View source for Biomedical Advanced Research and Development Authority

{{short description|Government organization in Washington D.C., United States}}
{{Undisclosed paid|date=November 2021}}
{{POV|date=March 2020}}
{{Infobox government agency
| agency_name = Biomedical Advanced Research and Development Authority
| employees = 150
| budget = $1.6 billion [[United States dollars|USD]] (2020)
| logo = File:Barda Logo.png
| logo_caption = 
| formed = December 2006
| preceding1 = 
| chief1_name = Gary Disbrow
| chief1_position = Acting Director
| headquarters = [[Hubert H. Humphrey Building]], Washington, D.C.
| jurisdiction = [[Federal Government of the United States]]
| parent_agency = [[Office of the Assistant Secretary for Preparedness and Response]]
| website = {{URL|https://www.medicalcountermeasures.gov/barda}}
}}

The '''Biomedical Advanced Research and Development Authority''' ('''BARDA''') is a [[United States Department of Health and Human Services|U.S. Department of Health and Human Services]] (HHS) office responsible for the procurement and development of [[medical countermeasure]]s, principally against [[bioterrorism]], including [[CBRN defense|chemical, biological, radiological and nuclear (CBRN) threats]], as well as pandemic influenza and emerging diseases.<ref name=":0">{{Cite book|url=https://books.google.com/books?id=1anMBQAAQBAJ|title=U.S. Government Counterterrorism: A Guide to Who Does What|last1=Kraft|first1=Michael|last2=Marks|first2=Edward|publisher=CRC Press|year=2016|isbn=9781439851470|location=Boca Raton, Florida|oclc=635488871|via=Google Books}}</ref>{{Rp|140}} BARDA was established in 2006 through the [[Pandemic and All-Hazards Preparedness Act]] (PAHPA) and reports to the [[Office of the Assistant Secretary for Preparedness and Response]] (ASPR). The office manages [[Project Bioshield Act|Project BioShield]], which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.<ref name=":0" />{{Rp|140}}

In addition to preparing and maintaining bioterrorism responses and countermeasures, [[United States Department of Health and Human Services | HHS]], through the [[Assistant Secretary for Preparedness and Response | ASPR]] and BARDA, prepares and maintains an integrated system of medical countermeasures for both known or unknown, and re-emerging or novel types of [[Public Health Emergency (United States)|public health emergencies]]. These include diagnostic tools, therapeutics, such as antibiotics and antivirals, and preventative measures, such as vaccines. BARDA is an established, official interface between the [[Federal Government of the United States | U.S. federal government]] and the [[Biomedicine|biomedical]] industry.<ref name=":0" />{{Rp|267}}  BARDA also participates in the governmental inter-agency [[Public Health Emergency Medical Countermeasures Enterprise]] (PHEMCE), providing coordination across the US federal government in developing and deploying such countermeasures.<ref name=":0" />{{Rp|267}}

BARDA works with the biomedical industry, using grants and other assistance, to promote advanced research, innovation and the development of medical devices, tests, vaccines and therapeutics. BARDA also procures and maintains stockpiles of materials, such as drugs, personal protective equipment (PPE) and vaccines, for the [[Strategic National Stockpile]] (SNS).<ref name="0:8">{{Cite web | website=www.phe.gov | access-date=May 21, 2020 | title="Strategic National Stockpile" | url=https://www.phe.gov/about/sns/Pages/default.aspx | archive-date=April 3, 2020 | archive-url=https://web.archive.org/web/20200403134414/https://www.phe.gov/about/sns/Pages/default.aspx | url-status=live }}</ref>

== History ==

=== Creation and legislative history ===

BARDA was created and authorized by Title IV Sec 401 of the [[Pandemic and All-Hazards Preparedness Act]] (PAHPA) of 2006. PAHPA amended the [[Public Health Service Act]] by the addition of section 319L to that law.<ref>{{Cite web | url=https://uscode.house.gov/view.xhtml?req=(title:42%20section:241%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section241)&f=treesort&edition=prelim&num=0&jumpTo=true | title=42 USC 241: Research and investigations generally |website=uscode.house.gov}}</ref> PAHPA provided new authorities for a number of programs to counter CBRN as well as epidemic, pandemic and emerging disease threats, established the position of [[Assistant Secretary for Preparedness and Response]] (ASPR) as well as BARDA reporting to the ASPR, and built on [[Project Bioshield Act|Project BioShield]], previously created in 2004.

PAHPA reauthorized the [[Public Health Security and Bioterrorism Preparedness and Response Act]] of 2002, following the [[2001 anthrax attacks]] ensuing the [[September 11 attacks|September 11, 2001]] terrorist attacks on the United States. BARDA was reauthorized by the [[Pandemic and All-Hazards Preparedness Reauthorization Act of 2013]] (PAHPRA) and again in the [[Pandemic and All-Hazards Preparedness and Advancing Innovation Act]] of 2019 (PAHPAI).

=== Leadership ===

The inaugural director of BARDA, from its inception in 2006 through April 2008 was Carol D. Linden, who served both as the principal deputy director and acting director.  From April 2008 through November 14, 2016, the director was Robin A. Robinson, formerly director of the BARDA Influenza and Emerging Diseases division.<ref>{{Cite web | website=www.biopharminternational.com | date=May 8, 2008 | access-date=May 22, 2020 | title="Robin Robinson named First Director of BARDA" | url=http://www.biopharminternational.com/robin-robinson-named-first-director-barda | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613113420/http://www.biopharminternational.com/robin-robinson-named-first-director-barda | url-status=live }}</ref> He was succeeded as director by [[Rick Bright]] from November 15, 2016 through April 20, 2020, when he was moved in what later became a whistleblower controversy during the [[COVID-19 pandemic in the United States]] (SARS-CoV-2).<ref>{{Cite web | website=www.globalbiodefense.com | date=November 15, 2016 | access-date=May 22, 2020 | title="Rick Bright Selected as New BARDA Director" | url= https://globalbiodefense.com/2016/11/15/rick-bright-selected-new-barda-director/}}</ref> As of April 23, 2020, Gary Disbrow is the BARDA director, formerly director of the Medical Countermeasures program and director of the CBRN division at BARDA. All early BARDA directors also concurrently served as Deputy [[Assistant Secretary for Preparedness and Response]].

