First treatment for smallpox approved in the US

Thanks to vaccination efforts, smallpox was eradicated in 1980. However, following concerns that it could be used in a bioterror attack, the FDA has just announced its approval of the first drug that can be used to treat the disease. The CDC in the US, and the Russian State Centre for Research on Virology and Biotechnology are the only two labs in the world that are currently approved to have smallpox.

Smallpox is spread between humans by direct contact. Symptoms usually start between 10 and 14 after contact, and include fever, headaches and exhaustion. The diseases hallmark is a rash, which begins with small pink bumps, and develop into sores. There can be serious complications in some cases. These can include encephalitis (inflammation of the brain) and sores on the surface of the eyes, which can lead to blindness.

According to the CDC’s website: “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.” In light of this, the FDA has given priority review to the new drug, which is called TPOXX and is a small-molecule antiviral treatment produced by SIGA Technologies Inc.

The recent approval was based on animal research into viruses “closely related to the virus that causes smallpox”, as well as clinical safety trials in healthy adults. FDA Commissioner Dr. Scott Gottlieb said in a statement: “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”

TPOXX is the first approved treatment for smallpox. Before its approval, treatment for smallpox would have consisted of managing the symptoms and treating it with three antivirals. These antivirals are not proven to be effective in treating the disease; however, they are considered the best line of defense. As well as this, a vaccination programme would be introduced to stop the virus from spreading further.

If a case of smallpox was to be reported and confirmed, it would be considered a medical emergency. The last outbreak of smallpox in the US was in 1949, and the last case globally was in 1977. Because of this, routine vaccination ceased in 1972 in the US, and therefore anyone born after that year are not vaccination. “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,” Gottlieb said.