IMD : A Global Health Burden1
SYMPTOMS USUALLY PROGRESS FAST!
High fever, headache, stiff neck, confusion, nausea, vomiting, exhaustion, purplish rash, and death can happen in 1–2 days.
UP TO 1 in 5 SURVIVORS SUFFER FROM PERMANENT COMPLICATIONS
- Brain Damage
- Kidney Damage
- Deafness Limb loss
170,000 Deaths worldwide
Schedule 3+1 and 2+1 Immunogenicity Data:
The percentage of subjects with hSBA titers ≥8 (95% CI) against Neisseria meningitidis serogroups A, C, W and Y immediately before the dose administered at 12 months of age (had been declines), by group.2
Schedule 3+1 and 2+1 Immunogenicity Data, European Medicines Agency 2013 Concern
During the evaluation, the CHMP had concern over the data provided by the company in children less than 2 years of age.3-4
Data showed a fall in antibodies between the third and fourth dose which could result in children lacking protection between 6 months and 1 year of age.
“The CHMP* concluded that the data provided were insufficient to extend the use of MenACWY-CRMto infants aged 2 to 23 months”
Schedule 1 Dose at 12-month Immunogenicity Data
Persistence of MenACWY-TT, Immune Response In Toddlers, aged 12-23 Months (After 2 Years)5
rSBAand hSBA antibody persistence 2 years after vaccination with MenACWY-TT at 12–23 months of age
Schedule 1 dose at 12-month wanning concern: MenACWY-TT Summary of Product Characteristics –Persistence Of Serum Bactericidal Antibody Titers Against MenA1
Special warnings and precautions for use6
“Studies with MenACWY-TT have shown a waning of serum bactericidal antibody titers against MenAwhen using human complement in theassay (hSBA)”1
"However, if an individual is expected to be at particular risk of exposure to MenAand received a dose of MenACWY-TT more than approximately one year previously, consideration may be given to administering a booster dose.”6
Schedule 1+1 Immunogenicity Data
Vaccine had a high immune response for all the different schedules, at ages 9 and 12 months, 9 and 15 months, or 12 and 15 months
Schedule 1+1 effectiveness data: MOH reported cases before and after mandatory MCV4 vaccination
Between 1995 and 2011:
- National surveillance data indicate that 1103 IMD cases were reported in KSA: 60% in 2000–2001, involving two (mainly MenW) outbreaks involving KSA citizens/residents and pilgrims focused inMecca and Medina.
Between 2012 and 2019,
- 44 IMD cases were reported, all in KSA citizens/residents, and chiefly in children or infants.
- No pilgrimage associated outbreaks have occurred since 2001.
- Serogroup data were available for 62.5% of all cases for 2002–2011; MenW(40.0%), MenA (35.7%), and MenB (16.5%).
- CDC Meningococcal Disease, available at https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/mening.pdf, accessed on16/2/2022.
- Stan L. Block, Julie Shepard, Hartley Garfield, Fang Xie, Linda Han, Peter M. Dull, and Igor Smolenov. Pediatr Infect Dis J2016;35:e48–e59.
- EMA/253316/2013. Questions and answers on the outcome of application to extend use of Menveo in children less than 2 years. 25April 2013.
- Jessica R. MacNeil. Use of MenACWY-CRM Vaccine in Children Aged 2 Through 23 Months at Increased Risk for MeningococcalDisease: Recommendations of the Advisory Committee on Immunization Practices, 2013. MMWR 63(24). 2014.
- Timo Vesikari, Aino Forsten, Veronique Bianco, Marie Van der Wielen, Jacqueline M. Miller. Trials in Vaccinology 3 (2014) 121–126.
- GSK. MenACWY- TT [SmPC]. EMA, Accessed August 2015
- Clinical trials. (2014). Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months ofAge. [online] Available at: https://clinicaltrials.gov/ct2/show/NCT00643916 [Accessed 1 February 2021].
- 2021 Infect Dis Ther, https://doi.org/10.1007/s40121-021-00467-x