FDA Approves First Smallpox Drug Treatment

The US Food and Drug Administration has approved the first drug specifically designed to treat smallpox. The drug, TPOXX, is a small-molecule antiviral treatment made by SIGA Technologies Inc. SIGA develops vaccines and medicines for biological, chemical, radiological and nuclear attacks.

Smallpox is a virulent disease spread by direct contact. The symptoms include fever, headache, backache, exhaustion, and a rash of small, pink bumps that develop into pus-filled sores. The FDA says that the symptoms typically emerge 10 to 14 days after a person is infected. As the illness progresses, sufferers may experience encephalitis (an inflammation of the brain), corneal ulceration, and blindness.

While the smallpox virus killed about 300 million people worldwide in the 20th century, was considered to be eradicated in 1980 thanks to vaccination efforts. The last naturally spread of smallpox in the entire world happened in 1977, according to the CDC. Only two labs in the world are approved and known to have smallpox: the US Centers for Disease Control and Prevention and the Russian State Centre for Research on Virology and Biotechnology.

In the US, the last natural outbreak of smallpox happened in 1949 and routine vaccination ended in 1972. Most people born after that year have not been vaccinated against the virus. If a single case of smallpox were to be identified, this would be considered an emergency. If smallpox were to reemerge, even those who have been vaccinated previously would need to be vaccinated again to ensure protection.

The FDA says that TPOXX is the first treatment approved under the Material Threat Countermeasure Priority Review Voucher. FDA Commissioner Dr. Scott Gottlieb said in a statement, “To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons.” The government partially paid for the development of TPOXX.

There are concerns that smallpox could be used in a bioterror attack. The CDC website states, “There is credible concern that in the past some countries made the virus into weapons, which may have fallen into the hands of terrorists or other people with criminal intentions.” SIGA has already delivered 2 million treatments to be stockpiled by the government.