Preventing the Threat of Bioterrorism with First-of-its-Kind Smallpox Treatment

The Food and Drug Administration (FDA) has just approved of Tecovirimat or Tpoxx, the first antiviral drug proven to treat smallpox. However, there isn’t necessarily a practical use for the drug as there hasn’t been a known case of smallpox since 1977.

According to FDA officials, the purpose of Tecovirimat is to combat the disease in the event that it’s used as a bioweapon. Initial research from Tecovirimat began after 9/11 when Smallpox Response Teams were created. According to The New York Times, there are two known stocks of smallpox in Russia and at the Centers for Disease Control and Prevention (CDC) in Atlanta. Since the 2014 discovery of six sealed vials containing smallpox at the National Institutes of Health in Bethesda, Maryland, experts are also concerned that other stores might be in existence.

"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher,” said FDA Commissioner Scott Gottlieb, MD. “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.”

If bioterrorists were to reconstruct smallpox and release it, everyone under the age of 40 would be vulnerable to the virus, since healthcare providers stopped issuing the vaccines after 1980. Today, the only people who receive the vaccine are certain military personnel, lab workers, and anyone else who would likely be vulnerable to the virus during possible biological warfare. However, the vaccine isn’t fully effective over time, and according to the CDC people might need to be revaccinated if there’s an outbreak.

During the testing phase, Tecovirimat successfully protected animals intentionally infected with the disease. The 359 healthy human test subjects — who were not infected — had minimal side effects including headache and nausea. The drug was approved under the FDA’s “animal rule” because the treatment couldn’t be tested on humans with the virus.