Who should receive Bexsero (Meningococcal group B vaccine)?

Bexsero (Meningococcal Group B Vaccine) Recommendations

Bexsero should be administered to persons 10 years and older who are at increased risk of serogroup B meningococcal disease, including those with complement deficiencies, asplenia, during outbreaks, and microbiologists working with Neisseria meningitidis. Additionally, adolescents and young adults 16-23 years (preferably 16-18 years) may receive Bexsero for short-term protection against most strains of serogroup B meningococcal disease 1.

Priority Groups for Bexsero Vaccination

Category A Recommendation (Routine Use)

Persons 10 years and older with:

1. Persistent complement component deficiencies:

   • Inherited or chronic deficiencies in C3, C5-C9, properdin, factor D, or factor H
   • Persons receiving eculizumab (Soliris) therapy 1

2. Anatomic or functional asplenia:

   • Including sickle cell disease 1

3. Microbiologists routinely exposed to isolates of Neisseria meningitidis 1

4. Persons at risk during outbreaks of serogroup B meningococcal disease 1

5. Unvaccinated household contacts of a MenB index case, who have a 100-200-fold increased risk in the year following contact despite chemoprophylaxis 2

Category B Recommendation (Individual Clinical Decision)

Healthy adolescents and young adults aged 16-23 years (preferred age 16-18 years) may receive Bexsero to provide short-term protection against most strains of serogroup B meningococcal disease 1.

Dosing Schedule

Bexsero is administered as a 2-dose series with doses given at least 1 month apart 1.

Clinical Considerations

• Bexsero is not interchangeable with other MenB vaccines (such as Trumenba) 1
• The same vaccine product must be used for all doses in a series 1
• Minimum interval between any two doses of MenB vaccine is 4 weeks 1
• Bexsero may be administered concomitantly with other vaccines at a different anatomic site 1

Rationale for Recommendations

High-Risk Groups

The recommendation for vaccination of high-risk groups is based on their significantly elevated risk of invasive meningococcal disease:

• Persons with terminal complement defects have a reported 10,000-fold higher risk 2
• Asplenic individuals have a 20-30-fold increased risk 2
• Laboratory staff with exposure to N. meningitidis aerosols have up to 271-fold increased risk 2

Adolescents and Young Adults

The permissive recommendation for adolescents and young adults is based on:

1. The peak age of serogroup B meningococcal disease in this population
2. Limited data on antibody persistence
3. Cost-effectiveness considerations (Table 3 in 1 shows the number needed to vaccinate to prevent one case ranges from 102,000-368,000)

Safety Profile

Clinical trials have shown Bexsero to be safe with no significant increased risk for serious adverse events 1. Common adverse reactions within 7 days of vaccination include:

• Pain at injection site (≥85%)
• Severe pain (20-29%)
• Fever (1-5%)
• Headache and fatigue (4-6% severe)
• Muscle pain (12-13% severe) 1

Important Caveats

1. Limited effectiveness data: Bexsero was licensed under accelerated approval regulations, and postmarketing studies are still required to confirm effectiveness against diverse meningococcal strains 1.

2. Coverage of circulating strains: Bexsero contains surface protein antigens expressed by approximately 80% of circulating serogroup B meningococci in Germany 2, but strain coverage may vary geographically.

3. Duration of protection: Data on long-term antibody persistence are still being collected 1.

4. No impact on carriage: The vaccine does not seem to impact acquisition of carriage of serogroup B isolates, though it does provide protection against disease 3.

5. Potential for protection against non-B serogroups: As Bexsero targets subcapsular proteins that can be conserved regardless of capsule type, it may provide some protection against non-B isolates such as serogroups W and X 3.

Human vaccines & immunotherapeutics

Meningococcal disease is rare but can cause significant mortality and morbidity, with case fatality rates ranging from 10-40% 1. Timely vaccination of high-risk individuals is essential to prevent these devastating outcomes.