Introduction to Immunization Safety and AEFI Surveillance

OVERVIEW

Immunization safety as an emerging issue

Need for immunization safety systems

Critical elements of an immunization safety system

(including the role of the National Regulatory Authority)

Anti-immunisation lobbyAnti-immunisation lobby

WHY IMMUNISATION SAFETY ?

Changing Regulatory norms Changing Regulatory norms

Vaccination campaignVaccination campaignMishandling rumoursMishandling rumours

Unsafe injectionUnsafe injection

Inadequate monitoringInadequate monitoring

UNSAFE INJECTIONS: ESTIMATED ANNUAL CONSEQUENCES

>20 billion injections annually

95% for curative purposes

>50% unsafe

8-16 million HBV

2-4.5 million HCV

75 000-100000 HIV

? millions of injection site abscesses

* Simonsen L et al. Bulletin of the World Health Organization, 1999

Unsafe injectionUnsafe injection

Key results of the Injection Safety AssessmentINDCLEN – Govt. of India 2003

Unsafe injection practices 67.3% of unsafe injections overall

55% of non-sterile injections

73.9% of unsafe injections in immunization

VACCINATION CAMPAIGNS - SPECIAL ISSUES

Apparent risemany doses over short period of time

more vigilance/awareness

Real rise from programmatic errors normal safe injection practices not observed

new staff unfamiliar

Adverse events generate criticism of campaign

Vaccination campaignVaccination campaign

CHANGING REGULATORY NORMS

Oldempirically defined procedure

reliance on QC testing

field studies done only for licensing

Newstrictly defined procedure for consistency

reliance on GMP rather than final product testing

continuous safety and effectiveness surveillance

Regulations are changingRegulations are changing

FUNCTIONS OF A NATIONALREGULATORY AUTHORITY

Marketing authorization and licensing

Post Marketing surveillance (PMS / AEFI monitoring)

System of lot release

Laboratory access

Regulatory inspections for GMPs

Oversight of clinical trials

THE ROLE OF THE NATIONAL REGULATORY AUTHORITY

What is the role of the NRA in vaccines safety surveillance?

Who (within the NRA) should be responsible for vaccines safety surveillance?

How and why should NRA and EPI work together?

A few terminologies …

Adverse Events Following Immunization (AEFI)

Adverse Drug Reaction (ADR)

Post Marketing Surveillance (PMS)

Adverse Events (AE)

Severe Adverse Events (SAE)

OBJECTIVES OF MONITORING AEFIs

Identify urgent problems for investigation and action

Detect signals for potential follow-up and research

Estimate rates for serious AEFIs for comparison between products to determine risks and benefits of immunization to validate pre-licensure data

Identify programmatic errors and batch problems

Create awareness of risks among health professionals

KEY ELEMENTS OF AN EFFECTIVE IMMUNIZATION SAFETY SYSTEM

Rapid notification of the basic information

Rapid and effective evaluation of information

Rapid and effective response/action

Ensure appropriate outcome of action/response

Adequate education and training of role players

OBJECTIVES OF THIS WORKSHOP

To provide us withimportance of this activity in our country

knowledge and skills to develop a AEFI surveillance system to

detect report assess and respond to AEFIs (including communication) prevent

Improve collaboration between NRA, NIP and others

Thank You

Thank You

SIMILARITIES AND DIFFERENCES

BETWEEN

VACCINES AND MEDICINES

SIMILARITIES BETWEEN VACCINES AND MEDICINES

Vaccines are also medicines

Potential for adverse effects

Multiple ingredients

Potential for interaction with disease and other

medicines

Also need to comply with standards of safety,

efficacy and quality

SPECIFIC ISSUES RELATED TO VACCINES

Use on a large scale

Use may be mandatory

Public relations:

we promote the product!

service providers have the responsibility

safety issues can be in conflict with programme

close relationship with manufacturer

SPECIFIC ISSUES RELATED TO VACCINES

Procurement, storage and handling

About 30 products compared with around 20 000 drugsFewer manufacturers but more recipientsMaintenance of the cold chain Imported vaccines - long distance transport

Promotion and Procurement: Vaccines vs Drugs

Vaccine

Public campaigns common

Access/safety

++government procurement / program

Collaboration UIP/Gov’t and manufacturers critical

Drugs

Public campaigns rare

Access/safety variable

++private procurement / programs

Drug manufacturers less relationship to gov’t

Storage and Distribution

Vaccines

mainly in field, offices and clinics

cold chain often critical

biological product-

lot variation, stability

Drugs

mainly in hospitals, clinics, pharmacies

most a room temp

chemical product

SPECIFIC ISSUES RELATED TO VACCINES

EFFICACY

Given to healthy individualsdifficult to detect lack of efficacy

Perceived need depends on disease burdenHerd immunityGoal: disease eradication Need vaccine distribution data (batch)Brand product specific manufacturing techniques (each product is different)

Efficacy: Vaccine vs Drugs

Vaccines

healthy

prevention of disease

large population

most used in

infants and children

Drugs

ill

treat disease

small population

most used in

adults

SPECIFIC ISSUES RELATED TO VACCINES

SAFETYLow public tolerance for adverse eventsAdverse drug reactions are more common Safety monitored by “promoters”Causality assessment difficult

need special expertiseLot-by-lot surveillance needed

Safety Monitoring Vaccines vs Drugs

Need to ensure that vaccine safety monitoring and causality assessment utilizes system that meets vaccine specific needs

Build on strengths of drug monitoring BUT modify and adapt to fit vaccines

WHO