ps2 1(south africa)final

7/30/2019 Ps2 1(South Africa)Final

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//*+"&''&//*+"&''&//*+"&''&//*+"&''&

01210121012101211111

Fifty-Fifth World Health Assembly, Agenda item 13.9/ 18 May 2002


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Threats to Immunization

realitySmallpox

Poliomyelitis

Measles mortality

Burden of preventable disease

perceptionUnsupported safety concerns

Less acceptance of riskOverload of immune system

Polio vaccine and contraception

Bentsi-Enchill A, Duclos P and Folb P (2002)

SmallpoxPoliomyelitisMeasles mortalityBurden of disease

-3-3-3-3

Unsupported safety concernsLess acceptance of risk

Overload of immune system




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Evolution of Immunisation Programmes

I n c

i d e

n c e

VaccineCoverage

Adverse Events(number and/or perception)

Disease

Outbreak

VaccinationStops

Pre-vaccineIncreasingCoverage

Loss ofConfidence

Resumptionof confidence

Eradication

Maturity of Programme

Adapted from: Grabstein JD, Hospital Pharmacy 1996


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Threats to Immunization

realitySmallpox

Poliomyelitis

Measles mortality

Burden of preventable disease

perceptionUnsupported safety concerns

Less acceptance of riskOverload of immune system



Estimated AEFI Rates FollowingChildhood Vaccines

45454545

) 6666

) ,,,,

) 575575575575

) 8-8-8-8-

Supplementary information on vaccine safety: WHO, Geneva, 2000 WHO/V&B/00.36

5--58-55--58-55--58-55--58-5%%%% 5,95,95,95,95555

1/1000 to 1/ 50 000 doses

1/ 3 million doses for 1st dose OPV

1/1 million doses

1/750 000 doses


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VACCINE DEVELOPMENT PIPELINE

100 to 1 000 million USD Into market and beyond

Proof of principle Proof of concept Implementation

Identity ofactivecompound(s)

Chemicalcharacteristics



Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Animalmodels

Phase I andPhase IIclinical

trials

Advancedtoxicitytesting

Animalmodels


trials


Dialogue withNRAs

Phase III trials

Dialogue withNRAs

Phase III trials

Regulatoryauthorities

Patent


Patent

Basic ResearchBasic ResearchDevelopment

andValidation

DevelopmentDevelopment

andand

ValidationValidationUpscale

Post-marketingsurveillance


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Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Animalmodels


trials


Animalmodels


trials


Dialogue withNRAs

Phase III trials

Dialogue withNRAs

Phase III trials


Patent


Patent


andValidation


andand




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Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Animalmodels


trials


Animalmodels


trials


Dialogue withNRAs

Phase III trials

Dialogue withNRAs

Phase III trials


Patent


Patent


andValidation


andand




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Design

Qualitative and quantitative assessment of safety - (192 trialsHIV, sinusitis, AMI, arthritis, H. pylori, others.

Results

Severity of adverse effect reported adequately in 39%Laboratory-determined toxicity reported adequately in 29%Reasons for discontinuation reported in 46%

Median space allocated to safety results 0.3 pages

ConclusionSafety reporting was inadequate in all cases

-Ioannidis JPA and Lau J. JAMA 2001; 285(4):437-443


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Preclinical data identifying possible safety issues

(includes adjuvants, additives, growth medium residuals)

Predetermined method for detection of adverse events

System for clinical assessment of adverse events

Procedures in place to minimise risk of harm

Management strategies for risks that might arise

Communication plan to deal with new safety information


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Causality assessment

consistency

strength of association

specificity

temporal relationbiological plausibility

Weekly Epidemiological Record 23 March 2001, 76, 85-89


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Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Vaccineformulation

Pharmaco-kinetics

Mechanism ofaction

Bioavailability

Animalmodels


trials


Animalmodels

Phase I andPhase IIclinicaltrials


Dialogue withNRAs

Phase III trials

Dialogue withNRAs

Phase III trials


Patent


Patent


andValidation


andand


Post-marketingSurveillance/PV


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8888 - diagnosis of ADRs

- spontaneous reporting

- research

%%%% peer review

9999- research- education and training

%%%% communication and training

- education

- 8888%%%%@@@@

ADRs; medication errors; system failures; non-compliance;

treatment failures; irrational drug use.


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Fig, 1. The reporting process for adverse events following

immunization (AEFIs)

Loop 1Loop 2

1 Initial report2 Report to action level3 Investigation4 Send on reports meeting

criteria5 Report for consultation/

action6 Decision communication

(regulatory, public healt

7 Public statement

8 Contract information

UNICEF

Ministry of healthVaccine

manufacturer

Health care worker Supervisor NIP coordinator NRA

Procurement

agency

Hospital

(referred medical

facility)

Public health

community

Patient

Public

1

1

7

3

4

5

66

5

5

8

5

2

3

Health careworker

Recognizes AEFIs

Reports AEFIs

Treats patient/ refers

patient for treatment

Supervisor

Stimulates reports

Investigates

Filters

Provides feedback

Manages data

Proposes classification

NIP coordinator

Receives reports

Transmits reports

Triages

Works with environment

Manages data

Ensures response

NRA

Receives reports

Transmits reports

Shares database

Evaluates reports

Takes action

Notifies

Functions

NIP, national immunization programme; NRA, national regulatory authority

6

6

6

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Widespread use of vaccine in under-serviced communities

Public intolerance of risk to healthy subjects

Political dimensions of the disease

Lack of reporting culture in the countries concerned

Threats to the vaccine of rare adverse events


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