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Adjuvanted Bird Flu Vaccine Approved by FDA

Adjuvanted Bird Flu Vaccine Approved by FDA

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First Posted: Dec 02, 2013 06:41 AM EST
FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease
FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease (Photo : Reuters)

The U.S. Food and Drug Administration has recently approved the first adjuvanted vaccine for H5N1 influenza, or what's already known as the avian or bird flu. However, this vaccine won't be available for commercial use and does not currently have a trade name in the United States, according to a press release from the FDA. 

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"This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human," Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, said in a news release. "Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic."

The World Health Organization (WHO) states that the bird flu can be transmitted to humans through exposure of dead animals or infected environments. In fact, as of 2003, the organization notes that a total of 641 human cases of bird flu involving 380 deaths--with most occurring in countries including Egypt, Azerbaijan and Indonesia. 

This vaccine that helps control the body's immune response would be available for those 18 and up, and was studied in over 3,000 adults over the age of 18 when compared to 1,100 adults that received a placebo. The organization found that approximately 91 percent of those who were between the ages of 18 and 64 were abelt or develop antibodies to the virus after receiving a two-dose regimen of the vaccine. 

According to the FDA, the vaccine was evaluated in over 3,000 adults over the age of 18 and compared to 1,100 adults who received a placebo. The FDA found that 91 percent of those who were between 18 and 64 were able to develop antibodies to the virus, after receiving a two-dose regimen of the vaccine.

"This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human," said Karen Midthun, MD, director of the agency's Center for Biologics Evaluation and Research, via a statement. "Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic."

 

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