=== Organizational structure ===

BARDA's 2011–2016 Strategic plan described its composition as the Office of the Director plus seven functional divisions:<ref name=":8"/>
{{ bulleted list | 
Chemical, Biological, Radiological and Nuclear Countermeasures (CBRN) Countermeasures | Clinical Studies | 
Influenza |
Manufacturing Facilities and Engineering | 
Modeling | 
Regulatory and Quality Affairs | 
Strategic Science and Technology
}}

In June 2018, BARDA announced a new initiative, its Division of Research Innovation and Ventures (DRIVe).<ref>{{Cite web | website=www.fiercehealthcare.com | date=June 5, 2018 | access-date=May 23, 2020 | title="HHS launches new initiative to address health concerns as national security threats" | url=https://www.fiercehealthcare.com/regulatory/department-health-and-human-services-drive-security-barda | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613124308/https://www.fiercehealthcare.com/regulatory/department-health-and-human-services-drive-security-barda | url-status=live }}</ref> DRIVe is a [[business accelerator]] to fund and support the development of a portfolio of healthcare products.

== Roles and purpose ==

BARDA plays a unique and unusual role within the structure of the US Federal Government, assisting in getting drugs, deemed essential during public health emergencies including attacks compromising US national security, to market. Such assistance ranges from direct funding, procuring and stockpiling medical countermeasures (MCM’s), to helping obtain US [[Food and Drug Administration|FDA]] approvals, including [[Emergency Use Authorization]] (EUA) if needed. By the rare nature of such public health emergencies, the required therapies or countermeasures, while critical during the emergency, may not constitute a financially viable or profitable investment, for sufficiently large pharmaceutical companies.

Such gaps in the US government medical countermeasures infrastructure have been described as "bridging the valley of death".<ref>{{Cite web | website=www.phe.gov | access-date=May 23, 2002 | title="BARDA's Vision, Mission and Values" | url=https://www.phe.gov/about/barda/stratplan/Pages/barda-vision-mission-and-values.aspx | archive-date=October 12, 2013 | archive-url=https://web.archive.org/web/20131012183904/http://www.phe.gov/about/barda/stratplan/Pages/barda-vision-mission-and-values.aspx | url-status=dead }}</ref><ref name=":8">{{Cite web | website=www.phe.gov | access-date=May 22, 2020 | title="BARDA Strategic Plan 2011-2016" | url=https://www.phe.gov/about/barda/stratplan/Pages/introduction.aspx | archive-date=May 22, 2020 | archive-url=https://web.archive.org/web/20200522014432/https://www.phe.gov/about/barda/stratplan/Pages/introduction.aspx | url-status=dead }}</ref> In this respect, BARDA provides services similar to those offered by [[venture capital]]ists or business accelerators in private industry, although BARDA takes no financial stake in the final product once approved by the FDA.<ref>{{Cite web | website=www.marketplace.org | date=October 30, 2014 | access-date=May 23, 2020 | title=BARDA: The venture capital firm buried in the US government | url=https://www.marketplace.org/2014/10/30/barda-venture-capital-firm-buried-us-government/ | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613113313/https://www.marketplace.org/2014/10/30/barda-venture-capital-firm-buried-us-government/ | url-status=live }}</ref>

BARDA acts in concert with the [[Public Health Emergency Medical Countermeasures Enterprise|PHEMCE]]. These activities (see below) include:
{{bulleted list | 
Setting Requirements for Medical Countermeasures (MCM’s) |
Funding Advanced Research and Development (ADR) for CBRN and pandemic MCM’s |
Administration of National Biodefense Fund(s) |
Promoting Innovation in Development and Manufacturing |
Acquiring and Maintaining MCM Stockpiles
}}

== Budget ==

During public health emergencies, BARDA’s budget may be increased by additional [[United States Congress|congressional]] appropriations.

In FY 2020, the annual budget of BARDA was approximately $1.6{{nbsp}}billion depending on the precise allocation of costs, including the costs of projects overseen or managed by BARDA on behalf of the ASPR.<ref>{{Cite web | work=Office of the Assistant Secretary for Preparedness and Response | publisher=U.S. Department of Health and Human Services | access-date=May 22, 2020 | title=Fiscal Year 2018 Budget-In-Brief Public Health and Social Services Emergency Fund | url=https://www.phe.gov/about/aspr/Documents/BIB-2018.pdf }}{{Dead link|date=May 2021 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{Cite web | work=Office of the Assistant Secretary for Preparedness and Response | publisher=U.S. Department of Health and Human Services | access-date=May 22, 2020 | title=Fiscal Year 2019 Budget-In-Brief Public Health and Social Services Emergency Fund | url=https://www.phe.gov/about/aspr/Documents/BIB-2019.pdf | archive-date=April 17, 2020 | archive-url=https://web.archive.org/web/20200417155833/https://www.phe.gov/about/aspr/Documents/BIB-2019.pdf | url-status=dead }}</ref><ref>{{Cite web | work=Office of the Assistant Secretary for Preparedness and Response | publisher=U.S. Department of Health and Human Services | access-date=May 22, 2020 | title="Fiscal Year 2020 Budget-In-Brief Public Health and Social Services Emergency Fund | url=https://www.phe.gov/about/aspr/Documents/BIB-2020.pdf }}{{Dead link|date=May 2021 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> The proposed budget in FY 2020, not reflecting any additional congressional appropriations due to the COVID-19 crisis, was an increase from $1.27{{nbsp}}billion in FY 2019, and $1.02{{nbsp}}billion in FY 2018. This figure included $512{{nbsp}}million in medical countermeasures including $192{{nbsp}}million for combating [[antibiotic-resistant bacteria]]<ref name="bard-carb">{{cite web | website=www.resistancecontrol.info | access-date=May 25, 2020 | title=The Role of the Biomedical Advanced Research and Development Authority Authority BARDA in Promoting Innovation in Antibacterial Product Development | url=https://www.resistancecontrol.info/2017/the-role-of-the-biomedical-advanced-research-and-development-authority-barda--in-promoting-innovation-in-antibacterial-product-development/ }}{{dead link|date=November 2020}}</ref> and $260{{nbsp}}million USD for advanced research and development (ARD).

