Bexsero (MenB-4C) Vaccine Dosing Recommendations
Critical Licensing Information
Bexsero is FDA-licensed only for persons aged 10-25 years in the United States, and use outside this age range is considered off-label. 1, 2, 3 There are no CDC recommendations for use in infants or children under age 10 years in the U.S., despite licensure in other countries for younger populations. 1, 3
Dosing by Risk Category and Age
For Healthy Adolescents and Young Adults (Ages 16-23 Years)
Administer 2 doses at 0 and 6 months based on shared clinical decision-making. 4 This represents an updated recommendation as of October 2024, extending the interval from the previous ≥1 month to 6 months between doses. 4
- The preferred age window is 16-18 years, though vaccination can occur anytime between 16-23 years. 5
- This is a Category B recommendation (permissive, not routine), requiring discussion with the patient/family about disease risk, short duration of protection, and lack of herd immunity. 5
- The minimum interval between any 2 doses is 4 weeks if accelerated dosing is needed. 2
For High-Risk Persons Aged ≥10 Years
Administer 3 doses at 0,1-2, and 6 months. 4, 2 This is a Category A recommendation (routine use) for the following high-risk groups:
- Persistent complement component deficiencies (including properdin, factor D, C3, C5-C9 deficiencies) 1, 2
- Anatomical or functional asplenia (including sickle cell disease) 1, 5
- Complement inhibitor therapy (e.g., eculizumab, ravulizumab) 2, 5
- Microbiologists routinely exposed to Neisseria meningitidis isolates 1, 5
- Persons at risk during serogroup B meningococcal disease outbreaks 1, 5
Booster Dosing for High-Risk Persons
For persons at continued increased risk, administer a single booster dose 1 year after completion of the primary series, then every 2-3 years thereafter. 2, 5 The same vaccine product (Bexsero) must be used for all booster doses. 2, 5
- Booster intervals may be shortened to ≥6 months during outbreak situations based on public health assessment. 1
Critical Implementation Pitfalls
Vaccine Interchangeability
Bexsero and Trumenba are NOT interchangeable—the same product must be used for all doses in a series. 1, 2, 5 If the original vaccine product is unknown, make every effort to identify it through immunization registries or previous providers before restarting the series. 5
Timing with Complement Inhibitor Therapy
Administer meningococcal vaccines at least 2 weeks before initiating complement inhibitor therapy whenever possible. 2 Patients on these medications remain at increased risk for invasive meningococcal disease even after vaccination. 6
Confusion with MenACWY Vaccines
Do not confuse Bexsero (MenB) with MenACWY vaccines, which ARE licensed for infant use starting at 2 months of age. 3 MenACWY vaccines protect against different serogroups (A, C, W, Y) and have entirely different dosing schedules. 1
Special Populations
Pregnancy and Lactation
Defer vaccination in pregnant or lactating women unless they are at increased risk for serogroup B meningococcal disease. 1 After consultation with the healthcare provider, benefits may outweigh potential risks in high-risk situations. 1
Adults Aged ≥26 Years
Bexsero is not routinely recommended for adults ≥26 years. 5 Use in this age group is off-label but may be considered for high-risk individuals (complement deficiency, asplenia, microbiologists, outbreak settings). 1
Immunocompromised Patients
Persons with altered immunocompetence may have reduced immune responses to Bexsero. 6 However, the 3-dose schedule should still be administered to high-risk immunocompromised patients (HIV infection, complement deficiencies, asplenia). 1
- Adults with HIV infection are not routinely recommended to receive MenB vaccines because meningococcal disease in this population is primarily caused by serogroups C, W, and Y, not B. 1
Administration Details
- Route: Intramuscular injection in the deltoid muscle 6
- Dose volume: 0.5 mL per dose 6
- Coadministration: Can be given with other vaccines but at different injection sites 6
- Fever management: Consider prophylactic paracetamol/acetaminophen, especially in infants (though U.S. licensure doesn't include infants) 7
Updated 2024 Alignment
As of October 2024, Bexsero dosing recommendations now align with Trumenba (MenB-FHbp) recommendations: 2 doses at 0 and 6 months for healthy adolescents, and 3 doses at 0,1-2, and 6 months for high-risk persons. 4 This represents a significant change from the previous 2-dose schedule with ≥1 month interval. 4