We have a new vaccine: Now what are we going to do with it? Prof. David Salisbury CB FRCP FRCPCH FFPH FMedSci

Transcription

1 We have a new vaccine: Now what are we going to do with it? Prof. David Salisbury CB FRCP FRCPCH FFPH FMedSci

2 Pressures for new vaccine introduction. International institutions. Vaccine manufacturers National authorities (GOs). Interest groups (NGOs). Professional organisations. Public at large. Opinion formers who influence the public at large.

3 Constraints on new vaccine introduction. You think your own priorities are more important than anyone else s - ability to influence prioritisation. Resource limitations at all levels, especially for preventative rather than curative services. Competing priorities for those implementing. Lack of receptivity at local level for problems of global, regional or national relevance - a predictable consequence of decentralisation.

4 Who? How much? Where is the money? How? Why? Immunisation Who will do it? strategy When? Did it work? Where? Why not? Is it worth it?

5 Is there a need? Is there a vaccine? That is safe and effective? Who should receive vaccine? Would it be a good use of public or personal funds?

6 Is there a need? Information requirements. Epidemiology of disease: Extent of burden in morbidity and mortality. Age of affected population. Projections for future disease burden. Clinical management of disease: Primary care implications. Secondary / tertiary care implications. Long term complications of disease and health requirements. Economic burden may consider time off work for those affected or their carers.

7 Annual cases of meningococcal infection England and Wales, ,500 1, Group B Group C

8 Is there a vaccine? Not at the time of start-up. Encouragement of manufacturers to collaborate with Phase II studies. DH funding for Vaccine Evaluation Consortium in place. Large increase in DH funding in 1997 to accelerate research. Identification of specific policy related questions for DH funded research, separate to manufacturers' interests, e.g. giving men C conjugate at same time as MMR, or other vaccines.

9 Purpose of DH investment. To accelerate the availability of much needed vaccines. To answer policy related questions that manufacturers would not necessarily address. To hasten the process of license through generation of high quality data. To evaluate vaccine effects in circumstances similar to routine use (e.g. immunisation of whole schools for adverse events).

10 % of estimates that are cost effective Economic benefits in health and strategies driven by economics HPV cost effectiveness acceptability curves Vaccination of girls 12, 13, or 14 years old (Age) per QALY gained Age 12 Age 13 Age years 20 years Life long Quadrivalent vaccine at 80% coverage, with different assumptions about vaccine duration of protection, based on results of 50,000 meta-scenarios combining epidemiological and economic assumptions ,000 20,000 30,000 40,000 50,000 60,000 Threshold ( /QALY) HPV, human papillomavirus vaccine; QALY, quality adjusted life years Jit M, Choi YH, Edmunds WJ. BMJ 2008;337:a769.

11 % of estimates that are cost effective Economic benefits in health and strategies driven by economics HPV cost-effectiveness acceptability curves Vaccination of 12-year-old girls (Coverage) per QALY gained 80% 70% 90% 10 years 20 years Life long Quadrivalent vaccine at different levels of three-dose coverage, and with different assumptions about duration of protection from vaccine ,000 20,000 30,000 40,000 50,000 60,000 Threshold ( /QALY) HPV, human papillomavirus vaccine; QALY, quality adjusted life years Jit M, Choi YH, Edmunds WJ. BMJ 2008;337:a769.

12 Economic benefits in health and strategies driven by economics Incremental cost-effectiveness ratio (Assumption: Life-long protection of HPV) Programme Median ( per QALY) 5% centile 95% centile Girls aged Catch-up for girls years old Catch-up for girls years old Catch-up for girls years old Catch-up for girls years old Girls & boys at 12 years old HPV, human papillomavirus vaccine; QALY, quality adjusted life years Jit M, Choi YH, Edmunds WJ. BMJ 2008;337:a769.

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14 Cost-effectiveness acceptability curves for the cohort model in scenarios analyses. Curves show results under routine infant vaccination (strategy A) of the effect of varying cost (per dose) of the vaccine, vaccine duration of protection (given in months following the priming and booster doses) and vaccine efficacy (VE). Vaccine May 28;31(23): doi: /j.vaccine Epub 2013 Apr 6. Introducing vaccination against serogroup B meningococcal disease: an economic and mathematical modelling study of potential impact. Christensen H1, Hickman M, Edmunds WJ, Trotter CL.

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16 Acquisition of resources. Cost - benefit analysis. Operational advantages. Urgency / public health concerns. Public / Professional pressures Political dimension /Government priorities.

17 Acquisition of resources MenC conjugate programme. At least four separate budget lines Vaccine purchase, promotion, service delivery (may involve two different processes, e.g primary care and school health services), implementation. Each requires separate negotiation with different groups. No guarantee that all will succeed.

18 TV ad for the launch of Hib vaccine 1992; MenC campaign Unknown disease raise awareness. Greatly feared disease manage expectations.

