BARDA Supports Next Steps for a New Antiviral Drug for Smallpox

A $24.8 million federal contract will support development a new antiviral drug to treat smallpox. The Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, will fund the contract with Chimerix, Inc., of Durham, N.C. The contract can be renewed for up to four additional years for a five-year total of up to $81.1 million.

"A critical component of the U.S. strategy for protecting the public against intentional or unintentional release of the smallpox virus is having two smallpox antiviral drugs," says BARDA director Dr. Robin Robinson. "In the event of a smallpox outbreak, a smallpox antiviral could augment our plans to use a vaccine because an antiviral medication can treat people who get the vaccine too late for the vaccine to be effective. An antiviral can save lives."

Routine smallpox vaccination ended in the United States in the early 1970s so people born after routine vaccination ended are not immune to the disease. The World Health Organization declared the disease eradicated worldwide in the 1980s. The variola virus, which causes smallpox, is kept only at the two WHO-approved repositories in the United States and Russia for limited use in research. If the virus were used in a bioterrorism attack, the U.S. government estimates that up to 1.7 million people or more could need treatment before the disease could be controlled through vaccination.

Although the Strategic National Stockpile includes smallpox vaccine, vaccines only protect against disease if a person is vaccinated before or very soon after being exposed to the virus. If further development efforts are successful, CMX-001 could be available to treat people who already have smallpox symptoms. In addition, the medication potentially could be used to treat other virus infections, such as adenovirus, cytomegalovirus, and BK virus, in people with severely weakened immune systems.

The contract uses the federal governments new approach to producing medical countermeasures the medications, vaccines, medical equipment and supplies needed for a health emergency. On Aug. 19, HHS secretary Kathleen Sebelius released an examination of the federal governments system to produce medical countermeasures, along with recommendations for a better approach. The recommendations included developing dual-use drugs drugs that can be used for bioterrorism as well as for other illnesses and to develop more countermeasures that are safe for children, the elderly, and other vulnerable populations such as those with compromised immune systems.

Under the contract, Chimerix will continue developing CMX-001, conduct studies to show that the drug is safe and effective and that the manufacturing process is adequate to ensure the quality of the drug. This work is required for the company to apply for approval of the drug through the U.S. Food and Drug Administration.

BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products such as ventilators for public health medical emergencies including chemical, biological, radiological, and nuclear threats, pandemic influenza, and other emerging infectious diseases.

For more information about BARDA and ASPR preparedness efforts for public health and medical emergencies, including the medical countermeasure review, visit www.phe.gov.

The Strategic National Stockpile (SNS), operated by the Centers for Disease Control and Prevention, has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the United States within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. To learn more, visit http://emergency.cdc.gov/stockpile/