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Why The FDA Just Approved A Drug For Smallpox, A Disease That No Longer Exists

Smallpox was eradicated in 1980, but there are at least two remaining stores of the virus: one in the U.S., the other in Russia.
An illustration from 1883 shows patients in Cape Town, South Africa, suffering from smallpox.
An illustration from 1883 shows patients in Cape Town, South Africa, suffering from smallpox.

In 1980, the World Health Organization declared the globe smallpox-free, three years after the last known case of the contagious and often deadly disease. Yet, on Friday, the U.S. Food and Drug Administration announced its approval of a new drug to treat the non-existent virus. What gives?

In a less-than-comforting statement, the FDA assured the public that the drug’s creation was just preemptive — you know, just in case bioterrorists choose to unleash smallpox on the world again.

“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said Dr. Scott Gottlieb, FDA commissioner. “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.”

Though it’s been decades since the world’s last case of smallpox, the virus that causes it — the variola virus — is not technically extinct. According to The New York Times, there are at least two known stores of the virus: one in Russia and another in the U.S.

In 2014, several vials of variola were discovered in a storeroom in a government lab in Maryland, prompting concerns that other stashes of the virus could exist elsewhere. Bioterrorism experts say the virus could also be engineered in a lab with modern gene-editing techniques.

With very few people now vaccinated for smallpox, the impact of a sudden release of the virus could be devastating, the Times notes.

In the 20th century alone, smallpox killed up to 500 million people. Highly contagious, the disease, which can cause pus-filled sores to appear over the whole body, had a fatality rate of about 30 percent.

The new FDA-approved drug for smallpox ― called tecovirimat or Tpoxx ― is the first treatment created specifically for smallpox.

Since the disease is no longer circulating, the FDA said it could not test the new drug in infected humans. It was, however, found to be highly effective at curing animals infected with two related diseases, monkeypox and rabbitpox. It was also safety-tested in over 300 healthy human volunteers.

Medical experts applauded the FDA approval of Tpoxx, saying it was especially important given the fact that the smallpox vaccine ― described in an earlier 60 Minutes episode as “the most dangerous vaccine” ― cannot be given to certain people, including pregnant women and people with immunosuppressive conditions and certain skin diseases, because of its risks.

The most frequently reported side effects of Tpoxx in humans were headache, nausea and abdominal pain, the FDA said.

Tpoxx’s maker, SIGA Technologies, said it has delivered 2 million treatments to the federal government, which will be stockpiling the drug, reported the Associated Press.

SIGA said it’s also looking into the possibility of developing the drug to treat other infectious diseases like monkeypox, a sometimes-fatal virus that African monkeys can transmit to humans.

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