The principles of new vaccine introduction.

Prof David Salisbury CBProf. David Salisbury CBDirector of Immunisation,

Department of Health, LONDON, UK.p f

Pressures for new vaccine introduction.Pressures for new vaccine introduction.

•• International institutions.International institutions.•• National authorities (GOs).National authorities (GOs).•• Interest groups (NGOs).Interest groups (NGOs).Interest groups (NGOs).Interest groups (NGOs).•• Professional organisations.Professional organisations.

P bli t lP bli t l•• Public at large.Public at large.•• Opinion formers who influence the public at Opinion formers who influence the public at

large.large.

Constraints on new vaccine introductionConstraints on new vaccine introductionConstraints on new vaccine introduction.Constraints on new vaccine introduction.

•• Your own priorities are more important thanYour own priorities are more important thanYour own priorities are more important than Your own priorities are more important than anyone else’s anyone else’s -- ability to influence prioritisation.ability to influence prioritisation.

•• Resource limitations at all levels especially forResource limitations at all levels especially for•• Resource limitations at all levels, especially for Resource limitations at all levels, especially for preventative rather than curative services.preventative rather than curative services.C ti i iti f th i l tiC ti i iti f th i l ti•• Competing priorities for those implementing.Competing priorities for those implementing.

•• Lack of receptivity at local level for problems of Lack of receptivity at local level for problems of global, regional or national relevance global, regional or national relevance -- a predictable a predictable consequence of decentralisation.consequence of decentralisation.

Who?Who?Who?

How?H ?H ?When?When?When?

How?How?How?Where?Where?Where?HowHowHow

much?much?much?Why?Why?Why?

ImmunisationImmunisationImmunisationmuch?much?much?

WhWhWhWhyWhyWhy

?strategystrategystrategyWhereWhereWhereis theis theis the

not?not?not?Is itIs itIs itmoney?money?money?

Who willWho willWho willIs itIs itIs itworth it?worth it?worth it?

do it?do it?do it? Did itDid itDid itwork?work?work?work?work?work?

••Is there a need?Is there a need?••Is there a need?Is there a need?••Is there a vaccine?Is there a vaccine?Th i f d ff i ?Th i f d ff i ?••That is safe and effective?That is safe and effective?

••Who should receive vaccine?Who should receive vaccine?••Would it be a good use of public Would it be a good use of public funds?funds?funds?funds?

Is there a need?Is there a need?

Information requirements.Information requirements.

•• Epidemiology of disease:Epidemiology of disease:E f b d i bidi d liE f b d i bidi d li•• Extent of burden in morbidity and mortality.Extent of burden in morbidity and mortality.

•• Age of affected population.Age of affected population.•• Projections for future disease burdenProjections for future disease burden•• Projections for future disease burden.Projections for future disease burden.•• Clinical management of disease:Clinical management of disease:•• Primary care implications.Primary care implications.y py p•• Secondary / tertiary care implications.Secondary / tertiary care implications.•• Long term complications of disease and health requirements.Long term complications of disease and health requirements.

E i b d i ti ff k f ff t d th iE i b d i ti ff k f ff t d th i•• Economic burden in time off work for affected or their carers.Economic burden in time off work for affected or their carers.

A f i i f iAnnual cases of meningococcal infection EnglandAnnual cases of meningococcal infection EnglandAnnual cases of meningococcal infection Englandand Wales, 1992 - 1999.and Wales, 1992 - 1999.and Wales, 1992 - 1999.

1,500

1 0001,000

500

1992 1993 1994 1995 1996 1997 1998 19990

Group B Group CGroup B Group C

Laboratory confirmed Group B and C meningococcal disease, Laboratory confirmed Group B and C meningococcal disease, E and W, July 1994E and W, July 1994 -- 1999.1999.

60

70E and W, July 1994 E and W, July 1994 1999.1999.

50

60

40

30

20

0

10

94/26 94/52 95/26 95/52 96/26 96/52 97/26 97/52 98/26 98/52 99/260

Group C Group B

Is there a vaccine?Is there a vaccine?

•• Not at the time of startNot at the time of start--upup

Is there a vaccine?Is there a vaccine?

