RWD33 Analysis of COVID-19 Vaccine-Related Adverse Events in Adults, Geriatrics and Pediatrics – A Retrospective Study

Abstract

Normally, drug discovery (including vaccines) is a long process that may take up to 10 to 15 years. Due to the mortality and contagious nature of the SARS-CoV2 virus, there was a need for the fast-track development and approval of the vaccine. The clinical trials conducted for the development of a vaccine for COVID-19 were of short duration. Therefore, there is a need to evaluate the safety of the vaccine through the analysis of real-world data.Analysis of selected adverse events after COVID-19 vaccination in adults (18 to 64 years), geriatrics (≥65 years), and pediatrics (<18 years). Optum’s de-identified Clinformatics® Data Mart database was used to identify the adults, geriatrics, and pediatrics patients who had received vaccination for COVID-19 from 1 Nov 2020 to 30 June 2021. The occurrence of the ICD-10 code for COVID-19 vaccination in the claims database was defined as the index event. These patients were then followed for 10 days to check for the adverse events (listed by the CDC). Patients with a confirmed diagnosis of COVID-19 before vaccination and during the follow-up period were excluded from the study. Patients having the ICD-10 for diseases listed in adverse events were also excluded from the study. Out of the 845,357 unique patients who received vaccination for COVID-19, 644,707 (76.3%) were adults, 160,799 (∼19.0%) were geriatrics, and 39,851 (∼5%) were pediatrics. The rate of thrombocytopenia was higher in geriatrics (628 and 721 cases per million after 1st and 2nd dose, respectively) as compared with adults (172 and 192 cases per million after 1st and 2nd dose, respectively). Cases for Guillain-Barré Syndrome (GBS), myocarditis, and pericarditis were rare. Further statistical tests will be applied to analyze the level of significance. Severe reactions after COVID-19 vaccination are rare. A long-term analysis of adverse events should be performed to support these findings.