(A-266) Feasibility Assessment of Using National Administrative Databases (SISPRO) to Support Post-Authorization Vaccine Safety Studies in Colombia

Background: Post market vaccine safety surveillance is critical for further characterizing vaccine safety profiles beyond what is assessed in clinical trials. National healthcare databases provide large sample sizes, enhancing the ability to efficiently detect rare adverse events in a timely manner through observational studies.

Objectives: To evaluate the feasibility and fitness-for-purpose use of national databases in Colombia to characterize the safety profile of Moderna’s COVID-19 vaccines targeting SARS-CoV-2.

Methods: A feasibility assessment was proposed using the COVID-PAIWEB and RIPS modules within the Integrated Information System of Social Protection (SISPRO) in Colombia, which contains comprehensive data on vaccination, COVID-19 cases, comorbidities, healthcare utilization, and mortality. A formal proposal and data requests were submitted to the Colombian Ministry of Health and Social Protection for access to de-identified patient-level data from 1 January 2021 to 31 December 2022.

Results: Access to two datasets was granted: the complete RIPS module (RIPS-full dataset) and a dataset deterministically linking vaccination records from the COVID-PAIWEB module with the RIPS module (ID-linked COVID-PAIWEB-RIPS dataset). It took 128 days to access the RIPS-full dataset and 343 days to access ID-linked COVID-PAIWEB-RIPS dataset. Access to the COVID-PAIWEB module alone was not granted. The ID-linked COVID-PAIWEB-RIPS dataset included 9,279,303 unique patients who received at least one dose of Moderna's COVID vaccine. However, it did not include patients who received other COVID-19 vaccines. The linked dataset included vaccination dates and corresponding vaccine dose numbers, except for dose 2. Patients in the COVID-PAIWEB module were approximately twice as likely to have a COVID-19 diagnosis compared to those in the RIPS module within the linked dataset. The overall agreement between the two modules in the linked dataset was 99% for death with a positive agreement of 89%, and 86% for COVID-19 diagnosis with a positive agreement of 54% in the reference to the RIPS module.

Conclusions: The study highlights challenges associated with using the Colombian national healthcare database, including prolonged waiting periods for data access and the absence of key data elements required for post-market vaccine safety surveillance. The potential use of this national healthcare database requires an improved data access pathway and data quality enhancements.