Not at the time of startNot at the time of start--up.up.•• Encouragement of manufacturers to collaborate with Encouragement of manufacturers to collaborate with Phase II studies.Phase II studies.se s ud es.se s ud es.•• DH funding for Vaccine Evaluation Consortium in place.DH funding for Vaccine Evaluation Consortium in place.•• Large increase in DH funding in 1997 to accelerate Large increase in DH funding in 1997 to accelerate g gg gresearch.research.•• Identification of specific policy related questions for DH Identification of specific policy related questions for DH funded research, separate to manufacturers' interests, eg funded research, separate to manufacturers' interests, eg giving men C conjugate at same time as MMR, or other giving men C conjugate at same time as MMR, or other

iivaccines.vaccines.

Purpose of DH investment.Purpose of DH investment.

•• To accelerate the availability of much needed To accelerate the availability of much needed vaccines.vaccines.

T li l d i hT li l d i h•• To answer policy related questions that To answer policy related questions that manufacturers would not necessarily address.manufacturers would not necessarily address.•• To hasten the process of license throughTo hasten the process of license through•• To hasten the process of license through To hasten the process of license through generation of high quality data.generation of high quality data.•• To evaluate vaccine effects in circumstancesTo evaluate vaccine effects in circumstances•• To evaluate vaccine effects in circumstances To evaluate vaccine effects in circumstances similar to routine use (e.g. immunisation of whole similar to routine use (e.g. immunisation of whole schools for adverse events).schools for adverse events).schools for adverse events).schools for adverse events).

A i i i fA i i i fAcquisition of resources.Acquisition of resources.

•• Cost Cost -- benefit analysis.benefit analysis.yy•• Operational advantages.Operational advantages.•• Urgency / public health concerns.Urgency / public health concerns.g y pg y p•• Public / Professional pressuresPublic / Professional pressures•• Political dimension /Government priorities.Political dimension /Government priorities.pp

Acquisition of resourcesAcquisition of resourcesAcquisition of resources Acquisition of resources

MenC conjugate programme.MenC conjugate programme.

• At least four separate budget linesAt least four separate budget lines

MenC conjugate programme.MenC conjugate programme.

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

Number of cases of invasive menC disease by year, 1996 Number of cases of invasive menC disease by year, 1996 –– 2005. England & Wales. HPA data2005. England & Wales. HPA data.gg

I t d i i / li iI t d i i / li iIntroducing new vaccines / new policies.Introducing new vaccines / new policies.

•• A complex multiA complex multi--faceted task that requires faceted task that requires the cothe co--ordination of :ordination of :the cothe co--ordination of :ordination of :•• policy makers / programme managementpolicy makers / programme management•• public health expertspublic health experts•• public health expertspublic health experts•• advertising & marketing expertsadvertising & marketing experts•• researchersresearchers•• researchersresearchers•• manufacturersmanufacturers•• regulatorsregulators•• regulatorsregulators•• parents and health professionalsparents and health professionals

Introducing new vaccines / new policies.Introducing new vaccines / new policies.

• Vaccine studiesVaccine studies • Coverage MeasurementCoverage Measurement•• Product selectionProduct selection•• Disease SurveillanceDisease Surveillance

gg•• Resources.Resources.•• Communication StrategyCommunication Strategy

•• Adverse Event monitoringAdverse Event monitoring•• Supply arrangementsSupply arrangements•• Call / recall programmingCall / recall programming

•• Professional training materialsProfessional training materials•• Vaccine failuresVaccine failures•• Impact assessmentImpact assessment•• Call / recall programmingCall / recall programming •• Impact assessmentImpact assessment

TV ad for the launch of Hib vaccine – 1992;

MenC campaign - 1999.

Unknown disease –raise awareness.

Greatly feared disease – manage expectations.

Cases of Hib disease, E & W, 1991 to 2007. HPA data.

900

1,000

Hib-

700

800

900

Hib catch-up 1-4y

HibMenC at 1y

umbe

rs

500

600

p y

Nu

300

400

100

200

Years1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20070

1998/9: MenC deaths in

Rate of invasive pneumococcal infection by Rate of invasive pneumococcal infection by E l d & W l HPA dE l d & W l HPA dage, England & Wales, HPA data.age, England & Wales, HPA data.

Awareness of the pneumococcal campaignAwareness of the pneumococcal campaign

Main message taken from pneumococcal campaignMain message taken from pneumococcal campaignMain message taken from pneumococcal campaignMain message taken from pneumococcal campaign(unprompted).(unprompted).

