General Information
Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of a vaccine that immunizes against meningococcal disease has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.
Latex hypersensitivity
Use of a meningococcal group B vaccine is contraindicated in patients with a previous allergic reaction to the vaccine. Additionally, caution must be exercised when using the meningococcal group B vaccine (3 strain) in patients with latex hypersensitivity as the tip caps of the pre-filled syringes contain natural rubber latex. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine.
Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency
Meningococcal group B vaccine (3 strain) is only indicated for intramuscular (IM) administration. Use caution when administering to patients with an increased risk for bleeding. Patients with thrombocytopenia, vitamin K deficiency, coagulopathy (e.g., hemophilia), or receiving anticoagulant therapy could have bleeding at the IM injection site.
Fever, infection
The decision to administer or to delay vaccination with meningococcal group B vaccine (3 strain) because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices has recommended that vaccinations be delayed during the course of a moderate or severe acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.
Agammaglobulinemia, chemotherapy, corticosteroid therapy, human immunodeficiency virus (HIV) infection, hypogammaglobulinemia, immunosuppression, neoplastic disease, radiation therapy, severe combined immunodeficiency (SCID)
Patients with significant immunosuppression may not have an adequate antibody response to meningococcal group B vaccine (3 strain). Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with the meningococcal polysaccharide vaccine (MPSV4) or the meningococcal conjugate vaccine (MCV4) within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored ; a definitive recommendation for the meningococcal group B vaccine has not yet been made. Similarly, evidence suggests that persons with human immunodeficiency virus (HIV) infection do not respond optimally to a single dose of MPSV4 or MCV4, which is the recommended regimen for immune competent patients. It is not known whether an alternate dosage series will be necessary for the meningococcal group B vaccine for this population.
Activities requiring coordination and concentration
Syncope can occur in association with administration of the meningococcal group B vaccine (3 strain). Ensure procedures are in place to avoid injury from falling associated with syncope. Observe patients after vaccination, and instruct patients and/or caregivers to avoid activities requiring coordination and concentration during the time period immediately after vaccine receipt.
Children, infants, neonates
Safety and efficacy of the meningococcal group B vaccine (3 strain) have not been established in neonates, infants, or children younger than 10 years.
Geriatric
Meningococcal group B vaccine (3 strain) is indicated for use in adults up to 25 years of age; the vaccine is not approved for administration to geriatric patients.
Pregnancy
No adequate and well controlled studies with Meningococcal group B vaccine (3 strain) have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. The manufacturer recommends use during pregnancy only if clearly needed. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in pregnant women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to meningococcal group B vaccine (3 strain); information about the registry can be obtained at BexseroPregnancyRegistry.SM@ppdi.com or by calling 1-877-413-4759.
Breast-feeding
Data are limited regarding use of the meningococcal group B vaccine (3 strain) during breast-feeding, and its excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in breast-feeding women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks.