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Short name:
IA2030 – SP 1.6 Vaccine safety
Rationale:
Indicator selected for global monitoring for Immunization Agenda 2030 Strategic Priority Objective 1.6: Vaccine safety

This indicator displays the proportion of countries using WHO’s global database VigiBase to report at least one serious adverse event following immunization (AEFI) per 1 million population per year, a marker that demonstrates a commitment to collecting robust, quality safety data to support policy making at all levels (this should also include data related to all vaccines that is used in the country including vaccines under EUL). Sharing AEFI data between all stakeholders within countries is critical to ensure that timely safety signals support an appropriate response at the country level. Further, pooling such reports into a global database can provide insights into epidemiological trends and regional characteristics of very rare but significant AEFI that may be difficult to detect through national aggregate data.

Definition:
Proportion of countries with at least one documented individual serious AEFI case safety report per million total population.

• Numerator: Number of WHO Member States which reported at least one documented individual serious AEFI case safety report per million total population.

• Denominator: Total number of WHO Member States.

• Baseline year: 2021

Associated terms:
Serious AEFI: An Adverse Event Following Immunization (AEFI) is considered serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Other situations, such as other important medical events that may jeopardize the patient or may require intervention to prevent one of the outcomes above, should also be considered serious after applying medical and scientific judgment.
Disaggregation:
WHO Member States
Method of measurement
National immunization programme and National Regulatory Authority jointly
Method of estimation:
Step 1: FCalculate the number of serious AEFI cases per million total population in each Member State.

1) Sum the number of serious AEFI cases from VigiBase for each Member State every year (this should also include data related to all vaccines that is used in the country including vaccines under EUL).

2) Divide the sum by country population estimates for the corresponding year obtained from the most recent United Nations Population Division's World Population Prospects (UNPD WPP) available at the time of reporting.

3) Multiply by one million.

Step 2: Count the number of WHO Member States which reported at least one serious AEFI case per million total population.

Step 3: Divide the indicator numerator by the total number of WHO Member States (denominator equals 194 WHO Member States).

Method of estimation of global and regional aggregates:
Unweighted proportion
Preferred data sources:
AEFI case reports: VigiBase
National population estimates: UN Population Division’s World Population Prospects (UNPD WPP)
Unit of Measure:
N/A
Unit Multiplier:
N/A
Expected frequency of data dissemination:
Annual
Expected frequency of data collection:
Annual (VigiBase data as of June 30th of each year for the previous year’s data)
Contact person email:
vpdata@who.int
IMRID:
7767
Links:
IA2030 Annex 1: Monitoring and Evaluation Framework || https://immunizationagenda2030.org/images/documents/IA2030_Annex_FrameworkForActionv04.pdf
UNDP World Population Prospects Methodology || https://population.un.org/wpp/Methodology/
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