== Major initiatives ==

{{unreferenced section|date=April 2020}}
* Research and development
 Medical countermeasures<ref>{{Cite web|title=Goals and strategies|url=https://www.phe.gov/about/barda/stratplan/Pages/goals-and-strategies.aspx|access-date=2020-10-25|website=Public Health Emergency, U.S. Department of Health and Human Services|archive-date=2020-10-28|archive-url=https://web.archive.org/web/20201028210634/https://www.phe.gov/about/barda/stratplan/Pages/goals-and-strategies.aspx|url-status=dead}}</ref> 
* Vaccines
* Antimicrobial drugs
* Therapeutic products
* Diagnostics
* Non-pharmaceutical medical supplies
* Stockpiling programs (see below)
 Project BioShield<ref>{{Cite web|title=MedicalCountermeaures.gov - Home|url=https://www.medicalcountermeasures.gov/barda/cbrn/project-bioshield-overview/|access-date=2020-10-25|website=www.medicalcountermeasures.gov|archive-date=2020-10-20|archive-url=https://web.archive.org/web/20201020015424/https://medicalcountermeasures.gov/barda/cbrn/project-bioshield-overview/|url-status=live}}</ref>
 Pandemic Influenza Emergency Supplemental Fund
 [[Strategic National Stockpile]]<ref>{{Cite web|title=Strategic National Stockpile|url=https://www.phe.gov/about/sns/Pages/default.aspx|access-date=2020-10-25|website=Public Health Emergency, U.S. Department of Health and Human Services|archive-date=2020-04-03|archive-url=https://web.archive.org/web/20200403134414/https://www.phe.gov/about/sns/Pages/default.aspx|url-status=live}}</ref> 
* Antibiotics
* Vaccines
 [[Anthrax Vaccine Adsorbed|Anthrax vaccine]]
* Antidotes
* Medical equipment and supplies
* Manufacturing infrastructure

== Setting requirements ==

BARDA sets the requirements for medical countermeasures in order to reduce the threats of public health emergencies such as pandemic influenza, [[CBRN defense|CBRN]] threats, and emerging diseases. The requirements formalize the minimum standards private industry needs to use in order to produce medical countermeasures acceptable to BARDA.

=== Formulation ===
Stakeholders across the federal government and the 
[[Public Health Emergency Medical Countermeasures Enterprise]] (PHEMCE) 
specify requirements. Once established, these requirements drive BARDA’s 
advanced research and development, as well as acquisition. Requirements
are created consistent with the planning and prioritization expressed in the 
HHS PHEMCE Implementation Plan for CBRN Threats.
<ref>{{Cite web |
url=https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx | title=HHS PHEMCE Strategy and Implementation Plan |
last=<!--no byline provided--> |
date=<!--no source date provided--> |
website=MedicalCountermeasures.gov |
publisher=U.S. Department of Health & Human Services |
archiveurl=https://web.archive.org/web/20111015054930/https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx |
archive-date=15 October 2011<!--last available copy--> |
access-date=<!--no access date included in original citation-->}}</ref>

=== Pandemic influenza ===
Pandemic Influenza requirements are defined by strategic objectives established in the "National Strategy for Pandemic Influenza"<ref>{{Cite web|url=http://www.flu.gov/professional/federal/pandemic-influenza.pdf|title=National Strategy for Pandemic Influenza|last=Homeland Security Council|date=November 2005|website=Flu.gov|publisher=U.S. Department of Health & Human Services<!--found in archive.org-->|access-date=1 October 2016<!--original access date unknown-->|archive-date=8 November 2011|archive-url=https://web.archive.org/web/20111108152451/http://www.flu.gov/professional/federal/pandemic-influenza.pdf|url-status=live}}</ref> and the "HHS Pandemic Influenza Plan".<ref>{{Cite web|url=https://www.hhs.gov/pandemicflu/plan/|title=HHS Pandemic Influenza Plan|last=<!--not indicated-->|date=<!--not indicated-->|website=HHS.gov|publisher=U.S. Department of Health & Human Services|archive-url=https://web.archive.org/web/20120302132121/http://www.hhs.gov/pandemicflu/plan/|archive-date=2 March 2012<!--last available copy-->|access-date=<!--not available for original insertion-->}}</ref>

== Advanced research and development ==

=== Overview ===
One of BARDA's major objectives is the creation of a robust and dynamic pipeline of medical countermeasures through advanced research and development (ARD). Its goal is to provide multiple product candidates in each program to both account for attrition in medical countermeasure deployment and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy.

BARDA medical countermeasures include vaccines, antimicrobial drugs, therapeutic products, diagnostics and non-pharmaceutical medical supplies, as well as devices for public health medical emergencies including chemical, biological, radiological, and nuclear threats (CBRN), 
pandemic influenza (PI) and emerging infectious diseases (EID).<ref>{{Cite web|url=https://www.phe.gov/about/barda/Documents/barda-strategic-plan.pdf|title=BARDA Strategic Plan 2011-2016|website=U.S. Department of Health and Human Services|access-date=2019-11-13|archive-date=2020-03-18|archive-url=https://web.archive.org/web/20200318060414/https://www.phe.gov/about/barda/Documents/barda-strategic-plan.pdf|url-status=dead}}</ref>

=== Influenza and emerging infectious diseases ===
One of BARDA's key activities includes the Influenza and Emerging Infectious Diseases Division.<ref>{{Cite web|title=MedicalCountermeasures.gov|url=https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/|access-date=2020-10-25|website=www.medicalcountermeasures.gov|archive-date=2020-10-28|archive-url=https://web.archive.org/web/20201028214849/https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/|url-status=live}}</ref> This program aims to support the advanced development of vaccines, therapeutic and diagnostic medical countermeasures that address emerging infectious disease threats.

