Dr Mary Ramsay's presentation at Meningitis Research Foundation's 2014 Meningitis Symposium http://www.meningitis.org/symposium2014

1. Dr Mary Ramsay
Head of Immunisation
Public Health England
What does it take to implement a new
vaccine?
11th June 2014

2. JCVI recommendation
• Before the meeting, project planning had already
commenced – including outlining the
• Objective(s) and deliverable(s)
• Assumptions, prerequisites, scope, and exclusions
• Interdependencies
• Communications plan and stakeholders
• Governance arrangements, risks and issues log
• All summarised in project plan - Gantt chart
Introducing a new vaccine2

3. Introducing a new vaccine3

4. Vaccine procurement – around 4 months
• Business case approval process
• Outline and full business cases developed
• Full financial implications and health outcomes enumerated
• Approval by DH and then to Her Majesty’s Treasury
• HMT grants approval to commence procurement
• EU tender for vaccine issued
• Statutory period for applications (one month)
• Negotiations commence, adjudication and contract
awarded
• Mandatory standstill period!
Introducing a new vaccine4

5. Introducing a new vaccine5

6. Vaccine supply & delivery – around 6 months
• Vaccine production by manufacturer commences
• Delivery to UK distribution centres
• Arrangements with Movianto for delivery and ordering by
general practices
• Consideration of fridge space and delivery capacity
• Build up sufficient stock to ensure all practices have
enough to vaccinate children as the infants come in
• Back-up stock for around 6 months supply in case of
batch failures
Introducing a new vaccine6

7. NHS contractual arrangements
• Section 7a mandate (new)
• Legal process by which SofS delegates delivery of public
health to NHS
• Agreed before financial year (financial and workload
commitment)
• Difficult to vary in year (e.g. HPV)
• Negotiations with General Practitioner’s Committee
• Generally done before financial year
• Already discussing contracts for 15/16
• Difficult to alter in year
Introducing a new vaccine7

8. Professional communications:
• Tripartite letter
• Announces commencement of programme
• Sign posts to all other information (FAQs, slides etc)
• Sign off by three organisations (PHE, DH, NHS England)
• GP contract enhanced service specification
• Development of detailed specification, eligibility and
payment period
• Sign-up of contract at local level
• Ordering advice and instructions for Immform
Introducing a new vaccine8

9. Professional and clinical issues:
• Clinical advice and guidance
• Green book chapter
• Communications for health professionals
• Training materials
• Patient group directions (to allow nurses to give vaccine
without a prescription)
• FAQs
• Workforce development (possible)
Introducing a new vaccine9

10. Difficult clinical issues with MenB - paracetamol
Introducing a new vaccine
• JCVI recommended given with vaccine, ideally with two
doses (x 2.5ml) over subsequent 16 hours
• Can it be given in general practice vaccination clinic
• Should supply be central (like the vaccine) – additional
costs central or costs to GP
• Sachets or bottles (would need spoons also)
• Can parents give paracetamol at home?
• Should we supply free of charge or make parents buy
(equity or risk of prescription costs)
• Sachets are 5ml – can parents split them?
10

11. Information and surveillance
• Add vaccine to the GP IT system – to record vaccine and
arrange payment
• Read codes generated by PRIMIS (contract and payment required)
• Specification to enable GP payment claims
• Add vaccine to Child Health Information System
• Schedule appointments for infants and extract data for coverage
• Specification agreed through Information Standards Board (HSCIC) and
committee to approve central returns
• Prepare for enhanced disease surveillance
• Collect vaccination status on all cases in eligible age groups
• Arrange additional typing of all cases (to confirm whether covered by
vaccine)
• Vaccine safety surveillance
Introducing a new vaccine11

12. Public communications:
Resources required
Multi-level approach targeting parents and health
professionals (plus older children and teachers for
teenager programme)
• Leaflet
• Parent consent form
• Information for local press, radio media
• Posters and factsheets for parents
• ? National television advert
Introducing a new vaccine12