33%Get your child vaccinated/immunised

19%Mention of a new immunisation/vaccine

10%Protection against/prevention of diseases

9%

diseases

Wait to be contacted

8%Available for children under 2

Diseases pneumococcal vaccine was thoughtDiseases pneumococcal vaccine was thoughtto protect against (unprompted).to protect against (unprompted).

74%Meningitis

58%Blood poisoning/

septicaemia

29%

52%Pneumonia

Ear infections 29%Ear infections

11%Don’t know

Perceived action to take for the pneumococcalPerceived action to take for the pneumococcalPerceived action to take for the pneumococcal Perceived action to take for the pneumococcal vaccine (unprompted)vaccine (unprompted)

72%

Contact health

Nothing/wait to becontacted

11%

Get more information

Contact healthvisitor/surgery for more

info

8%

Contact health/

Get more informationfrom a leaflet

4%

Visit immunisation

visitor/surgery to makeappt

2%website

Cumulative weekly number of reports of Invasive Pneumococcal Disease due to any of the seven serotypes in Prevenar™ : Children aged < 2 Years in England and Wales by Epidemiological Year:

July-June (2003- To Date)

350

July June (2003 To Date)

03-04 04-05 05-06 06-07 07-08

300

200

250

Rep

orts

150

Num

ber o

f R

Introduction of Prevenar™ GREEN LINE Week 36 2006

50

100

0

WEEK

Cumulative weekly number of reports of Invasive Pneumococcal Disease due to any of the seven serotypes in Prevenar™ : Children aged 5-14 Years in England and Wales by

60

seven serotypes in Prevenar : Children aged 5 14 Years in England and Wales by Epidemiological Year: July-June (2003- To Date)

03-04 04-05 05-06 06-07 07-08

50

60

30

40

of R

epor

ts

20Num

ber o

Introduction of Prevenar™ GREEN LINE Week 36 2006

0

10

WEEK

Daily MirrorTimes

Daily Telegraphy g p

Daily Star

Delivery: Practical issues to consider

• A f i ti• Age of vaccination. • Girls (and boys?).• Catch-up campaign.• School based programme vs GP practice.Sc oo b sed p og e vs G p c ce.• Parent and child acceptability.

Delivery

UK has extensive experience of delivering school immunisation programmesimmunisation programmes.

• Tuberculin testing and BCG vaccine programme.• Measles Rubella (MR) vaccine catch-up.• Meningitis C (MenC) vaccine campaign.

%Coverage (%) in MenC school cohorts by age

(yrs)

90

100% (yrs)

70

80

50

60

20

30

40

0

10

20

05 6 7 8 9 10 11 12 13 14 15 16 17 All

Age (yrs)

BRIEFING AND CORRESPONDENCE

PROJECT MANAGEMENT

HPV vaccine programme board meetings

HPV Project Planning

SCIENCEGROUP

S ill

BRIEFING AND CORRESPONDENCE

COMMUNICATIONS

VACCINE SUPPLYGROUP

Vaccine purchase and distributionSurveillance

JCVI

Factsheet

GROUP

Comms group

MINISTERS, GOVERNMENT AND STAKEHOLDERSGROUP

Submissions

S k h ld O h G DGreen book chapter

IMPLEMENTATIONGROUP

NHS i l i di i (i DfES)

Field comms

CMO letter

Internal comms

Distribution of information

Leaflet second pre-test

Leaflet

Stakeholders – Other Government Departments

GP and PCT legal issues (including guidance)

NURSES AND OTHER HEALTH PROFESSIONALNHS implementation discussion group (inc DfES)

Second HPV immunisation co-ordinators conference

Capacity (workforce assessment)/mapping

Media handling

Information packComprising folder, leaflet, Q&A, fact sheet, Green book chapter, ‘Credit card’ record card, A3 poster,

Q&A

Immunisation website (mini-site)

NURSES AND OTHER HEALTH PROFESSIONAL ISSUES

Capacity (workforce assessment)/mapping (scheduling)

Consent/data record

PGDs

October 2007 press release, covering letter

Training materials-Information pack-Slide set (KP)

Advertising

Advertising pre-test

Advertising second pre-test

DATAGROUP

PGDs

Local data Recording/Sharing

Web-based toolkitWhich will include an HPV element

Slide set (KP)-E Learning package? (PK)HPV in formation line

Pre Campaign tracking research

P t i t ki h

Vaccine Uptake Data Collection

INEQUALITIESGROUP Which will include an HPV elementPost campaign tracking researchInequalities

The principles of new vaccineThe principles of new vaccine introduction.