Turning the Tide Against Meningococcal Disease: Men B Vaccine Now Available in the Philippines | Multidisciplinary

^{Fictional patient. For illustration purposes only.}

4CMenB (Bexsero) – the first and only Men B Vaccine now available in the Philippines^1-3

The Philippine Food and Drug Authority recently approved Bexsero, GSK’s Meningococcal Group B Vaccine (recombinant, adsorbed), for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 2 months and older.^1,4

This should be a welcome relief in light of the lingering threat of invasive meningococcal disease. With the introduction of Bexsero in the Philippine market, the circle of protection against the various N. meningitidis serogroups and other local causative agents of bacterial meningitis is complete.^5,6 And the tides of the battle, particularly against serogroup B meningococcal disease, may finally be at a turning point.

The World Responds: WHO’s Defeating Meningitis by 2030 Roadmap

In recognition of the alarming threat and burden of meningitis, the World Health Organization developed Defeating Meningitis by 2030, a global roadmap approved by the World Health Assembly in 2020 and endorsed unanimously by WHO member states. It aims, by 2030, to eliminate bacterial meningitis epidemics, including Men B, reduce vaccine-preventable cases by 50% and deaths by 70% and reduce disability after meningitis.⁷

The Insidious Threat of Men B in the Philippines

Meningococcal disease remains a significant global public health threat. Although rare, its two primary clinical forms, meningitis and meningococcal sepsis, are both acute serious illnesses with devastating complications. The disease sets in insidiously – with symptoms often resembling influenza – making it a diagnostic challenge. This, together with its rapid disease course, results in a high mortality rate with death possible within 24-48 hours of onset in up to 50% of those who don’t receive the right treatment. 20% of survivors are also at risk for developing debilitating sequelae.^7-10

In the Philippines, majority of invasive meningococcal disease is caused by the serogroup B of the causative agent, N. meningitidis.⁷^,11 While it can affect people of all ages, children less than 5 months of ageare at the highest risk, highlighting the need for, effective protection in this age group.¹² Studies have also reported an asymptomatic nasopharyngeal carriage rate of 3.7% in the 5-24 year old population, with serogroup B in 65.7% of isolates – a grim reminder that the threat of invasive meningococcal disease is indeed just a short breath away.^13,14

Serogroup Distribution of Confirmed Meningococcal Cases in the Philippines (2018 - 2023)¹¹

^{Data Source: National Reference Laboratory for Invasive Vaccine-Preventable Bacterial Diseases - Research Institute for Tropical Medicine [unpublished].

This graph has been independently created by GSK from the original data.}

Novel Men B Vaccine Technology – beating the challenge of strain coverage and immunogenicity

Vaccines are serogroup-specific and while immunization against serogroups A, C, W and Y are already available locally, challenges in developing a effective vaccine against serotype B has left a gap in vaccine access.

Serogroup B has a capsule that is poorly immunogenic making capsular vaccines - which was successful in other serogroups - ineffective for MenB.¹⁵ Outer-membrane vesicle (OMV) - based vaccines were shown to be effective against single homologous MenB strain but ineffective against heterologous strains.¹⁵ These factors necessitated the employment of reverse vaccinology technology to come up with a vaccine with multiple antigenic components to enhance strain coverage.¹⁵

Impact and effectiveness of 4CMenB (Bexsero), the only Men B vaccine now available in the Philippines^1-4

The recombinant technology of the new GSK vaccine – with an immunogenicity that confers broad coverage across a few strains – was shown in clinical studies to have high immunogenicity and persistence even in infants.^3,16 Studies also show it has an excellent tolerability profile.^3,16 Furthermore, real-world data from countries like the UK, Italy, Spain, Portugal, Canada, Australia and the US have consistently shown its impact and effectiveness by offering unrivalled protection to match the threat of invasive meningococcal disease, as the first and only MenB vaccine powered with real-world evidence and faster series completion in adolescents.^3,12,17-22How to Administer 4CMenB (Bexsero) to Protect Your Patients from the Predominant MenB

Meningococcal group B vaccine (Bexsero) is approved for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by N. meningitidis. It is available in suspension for intramuscular injections. Primary immunization of infants 2 to 5 months of age includes 3 injections of 0.5ml not less than 1 month apart, with a booster dose at 12-15 months of age. From 6 months of age onwards, the primary series consists of 2 doses with not less than 2 months interval for children below 2 years, and not less than 1 month for older children and adults. Booster doses are recommended at the 2nd year of life for infants who received primary vaccination at 6-11 months old, after 12- 23 months of the primary series in those 12 to 23 months old, and in older children and adults at continued risk of exposure.³

Meningococcal Group B vaccine (rDNA, component,adsorbed) (Bexsero) Safety Information³:

Bexsero should not be administered to subjects with known hypersensitivity to any component of the vaccine.

