Second meningococcal group B vaccine approved

New Drug

The second vaccine to prevent serogroup B meningococcal disease (Bexsero—Novartis) has been approved, just 3 months after the approval of the very first vaccine, Trumenba (Pfizer). These two vaccines are welcome additions, as previously approved meningococcal vaccines targeted only four of the five major kinds of meningococcal bacteria—types A, C, Y, and W. These new vaccines now protect against type B, which has generally been an issue in organizational-based settings such as universities and schools. A primary difference between the two vaccines is that Pfizer’s product is to be administered as a three-dose series at 0, 2, and 6 months, whereas Novartis’s product can be given as a two-dose series at least 1 month apart.

Recent outbreaks

Although rare, meningitis B can be an aggressive disease and result in serious lifelong disabilities and even death. Initial signs may be nonspecific and mimic influenza-like symptoms, making diagnosis by a health care provider difficult in the early stages. According to CDC, approximately 500 total cases of meningococcal disease were reported in the United States in 2012, with 160 of these cases caused by serogroup B.

From 2008 to 2010, a prolonged outbreak of serogroup B occurred on a university campus in Ohio and resulted in 13 cases and one death. In addition, in 2013, meningococcal type B outbreaks occurred at Princeton University and the University of California, Santa Barbara, with 13 cases and one death also reported at these two campuses.

Clinical efficacy, safety

Approval was based on data from three multinational studies that included patients 11 to 24 years of age. One month after administration of the second dose of the vaccine, 63% to 88% of patients had antibodies to three different Neisseria meningitidis serogroup B strains, compared with 0% to 24% of these patients at baseline (i.e., prevaccination).

The most common adverse reactions observed in clinical trials were pain at the injection site (≥ 83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%). In addition, the vaccine’s safety was demonstrated in more than 15,000 individuals who received the vaccine before its approval during the meningitis B outbreaks at Princeton University and the University of California, Santa Barbara.

CDC’s interim guidance

CDC has interim guidance on its website for control of serogroup B meningococcal disease outbreaks in organizational settings such as universities, schools, daycare centers, occupational training centers, or correctional facilities. The guidance provides information on the many factors to consider when determining the need for vaccination against serogroup B, such as number of cases, interval time between cases, and whether the strains causing disease are identical.

In addition, the guidance reviews other control measures such as antimicrobial chemoprophylaxis of close s.

Clinicians can access the interim guidance on .

Patient counseling

Counsel parents, caregivers, and patients on the importance of completing the two-dose immunization series. Inform them of the vaccine’s most common adverse effects, including pain and/or redness at the injection site, muscle pain, fatigue, and headache, and encourage them to report any suspected reactions to their health care provider. Give a copy of the to all patients receiving the vaccine. Also educate women who receive the vaccine while pregnant to register in the pregnancy registry by calling 877-683-4732.

Meningococcal group B vaccine (Bexsero)

Manufacturer: Novartis

Drug class: Immunization

Indication: For the active immunization of patients 10 to 25 years of age to prevent invasive disease caused by Neisseria meningitidis serogroup B

Dosage: Two doses (0.5 mL each) given as an intramuscular injection at least 1 month apart

  • Use is contraindicated for patients who have had a hypersensitivity reaction, including a severe allergic reaction, to any component of the vaccine. Appropriate observation and medical treatment should be readily available to manage acute anaphylactic reactions if such reactions occur. Allergic reactions may also occur in latex-sensitive patients, as the prefilled syringes contain natural rubber latex.
  • Syncope can occur after administration of the vaccine, so procedures should be in place to avoid falling injuries.
  • Patients who are immunocompromised may have a reduced immune response to the vaccine, and the vaccine may not provide protection against all meningococcal serogroup B strains.