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Bexsero

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Real World Evidence with BEXSERO

Consistently reduced the incidence of MenB disease across settings and target populations.1-3

UNITED KINGDOM-NIP SETTING

More than 1 million infants were vaccinated with BEXSERO in a national immunisation programme in the United Kingdom from 2015 to 20174

CANADA-OUTBREAK SETTING

Beginning in 2014, more than 49,000 people from age 2 months to 20 years were vaccinated with at least one dose of BEXSERO in response to outbreak in the Saguenay— Lac-Saint-Jean region of Quebec, Canada5

TUSCANY & VENETO, ITALY-REGIONAL

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

PORTUGAL-ENDEMIC SETTING

In an endemic setting in Portugal, the effectiveness of BEXSERO was evaluated in a case-control study from 2014 to 2019 (2 months to 18 years).6

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 trials4,5

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 years1,7

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 20118
  • 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

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% CI: -2%, 98%].2

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

Real world use of BEXSERO demonstrated consistent safety findings

  • 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

Infants and young children

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

Estimated Vaccine
Effectiveness with BEXSERO:
Regional setting in Tuscany and Veneto, Italy

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 protocols (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

Infants, young children, and adolescents

In an endemic setting in Portugal, the effectiveness of BEXSERO was evaluated in a case-control study from 2014 to 2019 (2 months to 18 years)6

BEXSERO demonstrated high-vaccine effectiveness against MenB disease: Endemic setting in Portugal

Infants, young children and adolescents
79% ESTIMATED VACCINE EFFECTIVENESS

Study design: An observational case-control,* endemicsetting study measured vaccine effectiveness of BEXSERO in children 2 months to 18 years of age in Portugal from 2014 to 2019. (Vaccine uptake: 40% to 60%)6

*A case-control design compares the odds of vaccination in individuals who develop the disease (cases) and those without the disease (controls) who are representative of the population where the cases originate.9

VACCINATE WITH CONFIDENCE AGAINST MenB KNOWING
THE REAL WORLD EVIDENCE BEHIND BEXSERO

Succinct Safety Information10

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions for use: As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection such as cold, should not result in the deferral of vaccination. The vaccine must not be injected intravascularly, subcutaneously or intradermally. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age). The safety and efficacy of Bexsero in individuals above 50 years of age have not been established.
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation.

Adverse Events: Very common: eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia, fever (≥38°C), injection site tenderness, injection site erythema, injection site swelling, injection site induration, irritability, nausea, myalgia, malaise.

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. Azzari C, Moriondo M, Nieddu F, et al. Effectiveness and Impact of the 4CMenB Vaccine against Group B Meningococcal Disease in Two Italian Regions Using Different Vaccination Schedules: A Five-Year Retrospective Observational Study (2014–2018).Vaccines 2020;8[469]; doi:10.3390/vaccines8030469.
  4. 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.
  5. 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.
  6. Rodrigues F, Marlow R, Ladhank S, Simões MJ, Finn A. Portuguese Meningococcus Group B Vaccine Effectiveness Study (PT-BEST)[publication pending].
  7. 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.
  8. 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.
  9. Lewallen S, Courtright P. Epidemiology in practice: case-control studies. Community Eye Health. 1998;11:57–58.
  10. Bexsero Summary of Product Characteristics, Version GDS 13.

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PM-SA-BEX-WCNT-230003 Date of preparation: August 2023