=== Nerve agents ===
Nerve agents and other chemical weapons are a priority for fighting CBRN threats. 
[[VX (nerve agent)|VX gas]], which was the nerve agent that reportedly killed 
the half-brother of [[North Korea]]n leader [[Kim Jong-un]], 
Provides an example. BARDA also stockpiles an anti-seizure medication,
[[midazolam]], developed by [[Meridian Medical Technologies]], to be made available in an autoinjector to
treat the effects of nerve agents on the neurological system.<ref name=":1" />

Research into substitute medical countermeasures (MCM) against nerve agents conducted by BARDA has shown the utility of current [[atropine]] solutions used in limited quantities in the treatment of cholinergic pathologies, to promote dilation of the eye, or organophosphate poisoning. Noting the lack of sufficient stocks in the case of mass-casualty situations, citing the [[Tokyo subway sarin attack|1995 Tokyo subway sarin attack]], the study proposed alternate routes of administration (ROI) for atropine. The bioavailability of atropine via alternate ROIs was proven to be effective, though consideration was placed on expansion of atropine stockpiles and the dispersion of MCMs to local entities.<ref>{{Cite journal |last1=Schwartz |first1=Michael D. |last2=Raulli |first2=Robert |last3=Laney |first3=Judith W. |last4=Coley |first4=William |last5=Walker |first5=Robert |last6=O'Rourke |first6=Anna W. |last7=Raine |first7=Kathryn |last8=Horwith |first8=Gary |last9=Gao |first9=Yonghong |last10=Eisnor |first10=Derek L. |last11=Lu |first11=Di |last12=Wolling |first12=Brenda |last13=David |first13=Gloria |last14=Johnson |first14=Keli |last15=Barry |first15=William T. |date=July 2022 |title=Systemic Bioavailability of Sublingual Atropine Ophthalmic Solution: a Phase I Study in Healthy Volunteers with Implications for Use as a Contingency Medical Countermeasure |journal=Journal of Medical Toxicology|volume=18 |issue=3 |pages=187–197 |doi=10.1007/s13181-021-00873-0 |issn=1937-6995 |pmc=9198126 |pmid=35312968}}</ref>

=== Antibiotic resistant bacteria ===
In October 2017 BARDA entered a nine-month $12-million contract with the San Francisco-based biopharmaceutical company Achaogen, sponsoring late-stage development of C-scape, an antibiotic used against resistant bacteria and a potential treatment against weaponized strains of bacteria.<ref>{{Cite web|url=http://www.biopharminternational.com/hhs-sponsors-development-antibiotic-resistant-anti-biowarfare-antibiotic|title=HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic|website=biopharminternational.com|date=11 October 2017|language=en|access-date=2017-12-20|archive-date=2017-12-22|archive-url=https://web.archive.org/web/20171222051603/http://www.biopharminternational.com/hhs-sponsors-development-antibiotic-resistant-anti-biowarfare-antibiotic|url-status=live}}</ref><ref>{{Cite web|url=https://www.phe.gov/Preparedness/news/Pages/biowarfare-treatment.aspx|title=News Release - PHE|website=phe.gov|language=en-us|access-date=2017-12-20|archive-date=2017-12-22|archive-url=https://web.archive.org/web/20171222050855/https://www.phe.gov/Preparedness/news/Pages/biowarfare-treatment.aspx|url-status=live}}</ref><ref>{{Cite news|url=https://homelandprepnews.com/stories/24697-barda-achaogen-partner-develop-antibiotic-combat-infections-drug-resistant-bacteria/|title=BARDA, Achaogen partner to develop antibiotic to combat infections from drug resistant bacteria|date=2017-10-12|work=Homeland Preparedness News|access-date=2017-12-20|language=en-US|archive-date=2019-03-05|archive-url=https://web.archive.org/web/20190305082846/https://homelandprepnews.com/stories/24697-barda-achaogen-partner-develop-antibiotic-combat-infections-drug-resistant-bacteria/|url-status=live}}</ref>
In April 2019, Achaogen declared bankrupt.<ref name="Jacobs">{{cite news |last1=Jacobs |first1=Andrew |title=Crisis Looms in Antibiotics as Drug Makers Go Bankrupt |url=https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance.html |access-date=23 November 2022 |work=The New York Times |date=25 December 2019 |language=en |archive-date=1 February 2021 |archive-url=https://web.archive.org/web/20210201230345/https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance.html |url-status=live }}</ref>

== Stockpile programs ==

The [[Pandemic and All-Hazards Preparedness Act]] (PAHPA) established BARDA as the focal point within HHS for the advanced development and acquisition of medical countermeasures to protect the American civilian population against Chemical, Biological, Radiological, and Nuclear (CBRN) and naturally occurring threats to public health.

BARDA's stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from Advanced Development. Stockpiling contributes to preparedness in two ways:

#Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak.
#Establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products.

BARDA's acquisitions for the stockpile are not one-time events, complete upon the approval/licensure of a product. Rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending Emergency Use Authorization. Furthermore, we aim to establish stockpiling milestones to address long-term commitments post-licensure.

=== CBRN stockpile programs ===

In FY 2004, the US Congress appropriated $5.6 billion [[United States dollar|USD]] to the [[Project BioShield]] Special Reserve Fund (SRF) to support the Project BioShield goal of acquiring CBRN medical countermeasures over a 10-year period. BARDA used these funds to support acquisition programs for the procurement of medical countermeasures against high priority CBRN threats. The agency gives funds to pharmaceutical companies to develop countermeasures.<ref name=":1">{{Cite news|url=https://homelandprepnews.com/stories/21394-biological-threats-mitigated-barda-shifts-focus-combat-highly-pathogenic-viruses-chemical-agents/|title=With some biological threats mitigated, BARDA shifts focus to combat highly pathogenic viruses, chemical agents|date=2017-03-06|work=Homeland Preparedness News|access-date=2017-03-14|language=en-US|archive-date=2019-12-25|archive-url=https://web.archive.org/web/20191225164233/https://homelandprepnews.com/stories/21394-biological-threats-mitigated-barda-shifts-focus-combat-highly-pathogenic-viruses-chemical-agents/|url-status=live}}</ref> As of January 2020, BARDA had helped obtain FDA approval for at least 50 products.<ref name=":6">{{Cite web | title=ASPR Blog | website=www.phe.gov | date=October 11, 2019 | access-date=May 19, 2020 | url=https://www.phe.gov/ASPRBlog/pages/BlogArticlePage.aspx?PostID=362 | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613155411/https://www.phe.gov/ASPRBlog/pages/BlogArticlePage.aspx?PostID=362 | url-status=dead }}</ref><ref>{{Cite web | title="51 FDA Approved Medical Countermeasures Backed by BARDA" | date=January 12, 2020 | access-date=May 21, 2020 | website=www.globalbiodefense.com | url=https://globalbiodefense.com/2020/01/12/50-fda-approved-medical-countermeasures-backed-by-barda/ | archive-date=May 18, 2020 | archive-url=https://web.archive.org/web/20200518231020/https://globalbiodefense.com/2020/01/12/50-fda-approved-medical-countermeasures-backed-by-barda/ | url-status=live }}</ref>

