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

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Aug 30, 2022, 09:00 ET

No adverse safety signals were found among the study population, who overwhelmingly completed the primary series of two doses (96%)

Study adds to growing body of evidence supporting mRNA vaccine safety

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.

The ongoing study was part of a broad pharmacoepidemiology plan 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. 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. Myocarditis/pericarditis were prioritized in the analysis, but since these events are rare and more common in young men, the VHA study population did not have a sufficient sample size of young men to generate statistically meaningful data.

"Our approach was to design a study that involved signal detection, evaluation, and verification, comparing vaccinated individuals to themselves but at different time periods, as well as to individuals vaccinated with the seasonal influenza vaccines in the past, and to contemporary unvaccinated controls," said study co-investigator Dr. Mei Sheng Duh, a Managing Principal and the Chief Epidemiologist at Analysis Group. "Our study helped track any potential safety risks of the Pfizer-BioNTech COVID-19 Vaccine in a timely manner, underscoring the importance of rapid, active safety surveillance in pandemic response."

"The program was designed to quickly identify emerging safety signals based on a meticulous scientific analysis," said Dr. Maral DerSarkissian, a Vice President at Analysis Group and a co-investigator. "As we continue the study, if signals are identified throughout the remainder of the 30-month period, they will be immediately subject to additional evaluation and verification through analyses, and a thorough clinical review of detailed case-level data through chart review to ensure that we fully understand any potential safety events."

"The accomplishments of so many involved in the inspiring science behind this vaccine are truly extraordinary," said Martha S. Samuelson, CEO and Chairman of Analysis Group. "We are honored to have worked with Pfizer and the VHA to contribute to such a vital effort for the health and wellbeing of hundreds of millions of people around the world."

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 presented at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, August 24–28, 2022, in Copenhagen, Denmark. In addition to Drs. Duh and DerSarkissian, investigators included Pfizer's Kofi Asomaning and Cynthia De Luise; the VHA's Yinong Young-Xu; and Analysis Group President Dr. Pierre Cremieux, Associates Catherine Nguyen, Mu Cheng, and Angela Lax, and Senior Analyst Tracy Guo.

To learn more about Analysis Group's health care capabilities, visit www.analysisgroup.com/healthoutcomes

About Analysis Group's Health Care Practice

Founded in 1981, Analysis Group is a leader in applying the tools of drug safety and epidemiology, biostatistics, and data science to provide insights concerning the value of bio-pharmaceuticals. Our internal experts, together with our network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise, and end-to-end consulting services, globally.

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SOURCE Analysis Group