CBRN VACCINE MEDICAL COUNTERMEASURES PROGRAM

Expanding our vaccine portfolio to protect against high-consequence biological threats.

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CBRN Vaccine MEDICAL COUNTERMEASURES OVERVIEW

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.

Hear directly from the CBRN Vaccine Program on their 2021 priorities.
BARDA Industry Day 2020
Dr. Lindsay Parish, Health Scientist & Dr. Daniel Wolfe, Branch Chief
BARDA CBRN Vaccine Branch; Pre-recorded for October 17, 2020

CBRN Vaccine Investment Areas

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Filovirus Vaccines

ebola

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.

  • Zaire Ebolavirus: We continue to work with our industry partners to ensure an initial inventory of vaccine and to support a second candidate through licensure. Studies are also underway to expand the potential use of these vaccines to special populations and to improve the current cold-chain requirements.
  • Sudan ebolavirus and Marburg virus: Vaccine to protect against these threats are earlier in the pipeline.
    • Our near-term goals for these programs are to establish a pipeline of vaccine candidates and to evaluate these programs in clinical stages of development.
    • Our primary focus is on monovalent candidates that are likely to be effective as single dose vaccines.
    • Given the sporadic nature of outbreaks, mass vaccination campaigns may not be feasible, so vaccines may be utilized as part of a response effort.
    • Single dose vaccines with rapid onset to protection would be of high utility to slow the spread of outbreaks byvaccinating healthcare workers, frontline responders, and high-risk contacts.
  • Anthrax Vaccines

    Anthrax Vaccine

    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).

    BARDA’s Anthrax Vaccine Strategy has two major components:

    1. Continue pushing a next-generation vaccine, AV7909, to licensure as a two-dose post-exposure prophylaxis. This will reduce the number of doses required for protection as well as the time to onset of protection.
    2. Invest in solutions that improve the operational logistics of the current lead vaccines. This will involve clinical development to support use in special populations and to extend the usable shelf life of vaccines.

    Future Investments Opportunities:

    • While these efforts are focused on licensed products and those nearing licensure, we continue to work with our interagency partners to evaluate earlier stage anthrax vaccine programs.
    We are interested in innovative approaches and technologies that may enable protection with a single dose and remove some of the downstream bottlenecks of distribution and administration.

    Smallpox Vaccines

    Countermeasures Smallpox

    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.

    Vaccines to Counter Multi-Drug Resistant (MDR) Threats

    Vaccines to Counter Multi-Drug Resistant (MDR) Threats

    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.

    Innovating Beyond The Needle

    BTN Logo

    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.

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    Learn More by visiting DRIVe’s “Beyond The Needle” webpage (source https://drive.hhs.gov/beyondtheneedle.html)

    BARDA Programs

    CBRN has a proven track record of developing life-saving medical countermeasures. We will continue to work with partners old and new to treat or prevent the medical consequences that result from CBRN threats.

    ADDITIONAL REFERENCES

    Website Refresh - www.medicalcountermeasures.gov is pleased to announce a phased launch of our newly redesigned public website. We are making website improvements to provide a more modern and customer-centric web experience. Over the next several months you will see differences throughout the site while we continue implementing updates. Thank you for your understanding and please let us know if you have any questions: techwatchinbox@hhs.gov