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FDA Okays First-Ever Smallpox Drug

The U.S. Food and Drug Administration recently approved the first-ever drug that will treat the smallpox illness. The highly contagious condition was put to rest in 1980 thanks to vaccinations; however, concerns have risen that it might be used within a bioterror threat.

Spread by direct contact, symptoms of smallpox emerge from ten to 14 days after infection. Signs of the illness include: headache, backache, fever, and fatigue. Smallpox starts off as small, pink bumps (rash) that turn into pus-filled sores, which eventually develop into scars and scabs. Complications linked to smallpox include: brain inflammation (encephalitis), as well as eye surface sores (corneal ulceration), and blindness.

The Russian State Centre for Research on Virology and Biotechnology and the U.S. Centers for Disease Control and Prevention are the facilities across the globe known and approved to have smallpox. The CDC states on its website that there is worry that some nations have turned the virus into weapons, with the possibility that it has fallen into terrorist hands or those with criminal intentions.

This is the reason why the FDA has reviewed and approved TPOXX, an antiviral drug produced by SIGA Technologies Inc.

Approval stemmed from research around treating animals who had viruses closely linked to that which causes smallpox. The approval falls under the FDA’s ‘animal rule’, which allows for findings via well-controlled and adequate animal research to support the agency’s approval when human trials are not ethical or feasible.

CNN reported that Dr. Scott Gottlieb, FDA Commissioner, stated that the approval offers an important milestone and affords around an additional option should this illness be used as a bioweapon.

Until this drug approval, the treatment of smallpox dealt with managing symptoms, along with three antiviral not proven to treat smallpox, rather was used as the best line of defense. Additionally, the vaccine is used to stop spreading the illness; while TPOXX is now the first-ever approved drug to actually treat smallpox.

As per the CDC, the last organic smallpox outbreak was in 1949, while the last naturally global-spread occurrence was in 1977.

Post-September 11th attacks, there have been military members and first responders vaccinated from smallpox as a precautionary measure. Should a smallpox attack occur, those who have been vaccinated would need the shot again to guarantee protection.

If a single case of smallpox was reported, this would be thought of as an emergency.

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