TPOXX, an antiviral drug approved by the Food and Drug Administration (FDA) for treating smallpox, could be one of the most important tools in fighting monkeypox. But red tape makes it hard to acquire.

Initially confirmed in May, the ongoing monkeypox outbreak has been quickly spreading across many countries, pushing the World Health Organization (WHO) to declare it a global public health emergency.

In the past three months, more than 5,000 Americans have been infected by the viral disease, according to data from the U.S. Centers for Disease Control and Prevention (CDC).

With many critics warning that the current public health response to the outbreak has been much too slow, physicians have decided to look at Tecovirimat on top of the current monkeypox vaccine supplied by the federal government.

Also known as TPOXX, the antiviral drug is FDA-approved for treating smallpox since the disease is in the same genus as monkeypox. However, TPOXX is only approved to treat smallpox infections under animal studies and not human trials — a process impossible to conduct given that smallpox has been extinct in the last four decades.

With no human trials for monkeypox, TPOXX’s use can only be conducted by doctors that are part of a hospital’s internal review board, but not without filling out dozens of pages of the required paperwork to secure the drug.

“Only certain individuals are allowed to do consent… that limits it to a small number of individuals. At UCLA, we’re trying to expand the number of people who have that authority, and I’m sure other institutions are as well, but that clearly is the limiting factor,” said Dr. Timothy Brewer, a professor of epidemiology at UCLA's Fielding School of Public Health and Medicine.

CDC changed the process last week, now allowing physicians to order the drug from the National Strategic Stockpile of medical supplies and start treatment before doing the paperwork.

Since the declaration of monkeypox as a global health emergency, physicians have proposed emergency use authorization for TPOXX.

“It would allow clinicians to use this medication without the cumbersome barrier of putting together an IRB,” said Dr. Abraar Karan, an infectious disease researcher at Stanford University, calling the requirement “quite an involved process.”

RELATED STORIES