13. Vaccine acceptability
Regular survey of parents
attitudes to vaccination
Introducing a new vaccine13

14. Acceptability of new vaccines
Parents of 0-2yrs who would immunise
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
%definiteorprobable
Source DH/HPE tracking survey, BRMB

15. Public communications
Research basis
• Routine research on parental attitudes
• Generally parents are very keen on meningitis vaccine
• Specific research comparing flu and meningitis B
undertaken in 2011
• Parents keen to have vaccine against meningitis and
septicaemia (more than flu!)
• Able to accept common side-effects of fever
• Slightly more worried about very high fever
• Reassured that fever could be reduced by paracetamol
• May need separate research for older children and
teenagers
Introducing a new vaccine15

16. Aimed at mothers Aimed at girls
Magazine adverts for HPV vaccine
Introducing a new vaccine16

17. Communication issues with MenB – catch-up
Introducing a new vaccine
• JCVI recommended vaccine is given alongside DTaP-
IPV-Hib at 2 and 4 months
• Catch up only for those attending for second and third
infant vaccines (3 and 4 months)
• Children born from certain date will become eligible for
MenB
• Parents may delay infant appointment to get MenB
• Should we offer MenB to infants presenting late for infant
vaccine – if so how late?
• Are we rewarding parents who attend late?
17

18. Measles
Flu
Tetanus
Mumps
Chicken pox
Common cold
Rubella
Whooping cough
Diphtheria
TB
Meningitis
Polio
HIGH RISKLOW RISK
Perception of severity of
childhood diseases in 1994
Source: HEA research during the Pre-campaign Pilot Study of parents of school aged childrenIntroducing a new vaccine18

19. Introducing a new vaccine19

20. Communications messages for MenB
• Most parents understand that meningitis is serious
• Message will probably need to aim manage demand
outside the eligible group
• Additional messages about fever and use of
paracetamol
• Aim to avoid unnecessary medical attendance
• Not put parents off attending for genuine illness
• But always be prepared for a backlash!
The Times
Monday 16 March
The Telegraph
Monday 16 March
Introducing a new vaccine20

21. What about teenagers? IMD in <25 year-
olds, England & Wales (2006/07-2010/11)
Introducing a new vaccine21

22. JCVI MenB 2014 recommendation
Although teenagers are less affected by meningococcal
disease
• vaccination of adolescents may be MORE cost-effective
than infant programme
• if the vaccine provides protection against carriage
Initial studies suggest vaccine does have biological effect on
carriage
• Less than impact of conjugate vaccines (<30%)
• Study undertaken in university students (very high rates)
JCVI recommended additional carriage studies in teenagers
Introducing a new vaccine22

23. Future carriage studies
in teenagers
Large carriage studies in adolescents planned for this year
• unable to obtain necessary clearance and funding for
including an intervention arm in time
Has been identified as a priority for DH Research and
Development
• Tender for carriage studies to inform use of vaccine likely
to occur in 15/16
More sophisticated studies may be recommended
• E.g. Reduction in carriage density and/or mucosal
immunity
Introducing a new vaccine23

24. Remaining uncertainties about
teenage vaccination
Duration of protection against carriage
• What age group should be targeted to maintain low
carriage rate?
• May take >20 years to confirm the expected impact
(unless major catch-up undertaken)
Strain coverage and potential for replacement
Alternative vaccine for study
• Pfizer vaccine targeted at adolescents
• Potential competition in the market
Introducing a new vaccine24

25. Summary
Considerable amount of additional steps required to ensure
a new programme is implemented safely
• Some steps can be run in parallel
Major time barriers are related to vaccine procurement and
ensuring sustainable vaccine supply
• Unable to vary due to legal limitations and sustainability of
programme
Contractual processes are time sensitive but can be
accelerated with willingness on all sides
Teenage programme is considerably further down the line
• Will be easier to implement if the vaccine is effective in infants
Introducing a new vaccine25