Timetable for MenB immunisation and other changes to the immunisation programme


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

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  • The first step is to design a public education campaign. The research conducted by the Health Education Authority shows how parents rate the risks of measles in relation to other diseases (see above).
    Q3. How do you think this could influence vaccine coverage?
    Many factors influence vaccine coverage. One factor is the perceived severity of the disease. If a disease is perceived to be severe, vaccine coverage is high and vice versa. When Hib vaccine was introduced vaccine coverage was high from the beginning as meningitis is perceived by parents to be the most severe disease of childhood for which there is a vaccine.
    Q4. What other factors determine whether or not parents choose to have their children vaccinated against measles?
    Factors which have been shown to affect parental decisions about vaccines (UK research 1987/8):
    -severity of the disease -infectiousness of the disease
    -effectiveness of the vaccine -safety of the vaccine
    Factors associated with low coverage (1987/8):
    -socio-demographic variables e.g.. social class, mobility, family size
    -personal variables e.g.. parental attitudes, professional attitudes and knowledge
    -health service variables
    Influences on parental decisions (research in 1987/8):
    -friends and relatives 21% -health visitors 28% - GPs 27%
    -health education material 22% -media 25% -no-one 27%

  • Timetable for MenB immunisation and other changes to the immunisation programme

    1. 1. Dr Mary Ramsay Head of Immunisation Public Health England What does it take to implement a new vaccine? 11th June 2014
    2. 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. 3. Introducing a new vaccine3
    4. 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. 5. Introducing a new vaccine5
    6. 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. 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. 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. 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. 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. 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. 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. 13. Vaccine acceptability Regular survey of parents attitudes to vaccination Introducing a new vaccine13
    14. 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. 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. 16. Aimed at mothers Aimed at girls Magazine adverts for HPV vaccine Introducing a new vaccine16
    17. 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. 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. 19. Introducing a new vaccine19
    20. 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. 21. What about teenagers? IMD in <25 year- olds, England & Wales (2006/07-2010/11) Introducing a new vaccine21
    22. 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. 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. 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. 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