=== Pandemic influenza stockpile programs ===

Using funds from the Pandemic Influenza Emergency Supplemental Fund, BARDA is leading the nation toward the vaccine and antiviral stockpile goals for preparedness for pandemic influenza.

In December 2019, BARDA awarded a $226 million 
[[United States dollar|USD]]
six-year contract to [[Sanofi Pasteur]], a global pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey,
to increase production capacity for an influenza vaccine. In September 2019,  a US presidential [[executive order]] 
required the US government to modernize influenza vaccines and technologies in order to improve national health security.<ref>{{Cite web|url=http://outbreaknewstoday.com/pandemic-influenza-vaccine-hhs-awards-sanofi-pasteur-226-million-contract-36021/|title=Pandemic Influenza Vaccine: HHS awards Sanofi Pasteur $226 million contract|date=2019-12-10|website=Outbreak News Today|language=en-US|access-date=2019-12-10}}</ref>

=== Strategic national stockpile ===

The [[Public Health Security and Bioterrorism Preparedness Response Act|Public Health Security and Bioterrorism Preparedness Act]] of 2002 directed the Secretary of [[United States Department of Health and Human Services|Health and Human Services]] to develop and maintain a [[Strategic National Stockpile]] (SNS). The mission of the SNS is to provide for the emergency health security of the United States in the event of a terrorist attack or any other public health emergency.<ref>{{Cite book|url=https://www.ncbi.nlm.nih.gov/books/NBK396378/|title=The Strategic National Stockpile: Origin, Policy Foundations, and Federal Context|date=2016-10-24|publisher=National Academies Press (US)|language=en|access-date=2017-01-19|archive-date=2020-05-07|archive-url=https://web.archive.org/web/20200507135802/https://www.ncbi.nlm.nih.gov/books/NBK396378/|url-status=live}}</ref>

The SNS is the largest US national supply of 
pharmaceuticals and medical supplies for use in a small outbreak to a large-scale, multiple-threat emergency. When state, local, tribal, and/or territorial responders request federal assistance to support their response efforts, the stockpile is used to ensure that supplies are available when and where needed.<ref>{{Cite web|url=https://www.cdc.gov/phpr/stockpile/|title=Strategic National Stockpile {{!}} PHPR|website=cdc.gov|language=en-us|access-date=2017-01-19|archive-date=2017-01-31|archive-url=https://web.archive.org/web/20170131190602/https://www.cdc.gov/phpr/stockpile/|url-status=live}}</ref> The SNS is
Intended to contains enough vaccines, antimicrobial drugs, therapeutic products, and non-pharmaceutical medical supplies in the wake of any public health emergency including terrorist attacks whether chemical, biological, radiological, and/or nuclear, as well as pandemic influenza and emerging infectious diseases.<ref>{{Cite news|url=https://www.npr.org/sections/health-shots/2016/06/27/483069862/inside-a-secret-government-warehouse-prepped-for-health-catastrophes|title=Inside A Secret Government Warehouse Prepped For Health Catastrophes|newspaper=NPR.org|language=en|access-date=2017-01-19|archive-date=2021-08-18|archive-url=https://web.archive.org/web/20210818204816/https://www.npr.org/sections/health-shots/2016/06/27/483069862/inside-a-secret-government-warehouse-prepped-for-health-catastrophes|url-status=live}}</ref>

[[Emergent BioSolutions]] manufactures the only 
[[Food and Drug Administration|FDA]] licensed vaccine against anthrax disease, called [[Anthrax Vaccine Adsorbed|BioThrax]], which is recommended by the [[Centers for Disease Control and Prevention|CDC]] as a post-exposure prophylactic for anthrax infection.<ref>{{Cite web|url=http://www.biospace.com/News/1-and-hpa-announce-botulinum-vaccine-collaboration/18703220|title=1 And HPA Announce Botulinum Vaccine Collaboration|website=biospace.com|access-date=2017-01-19}}</ref>

As part of a $450 million contract with BARDA for the SNS, 
Emergent also developed the only FDA-licensed botulinum antitoxin, 
[[Heptavalent Botulism Antitoxin]] (BAT) for treating naturally occurring 
botulism.[[# edn5|[v]]] Canada also approved BAT.<ref>{{Cite news|url=https://homelandprepnews.com/stories/20437-health-canada-approves-emergent-biosolutions-botulism-antitoxin/|title=Health Canada approves Emergent BioSolutions' botulism antitoxin|date=2016-12-13|newspaper=Homeland Preparedness News|language=en-US|access-date=2017-01-19}}</ref>

The US federal government approved a plan against CBRN threats after the 2001 anthrax letters attack, at the time the worst biological attack in United States history.
<ref name=":1" />

BARDA also invested in the late stage development of a product called NuThrax developed by Emergent Biosolutions, which makes the other anthrax vaccine, BioThrax. According to ''Homeland Preparedness News'', NuThrax will be able to provide immunity to anthrax after two doses, versus the three doses under the currently stockpiled vaccine (BioThrax).<ref name=":1" />

== Manufacturing and building infrastructure ==

Ensuring the availability of medical countermeasures for public health emergencies is central to BARDA's mission. This includes ensuring that manufacturing infrastructure is sufficient to support the production of required products, in a manner that is timely, reliable and cost effective.

