P-1498. Real-World Vaccine Effectiveness and Impact of the 4CMenB Vaccine in Infants, Children, and Adolescents: A Systematic Literature Review

TL;DR

This study reviews real-world data to assess how well the 4CMenB vaccine protects infants, children, and adolescents against meningococcal disease and how much it reduces disease incidence.

Contribution

The study provides a systematic review of global real-world evidence on the 4CMenB vaccine's effectiveness and impact across different age groups.

Findings

High vaccine effectiveness (59–100%) was observed in infants, children, and adolescents after 2–4 doses of 4CMenB.

The vaccine significantly reduced MenB incidence by up to 94% in several regions after several years of implementation.

Vaccine impact varied by region and age group but was consistently substantial in reducing disease rates.

Abstract

Meningococcal serogroup B (MenB) is a leading cause of invasive meningococcal disease. The multicomponent MenB vaccine (4CMenB) has been widely used since 2013. To establish a robust range of vaccine effectiveness (VE) and determine the vaccine impact (VI) of 4CMenB programs on MenB incidence in infants, children, and adolescents, a systematic literature review of real-world evidence was conducted.Figure 1.4CMenB Vaccine Effectiveness Against MenB in Fully Vaccinated Infants, Children, Adolescents, and Young AdultsTable 1.Study References for Vaccine Effectiveness and Impact

4CMenB Vaccine Effectiveness Against MenB in Fully Vaccinated Infants, Children, Adolescents, and Young Adults

Study References for Vaccine Effectiveness and Impact

MEDLINE, Embase, gray literature, and clinical trial registries were searched in November 2024; studies were screened against preset criteria per PRISMA guidelines. VE and VI were synthesized separately for infants, children, and adolescents/young adults.

Nine studies from Australia, Canada, England, Italy, Portugal, and Spain evaluated VE; all included infants, 8 included children, 2 included adolescents.1–11 Nine studies from Australia, Canada, England, and Italy reported VI.1–7, 10–14 (Table 1)

High estimated VE against MenB was reported for fully vaccinated (2–4 doses) infants and children. In South Australia (SA), VE was 90.7–94.7% in infants/children with 2 doses 2–3 years (y) after introducing a 4CMenB program and no cases occurred in those with 3 doses after 3 y.1,2 In England, VE was 82.9% 10 months (m) after 4CMenB introduction in infants and 59.1–80.1% after 3 y in infants/children.3–5 VE across Italy ranged 91.0–100% 3–6 y after 4CMenB introduction in infants/children.6,7 In Spain, VE was 71% in infants/children 4 y after 4CMenB became available.8 In Portugal, VE was 79% in infants/children 5 y after 4CMenB was licensed.9 (Figure 1)

VE was also high in fully vaccinated (2 doses) adolescents/young adults. In SA, VE was 100% 2 y after 4CMenB program introduction and 83.5–89.4% after 3 y.1,2 In Quebec, after a 4CMenB campaign among those aged 2 m–20 y, VE was 100%, 79%, and 59%, at 2, 4, and 5 y, respectively.10,11,14

VI (decrease in MenB incidence post-4CMenB program) in targeted age groups was 75% in England (18 weeks [w]–2 y) after 3 y, 63% and 79% in SA (12 w–11 m and adolescents) after 3 y, 50% across Italy (0–6 y) after 6 y, and 94% in Quebec (2 m–20 y) after 5 y. 1–7, 10–14

With 11 years of global use, 4CMenB has demonstrated robust real-world VE (59–100%) and substantial VI in reducing MenB incidence in infants, children, and adolescents.

Funding: GSK VEO-001056

Pavo Marijic, PhD, GSK: employee|GSK: Stocks/Bonds (Public Company) Lucian Gaianu, MSc, GSK: Employee Gaurav Mathur, MD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Thatiana Pinto, PhD, GSK: employee|GSK: Stocks/Bonds (Public Company) Anar Andani, BSc, Medical director, GSK: Employee|GSK: Stocks/Bonds (Public Company) Reena Ladak, MS, GSK: Employee Elise Kuylen, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Karolina Szewczyk, MSc, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Elzbieta Olewinska, MSc, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Beata Smela, PhD, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Helen Petousis-Harris, PhD, Bexsero and gonorrhea trial (USA): Data and Safety Monitory Board Member|CDC: Funding to institution|GSK: Advisor/Consultant|GSK: Funding to institution; payment for study|Maternal pneumococcal vaccine trial (Australia): Data and Safety Monitory Board Member|New Zealand Medical Council: Advisor/Consultant|The Ministry of Health New Zealand: Funding to institution Zeki Kocaata, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company)

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