timetable for menb immunisation and other changes to the immunisation programme

Dr Mary RamsayHead of ImmunisationPublic Health England

What does it take to implement a new vaccine?

11th June 2014

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 vaccine 2

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!


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


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


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


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)


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

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


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


Vaccine acceptability

Regular survey of parents attitudes to vaccination


Acceptability of new vaccines Parents of 0-2yrs who would immunise

Hepat

itis B

Chick

en P

ox

Pneu

moc

occu

s

Pneu

mon

ia

Pnu,

Men

, OM

Men

0%10%20%30%40%50%60%70%80%90%

100%

% d

efin

ite o

r pr

obab

le

Source DH/HPE tracking survey, BRMB

Public communicationsResearch 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


Aimed at mothers Aimed at girls

Magazine adverts for HPV vaccine


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

Measles

Flu

Tetanus

Mumps

Chicken pox

Common cold

RubellaWhooping cough

DiphtheriaTB

MeningitisPolio

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 children Introducing a new vaccine18

Introducing a new vaccine19

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


What about teenagers? IMD in <25 year-olds, England & Wales (2006/07-2010/11)


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


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


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


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


timetable for menb immunisation and other changes to the immunisation programme

Health & Medicine