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Real World Evidence with BEXSERO

Significant impact in reducing the incidence of meningococcal B disease (MenB) across countries, settings and target populations.¹,²

No additional safety concerns in real world use beyond those identified in clinical trials.³,⁴

More than 50 million doses distributed worldwide.⁵

75% reduction in incidence of MenB
(rate ratio: 0.25; 95% CI 0.19 to 0.36)

in a national immunisation programme in the United Kingdom¹

 

96% reduction in incidence of MenB

in response to an outbreak in the Saguenay—Lac-Saint-Jean region of Quebec, Canada²

 

ITALY–REGIONAL IMMUNIZATION SETTING

In Tuscany, Italy, between 2014 and 2018, children were vaccinated with BEXSERO using a 3+1 dosing schedule starting at 2 months of age. In Veneto, Italy, between 2015 and 2018, children were vaccinated with a 2+1 dosing schedule starting at 7 months of age.³

 

Impact with BEXSERO: National Immunisation Programme (NIP) in the United Kingdom

  • BEXSERO was introduced for all infants in the UK in September 2015¹
  • Infants were administered the vaccine at 2, 4 and 12 months, which resulted in a 75% reduction in MenB incidence in all fully eligible children in England¹
  • No additional safety concerns in real world use of BEXSERO beyond those identified in clinical trials³,⁴

Study design: 3-year observational study with impact measured by comparing observed incidence to that expected based on the 4-year prevaccination incidence in equivalent cohorts and using disease trends in vaccine-ineligible cohorts aged <5 years.¹

277 cases of MenB were estimated to be prevented with BEXSERO over the course of 3 years¹,⁶

The same results were first published in the Archive of Diseases in Children, 2020. The graph has been independently created by GSK from the original data.

  • The 277 cases averted during the program represented 1 case of MenB averted every 4 days¹

Impact with BEXSERO: Outbreak setting in the Saguenay—Lac-Saint-Jean region of Quebec, Canada

  • MenB was responsible for 88% of all reported invasive meningococcal disease and 61% of deaths in Quebec, Canada from 2009 to 2011⁷
  • The rate of MenB in the targeted age group prior to the introduction of BEXSERO was 11.4 MenB cases per 100,000 people (11.4/100,000)²
  • An outbreak response programme with BEXSERO was introduced in 2014, resulting in a 96% reduction in MenB incidence in vaccine-eligible cohorts—0.4 cases for every 100,000 people (P<0.0001)²
  • 83% of 59,000 residents aged 2 months to 20 years received BEXSERO²

Study design: Observational study with impact measured by comparing observed incidence before the programme to 4 years post-vaccination in vaccine-eligible cohorts aged 2 months to 20 years.²

ᵃNote during the assessment period MenB disease also decreased in the other regions where no vaccination took place; the magnitude of that decrease in younger and older age groups was more than 50%. Taking into account the decrease in MenB incidence at the provincial level, the overall campaign impact in Saguenay—Lac-Saint-Jean, Quebec, Canada was 86% [95% Cl: -2%, 98%].²

Real world use of BEXSERO demonstrated consistent safety findings with the label

  • No additional safety concerns in real world use of BEXSERO beyond those identified in clinical trials⁴,⁵
  • No major safety concerns were identified with more than 3 million doses administered in the United Kingdom programme and more than 90,000 doses administered in Saquenay—Lac-Saint-Jean, Quebec, Canada¹,⁵

 

Estimated vaccine effectiveness and impact with BEXSERO: Regional setting in Tuscany and Veneto, Italy

In Tuscany, Italy, between 2014 and 2018, children were vaccinated with BEXSERO using a 3+1 dosing schedule starting at 2 months of age. In Veneto, Italy, between 2015 and 2018, children were vaccinated with a 2+1 dosing schedule starting at 7 months of age.³

greaterthan
  • Higher vaccine impact was observed in infants and young children when vaccination started earlier (2 months vs. 7 months) during the 4 years of the study in Tuscany and the 3 years in Veneto.³
  • Overall impact (evaluating both vaccinated and unvaccinated children) was 68% (95% CI: 0.10; 0.89) in Tuscany* and 31% (95% CI: -0.56; 0.69) in Veneto.** Vaccine impact was statistically significant in Tuscany and not in Veneto.³

Study design³: The observational, retrospective study (2014–2018) evaluated vaccine effectiveness and impact in two regions in Italy using two different vaccination schedules (3+1 dosing schedule starting at 2 months of age in Tuscany and 2+1 dosing schedule starting at 7 months of age in Veneto). The data collected referred to the period 2006–2018 for Tuscany and 2007–2018 for Veneto with vaccination beginning in 2014 in Tuscany and 2015 in Veneto. Vaccine impact was calculated by comparing incidence in the pre- and post-vaccination periods. It was evaluated as overall impact (the effect of the BEXSERO vaccination program on the entire population, regardless of vaccination status) and the total impact (the effect of BEXSERO vaccination on the vaccinated population).

*The crude incidence of MenB in Tuscany was 1.96 (95% CI: 1.52; 2.40) per 100,000 children in the pre-vaccine era and it dropped to an ASR of 0.62 (95% CI: 0.60; 0.64; p=0.058) in the post-BEXSERO era.³

**The crude incidence of MenB in Veneto, was 1.94 (95% CI: 1.92; 1.96) in the pre-vaccine era while the ASR in the post-vaccine era was 1.34 (95% CI: 1.31; 1.38, p=ns).³

The BEXSERO Book of Experience

The following video illustrates the real world evidence with BEXSERO.

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VACCINATE WITH CONFIDENCE KNOWING THE REAL WORLD EVIDENCE BEHIND BEXSERO

References

  1. Ladhani SN, et al. Vaccination of infants with meningococcal group B vaccine (4CMenB) in England. N Engl J Med. 2020;382(4):309–317.
  2. Deceuninck G, et al. Impact of a mass vaccination campaign against serogroup B meningococcal disease in the Saguenay-Lac-Saint-Jean region of Quebec four years after its launch. Vaccine. 2019;37(31):4243–4245.
  3. Bryan P, Seabroke S, Wong J, et al. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisationin the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;2(6):395–403.
  4. De Serres G, Billard MN, Gariépy MC, et al. Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada. Vaccine. 2018;36(52):8039–8046.
  5. GlaxoSmithKline. Data on file 2017N320400_05. 2020.
  6. Isitt C, Cosgrove CA, Ramsay ME, Ladhani SN. Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience. Arch Dis Child. 2020;105(8):784-790.
  7. Gilca R, Deceuninck G, Lefebvre B, et al. The changing epidemiology of meningococcal disease in Quebec, Canada, 1991–2011: potential implications of emergence of new strains. PLoS One. 2012;7(11):e50659.

 

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PM-SA-BEX-WCNT-200012 | Date of preparation: December 2020