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Dr Andrew Riordan's presentation at Meningitis Research Foundation's 2014 Meningitis Symposium http://www.meningitis.org/symposium2014
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JCVI recommendation on MenB vaccine
Serogroup B Meningococcus
• Commonest cause of meningococcal disease in UK
• Similar to antigen on foetal brain tissue
• Other vaccine targets being investigated (OMPs)
• A group B vaccine was always 5 years away!
Meningococcal Cell Wall
MeNZB vaccine
• Epidemic of group B P1.7-2,4
• Tailor made vesicle vaccine for <20s
• Effectiveness ~73%• (against epidemic strain)
Clin Infect Dis 2009;49:597–605
Meningococcal disease in New Zealand 1970–2007
Reverse vaccinology
• Genome of serogroup B strain used to identify vaccine candidates
• 350 candidate antigens expressed
• Identified 7 proteins; surface exposed, conserved, induce bactericidal antibody response
Science 2000;287:1816-20
4CMenB vaccine
• Neisseria Heparin-Binding antigen (NHBA)• Neisserial adhesin (NadA) • Factor H-binding protein (fHbp)• PorA from MeNZB
Men B vaccine;What do the JCVI want to know?
• Is it effective?• Is it safe?• Is it worth it?
Invasive meningococcal B infections, E&W; 1998-2012
<1 1-4 5-9 10-14 15-19 20-24 25-29 30-34 >350
1000
2000
3000
4000
5000
6000
Age (Years)
Immunogenicity in Infants
• 4CMenB vaccination at 2, 3, and 4 months with routine vaccines + 12 month booster
• 88 - 99% infants developed hSBA titers ≥1:5 against indicator strains
• Responses to routine vaccines non-inferior (except pertactin and Pneumo 6B)
JAMA 2012;307:573-82, Lancet 2013;381:825-835
Immunogenicity in InfantsLancet 2013;381:825-835
What will 4CMenB cover?
Lancet Infect Dis. 2013 ;13:416-25
Meningococcal antigen typing system (MATS)78% of European MenB strains would be killed
88% strains (E&W2007-2008) killed in hSBA assay.
Vaccine 2013; 31: 4968-74.
Safety in Infants
• “Most notable systemic reaction was fever” esp when co-administered with routine imms
• More anti-pyretic use – prophylactic paracetamol advised
• 4 cases of Kawasaki disease
Lancet 2013;381:825-835
DUTY ON THE SECRETARY OF STATE FOR ENGLAND
• The Health Protection (Vaccination) Regulations 2009 place a duty on the Secretary of State for Health in England to ensure, so far as is reasonably practicable, that the recommendations of JCVI are implemented,
where those recommendations:
DUTY ON THE SECRETARY OF STATE FOR ENGLAND
a. New national vaccination programme;b. made by JCVI;c. in response to a question by the Secretary of
State; d. based on an assessment which demonstrates
costeffectiveness;e. not travel or occupational health vaccines.
Cost-effectiveness
Meningococcal vaccines likely to be cost effective;
• when the incidence of disease is high• if vaccine gives “indirect protection” (herd
immunity from preventing carriage)
Invasive meningococcal infections, England and Wales
0
500
1,000
1,500
2,000
2,500
3,000
YW135CB
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Incidence of disease is low
Meningococcal carriage by age
Lancet Infect Dis. 2010;10:853-61.
Infants 4•5% 19-year olds 23•7% 50-year olds 7•8%
Economic and mathematical modelling study of potential impact
• Unlikely to be cost-effective in the NetherlandsHum Vaccin Immunother. 2013;9(5).
• In UK could prevent 27% of cases by vaccinating infants
• Could prevent 71% case by vaccinating infants PLUS catch-up campaign, if vaccine protects against carriage
Vaccine. 2013 Apr 5. pii: S0264-410X(13)00369-1
• Data on 4CMenB preventing carriage in teenagers - uncertain
Interim position statement Men BJuly 2013
• “on the basis of the available evidence routine infant or toddler immunisation is highly unlikely to be cost effective at any vaccine price”
• JCVI found assessment challenging – absence of key data
• JCVI concerned about adverse impact – large uncertainties
Needs;- population based evaluation in adolescents; ?carriage effect- evaluation of infant immunisation in a large cohort (i.e. The UK)
MenB statement March 2014
• A programme providing vaccinations at 2, 4, and 12 months schedule was likely to be both effective and cost-effective, albeit at a price significantly lower price than the list price for Bexsero®.
• Even in the most favourable of scenarios no infant programme could demonstrate cost-effectiveness at the list price for Bexsero®.
Recommendation – March 2014
• JCVI recommended a programme for use of the MenB vaccine at 2, 4, 12 months of age in a carefully planned programme.
• Plans for implementation should anticipate a sustainable and cost-effective programme.
• Advised a targeted carriage study in adolescents to assess the impact on carriage.
Men B vaccine;What do the JCVI want to know?
• Is it effective? – immunogenic?coverage, ?efficacy
• Is it safe? – fevers, ?Kawasaki>5000 infants and toddlers
• Is it worth it? – cost effective at low vaccine price