19 Number of cases Haemophilus influenzae type b (Hib) E&W; Confirmed cases of invasive Hib disease in England and Wales Hib vaccine introduced All ages including under five years Under five years Hib booster at 12 months introduced into the routine immunisation programme Hib Catch-up 1 Hib Catch-up Year Source HPA

20 Number of Men C cases Neisseria meningitidis type C (MenC). E&W; Introduction of the Meningococcal C vaccine Under 20 years old Over 20 years old Year Source HPA

21 Introduction of HPV vaccine - Practical issues to consider Choice of vaccine Age of vaccination. Girls (and boys?). Catch-up campaign. School based programme vs GP practice. Parent and child acceptability.

22 Delivery Primary Care or School based service? UK has extensive experience of delivering school immunisation programmes. Tuberculin testing and BCG vaccine programme. Measles Rubella (MR) vaccine catch-up. Meningitis C (MenC) vaccine campaign. School-leaving Td/IPV vaccine.

23 % Coverage (%) in MenC school cohorts by age (yrs) All Age (yrs)

24 Attitudinal Research

25 Attitudes towards vaccination Parents of 8 10 year old children (2005) Most participants were very positive - vaccination is an important parental responsibility. Mothers seemed more involved in health generally, few differences in parents views. Perception that vaccination carries risks - assumed responsibility for protecting children against risk. Protector role and MMR controversy meant they were more conscious of risks for children than for adults. Children were too young at primary school.

26 Research summary for 11 to 12 year olds key concerns (2007). Parents Vaccine safety and potential for damaging girls future fertility A licence to engage in underage and unprotected sex Consent; parents were against the idea of their year old children having the right to decide The majority supported the idea of a catch-up programme for thirteen to eighteen year olds. Girls Worried about the trauma of the injection Most girls were in favour of having the vaccination, and many felt that their parents would be supportive. Professionals In favour of the vaccine providing programme adequately resourced.

27 Setting the communications agenda Market research to Identify ideal age for vaccination Identify key messages Develop and evaluate communication materials. Introducing the full HPV story tends to lead towards confusion and rejection - the cervical cancer story is more significant and more easily understood. HPV vaccine protects against cervical cancer. The vaccine will be part of the routine immunisation programme. Parents immunise to protect their children against disease, not against the viruses that cause them.

28 Pre testing of leaflets

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32 Press advertising 12-13s Launch ad national press

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35 Branded HPV vaccine room

36 Habbo Hotel partnership Habbo has 223,000 unique female users aged Activity included: 4 x 2 hour weekly group chat sessions with NHS health advisors Mini poll question HPV branded badge awarded to 50 users who complete poll Bots walk around Habbo sharing key information about vaccine Advertorial to support the activities Traffic drives users to advertorial to find out more Spot the difference game appears on site.

37 % Uptake 100. HPV Vaccine Uptake Year Olds 2008/09, 2009/10, 2010/11, 2011/12 & 2012/ Final 2013 data: First dose 91% Second dose 90% Third dose 86% 0. Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Month 1 Dose (Coh 1, 12-13y 2008/09) 2 Dose (Coh 1, 12-13y 2008/09) 3 Dose (Coh 1, 12-13y 2008/09) 1 Dose (Coh 7, 12-13y 2009/10) 2 Dose (Coh 7, 12-13y 2009/10) 3 Dose (Coh 7, 12-13y 2009/10) 1 Dose (Coh 8, 12-13y 2010/11) 2 Dose (Coh 8, 12-13y 2010/11) 3 Dose (Coh 8, 12-13y 2010/11)

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39 Training slide sets 39

40 Learning outcomes After completing this training resource, healthcare practitioners will be able to: Describe the aetiology and epidemiology of rotavirus Have an understanding of how rotavirus is transmitted and the potential complications of infection in infants Discuss the importance of vaccination against rotavirus Have a knowledge of the contraindications for rotavirus vaccination Safely administer the vaccine Have an understanding of potential adverse reactions and how to report these Be aware of sources of additional information 40 The infant rotavirus vaccination programme

41 _update_2016_week_06.pdf

42 Vaccine Supplies. You cannot run a new vaccine programme unless supplies are in place before the start date

43 Vaccine Supplies. You cannot run a new vaccine programme unless supplies are in place before the start date

44 The process of introducing new vaccines. Epidemiology before and after implementation. Cost-effectiveness analysis with modelling of expected impact Resources Training for Health Professionals with nationally developed materials. Supply arrangements selection, purchase, distribution. Surveys of public attitudes, knowledge and acceptability. Communications research and pre-testing of advertising materials. Development of communications packages (Television, radio, leaflets, newspapers, social networking, internet). Tracking of vaccinations through national systems. Adverse event monitoring Evaluation of communication materials. Impact assessment.

45 Elements of new vaccination Vaccine delivery - supply, clinics Surveillance of coverage Surveillance of population susceptibility Surveillance of diseases programmes Budget & resource Vaccine development Policy development Predicting the future - modelling Training Communication Planning, Implementation, Coordination, Management. Monitoring attitudes to vaccination Adverse events surveillance