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Meningococcal group B vaccine

(Bexsero®)

Bexsero®

Drug updated on 11/1/2024

Dosage FormInjection (intramuscular; 0.5 mL [50 mcg])
Drug ClassVaccines
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B
  • Bexsero is approved for use in individuals aged 10 through 25 years.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • The meningococcal B OMV (outer membrane vesicle) vaccines, including 4CMenB (Bexsero), demonstrated adjusted vaccine effectiveness (VE) against gonorrhoea ranging from 22% to 46%, with pooled VE estimates between 33% and 34% after the full vaccine series. Vaccination impact (VI) for these vaccines ranged from a 30% to 59% reduction in gonorrhoea incidence, while MenB-FHbp showed no protection against gonorrhoea.
  • Real-world studies indicated that the 4CMenB (Bexsero) vaccine demonstrated high effectiveness against group B invasive meningococcal disease (IMD) with a VE of 59% to 94% and a VI of 31% to 75%. Comparatively, MenACWY vaccines showed an odds ratio (OR) of 0.31 [95% CI (confidence interval), 0.20-0.49] against group ACWY IMD (Invasive meningococcal disease), and OMV vaccines showed an OR of 0.35 [95% CI, 0.25-0.48] against group B IMD, slightly less effective than the group C vaccine's OR of 0.13 [95% CI, 0.07-0.23] against group C IMD.
  • There is no safety information available in the reviewed studies.
  • The reviewed studies highlight population-specific findings, showing that OMV-based MenB vaccines, including 4CMenB (Bexsero), demonstrated effectiveness against gonorrhoea particularly in individuals aged 15-30, with adjusted vaccine effectiveness (VE) ranging from 22% to 46%. Real-world studies of 4CMenB also indicate diverse VE estimates (59%-94%) across various age groups. Additionally, an infant 4CMenB program showed reduced group B invasive meningococcal disease (IMD) incidence, with an incidence rate ratio of 0.25 [95% CI, 0.19-0.36].