New Smallpox Drug Approved By FDA To Address Bioterrorism Risks


The U.S. Food and Drug Administration just approved the first drug for the treatment of smallpox, even if the disease has been considered eradicated since 1980. The approval comes in response to concerns regarding the disease’s potential to be used as a bioweapon.

TPOXX Approved By FDA

On July 13, the U.S. FDA announced the approval of tecovirimat (TPOXX), a drug that’s specifically indicated for the treatment of smallpox. Prior to the approval, there were no specific drugs used for the treatment of smallpox, and smallpox was mainly treated using antiviral drugs that prevent the symptoms from getting worse.

TPOXX’s effectiveness was tested using trials wherein animals were injected with a virus that’s closely related to the variola virus, the virus that causes smallpox. In total, more of the animals that were treated with TPOXX lived than the animals that were treated with a placebo.

Animals were used in the tests, as it was not feasible to test the drug on humans, but 359 human volunteers who were not infected with smallpox were used to test the drug's safety. In the test, it was found that nausea, abdominal pain, and headaches were the most common side effects.

Bioterrorism Threat

In a press release, the FDA stated that even though the World Health Organization has since declared smallpox as an eradicated disease, there is a threat of the disease being used as a bioweapon. Although there is no modern record of smallpox being used as a weapon in bioterrorism, history shows that it has been used in such a manner, as people have deliberately infected enemies with the disease.

According to the Centers for Disease Control and Prevention, there is serious concern that in the past, some countries created weapons using smallpox and that such weapons may fall into the hands of people with terrorist or criminal intent.

As such, research on the development of vaccines, diagnostic tests, and drugs continues, and today only two laboratories in two countries are approved to carry the smallpox virus for the purposes of research. These are the CDC in the United States, and the Russian State Centre for Research on Virology and Biotechnology in the Russian Federation.

“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” 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.”

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