Adverse events associated include:

Infants and children (up to 10 years of age)

Very common (≥1/10):

-General disorders and administration site conditions: fever (≥38°C), injection site tenderness (including sever injection site tenderness as crying when injected limb is moved),

injection site erythema, injection site swelling, injection site induration, irritability

-Gastrointestinal disorders: diarrhoea, vomiting (uncommon after booster)

-Musculoskeletal and connective tissue disorders: arthralgia

-Skin and subcutaneous tissue disorders: rash (children aged 12 to 23 months) (uncommon after booster)

- Metabolism and nutrition disorders: eating disorders

- Nervous system disorders: sleepiness, unusual crying,headache

Common (≥1/100 to <1/10):

-Skin and subcutaneous tissue disorders: rash (infants and children 2 to 10 years of age)

Adolescents (from 11 years of age) and adults

Very common (≥1/10)

-General disorders and administration site conditions: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise

-Gastrointestinal disorders: nausea

-Nervous system disorders: headache

-Musculoskeletal and connective tissue disorders: myalgia, arthralgia

Abbreviations

4CMenB, Meningococcal group B Vaccine (rDNA, component, adsorbed); MenB, Meningococcal Serogroup B;

MenACWY, Meningococcal Serogroup ACWY

References:

1. Bexsero FDA Market Authorization Philippines;2024;1-2.

2. Food and Drug Administration Philippines; Verification on meningococcal vaccines; https://verification.fda.gov.ph/drug_productslist.php?cmd=search&t=drug_products&psearch=meningococcal&psearchtype= ; Access Date: September 9, 2024.

3. Bexsero Prescribing Information GDS16 / Date of issue: 15August 2022.

4. GSK Press release. About meningococcal serogroup B disease. October 2024.

5. World Health Organization, Meningococcal Meningitis, 2024;1-5; https://www.who.int/teams/health-product-policyand-standards/standards-and-specifications/norms-andstandards/vaccine-standardization/meningococcal-meningitis, Access Date: January 2025

6. CDC;2024;1-5;Meningococcal Vaccination for Adolescents

7. World Health Organization (WHO). Meningococcal meningitis fact sheet. 2021 http://www.who.int/mediacentre/factsheets/fs141/en/# (accessed January 2025).

8. ECDC;2017;1-10-Invasive meningococcal disease – Annual Epidemiological Report for 2017

9. CDC;2019;1-2;Active Bacterial Core surveillance (ABCs) Surveillance Reports

10. Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397–403.

11. Data on File-Serogroup ACB Distribution of Meningococcal Cases in Philippines. 2024;1-1

12. Ladhani SN; First real world evidence of meningococcal group B vaccine, 4CMenB, Protection against meningococcal group W disease; prospective enhanced national surveillance, England. Clinical Infectious Diseases;2020;1-28

13. Gonzales MLA; Meningococcal carriage in children and young adults in the Philippines: a single group, cross-sectional study. Epidemiology Infectious Diseases; 2017;145;126-132

14. Ong-Lim AT. Pediatric Infectious Disease Society of the Philippines Journal. 2022;23:5–9

15. Sadarangani, M., et al. (2010). Serogroup B meningococcal vaccines – An unfinished story. The Lancet Infectious Diseases, 10(2), 112–124.

16. Vesikari T et al. Immunogenicity and safety of an investigational multicomponent, recombinant,

meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet 2013;381:825–835

17. Gossger N et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules. JAMA 2012;307:573–582.

18. 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;37:4243–4245.

19. Azzari C 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 (Basel) 2020;8:E469.

20. Rodrigues FMP et al. Association of Use of a Meningococcus Group B Vaccine With Group B Invasive Meningococcal Disease Among Children in Portugal. JAMA 2020;324:2187–2194.

21. Watson PS; Clinical experience with the meningococcal B vaccine, Bexsero(®): Prospects for reducing the burden of meningococcal serogroup B disease. Vaccine;2016;34;875-80.

22. Martinón-Torres F et al. Recent advances in meningococcal B disease prevention: real-world evidence

from 4CMenB vaccination. Journal of Infection. 2021;83:17–26.

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Date of Preparation: January 2025

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