Expanding our vaccine portfolio to protect against high-consequence biological threats.
Biological threats, whether naturally occurring or intentionally engineered, pose serious threats for which we must be prepared. Vaccines can and will be a major component of response efforts for public health emergencies like smallpox, anthrax, and viral hemorrhagic fevers.
The CBRN Vaccines Program continues to support late-stage development and licensure of programs addressing key high-consequence biological threats. In parallel, we are investing in earlier stage candidates for the next generation of threats. Our goal is to expand our level of preparedness and ensure safe and effective vaccines are ready and stockpiled as part of a comprehensive response to future threats.
Smallpox is a highly lethal disease that was eradicated over 40 years ago. However, we must maintain a high level of preparedness against this disease given how easily it could spread if ever re-introduced. Importantly, advances in synthetic biology have potential to make the re-introduction of smallpox more feasible.
We continue to foster a level of preparedness by improving on the current baseline. We have licensed vaccines, one of which can be used in special populations such as older adults and immune-compromised individuals. We will continue to pursue efforts to improve the operational use of the licensed vaccines. The Vaccine Program will also work towards a lyophilized formulation to create a product with a much longer shelf-life, greatly enhancing the financial sustainability of the program.
Multi-drug resistant organisms are a threat to national security and public health. As rates of antimicrobial resistance (AMR) in pathogens continue to increase, new therapeutics and vaccines are essential to combat the growing crisis.
The CBRN Vaccine and Antibacterial Teams are working together on this joint initiative to support programs for vaccines for MDR pathogens in the late preclinical stage through phase II clinical development.
Our priority pathogens include the following:
The CBRN Vaccine and DRIVe teams are partnered together to support alternative delivery platforms that transform vaccination and other drug delivery by bringing new technologies into the marketplace.
The Beyond the Needle initiative is developing alternative technologies that aim to transform the paradigm by making vaccines easier to administer and more widely available without the need for needles, syringes, vials, and cold-chain distribution burdens. The CBRN Vaccine team wants to take the concept further and revolutionize vaccine production.
In parallel with evaluating needle-free approaches, the team is seeking to use 3D printing or related technologies that may enable distributed, on-demand vaccine manufacturing. Distributed manufacturing may be a key to reducing or removing some of the downstream bottlenecks associated with manufacturing scale up and distribution.
Learn More by visiting DRIVe’s “Beyond The Needle” webpage.
Ebola viruses and Marburg viruses are members of the filovirus family that cause highly lethal viral hemorrhagic fevers. The 2014-2016 Ebola outbreak in West Africa resulted in major investments to push a vaccine against Ebola Zaire to licensure, and this vaccine is now being used as part of ongoing outbreak responses. However, unlike Zaire ebolavirus, we currently do not have licensed vaccines against Marburg virus or Sudan ebolavirus if an outbreak of those species were to occur.
BARDA has several near and long-term requirements in the filovirus vaccine space.
Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis, which can cause human disease via gastrointestinal, cutaneous, or inhalational (pulmonary) routes. Clinical manifestations of the disease differ by route and inhalational anthrax is the most lethal. Biothrax is currently licensed for use as pre- and post-exposure prophylaxis (post-exposure in combination with antibiotics).
Smallpox is a highly lethal disease that was eradicated over 40 years ago. However, we must maintain a high level of preparedness against this disease given how easily it could spread if ever re-introduced. Importantly, advances in synthetic biology have potential to make the re-introduction of smallpox more feasible.
We continue to foster a level of preparedness by improving on the current baseline. We have licensed vaccines, one of which can be used in special populations such as older adults and immune-compromised individuals. We will continue to pursue efforts to improve the operational use of the licensed vaccines. The Vaccine Program will also work towards a lyophilized formulation to create a product with a much longer shelf-life, greatly enhancing the financial sustainability of the program.
These four pathogens are among the top public health threats because of their cost, incidence, morbidity and mortality, and their overlap with other public health emergencies. AMR can hinder emergency response by worsening outcomes, regardless of root cause.
Learn more by visiting our Partnering on Vaccines to Counter Multi-Drug Resistant (MDR) webpage where we outline how we can work together to develop a vaccine against MDR Vaccines.
The CBRN Vaccine and DRIVe teams are partnered together to support alternative delivery platforms that transform vaccination and other drug delivery by bringing new technologies into the marketplace.
The Beyond the Needle initiative is developing alternative technologies that aim to transform the paradigm by making vaccines easier to administer and more widely available without the need for needles, syringes, vials, and cold-chain distribution burdens. The CBRN Vaccine team wants to take the concept further and revolutionize vaccine production.
In parallel with evaluating needle-free approaches, the team is seeking to use 3D printing or related technologies that may enable distributed, on-demand vaccine manufacturing. Distributed manufacturing may be a key to reducing or removing some of the downstream bottlenecks associated with manufacturing scale up and distribution.
Learn More by visiting DRIVe’s “Beyond The Needle” webpage (source https://drive.hhs.gov/beyondtheneedle.html)
