Pfizer Inc announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that for persons at increased risk for meningococcal disease and for use during serogroup B outbreaks, 3 doses of Trumenba should be administered at 0, 1-2, and 6 months.
When given to healthy adolescents who are not at increased risk for meningococcal disease, 2 doses of Trumenba should be administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 6 months after the first dose, recommended CDC ACIP.
“Today’s ACIP recommendation is an important update that offers clear guidance to healthcare providers administering Trumenba to help prevent meningococcal group B disease, also known as MenB, in healthy adolescents and young adults, as well as those at increased risk for the disease,” said Dr. Laura York, global medical lead for meningococcal vaccines, Pfizer Vaccines. “This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to MenB, which makes it easier for healthcare providers to help protect individuals from this uncommon but life-threatening disease.”
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.
In 2015, the CDC’s ACIP recommended serogroup B meningococcal vaccination for certain persons aged 10 years and older at increased risk for meningococcal disease. They also recommended that a MenB vaccine series may be administered to adolescents and young adults 16 through 23 years of age (preferred age 16 through 18) to provide short-term protection against most strains of MenB disease. In October 2014, Trumenba 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.
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 and Europe. 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 programs.
In April 2016, the FDA approved a revised dosing schedule for Trumenba based on data from the US and European phase 2 trials.
Trumenba is now approved to be administered in two dosing schedules: three-dose schedule: administer a dose (0.5 ml) at 0, 1-2, and 6 months; or two-dose schedule: administer a dose (0.5 ml) at 0 and 6 months.
The choice of dosing schedule may depend on the risk of exposure and the patient’s susceptibility to meningococcal serogroup B disease.
The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y). MenB affects all age groups in the US, but incidence is highest among infants younger than one year, adolescents and young adults. MenB accounts for nearly 50 percent of all US meningococcal cases in 17-23 year olds.
Although uncommon, MenB may result in life-altering, significant long-term and permanent medical disabilities. However, even with antibiotic treatment, 10 to 15 per cent of patients with MenB die and many of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.