FDA approves H5N1 bird flu vaccine

Vaccine intended to supplement national stockpile of flu vaccines

November 26, 2013


The U.S. Food and Drug Administration has approved the first adjuvanted pandemic influenza vaccine, Q-pan, to prevent against avian influenza A (H5N1) in adults at greater-than-average risk of exposure.

Using adjuvants in vaccine can reduce the amount of vaccine antigen needed to stimulate an immune response in people, Dr. Nicole Lurie, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, said in a statement.

While most strains of avian flu don’t infect people, the H5N1 virus has caused “serious illness and death in people outside of the United States, mostly among people who have been in close contact with infected and ill poultry,” the agency said in a news release announcing the approval.

The influenza H5N1 virus monovalent vaccine is intended for people ages 18 years and older and is designed to be administered in two doses given three weeks apart. The vaccine is not intended for commercial distribution, but to supplement the national stockpile of influenza vaccines, the FDA said.

The vaccine, manufactured by GlaxoSmithKline, was developed in partnership with the Biomedical Advanced Research and Development Authority, which is under the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services.

“This vaccine could be used in the event that the H5N1 avian influenza develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the glove.” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the news release.

Among people who have become infected with H5N1, mortality is about 60%, according to WHO. Health officials have determined the H5N1 strain of influenza has “pandemic potential” because it continues to affect wild birds and poultry populations, and most humans have no immunity to it.

In an H5N1 pandemic, the U.S. government could have more than 35 million doses of this adjuvanted vaccine available within weeks to protect people, and GSK could produce additional doses to meet the nation’s needs for this vaccine, according to Lurie.


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