FDA Investigates Reports of Unlicensed Influenza Vaccine

WASHINGTON, D.C. -- The 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, the FDA has received reports of offers to sell unlicensed influenza vaccine in the U.S., and of individuals who are not licensed healthcare professionals administering questionable influenza vaccine in apparent efforts to take advantage of reports that influenza vaccine is in short supply. The FDA is actively investigating these reports and taking prompt action, when appropriate. For example, the FDA and the Florida Department of Health worked together to prevent unlicensed product from entering the country and being offered for sale.

The FDA has licensed three influenza vaccines for use in the U.S.: 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.

CDC continues to work closely with FDA to obtain additional quantities of licensed influenza vaccine. Consumers with questions about flu vaccination itself, including who should be vaccinated or where to receive the vaccine, should ask a doctor or pharmacist. In addition, information is available on the FDA website at http://www.fda.gov/cber/flu/flu.htm, or the CDC website at http://www.cdc.gov/flu/.

To help assure that the influenza vaccine Americans receive is safe and effective, the FDA recommends that healthcare providers purchase the vaccine from reliable sources. Careful discretion should be used in determining whether the vaccine is being sold by reputable distributors with proper evidence that the vaccine is licensed for sale in the United States. Likewise, it is also recommended that consumers obtain influenza vaccine from licensed healthcare providers only. Healthcare professionals and consumers should report any suspicious offers or practices to FDA or local health authorities.

Source: FDA