FDA approves smallpox drug in case of biological terrorist attack

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On any list of the most devastating diseases that humanity has ever had to face, smallpox almost reaches the top.

The contagious and potentially fatal disease is caused by the variola virus. It killed about 300 million people before mass vaccination campaigns made smallpox the first infectious disease to be eradicated from nature in 1980.

But that does not mean it's gone for real.

The Food and Drug Administration (FDA) announced on July 13 that it had approved for the first time a drug capable of treating smallpox if it was ever released as a weapon in a terrorist attack. The drug is called TPOXX (tecovirimat).

"To counteract the risk of bioterrorism, Congress has taken steps to allow the development and approval of countermeasures to counteract the pathogens that can be used as weapons," said the commissioner. FDA, Scott Gottlieb. "Today's approval is an important milestone in these efforts, and this new treatment offers us an additional option if smallpox is to be used as a biological weapon."

The potential release of smallpox as a weapon is a very worrying scenario; Many experts believe that a form of armed disease is one of the biggest risks that humanity faces.

The world is not ready for this possibility and it is not ready to react to a pandemic that occurs naturally. This means that it is plausible that a species of deadly pathogen – probably a virus – can spread throughout the world.

As Bill Gates has said at a recent conference, the world's governments are ill prepared for this kind of scenarios.

"In the case of biological threats, this sense of urgency is lacking," said Gates. "The world must prepare for pandemics in the same serious way that it is preparing for war."

Shutterstock / Tonhom1009

The return of smallpox

There is good reason to be concerned about a possible release of smallpox.

In theory, only two laboratories in the world are allowed to own the smallpox virus: the CDC in Atlanta and the State Research Center on Virology and Biotechnology in Russia.

But there may be more samples of the virus. In 2014, vials containing smallpox were found in a cold room of an FDA laboratory on the campus of the National Institutes of Health in Bethesda, Maryland. The possibility of an accidental release of this kind of forgotten sample is remote but real.

More worrisome is the fact that researchers think that it would not be difficult for a malicious actor to create a version of the smallpox virus – even a more dangerous one – in a lab.

Now that smallpox has been "eradicated," most people are no longer getting the vaccine, which means that the vast majority of the world is vulnerable to an epidemic.

The Department of Defense recently commissioned a report on defense against biological weapons from the National Academy of Sciences, Engineering and Medicine. The report, released in June, said re-creating pathogenic viruses known as smallpox using synthetic biology techniques should be "the biggest concern" for the United States.

"The US government should pay special attention to this rapidly advancing field, as well as to advances in chemistry and physics during the Cold War," said Michael Imperiale, professor of microbiology and immunology at the University of California. University of Michigan and chair of the committee that drafted the report, said in a statement.

Last year, a Canadian researcher studying synthetic biology demonstrated that it was possible to create smallpox-related pox viruses using genetic material purchased through the mail. According to a report from the World Health Organization, this cost the researcher $ 100,000 and "did not require exceptional biochemical knowledge or skills, large funds, or considerable time."

National Institute of Infectious Diseases and Allergies, National Institutes of Health

Other dangerous diseases

Smallpox by arms is far from the only disease that, according to the researchers, could lead to a pandemic.

Experts believe that if a flu like the 1918 version were to reappear, it could kill 30 million people within six months. Even more frightening flus are also possible: in ongoing studies in 2014 that resumed last year, scientists have shown how to make the flu virus more deadly. They have also shown that more dangerous viruses can be manipulated to become more contagious.

Experts from the CDC and the World Health Organization keep lists of the diseases most likely to cause a deadly pandemic. These lists include a number of natural pathogens, some of which could be transformed into biological weapons, such as Ebola, Marburg, SARS, anthrax, botulism, plague, tularaemia and smallpox.

Experts also performed simulations to see how the world would react to the intentional release of a pandemic disease. The general consensus was that humanity would not be doing well.

In May, the Johns Hopkins Center for Health Security performed a simulation demonstrating what could happen if a marginal group were to release a modified Nipah-related illness. An unrecognized Nipah virus outbreak in India in May sickened at least 18 and killed 17 of those infected.

In the Johns Hopkins simulation, the modified virus killed more than 150 million people in one year.