BARDA has taken multiple approaches to bringing online the necessary infrastructure for medical countermeasure manufacturing; it supports the construction of new facilities as well as retrofitting existing facilities for maximal capacity and flexibility. It has also explored the use of multi-product manufacturing facilities to provide flexibility and surge capacity and enable rapidly providing countermeasures in the dosage forms required for use in the field. BARDa has also established a network of formulation/fill-finish manufacturers for emergency production and distribution. BARDA has also explored the creation of centers of excellence for the development and production of non-commercial products with assistance from industry partners.
<ref>{{Cite web | website=www.phe.gov | date=September 30, 2019 |
access-date=May 23, 2020 | title="HHS Awards $6 million to Create Pediatric Disaster Care Centers of Excellence" |
url= https://www.phe.gov/Preparedness/news/Pages/pdcc-award-30sept19.aspx
}}</ref>
<ref>{{Cite web | website=www.news.sanofi.us | date=December 9, 2019 | access-date=May 23, 2020 | title="Sanofi Awarded $226 million by US Government to Expand Pandemic Influenza Preparedness" | url=http://www.news.sanofi.us/2019-12-09-Sanofi-awarded-226-million-by-US-government-to-expand-pandemic-influenza-preparedness | archive-date=June 2, 2020 | archive-url=https://web.archive.org/web/20200602174825/http://www.news.sanofi.us/2019-12-09-Sanofi-awarded-226-million-by-US-government-to-expand-pandemic-influenza-preparedness | url-status=live }}</ref>

== Advancing innovation ==

[[Pandemic and All-Hazards Preparedness Act|PAHPA]] charges BARDA to support innovation to reduce the time and cost of medical countermeasures and product advanced research and development. This was to be accomplished through development of technologies that assist the advanced development of countermeasures, investment in research tools and technologies, and research to promote strategic initiatives including rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
[[Pandemic and All-Hazards Preparedness and Advancing Innovation Act|PAHPAI]] provided further authorities for BARDA to promote innovation through industry 
assistance and partnerships.

BARDA has taken this innovation mandate as an opportunity to work with its partners (including NIH, DoD, CDC, industry, and academia) to create new ways to “make medical countermeasure better.” Examples of this approach to innovation could include the development of animal models to support efficacy testing, immune modulation and other broad-spectrum approaches, immunity assessment, and analytical (potency) assays.

A cited example of BARDA’s approach to innovation 
from the Pandemic Influenza program is BARDA's “Mix and Match” study, assessing various combinations of antigens and adjuvants to obtain a more robust immune response.<ref>World Health Organization. (2010). [http://apps.who.int/iris/bitstream/10665/70637/1/WHO_IVB_10.13_eng.pdf Proceedings of the ninth global vaccine research forum and parallel satellite symposia]: Bamako, Mali 6–9 December 2009.</ref> BARDA has stated
plans to support similar initiatives, leveraging technology platforms and products from multiple companies. For example, PAHPA provided an “antitrust” authority that BARDA has used to facilitate cooperation between companies for whom such cooperation would otherwise be difficult to accomplish.

[[Fujifilm|Fujifilm Corporation]] announced in April 2017 that it would invest $130 million to increase production capacity for its BioCDMO division. The division “focuses on contract development & manufacturing for biologics.”<ref name=":2">{{Cite news|url=http://www.business-standard.com/content/b2b-pharma/fujifilm-expands-biopharma-facilities-in-us-uk-with-130-mn-investment-117042400362_1.html|title=Fujifilm expands biopharma facilities in US & UK with $ 130 mn investment|date=2017-04-24|work=Business Standard India|access-date=2017-04-25|archive-date=2017-04-26|archive-url=https://web.archive.org/web/20170426151411/http://www.business-standard.com/content/b2b-pharma/fujifilm-expands-biopharma-facilities-in-us-uk-with-130-mn-investment-117042400362_1.html|url-status=live}}</ref> Fujifilm Diosynth Biotechnologies, with help from a BARDA grant, invested around $93 million to build a production facility in the US state of Texas. The facility would include “mammalian cell culture bioreactors” and was planned to open operations at the start of 2018.<ref name=":2" />

In April 2017, Switzerland-based [[Basilea Pharmaceutica]] and the [[Food and Drug Administration]] reached an agreement regarding two phase 3 clinical studies of an antibiotic developed by Basilea, [[ceftobiprole]]. The two clinical studies 
would examine ceftobiprole for the treatment of “[[Staphylococcus aureus]] bacteremia (bloodstream infections) and acute bacterial skin and skin structure infections.”<ref name=":3">{{Cite news|url=https://finance.yahoo.com/news/basilea-announces-agreement-fda-special-051802737.html|title=Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections|date=2017-04-21|work=Yahoo Finance|access-date=2017-04-25|language=en-US}}</ref> Basilea signed a contract with BARDA, which it entered into in 2016 for the clinical phase 3 development of the antibiotic. BARDA provided initial funding of $20 million but could provide up to $100 million over a period of 4–5 years.<ref name=":3" />

In 2017, BARDA signed a three-year $8.1 million contract with InBios International, Inc. of Seattle, Washington to develop a “[[Point-of-care testing|point-of-care diagnostic test]] that may be able to determine within 15 minutes whether a patient has been infected with the bacterium that causes [[anthrax]].”<ref>{{Cite news|url=http://outbreaknewstoday.com/anthrax-hhs-advances-point-care-diagnostic-test-60967/|title=Anthrax: HHS advances point-of-care diagnostic test - Outbreak News Today|date=2017-09-26|work=Outbreak News Today|access-date=2017-10-01|language=en-US|archive-date=2017-10-02|archive-url=https://web.archive.org/web/20171002070410/http://outbreaknewstoday.com/anthrax-hhs-advances-point-care-diagnostic-test-60967/|url-status=live}}</ref>

