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H5N1 Vaccine Approved

The US Food and Drug Administration OKs a vaccine against the virus that last year had the scientific community debating the regulation of deadly pathogen research.

By | November 25, 2013

CDC, DEBORA CARTAGENAThe US Food and Drug Administration announced on Friday (November 22) that GlaxoSmithKline’s vaccine against H5N1 avian influenza was approved for use should the virus threaten to spread through human populations in an epidemic-like fashion.

“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,” Karen Midthun, director of the FDA’s biologics division, said in a statement. Though it is not available for commercial use, the vaccine will be added to the national stockpile and distributed by public health officials if such an epidemic were ever to arise.

H5N1 made news around the globe last year when two groups of researchers published on mutations that could make the virus transmissible between ferrets, an oft-used model for the dynamics of human infections. With an estimated 50 percent to 60 percent mortality rate in people, mutations that allowed the virus to pass from human to human could cause a massive epidemic. As a result of this threat, many argued that the research should not be published in full, and some even questioned who should be allowed to conduct such research at all.

The new vaccine, approved for use in people over the age of 18 who are at increased risk of exposure to the virus, is the first US-approved H5N1 vaccine that contains an adjuvant to boost the body’s natural immune response to the virus, and despite ongoing debate over the safety of such adjuvants, the new vaccine is “the first to show it can confer protection in the event of a pandemic,” Reuters reported.

The vaccine is already approved in Europe, under the brand name Pumarix.

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