Analysis Group and Pfizer Present Interim Data on COVID-19 Vaccine Safety Surveillance Program Showing No Adverse Safety Signals Among US Veterans Health Administration Patients
Retrieved on:
Tuesday, August 30, 2022
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BOSTON, Aug. 30, 2022 /PRNewswire/ -- During the International Society of Pharmacoepidemiology's annual meeting, researchers from Analysis Group (a global leader in health care consulting), the Veterans Health Administration (VHA), and Pfizer presented interim data from 1,448,043 US veterans who were among the first to receive the Pfizer-BioNTech COVID-19 vaccine, between December 11, 2020, and September 24, 2021. In this interim analysis, no adverse safety signals were found among the study population, who overwhelmingly completed the primary series of two doses (96%). With study completion planned for December 2023, the safety of the vaccine will continue to be evaluated by study investigators.
Key Points:
- In this interim analysis, no adverse safety signals were found among the study population, who overwhelmingly completed the primary series of two doses (96%).
- With study completion planned for December 2023, the safety of the vaccine will continue to be evaluated by study investigators.
- Analysis Group researchers designed the study protocol and collaborated with the VHA to identify near real-time safety signals among vaccinated individuals over the course of 30 months.
- Forty-six pre-specified safety events of interest were included in the vaccine safety surveillance program, including cerebrovascular non-hemorrhagic stroke, acute myocardial infarction, chilblain-like lesions, anaphylaxis, and acute kidney injury.