Immunization Safety Surveillance

IMMUNIzATION SAFETY SURVEILLANCE
Netaji Subhas Chandra Bose Institute of Pharmacy

URMISTHA SARKAR
M.PHARM 1ST YEAR
 strategies and systems for ensuring quality and safety of
vaccines,
 new classification of AEFIs and the objectives of
immunization safety/AEFIs surveillance,
 understanding vaccine reactions for better decision-
making,
 AEFI surveillance system: reporting, investigating,
causality assessment and responding processes,
 best use of surveillance data, and
 communication strategy on immunization safety for the
public and the media.
 Immunity is described as the body’s protective ability against
disease.
There are two basic mechanisms for acquiring immunity:
active and passive.
 Active immunity can be either natural, following an infection, and
can last a lifetime, or through vaccination, which also lasts for a long
period.
 Passive immunity also can be either natural or artificial; both last
relatively for a short period.
 Vaccine is a biological product that improves immunity to a given
disease and is divided into four types: live-attenuated, inactivated
whole cell (killed), subunit and toxoid.
 Excipients (adjuvant, preservatives and other additives) contained
in vaccines can cause occasional reactions. Knowledge of them is
important in immunization safety surveillance.
 Vaccine reaction: event caused or precipitated by the
vaccine when given correctly, caused by the inherent
properties of the vaccine.
 Programme error: event caused by an error in vaccine
preparation, handling, or administration.
 Coincidental: event that happens after immunization
but not caused by the vaccine - a chance association.
 Injection reaction: event from anxiety about, or pain
from, the injection itself rather than the vaccine
 Unknown: event’s cause cannot be determined.
Effective immunization safety surveillance needs to involve the following
people:
 peripheral health workers
 district level supervisor
 province level AEFI investigator
 regional/national assessor
 regional/national Immunization Safety Committee
Roles and responsibility of the NRA should include:

 licensing vaccines according to published requirements
 evaluating clinical performance of the vaccine
 controlling and releasing each batch or lot of vaccine individually, including recall if
Necessary
 performing laboratory testing
 vaccine performance (including safety)
 inspecting manufacturing facilities and processes regularly.
Steps for developing an immunization safety surveillance system:
1. Clarify respective roles of the national regulatory authority and EPI,
and agree on the objectives for the system.
2. Identify the resources available and needed and establish political
commitment to immunization safety surveillance.
3. Appoint or designate regional/national assessors for immunization
safety.
4. Establish an expert regional/national Immunization Safety Committee.
5. Develop and disseminate a list of events to be reported and their case
definitions; a standard investigation procedure; and AEFI report and
investigation forms.
6. Designate and train staff to prepare reports (peripheral health worker),
complete report forms (district level) and investigate AEFI (province
level).
7. Inform all health workers/clinicians of the need to report an AEFI
immediately, and clarify which ones should be reported.
8. Consider establishment of a compensation scheme for specified AEFIs.
 Availability of a list of AEFIs to be reported is necessary.
 Case definition (e.g. by Brighton Collaboration) for each
reportable event should be made available.
 AEFI reporting should be made on standardized reporting
form using a minimal set of core variables to enable global
evaluation of signals that will benefit countries in their
evaluation of AEFI.
 Private sector reporting is encouraged.
 Sharing reports with the Western Pacific Region and
globally (WHO Programme for International Drug
Monitoring /UMC) is encouraged.
 Identifying barriers to report and taking appropriate action
will improve the reporting process.
 Investigation should be timely, comprehensive and
methodical.
 Laboratory investigation(s) is (are) important, but
should not be routine. To be conducted if only indicated
and necessary.
 Autopsy investigations are encouraged.
 Data analysis is important to identify problems, generate
hypothesis and decision-making.
 Interpretation of data needs to be cautious: compare rates,
but not absolute numbers, and give attention to case
definitions and used denominators. WHO information
sheets on vaccine reaction rates provide rates of reactions of
specific vaccines that can be helpful when comparing rates.
 Comparing background data with observed data does not
conclude the causality. It only generates the hypothesis. To
conclude that a vaccine causes a vaccine reaction, it is
necessary to demonstrate that the risk in vaccinated
individuals is greater than that in the non vaccinated.
 Causality assessment is the systematic review of individual or
population data about an AEFI case to determine the likelihood
of a causal association between the event and the vaccine/s
received.
 The quality of the causality assessment depends on factors such
as the effectiveness of the reporting system and the quality of the
causality review process.
 Whether an AEFI is attributable or not to the vaccine or the
vaccination programme, causality assessment determines what
steps need to be taken to address the event.
 The response and follow-up for the AEFI will depend on
the findings of the investigation.
 It is worth disseminating the results of the investigation so
that others can learn from the experience. The investigation
can also make a useful teaching resource in training
investigators in the future.
 Immunization errors will need to be corrected. There
should be a checking mechanism to ensure that they do not
re-appear.
 For coincidental events, the main task is communication to
avoid false attribution of blame.
Timeliness, completeness and accuracy of AEFI reporting:
 monitoring information from reports and site visits;
 comparing reports with the facility patient register; and
 talking to health workers and observing their work.
(Please refer to Training for Mid-Level Managers: Disease Surveillance
WHO/IVB/08.08)
Timeliness, completeness of investigations:
 checking reports to ensure that those meeting the investigation criteria
were investigated;
 checking that investigation began within the defined time criteria; and
 confirming the adequacy of the investigation and soundness of the
conclusion reached and corrective action recommended.
Audit of corrective action:
 review by regional/national assessor to check that corrective action
recommended has been checked, and adequacy of change in practice to
prevent future programme error (programmatic errors).

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IMMUNIzATION SAFETY SURVEILLANCE

Netaji Subhas Chandra Bose Institute of Pharmacy

Roles and responsibility of the NRA should include:

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