Real-World Evidence Header

The persons depicted are models used for illustrative purposes only.

BEXSERO:
THE MenB VACCINE WITH
REAL-WORLD EVIDENCE
IN ADOLESCENTS

In a state-funded, observational, interrupted time-series study in South Australia, vaccination with 2 doses of BEXSERO was associated with:

Real-world Experience Header

The persons depicted are models used for illustrative purposes only.

BEXSERO:
THE MenB VACCINE WITH
REAL-WORLD EVIDENCE
IN ADOLESCENTS

In a state-funded, observational, interrupted time-series study in South Australia, vaccination with 2 doses of BEXSERO was associated with:

Real-World Evidence data header
Real-World Evidence data header

Vaccine Impact on the Incidence of MenB IMDa Before and 3 Years After the Implementation of the Adolescent Vaccination Program in South Australia1,b

Vaccine impact on the incidence of MenB infographic
Vaccine impact on the incidence of MenB infographic

aIRR=adjusted incidence rate ratio; CI=confidence interval; IMD=invasive meningococcal disease; IRR=incidence rate ratio; MenB=meningococcal serogroup B; VI=vaccine impact.

aConfirmed serogroup B IMD cases in adolescents, as per the Australian national IMD surveillance case definition.

bTable adapted from Wang B, et al. J Infect. 2023;87(2):95-102.

cTo obtain the aIRR, a Poisson regression model was applied to evaluate VI on MenB disease.

dThe aIRR was adjusted according to changes in the incidence of MenB disease in the age cohort of adolescents/young adults who were not eligible to receive the free BEXSERO vaccine.

 

 

 

These real-world data are designed to evaluate association among variables; causality cannot be established. Results are descriptive only.

Study design: Observational, interrupted time-series analysis assessing vaccine impact (VI) of BEXSERO on invasive MenB disease incidence in adolescents 15-18 years of age in the state of South Australia.1,2 VI was estimated as the incidence rate ratio (IRR) and adjusted incidence rate ratio (aIRR), obtained by comparing the average annual incidence of MenB cases in the 3-year period following the start of the vaccination program (2019-2021) with the average incidence of MenB cases in the equivalent age cohort during the prevaccination program years (2011-2019).1

Study limitations: The study was conducted only in South Australia, where 1 of the 4 antigenic components (PorA) of the BEXSERO vaccine was closely matched to the circulating disease-causing isolate. The impact of the vaccine may differ for the US with different serogroup B isolates.1,3

Public health strategies implemented during the COVID-19 pandemic may have inadvertently contributed to reductions in MenB disease incidence during the second and third years of the program. These interventions, aimed against SARS-CoV-2 transmission, may have contributed to reductions in MenB disease incidence and impact in 2019-2020. The authors’ previous research showed the usual seasonal increase in N. meningitidis oropharyngeal carriage during this period of physical distancing policies. The VI analysis does not take into account vaccine uptake and might be vulnerable to confounding factors due to trends unrelated to the intervention.1

Bias may be introduced in time-series studies due to inadequately modeled time trends, or cyclical variations in disease, case detection, population characteristics, or introduction of concomitant interventions.3

One case of MenB disease was observed 3 years after an adolescent received 2 doses of BEXSERO in the B Part of It trial in South Australia that predated the state-funded program.1,3

Vaccination may not protect all recipients.

CI=confidence interval.