Almost 15 years ago, an attacker mailed three letters containing a deadly form of anthrax, killing five people and sickening 17 others. At the time, people who were exposed or who may have been exposed had few treatment options available and no vaccine at-the-ready to prevent illness. Today, that’s changed. On November 23, FDA announced licensure of a vaccine to prevent illness after exposure to anthrax. After a bioterrorism incident, a licensed vaccine could save countless lives.
The vaccine, BioThrax® (also called Anthrax Vaccine Adsorbed or AVA), had been licensed only for use before people were exposed. The military has used BioThrax® successfully for decades to protect people going into war zones where they could come in contact with anthrax. However, civilians’ greatest risk of exposure is after an anthrax attack, so they need a vaccine that can be used safely and effectively after being exposed to anthrax bacteria.
Reaching this milestone required collaboration across the federal government and industry. BARDA provided technical assistance and funding for phase 2 and 3 studies, which were needed for the vaccine developer, Emergent Biosolutions, to request FDA licensure of BioThrax® for community-wide post-exposure use.
Other federal agencies also had important roles in the vaccine’s advances. BARDA and Emergent built on previous development work sponsored by DoD for pre-exposure use and on long-term safety studies sponsored by CDC. In addition, progress the National Institute of Allergy and Infectious Diseases (NIAID) made in developing non-clinical models, research concepts, and in working with FDA on a clear regulatory path for post-exposure prophylaxis anthrax vaccines ultimately provided the roadmap for BioThrax’s successful licensure.
Based on additional studies sponsored by BARDA, this vaccine is expected to be effective as part of a larger treatment regimen of antibiotics and antitoxins. BARDA-supported studies, for example, demonstrated that BioThrax® would not interfere with antibiotics likely to be used for treatment of anthrax exposure.
This vaccine joins other medical products – including four antibiotics and two antitoxins – approved for use after an anthrax attack. Yet our work is not complete. BARDA is continuing to develop new treatments should anthrax become resistant to current antibiotics; a new antitoxin is in the works. BARDA also is pushing to improve BioThrax and develop other vaccines so that people are protected with the fewest possible doses of vaccine. Currently, BioThrax must be administered in three doses. To protect people faster in large-scale vaccination efforts, BARDA is working with NIAID and private industry on anthrax vaccine formulations that use dose- or antigen-sparing techniques so that only one or two doses of vaccine would be needed in short succession instead of three doses over a month after exposure. These programs have transitioned to BARDA from earlier development at NIAID and highlight the coordination across the Public Health Emergency Medical Countermeasures Enterprise.
Threats to public health constantly evolve, and along with these come ever-growing challenges in protecting our nation’s health security. Working together across federal agencies and with private industry, we can meet the challenge and provide a full range of approved products available to protect health in future bioterrorism incidents.
