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FDA Approves First Adjuvant Bird Flu Vaccine

Last updated Sept. 19, 2015

Approved by: Maulik P. Purohit MD MPH

The Food and Drug Administration (FDA) approved the first adjuvanted vaccine for the prevention of the H5N1 influenza, also known as the avian or bird flu. The influenza A (H5N1) virus monovalent vaccine is intended for the individuals 18 years of age and older who are in environments with increased risk of exposure to the H5N1 influenza virus.


The Food and Drug Administration (FDA) approved the first adjuvanted vaccine for the prevention of the H5N1 influenza, also known as the avian or bird flu. The influenza A (H5N1) virus monovalent vaccine is intended for the individuals 18 years of age and older who are in environments with increased risk of exposure to the H5N1 influenza virus.

Avian influenza A is an infectious disease that usually affects birds but not humans; however, some viruses, like H5N1, have caused serious, sometimes fatal, illnesses in people outside of the United States. The highest exposure of N5N1 were by people in close contact with infected poultry. According to the World Health Organization, 60% of individuals die once infected with the H5N1. 

“This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”

The H5N1 vaccine contains the H5N1 component and an immunological substance that enhances the antigenic response, the adjuvant AS03. The two components are contained in two separate vials. These components must be combined prior to use and is administered via intramuscular injection in two doses, three weeks apart.

2,000 H5N1 vaccinated adults’ immune responses were evaluated, in order to test the success of the vaccine. 91 percent of the H5N1 vaccinated individuals between the ages of 18 and 64 years as well as 74 percent of the H5N1 vaccinated individuals 65 years and older developed antibodies expected to reduce the risk of receiving the H5N1 influenza virus. Side effects from the vaccine included the following: redness and swelling at the injection site, muscle aches, headaches, and fatigue.

The H5N1 influenza virus is not intended for commercial availability but to supplement the national stockpile of influenza vaccines, according to the FDA.

For more information:

http://www.flu.gov
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376444.htm
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/default.htm 

Additional resources from DoveMed:

Read more about Influenza test

Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: Nov. 26, 2013
Last updated: Sept. 19, 2015