The first meningococcal serogroup B vaccine, TRUMENBA, manufactured by Wyeth (Pfizer) pharmaceuticals, received FDA approval for use in persons aged 10 through 25 years of age on October 29, 2014. Less than five months earlier, TRUMENBA was given Breakthrough Therapy designation by the FDA and as meningococcal serogroup was considered a significant health threat, the FDA’s Center for Biologics Evaluation and Research (CBER) to agree to review TRUMENBA under the accelerated approval regulation. Pre-licensing clinical trials of TRUMENBA involved less than 4,600 healthy individuals predominantly between the ages of 11 and 18 years and the vaccine was only studied for safety and immunogenicity when administered with HPV4 vaccine. Pre-licensing clinical studies did not evaluate safety or immunogenicity of administering TRUMENBA with Tdap, influenza, HPV9 or any licensed meningococcal conjugate vaccines.
BEXSERO, a second meningococcal serogroup B vaccine, manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline), received FDA approval for use on January 23, 2015. However, in late 2013 – early 2014, prior to FDA approval, the unlicensed vaccine was permitted by the CDC and FDA for use at both Princeton University and the University of California Santa Barbara (UCSB) where outbreaks of meningococcal serogroup B disease had been reported. At UCSB, where 51 percent of students received one vaccine dose and only 37 percent completed the recommended two dose series, no additional cases of meningococcal serogroup B disease were reported. At Princeton University, where 90 percent of students opted to receive 2 doses of the unlicensed vaccine, no further cases of meningococcal serogroup B disease were reported among vaccinated Princeton students but one additional case was reported in a student from another local university who had been in close contact with several Princeton University students. Vaccine researchers concluded that while the vaccine appeared effective at protecting vaccinated individuals, it likely had no impact on nasopharyngeal carriage and vaccinated individuals could still potentially spread the disease to others.
BEXSERO also received Breakthrough Therapy designation by the FDA, and through the accelerated approval designation, it was licensed within 10 months. At the time of FDA approval, no clinical studies had examined the safety or immunogenicity of BEXSERO when administered concomitantly with any other vaccine.
At the CDC’s February 2015 ACIP meeting, the two newly licensed meningococcal group B (MenB) vaccines were recommended for use in persons 10 years and older with functional or anatomical asplenia, complement component deficiencies, as well as individuals taking eculizumab (Soliris®) medication, microbiologists routinely exposed to Neisseria meningitidis, and in the event of a meningococcal serogroup B disease outbreak. At the June 2015 ACIP meeting, the committee declined to routinely recommend MenB vaccines but stated that they could be administered to adolescents and young adults between the ages of 16 and 23 years of age, with the preferred age considered between 16 and 18 years. Routine MenB vaccination was not considered cost effective as data suggested that overall, it would only prevent between 15 and 29 cases, and 2 to 5 deaths, and among college students, approximately 9 cases and 1 death.
In June 2016, HIV-positive individuals aged two months and older were added to the list of persons considered at high risk for meningococcal disease and recommended by ACIP to receive meningococcal conjugate vaccines (serogroup A, C, Y and W-135). At the time of this recommendation, committee members admitted that there had never been any safety or immunogenicity studies of the vaccine for use in HIV-positive children aged two months to two years or among HIV-positive adults 25 years of age and older. Further, this decision was made despite conflicting data on meningococcal disease case-fatality rates. Studies from South Africa had noted a high meningococcal disease death rate among HIV-positive persons whereas studies from New York City and the United Kingdom had found lower death rates among HIV-positive individuals in comparison to persons without HIV disease.
In February of 2017, Sanofi Pasteur announced the discontinuation of the Menomune tetravalent meningococcal polysaccharide vaccine. In response, the CDC announced that persons 56 years of age and older recommended to receive meningococcal vaccination could be administered a meningococcal conjugate vaccine. This recommendation was made despite acknowledging that neither available meningococcal conjugate vaccine was FDA approved for use in persons older than 55 years of age.
On April 23, 2018, Pfizer (Wyeth) announced that its TRUMENBA meningococcal group B vaccine had once again received Breakthrough Therapy designation by the FDA. The designation involved the use of TRUMENBA in children 12 months through 9 years of age. FDA approval for use of the vaccine in this population is still currently pending.
