Analysis Group and Pfizer Present Final Data on COVID-19 Vaccine Safety Surveillance Program of US Veterans Health Administration Patients

August 26, 2024

Researchers from Analysis Group, the Veterans Health Administration, and Pfizer have completed an active safety surveillance program to identify potential safety signals in real time in a population of 1,652,514 US veterans. The study, “Post-Emergency Use Authorization (EUA) Active Safety Surveillance Study among Individuals in the Veterans Affairs Health System Receiving Pfizer BioNTech Coronavirus Disease 2019 (COVID 19) Vaccine,” was required by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in connection with the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine in December 2020. Forty-six safety events of interest were pre-specified for assessment over the course of 30 months, including myocarditis and pericarditis, which were prioritized.

Based on the final analysis from the study, none of the safety events of interest were found to be associated with the Pfizer-BioNTech COVID-19 vaccine. These findings are consistent with prior interim reports in which no safety signals persisted after conducting signal evaluation analyses. A poster on the final results from this study is scheduled to be presented at the annual meeting of the International Society for Pharmacoepidemiology in 2024.

The Analysis Group team was led by Managing Principal and Chief Epidemiologist Mei Sheng Duh and Managing Principal Maral DerSarkissian, with analytical and review support from President Pierre Cremieux; Manager Catherine Nguyen; and Associates Mu Cheng, Angela Lax, and Tracy Guo.