In September 2017, BARDA awarded Velico Medical $15.5 million for development of a technology that uses spray drying of human [[Blood plasma|plasma]] for transfusions. The current industry standard is to freeze plasma. Frozen plasma can take 40 or more minutes to defrost and deliver.<ref>{{Cite news|url=https://www.prweb.com/releases/velico_medical_announces_a_further_18_9m_barda_funding_for_spray_dried_alternative_to_frozen_plasma/prweb14735224.htm|title=Velico Medical Announces a Further $18.9m BARDA Funding for Spray Dried Alternative to Frozen Plasma|work=PRWeb|access-date=2017-10-01}}</ref> According to Fierce Biotech, “Velico has Spray Dried Plasma technology (SpDPTM) that enables the storage of blood as dry powder, rather than the typical freezing, for subsequent rehydration. It's expected to be useful in hospital [[Emergency department|emergency rooms]], operating suites and [[intensive care unit]]s--as well as in a military or field hospital setting.”<ref>{{Cite web|url=http://www.fiercebiotech.com/medical-devices/startup-velico-nabs-another-15-5m-from-barda-for-dried-plasma-tech|title=Startup Velico nabs another $15.5M from BARDA for dried plasma tech {{!}} FierceBiotech|website=fiercebiotech.com|date=11 September 2015|language=en|access-date=2017-10-01|archive-date=2017-10-02|archive-url=https://web.archive.org/web/20171002022231/http://www.fiercebiotech.com/medical-devices/startup-velico-nabs-another-15-5m-from-barda-for-dried-plasma-tech|url-status=live}}</ref>

In July 2005, at the hearings before the Committee on Health, Education, Labor, and Pensions, the first CEO and Director of the center, [[Tara O'Toole]], MD, MPH, has pointed to center's role as the "BioDARPA" (i.e. "biomedical [[DARPA]]").<ref>[https://www.gpo.gov/fdsys/pkg/CHRG-109shrg28743/html/CHRG-109shrg28743.htm Hearing before the Committee On Health, Education, Labor, And Pensions United States Senate, One Hundred Ninth Congress] {{Webarchive|url=https://web.archive.org/web/20180220033604/https://www.gpo.gov/fdsys/pkg/CHRG-109shrg28743/html/CHRG-109shrg28743.htm |date=2018-02-20 }} (July 14, 2005). U.S. Government Printing Office, Washington : 2007</ref><ref>{{Cite journal|last=Klabukov|first=Ilya|date=2017|title=The BioDARPA Concept|url=https://ssrn.com/abstract=2951926|journal=SSRN Electronic Journal}}</ref>

== Pandemic and emerging disease responses ==
=== Anthrax ===
Since the [[2001 anthrax attacks]] in the United States, BARDA has supported the research and development 
<ref>{{Cite web | website=www.phe.gov | access-date=May 21, 2020 | title="BARDA's Anthrax Medical Countermeasure Strategy and Portfolio" | url=https://www.phe.gov/about/barda/anthrax/Pages/default.aspx | archive-date=May 21, 2020 | archive-url=https://web.archive.org/web/20200521124932/https://www.phe.gov/about/barda/anthrax/Pages/default.aspx | url-status=dead }}</ref>
of diagnostics, therapeutics and vaccines for [[anthrax]]. 
Therapeutics include the antibiotics 
[[Eravacycline|XERAVA]] Of [[Tetraphase Pharmaceuticals]],
[[Plazomicin|ZEMDRI]] of [[Achaogen]] (rights ex-Greater China bought by [[Cipla]] USA)
[[Gepotidacin]] of [[GlaxoSmithKline]] and 
[[Tebipenem|SPR994]] of [[Spero Therapeutics]]. 
In July 2018, Spero was jointly awarded
<ref>{{Cite web | website=www.investors.sperotherapeutics.com | date=July 16, 2018 | access-date=May 22, 2020 | title="Spero awarded up to $54 million by BARDA and DTRA to Support SPR994 Development" | url=https://investors.sperotherapeutics.com/news-releases/news-release-details/spero-awarded-54-million-barda-and-dtra-support-spr994 | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613160148/https://investors.sperotherapeutics.com/news-releases/news-release-details/spero-awarded-54-million-barda-and-dtra-support-spr994 | url-status=dead }}</ref>
up to USD $54 million by BARDA and the 
[[Defense Threat Reduction Agency]] (DTRA), in support of SPR994 development.
SPR994 also has application to the treatment of 
[[Multiple drug resistance|multi-drug resistant]] (MDR) bacteria.

BARDA also supported the development of the antitoxins
[[Anthrax immune globulin|Anthrasil]] of [[Cangene]] (March 2015 FDA approval) and
[[Obiltoxaximab|Anthim]] of [[Elusys Therapeutics]] (March 2016 FDA approval). 
Anthrax vaccines whose development was supported by BARDA include 
[[Anthrax vaccine adsorbed|BioThrax]] (AVA), 
[[AV7909]] of [[Emergent BioSolutions]]
[[Px563L]] of [[Pfenex]]
and [[NasoShield]] of [[Altimmune]].

=== Botulism ===

[[Botulism]] is caused by the [[botulinum toxin]], one of the deadliest known toxins. While the bacteria that cause botulism
<ref>{{Cite web | website=www.cdc.gov | access-date=May 21, 2020 | title="Botulism" | date=19 August 2019 | url=https://www.cdc.gov/botulism/index.html | archive-date=11 January 2023 | archive-url=https://web.archive.org/web/20230111041341/https://www.cdc.gov/botulism/index.html | url-status=live }}</ref>
<ref>{{Cite web | website=www.who.int | access-date=May 21, 2020 | title="Botulism" | url=https://www.who.int/news-room/fact-sheets/detail/botulism | archive-date=March 23, 2019 | archive-url=https://web.archive.org/web/20190323162924/https://www.who.int/news-room/fact-sheets/detail/botulism | url-status=live }}</ref>
occur naturally, botulism outbreaks are considered rare and unlikely by the US 
[[Centers for Disease Control and Prevention|CDC]], except as the result of a bioterrorism attack. BARDA maintains a supply of botulism antitoxins through the [[Strategic National Stockpile]] (SNS).

