salisbury david [mode de compatibilité] · 2019. 2. 26. · menc conjugate programme. • at least...
TRANSCRIPT
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The principles of new vaccine introduction.
Prof David Salisbury CBProf. David Salisbury CBDirector of Immunisation,
Department of Health, LONDON, UK.p f
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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.
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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.
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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?
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••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?
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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.
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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
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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
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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.
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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).
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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
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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.
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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
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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
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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
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TV ad for the launch of Hib vaccine – 1992;
MenC campaign - 1999.
Unknown disease –raise awareness.
Greatly feared disease – manage expectations.
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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
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1998/9: MenC deaths in
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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.
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Awareness of the pneumococcal campaignAwareness of the pneumococcal campaign
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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
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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
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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
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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
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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
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Daily MirrorTimes
Daily Telegraphy g p
Daily Star
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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.
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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.
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%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)
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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
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The principles of new vaccineThe principles of new vaccine introduction.