Influenza Vaccine Licensure: Are We Ready for the Next Pandemic or New Influenza Vaccines?
*Tsai-Lien Lin, CBER, FDA 

Keywords: influenza vaccine, statistical issues

Under the current available pathways for licensing influenza vaccines, the 2009 swine flu H1N1 vaccine was licensed in record time. There were several issues faced by the FDA during the process. Some of these issues became not critical as time went. However, they pointed out potential problems we may face when the next pandemic comes. The development of new seasonal and pandemic influenza vaccines also presents new statistical issues that are not addressed in the current guidance. An overview of the pathways for licensing influenza vaccines and the challenges we are facing will be covered in this presentation.