FDA Develops First Smallpox Drug to Combat Bioterrorism

FDA Develops First Smallpox Drug to Combat Bioterrorism

It takes anywhere from 10 to 15 years to develop a successful medicine or vaccine. The U.S. Food and Drug Administration (FDA) recently approved the first-ever drug in order to treat the smallpox disease, specifically for combating bioterrorist attacks.


According to CBS News, U.S. regulators approved the first treatment for smallpox, a deadly viral disease that was wiped out nearly four decades ago. Though the average individual should not have to worry about contracting smallpox and similar diseases, terrorists have the capability to administer large-scale attacks involving smallpox, causing catastrophic damages.


The World Health Organization estimated that the variola virus — which causes smallpox — killed about 30% of the people who were infected throughout the years. Complications of smallpox could include encephalitis (inflammation of the brain), corneal ulcerations, and blindness. If you believe you have been unintentionally infected by any kind of virus, it’s recommended to immediately seek medical attention. Approximately 85% of urgent care centers are open seven days a week, the majority of those facilities can assist with certain viruses and similar conditions.

The drug is called TPOXX and 2 million treatments are currently being manufactured and stockpiled by the U.S. government.


“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said Dr. Scott Gottlieb, head of the FDA. “Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”


As reported in the New England Journal of Medicine and the journal Antimicrobial Agents and Chemotherapy, in order to test the drug’s effectiveness, rabbits and monkeys were infected with a similar virus and then given TPOXX. More than 90% of the animals survived. The drug was also administered to a few hundred humans who volunteered to test symptoms without being infected with smallpox. Researchers noted that side effects included headaches, abdominal pain, and nausea, though all were relatively mild.


TPOXX comes in the form of a capsule, and should be administered twice a day for 14 days once infected with the smallpox virus.


Forbes adds that the efforts and funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) helped make TPOXX a reality.


“To address the risk of bio-terrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” added Dr. Gottlieb.


Research on treatment for smallpox-related bioterrorism began at the National Institute of Allergy and Infectious Diseases after the September 11 terrorist attacks. Scientists worked to safely dilute the U.S. national stockpile of smallpox vaccines. SIGA currently has a $472 million procurement and development contract with the agency.

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