Post-emergency use authorization active safety surveillance study of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine in the Veterans Affairs health system: Findings from a three-year, comprehensive safety assessment program
Vaccine: X, 2026
Active safety surveillance is an essential part of vaccine evaluation, and its role is even more critical in the context of public health emergencies such as the COVID-19 pandemic. A safety surveillance study conducted by researchers from Analysis Group, Pfizer, and the Veterans Health Administration (VHA) fulfilled a necessary regulatory requirement for the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), finding no increased safety risks associated with the vaccine.
In March 2020, the World Health Organization declared a global pandemic for COVID-19, caused by infection with severe acute respiratory syndrome coronavirus 2. Nine months later, the FDA and EMA granted emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for individuals 16 and older. Regulatory agencies required post-EUA safety studies using Veterans Affairs (VA) electronic medical record (EMR) data to assess long-term safety risk beyond the observation period in clinical trials for over 40 safety endpoints in a diverse real-world population.
To meet this research objective, an Analysis Group team led by Managing Principal and Chief Epidemiologist Mei Sheng Duh and Managing Principal Maral DerSarkissian – with analytical and review support from CEO Pierre Cremieux; Vice President Marianne Cunnington; Managers Catherine Nguyen, Angela Lax, and Mu Cheng; and Associate Tracy Guo – partnered with researchers from Pfizer and the VHA to conduct a safety surveillance study to assess potential serious safety events associated with the vaccine that may not have been detected during clinical trials. This study was critical for the Pfizer-BioNTech vaccine because its clinical trial had had a shorter-than-usual median observation time, given the expanding COVID-19 health crisis.
For the study to be included in the EUA application, a protocol – which served as the study’s technical foundation and outlined its rationale and design, and the methods by which data would be collected and outcomes assessed – was needed on an accelerated timeline for inclusion in the submission package to regulatory agencies. Analysis Group researchers designed the study protocol in collaboration with Pfizer and the VHA to identify near-real-time safety signals among vaccinated individuals. Forty-six pre-specified safety events of interest were included in the safety surveillance program, including myocarditis/pericarditis, cerebrovascular non-hemorrhagic stroke, acute myocardial infarction, and anaphylaxis.
Once the EUA was issued, the team began analyzing data to assess whether safety signals were observed in the VHA population of Pfizer-BioNTech COVID-19 vaccinees as compared with a control group of seasonal flu vaccine recipients. Researchers analyzed data continually over three and a half years and found no increased safety risk associated with the Pfizer-BioNTech COVID-19 vaccine.
More broadly, this study generated robust scientific evidence on safety of the Pfizer-BioNTech COVID-19 vaccine to a broader population, bolstering public confidence and addressing an ongoing need for scientifically sound research in the vaccine safety area.
The findings of the study were reported in the article “Post-emergency use authorization active safety surveillance study of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine in the Veterans Affairs health system: Findings from a three-year, comprehensive safety assessment program,” published in Vaccine: X in March 2026.
Authors
Asomaning K, Duh MS, DerSarkissian M, de Luise C, Nguyen C, Cheng M, Lax A, Guo T, Cunnington M, Cremieux P, Young-Xu Y, Korves C, Lucca JD