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Activity Number:
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35
- Stories from COVID-19 Vaccine Development: Statistical Challenges and Opportunities
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Type:
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Invited
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Date/Time:
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Sunday, August 8, 2021 : 3:30 PM to 5:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #315497
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Title:
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Statistical Observations on Vaccine Clinical Development for Pandemic Diseases
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Author(s):
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Scott Patterson* and Bo Fu and Fabrice Bailleux and Josh Chen
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Companies:
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Sanofi Pasteur and Sanofi Pasteur and Sanofi Pasteur and Sanofi Pasteur
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Keywords:
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SARS-CoV-2;
COVID-19;
efficacy;
safety;
vaccine;
crisis
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Abstract:
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Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, and accelerated Phase I-II-III clinical programs are being applied. This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis. Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such clinical development programs, will be discussed.
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Authors who are presenting talks have a * after their name.
