BARDA exercises contract option for additional smallpox treatments in early 2023

Amid a monkeypox outbreak that continues to grow internationally, the Biomedical Advanced Research and Development Authority (BARDA) exercised an option on an existing contract this week to acquire additional intravenous (IV) doses of the TPOXX smallpox treatment.

TPOXX is a U.S. Food and Drug Administration (FDA) approved treatment for smallpox inflections, created by SIGA Technologies and available in both capsule and IV formulations. While the capsules are meant for those weighing more than 26 pounds, the IV formulation can be used by anyone weighing more than 6 pounds, expanding its reach significantly. However, while the capsules can be prescribed for outpatient use, IV formulations offer a critical means of aid for hospitalized patients with severe infection, benefiting them even when they cannot swallow or otherwise benefit from the capsule.

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). Collaboration between SIGA and BARDA on TPOXX has been ongoing since 2011 when the National Institutes of Health initially funded advanced research and development that led to its creation. Ultimately, its oral form was FDA-approved as the first antiviral treatment for smallpox in 2018, followed by the IV form in May 2022.

Authority to utilize the contract option for additional IV doses was provided under the Project Bioshield Act, which allows the Department of Health and Human Services to hasten R&D, purchase, and availability of effective medical countermeasures for use against chemical, biological, radiological, and nuclear (CBRN) threats. In this case, the result should be additional IV treatment courses delivered beginning in early 2023.