Analysis Group and Pfizer Present Interim Data on COVID-19 Vaccine Safety Surveillance Program of US Veterans Health Administration Patients
August 30, 2022
Researchers from Analysis Group, the Veterans Health Administration, and Pfizer have implemented an active safety surveillance program to identify potential safety signals in real time in a population of 1,448,043 US veterans. The study 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. Interim data found no adverse safety signals based on pre-established definitional criteria. The safety of the vaccine will continue to be evaluated by study investigators.
The results of the interim analysis, “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,” were presented at the annual International Conference on Pharmacoepidemiology and Therapeutic Risk Management. The Analysis Group team was led by Managing Principal and Chief Epidemiologist Mei Sheng Duh and Vice President Maral DerSarkissian, with analytical and review support from President Pierre Cremieux, Associates Catherine Nguyen, Mu Cheng, and Angela Lax, and Senior Analyst Tracy Guo.