meningococcal group B vaccine

Meningococcal group B vaccine is administered to protect people from meningococcal disease caused by the bacteria Neisseria meningitidis serogroup B. Meningococcal disease is a severe and sometimes, life-threatening bacterial infection of the lining of the brain, spinal canal, and the bloodstream. There are at least 13 strains of N. Meningitidis, but serogroups A, B, C, W, X and Y account for a majority of invasive disease and among these, B, C and Y are the most prevalent in the United States.

Meningococcal disease can affect anyone, even healthy individuals, and turn fatal within 24 hours. It is, however, more common in children younger than 1 year old, young adolescents and adults 16-23 years old, and elderly persons 65 years or older. Meningococcal group B vaccine is indicated for individuals of age 10 to 25 years and is administered as intramuscular injections in 2 or 3 doses in a 6-month period.

N. meningitidis lives in the nose and throat of approximately 10% of the population without causing disease. N. meningitidis is transmitted through saliva and nasal droplets of a carrier and can cause invasive disease in people who are vulnerable due to age, medical conditions, compromised immunity or other factors. The bacteria get into the bloodstream, cross the blood-brain barrier and infect the membranes of the brain and spinal cord.

Meningococcal group B vaccine is an inactivated bacterial vaccine prepared from 3 unique proteins (antigens) present on the surface of N. meningitidis serogroup B. The proteins are individually grown in Escherichia coli bacteria, purified and inactivated to eliminate disease-causing ability. The vaccine stimulates the complement immune system, which produces antibodies that recognize the N. meningitidis bacterial antigens, attack and kill them, protecting the vaccinated individual from severe disease if exposed to the bacteria in the future.

• Do not administer meningococcal group B vaccine to anyone with hypersensitivity to any component of the vaccine or to a previous dose of the vaccine.
• Meningococcal group B vaccine should be administered as an intramuscular injection.
• Meningococcal group B vaccine should be administered only in a clinical setting where medical facilities and trained personnel are readily available to manage severe reactions (anaphylaxis), should they occur.
• Some patients may lose consciousness following administration of meningococcal group B vaccine. Procedures should be in place to prevent vaccine recipients from falling and injuring themselves.
• Meningococcal group B vaccine may not provide protection against all meningococcal group B strains, and may not protect all vaccine recipients.
• Immunocompromised individuals may have reduced immune response to meningococcal group B vaccine.
• Persons with deficiencies in the complement immune system and those taking treatment that inhibits terminal complement system activation are at an increased risk for invasive disease even if they develop antibodies after vaccination.

Common side effects of meningococcal group B vaccine include:

• Injection site reactions including:
  • Pain
  • Redness (erythema)
  • Tissue hardening (induration)
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Fatigue
• Headache
• Fever
• Nausea
• Nose and throat inflammation (nasopharyngitis)

Less common side effects of meningococcal group B vaccine include:

• Lymph node swelling (lymphadenopathy)
• Injection site and local reactions including:
  • Nodule
  • Blisters at and around the injection site
  • Extensive swelling of the vaccinated limb
• Hypersensitivity reactions including:
  • Rash
  • Eye swelling
  • Severe allergic (anaphylactic) reactions
• Vasovagal response (sudden drop in heart rate and blood pressure)
• Fainting (syncope)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Intramuscular (IM) suspension

• 0.5 mL/syringe

Adult and Pediatric:

Meningococcal Serogroup B Immunization

• To prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in adults and children 10 years and older at increased risk for meningococcal disease
• Current vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.htm

Trumenba

• Two-dose schedule: 0.5 mL intramuscular (IM) at 0 and 6 months OR
• Three-dose schedule: 0.5 mL IM at 0, 1–2, and 6 months; if the second dose is administered in less than 6 months after first dose, a third dose should be administered at least 4 months after the second dose
• Choice of dosing schedule may depend on patient risk of exposure and susceptibility to meningococcal serogroup B disease

Bexsero

• 0.5 mL IM as a 2-dose series administered at least 1 month apart

ACIP recommendations for at risk adults and adolescents

• Immunize at risk adults with primary series (use same product for all doses in series)
• Booster dose: Administer 1 year after primary series completed and repeat booster dose every 2-3 years if risk remains
• At risk individuals include
  • Anatomical or functional asplenia, including sickle cell disease
  • Persistent complement component deficiency
  • Complement inhibitor use (e.g., eculizumab, ravulizumab)
• Microbiologists routinely exposed to Neisseria meningitidis

ACIP recommendations for adults and adolescents not at risk

• Need for primary series vaccination in adults and adolescents aged 16-23 years (preferred age 16-18 years) not at high risk is based on shared decision making between patient and clinician

Dosing Considerations

• MenB vaccines are not interchangeable (use same product for all doses in series)
• Approval for each vaccine was based on the demonstration of immune response, as measured by serum bactericidal activity against 3 serogroup B strains representative of prevalent strains in the United States
• Trumenba: Vaccine is a suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N meningitidis serogroup B – 1 from fHbp subfamily A and 1 from subfamily B (A05 and B01, respectively)
• Bexsero: Vaccine is a suspension composed of 4 distinct antigens including factor H binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA), and PorA P1.4 immunodominant antigen of OMV NZ (strain NZ98/254)

Overdose

There is no information available on meningococcal group B vaccine overdose.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

Meningococcal group B vaccine has no listed severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Animal reproduction studies did not reveal fetal harm with the use of meningococcal group B vaccine during pregnancy. There are no clinical studies on the use of the meningococcal B vaccine in pregnant women to determine a vaccine-associated risk to the fetus.
• There are no data on the presence of meningococcal group B vaccine in breastmilk, or its effect on milk production or the breastfed infant. Decision to breastfeed should be made after considering the developmental and health benefits of breastfeeding, along with the potential adverse effects to the infant from the vaccine or the mother’s susceptibility to contracting the disease that the vaccine prevents.

• If you receive immunization with meningococcal group B vaccine, complete the full course of doses.
• Report any adverse reactions to the healthcare provider.