Regulatory Requirements for Clinical Development of Novel Influenza Vaccines
Influenza is an ongoing threat to global public health. While there are no accurate data on the incidence of influenza infections worldwide, the United States Centers for Disease Control and Prevention (CDC) estimate that between 5 and 20 percent of the U.S. population contracts influenza each year. The most effective way to combat influenza is vaccination.The World Health Organization estimates that an effective seasonal influenza vaccine can prevent 70 to 90 percent of influenza infections in healthy adults and, among the elderly, can reduce severe illnesses and complications by up to 60 percent and deaths by 80 percent.
In this white paper, PPD Laboratories regulatory and clinical development experts summarize the prevailing regulatory landscape for seasonal and pandemic influenza vaccines and discuss the guidelines for clinical development of influenza vaccines in the European Union and U.S.