Online Program

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Tuesday, September 24
Tue, Sep 24, 2:45 PM - 4:00 PM
Thurgood Marshall East
Statistical Considerations in the Evaluation of Vaccine Efficacy and Effectiveness

Effectiveness Study to Support Pandemic Influenza Vaccine Licensure Application – Experience Sharing (301057)

*Ping Li, Pfizer 

Vaccination is widely considered as one of the greatest medical achievements. Yearly influenza vaccination for nearly all people over the age of six months, especially those at high risk is recommended by WHO and CDC, as the vaccine protection from the infection has been demonstrated through various clinical studies and epidemiology data. However, it’s quite challenge to conduct clinical studies to demonstrate the effectiveness of pandemic influenza vaccine.

This presentation begins with a history of the development of a pandemic influenza vaccine and the BLA. It then shares the experience of the BLA strategy using the real world data (a case-control study) as supportive for the effectiveness evidence, as well as the lessons learned.