BARDA’s Preparedness Investments Enabled Rapid Response to U.S. Monkeypox Outbreak

Products for monkeypox are among BARDA’s 63 FDA-cleared medical countermeasures

June 08, 2022

BARDA’s Preparedness Investments Enabled Rapid Response to U.S. Monkeypox Outbreak Photograph

Recent cases of monkeypox reported since mid-May reinforce the value of public health emergency preparedness, which is BARDA’s mission. Because vaccines and therapeutics that could work against monkeypox were already developed, approved by the U.S Food and Drug Administration (FDA), and procured by the U.S. government, state public health departments and physicians can get the products they need. Our years of investment in developing these medical countermeasures (MCMs) has enabled them to be available for the current monkeypox clusters.

As part of our efforts to address a potential smallpox emergency, BARDA supported the advanced development, FDA licensure and initial procurement of three products approved by the FDA for treatment of smallpox and prevention of smallpox and monkeypox. These are antiviral therapeutics (TPOXX and TEMBEXA) for smallpox treatment and a vaccine (JYNNEOS) to prevent smallpox and monkeypox. At least one of the antivirals can be administered to treat individuals infected with monkeypox under an expanded access investigational new drug (IND) application held by the U.S. Centers for Disease Control and Prevention (CDC).

These products are among 63 FDA-approved MCMs developed with BARDA’s support. In addition to funding, BARDA provides scientific and technical expertise in areas such as toxicology, virology, pre-clinical and clinical study design, data analysis, large-scale manufacturing, and regulatory affairs.

Getting these products from early-stage laboratory research through clinical trials and regulatory clearance is long, complex and costly. Without a commercial market for products that are only rarely needed, it is government funding and potential for stockpiling that create the necessary incentives for companies to develop them.

Since smallpox has been eradicated, approval of antiviral drugs was accomplished under the FDA Animal Rule. As part of the development process for both vaccine and antivirals, non-clinical evaluation against monkeypox infection showed that at least two of these products could be effective. The European Medicines Agency approved TPOXX for treatment of orthopox viruses including monkeypox based on non-clinical data.

BARDA’s collaborators on this effort include private sector partners, the National Institutes of Health (NIH), the Department of Defense (DOD), and the CDC.

BARDA’s approach to supporting development, licensure, and procurement of products like these countermeasures for smallpox is a foundational goal of the American Pandemic Preparedness Plan and BARDA’s Strategic Plan: continuing to develop treatments and vaccines that can be used against multiple health threats. BARDA aims to support products that can be approved or licensed, stockpiled, and available immediately when needed to respond to a wide range of potential health emergencies.

ABOUT CBRN:

BARDA’s Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures Division works to support innovative products through all phases of the development pipeline with a primary focus on advanced development, licensure and procurement of life-saving products.

Last Updated: June 08, 2022

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