BARDA procures additional doses of intravenous TPOXX for national preparedness

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As part of ongoing and long-planned national preparedness efforts for emergencies involving smallpox, BARDA is procuring intravenous (IV) TPOXX treatment courses, exercising an option on an existing contract using authority under the Project Bioshield Act. Delivery of the initial IV treatment courses is expected in early 2023. 

Naturally occurring smallpox is believed to have been eradicated worldwide by 1980, although samples of variola virus (the virus that causes smallpox) are kept at the highest biosafety and biosecurity levels for research purposes, leading to concerns that the virus could be used as a biological warfare agent or accidentally released. Smallpox, which historically had a case-fatality rate of about 30 percent, has been deemed a material threat to national security. These potential consequences make planning for a smallpox emergency critical.   

TPOXX is approved by the U.S. Food and Drug Administration (FDA) for use in treating smallpox infections. While the capsule formulation of the product can be used by people weighing more than 26 pounds (13 kilograms) and can be prescribed for outpatient use, the IV formulation is an option for patients unable to swallow or otherwise benefit from the oral capsule and is approved for people weighing more than 6 pounds (3 kilograms). The IV formulation is also a critical therapeutic for hospitalized patients with severe infection.   

Currently, TPOXX, in capsule form previously procured by BARDA, is being made available to treat monkeypox patients under non-research expanded access investigative new drug (EA-IND) protocol sponsored by the U.S. Centers for Disease Control and Prevention (CDC).  

BARDA began collaborating with SIGA in 2011 to continue advanced research and development activities initially funded by the National Institutes of Health (NIH) for an oral formulation of SIGA’s smallpox antiviral, Tecovirimat (TPOXX). TPOXX is a small molecule that inhibits the exit of orthopoxviruses, including variola virus, vaccinia virus, and monkeypox virus, from infected cells, preventing infection of other cells and systemic spread. FDA approved oral formulation of TPOXX in 2018 as the first antiviral for the treatment of smallpox, and approved the IV formulation in May 2022.  

Since 2004, Project BioShield Act authority and funding have allowed HHS to accelerate the research, development, purchase, and availability of effective medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats. Having FDA-approved products readily available during a disaster can save lives and increase preparedness by streamlining and simplifying the emergency response.

Last Updated: August 22, 2022

CBRN Portfolio

The CBRN investments support advanced research and development and national security procurement of medical countermeasures to addresses national security threats. This award is one component of BARDA's CBRN medical countermeasure portfolio; visit the CBRN Portfolio to learn more.