JCVI recommendation on MenB
vaccine
Serogroup B Meningococcus
• Commonest cause of
meningococcal disease in UK
• Similar to antigen on foetal brain
tissue
• O...
Meningococcal Cell Wall
MeNZB vaccine
• Epidemic of group B
P1.7-2,4
• Tailor made vesicle
vaccine for <20s
• Effectiveness ~73%
• (against epidem...
Reverse vaccinology
• Genome of serogroup B
strain used to identify
vaccine candidates
• 350 candidate antigens
expressed
...
4CMenB vaccine
• Neisseria Heparin-Binding antigen (NHBA)
• Neisserial adhesin (NadA)
• Factor H-binding protein (fHbp)
• ...
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
0
1000
2000
3000
4000
5000
6000
<1 1-4 5-9 10-14 15-19 20-24 25-29 30-...
Immunogenicity in Infants
• 4CMenB vaccination at 2, 3, and 4 months
with routine vaccines + 12 month booster
• 88 - 99% i...
Immunogenicity in Infants
Lancet 2013;381:825-835
What will 4CMenB cover?
Lancet Infect Dis. 2013 ;13:416-25
Meningococcal antigen typing system (MATS)
78% of European MenB...
Safety in Infants
• “Most notable systemic reaction was fever”
esp when co-administered with routine imms
• More anti-pyre...
DUTY ON THE SECRETARY OF STATE
FOR ENGLAND
• The Health Protection (Vaccination) Regulations 2009
place a duty on the Secr...
DUTY ON THE SECRETARY OF STATE
FOR ENGLAND
a. New national vaccination programme;
b. made by JCVI;
c. in response to a que...
Cost-effectiveness
Meningococcal vaccines likely to be cost
effective;
• when the incidence of disease is high
• if vaccin...
Invasive meningococcal
infections, England and Wales
0
500
1,000
1,500
2,000
2,500
3,000
Y
W135
C
B
1998 1999 2000 2001 20...
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 Netherlands
Hum Vacci...
Interim position statement Men B
July 2013
• “on the basis of the available evidence routine
infant or toddler immunisatio...
MenB statement March 2014
• A programme providing vaccinations at 2, 4,
and 12 months schedule was likely to be both
effec...
Recommendation – March 2014
• JCVI recommended a programme for use of
the MenB vaccine at 2, 4, 12 months of age in
a care...
Men B vaccine;
What do the JCVI want to know?
• Is it effective? – immunogenic
?coverage, ?efficacy
• Is it safe? – fevers...
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JVCI recommendation on Men vaccine

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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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JVCI recommendation on Men vaccine

  1. 1. JCVI recommendation on MenB vaccine
  2. 2. 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!
  3. 3. Meningococcal Cell Wall
  4. 4. 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
  5. 5. 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
  6. 6. 4CMenB vaccine • Neisseria Heparin-Binding antigen (NHBA) • Neisserial adhesin (NadA) • Factor H-binding protein (fHbp) • PorA from MeNZB
  7. 7. Men B vaccine; What do the JCVI want to know? • Is it effective? • Is it safe? • Is it worth it?
  8. 8. Invasive meningococcal B infections, E&W; 1998-2012 0 1000 2000 3000 4000 5000 6000 <1 1-4 5-9 10-14 15-19 20-24 25-29 30-34 >35 Age (Years)
  9. 9. 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
  10. 10. Immunogenicity in Infants Lancet 2013;381:825-835
  11. 11. 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.
  12. 12. 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
  13. 13. 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:
  14. 14. 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.
  15. 15. 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)
  16. 16. Invasive meningococcal infections, England and Wales 0 500 1,000 1,500 2,000 2,500 3,000 Y W135 C B 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Incidence of disease is low
  17. 17. Meningococcal carriage by age Lancet Infect Dis. 2010;10:853-61. Infants 4•5% 19-year olds 23•7% 50-year olds 7•8%
  18. 18. Economic and mathematical modelling study of potential impact • Unlikely to be cost-effective in the Netherlands Hum 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
  19. 19. Interim position statement Men B July 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)
  20. 20. 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®.
  21. 21. 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.
  22. 22. 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
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