Officials look toward fall for clinical data on pandemic vaccines

Abstract

Federal health officials hope this month to have their first look at safety and efficacy data from human trials of vaccines against the pandemic-causing novel influenza H1N1 virus. “I think the latter half of September is when we’re going to be seeing that [data],” Robin Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA), said in late July. BARDA is the federal entity responsible for the development and purchase of vaccines, drugs, and diagnostic tools for public health medical emergencies. Robinson’s remark referred to monovalent vaccines, produced by manufacturers of U.S.-licensed seasonal influenza vaccines, against what FDA refers to as the pandemic H1N1 2009 influenza virus. Information from the trials will be used to fine-tune a nationwide vaccination program if health officials decide that such a program is needed to combat the new virus. Unlike seasonal influenza viruses that circulate during the fall and winter in the United States, the pandemic H1N1 2009 influenza virus emerged in the spring and has continued to cause disease throughout the summer.