Advanced Development and Procurement
The potential for an anthrax attack is still a very real and serious threat to national health security and BARDA is working in collaboration with our PHEMCE partners to continue the development of medical countermeasures to prevent and treat infection. Anthrax vaccines are a major component of the PHEMCE’s strategy to protect the American people from anthrax.
Current Programs
BARDA is supporting the following anthrax vaccines:
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BioThrax (Anthrax Vaccine Adsorbed or AVA): Biothrax is the only licensed anthrax vaccine. This product has been procured to enhance national health security for many years. However, Biothrax requires three doses administered at two week intervals in combination with 60 days of antibiotics. While Biothrax is a critical component of our nation’s anthrax preparedness, it relies on a complex administration schedule and requires two months of antibiotic therapy in conjunction with the vaccine.
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AV7909: BARDA is supporting the late-stage development of AV7909, a next-generation anthrax vaccine which uses AVA vaccine in combination with an immune system stimulant or adjuvant. This product would potentially only require two doses administered two weeks apart, thereby protecting people more quickly. Because AV7909 provides more rapid protection than BioThrax, it may be possible to reduce the requirement for antibiotic therapy. Such a reduction would allow the SNS to significantly reduce its antibiotic holdings while maintaining the current level of preparedness against anthrax. If AV7909 development is successful, the SNS will also be able to transition from a three-dose vaccine to a two-dose vaccine, potentially allowing for an increased level of preparedness for current costs or decreased cost if current levels of preparedness are maintained and an increase in our concepts of operations requiring fewer touch points with individuals during and after a response.
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Px563L: BARDA is supporting the development of Px563L, a mutated, recombinant protective antigen (rPA) anthrax vaccine. This product would potentially require two doses to be administered to provide protection. However, Px563L is currently in an earlier phase of development than AV7909.
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NasoShield: BARDA is also supporting the advanced development of a single dose anthrax vaccine, NasoShield. This vaccine will be administered as an intranasal spray and would be used to protect against infections caused by inhalation anthrax. However, NasoShield is currently in an earlier phase of development than AV7909.
Future Directions
BARDA will work with its partners in the PHEMCE to continue to develop single-dose anthrax vaccines. In the future, U.S. government investments will focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine.
BARDA is not seeking additional anthrax vaccines under its existing
Broad Agency Announcement (BAA). However, BARDA is interested in expanding the availability of licensed anthrax vaccines to at-risk populations, including pediatric populations. For more information, see the
BARDA Broad Agency Announcement (AOI 1.3).
