complement (hSBA).
In 2014, Trumenba was reviewed and received accelerated approval under the FDA's Breakthrough Therapy designation and Priority Review programmes.
The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidisserogroups (A, B, C, W and Y). Serogroup B meningococcal disease affects all age groups in the US, but incidence is highest among infants younger than one year, adolescents and young adults. In 2013, approximately 500 cases of meningococcal disease occurred in the United States, more than 30 per cent of which were caused by serogroup B.
Serogroup B meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities. Despite the availability of antibiotic treatment, 12.5 per cent of patients with serogroup B meningococcal disease die and many of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.