The US Food and Drug Administration (FDA) has received reports of potential distribution of unlicensed influenza vaccine in the United States. The agency is aggressively working with state health authorities and the Centers for Disease Control and Prevention (CDC) to investigate the source and quality of influenza vaccine being made available through unusual suppliers.
Specifically, FDA has received reports of offers to sell unlicensed influenza vaccine in the US, and of individuals who are not licensed health care professionals administering questionable influenza vaccine in apparent efforts to take advantage of reports that influenza vaccine is in short supply. FDA is actively investigating these reports and taking prompt action, when appropriate. For example, FDA and the Florida Department of Health worked together to prevent unlicensed product from entering the country and being offered for sale.
FDA has licensed three influenza vaccines for use in the US: Fluzone, manufactured by Aventis Pasteur, Inc., and Fluvirin, manufactured by Evans Vaccines (a subsidiary of Chiron Corporation), both of which are given as injections; and FluMist, manufactured by Medimmune, which is given as a nasal spray. These vaccines are available from licensed sources, such as doctors, pharmacies and health care clinics.