In the frame of the COVID-19 pandemic and the vaccines introduction efforts the Pan American Health Organization has focused on strengthening pharmacovigilance following immunization.
An ESAVI (Event Supposedly Attributable to Vaccination and Immunization) is “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease.” (Manual for surveillance of Events Supposedly Attributable to Vaccination or Immunization in the Region of the Americas). It is also known as AEFI (adverse event following immunization) or MAPI in other regions. If not rapidly and effectively dealt with, co lo uld delay the identification of risks related to vaccines or can undermine confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and disease incidence, when coincidental events are wrongly attributed to the vaccine.
The PAHO ESAVI project aims at developing a sensitive, timely, standard, reliable and integrated ESAVI surveillance system with involvement of all stakeholders including National Immunization Programs, National Regulatory Authorities, Epidemiological Surveillance Units and other units at the Ministries of Health
“This initiative will help maintain confidence in vaccination and acceptance of immunization in the Americas” says @Daniel_Rizzato_Lede , project manager for the DHIS2 collaboration.
At the beginning of 2020, 62% of the countries in the PAHO region work this surveillance with paper and spreadsheet based systems and only 17% of existing solutions for ESAVI reporting are centralized web systems. The remaining 21% have fragmented and isolated systems.
Public skepticism to the new covid vaccines and a need for transparency and swift information flows have increased country demand for a flexible system which can interoperate and use vaccine safety standards. Countries are also expected to report to regional and global vaccine safety databases.
At the same time, the goal of strengthening countries’ information systems should help increase the quality and usefulness of data as well as to reduce the administrative burden.
PAHO has adapted and expanded the existing DHIS2 AEFI Tracker Package to fulfill regional guidelines and is currently running their own instance for reporting of adverse events in sentinel sites. This new package adds a new stage for the investigation process and includes clinical terminology dictionaries as well as pharmaceutical standards.
Countries can report directly into this instance from sentinel hospitals and contribute to the regional database. This also serves as a testing and piloting ground for countries considering their own national implementation for a broader ESAVI surveillance.
The program has been standardized and is currently in the process of being packaged and is offered to countries who want their own ESAVI implementation.
Currently, Brazil and Paraguay are already entering data in the PAHO regional instance, and several other countries are considering joining the regional implementation or starting their own.
The DHIS2 ESAVI programme has been adapted to include WHODrug and MedDRA as coding standards, as it would ease the data exchange and analytics process. Nevertheless, countries can include the terminology standard which better suits their needs, including ICD-11 or SNOMED.
Moreover, PAHO aims at maintaining a FHIR server and an ESAVI FHIR implementation guide to support interoperability between the regional pharmacovigilance database, the global pharmacovigilance database VigiBase, DHIS2 and other country systems.
If you want to know more about this check out the presentation “Digital Transformation of Vaccine Safety in the Americas” from the DHIS2 annual conference 2022 Immunization - YouTube
If you are interested in other PAHO projects with DHIS2, vigilance, or DHIS2 in the Americas you should also check out the presentation about Surveillance of Vaccine preventable diseases : Surveillance strengthening in Iraq, Tanzania and Pakistan #dac2022 - YouTube