=== COVID-19 ===
{{see also|COVID-19 vaccine clinical research#Trial and authorization status}}

As of June, seven companies had been chosen for funding from [[Operation Warp Speed]] to expedite development and preparation for manufacturing their respective vaccine candidates: Johnson & Johnson ([[Janssen Pharmaceutical]]), [[AstraZeneca]]-[[University of Oxford]], [[Pfizer]]-BioNTech, [[Moderna]], [[Merck & Co.|Merck]], [[Vaxart]], and [[Inovio]].<ref name="gen">{{cite web | title=Vaxart oral COVID-19 vaccine joins Trump's "Warp Speed," ramps up manufacturing capacity | publisher=Genetic Engineering and Biotechnology News | date=2020-06-29 | url=https://www.genengnews.com/news/vaxart-oral-covid-19-vaccine-joins-trumps-warp-speed-ramps-up-manufacturing-capacity/ | access-date=2020-07-01 | archive-date=2020-09-29 | archive-url=https://web.archive.org/web/20200929213736/https://www.genengnews.com/news/vaxart-oral-covid-19-vaccine-joins-trumps-warp-speed-ramps-up-manufacturing-capacity/ | url-status=live }}</ref><ref name="gen2">{{cite web | title=INOVIO Reports Positive Interim Phase I Data for COVID-19 DNA Vaccine, Joins "Warp Speed" Primate Study | publisher=Genetic Engineering and Biotechnology News | date=2020-06-30 | url=https://www.genengnews.com/news/inovio-reports-positive-interim-phase-i-data-for-covid-19-dna-vaccine-joins-warp-speed-primate-study/ | access-date=2020-07-01 | archive-date=2020-10-01 | archive-url=https://web.archive.org/web/20201001233159/https://www.genengnews.com/news/inovio-reports-positive-interim-phase-i-data-for-covid-19-dna-vaccine-joins-warp-speed-primate-study/ | url-status=live }}</ref> Funding from BARDA totaled more than $2 billion by the end of June, with the largest awards of $1.2 billion given to AstraZeneca and $483 million to Moderna.<ref name=gen/>

In June 2020, BARDA and the [[United States Department of Defense|U.S. Department of Defenses]] signed a  $143 million contract with SiO2 Materials Science to ramp up production of vials and syringes used for COVID drugs and vaccines.<ref>{{Cite web|date=2020-06-08|title=SiO2 Materials Science Receives $143 Million Contract from U.S. Government to Accelerate Capacity Scale-Up of Advanced Primary Packaging Platform for COVID-19 Vaccines and Therapeutics|url=https://www.businesswire.com/news/home/20200608005120/en/SiO2-Materials-Science-Receives-143-Million-Contract|access-date=2020-06-09|website=www.businesswire.com|language=en|archive-date=2020-06-09|archive-url=https://web.archive.org/web/20200609065625/https://www.businesswire.com/news/home/20200608005120/en/SiO2-Materials-Science-Receives-143-Million-Contract|url-status=live}}</ref>

=== Ebola ===

After the 2014 [[West Africa Ebola virus epidemic]]
(followed by the [[Kivu Ebola epidemic]] starting in 2018),
BARDA supported the development of the first
[[Ebola]] vaccine, [[rVSV-ZEBOV|ERVEBO]], by
[[BioProtection Systems]], a subsidiary of 
[[NewLink Genetics]] Inc. (now [[Lumos Pharma]]).
The vaccine was announced
<ref>{{Cite web | website=www.phe.gov | title="ASPR Blog" | date=December 19, 2019 | access-date=May 21, 2020 | url=https://www.phe.gov/ASPRBlog/Pages/BlogArticlePage.aspx?PostID=370 | archive-date=May 14, 2020 | archive-url=https://web.archive.org/web/20200514114927/https://www.phe.gov/ASPRBlog/pages/BlogArticlePage.aspx?PostID=370 | url-status=dead }}</ref>
by the ASPR on December 19, 2019; ERVEBO
,<ref>{{Cite web | website=www.investors.merck.com | 
title="Merck announces FDA Approval for ERVEBO (Ebola Zaire vaccine, Live)" | date=December 20, 2019 | access-date=May 21, 2020 | 
url= https://investors.merck.com/news/press-release-details/2019/Merck-Announces-FDA-Approval-for-ERVEBO-Ebola-Zaire-Vaccine-Live/default.aspx}}
</ref> 
a vaccine for the [[Zaire ebola virus]] was licensed from NewLink Genetics in 2014 and produced and taken to market by [[Merck & Co.|Merck]]. It was successfully used in the 2018 Ebola virus epidemic in the [[Democratic Republic of the Congo]] (DRC).

=== Influenza ===

=== Smallpox ===
[[Smallpox]] is a highly contagious, potentially fatal disease caused by the [[Variola virus]].
While the US discontinued immunization in 1972, and it was declared eradicated
<ref>{{Cite web | website=www.who.int | title="Smallpox" | access-date=May 22, 2020 | url=https://www.who.int/csr/disease/smallpox/en/ | archive-date=September 22, 2007 | archive-url=https://web.archive.org/web/20070922184729/http://www.who.int/csr/disease/smallpox/en/ | url-status=live }}</ref>
<ref>{{Cite web | website=www.who.int | title="Smallpox Eradication Program" | 
access-date=May 22, 2020 | url= https://www.who.int/features/2010/smallpox/en/
| archive-url= https://web.archive.org/web/20100518163719/http://www.who.int/features/2010/smallpox/en/
| url-status= dead
| archive-date= May 18, 2010
}}
</ref>
by the [[World Health Organization]] (WHO) in 1980 (the last known naturally occurring case was seen in 1977, in Somalia), 
it is still considered a potent bioterrorism threat. 
BARDA began stockpiling smallpox vaccines in 2010. 
<ref>{{Cite web | website=www.hhs.gov | date=September 24, 2019 | access-date=May 22, 2020 | title="HHS Blog" | url=https://www.hhs.gov/blog/2019/09/24/newly-fda-licensed-vaccine-prevention-smallpox-marks-milestone-global-health-security.html | archive-date=January 17, 2021 | archive-url=https://web.archive.org/web/20210117003938/https://www.hhs.gov/blog/2019/09/24/newly-fda-licensed-vaccine-prevention-smallpox-marks-milestone-global-health-security.html | url-status=live }}</ref>
<ref>{{Cite web | website=www.hhs.gov | date=September 3, 2019 | access-date=May 23, 2002 | title="HHS Purchases Smallpox Vaccine to Enhance Biodefense Preparedness" | url=https://www.hhs.gov/about/news/2019/09/03/hhs-purchases-smallpox-vaccine-to-enhance-biodefense-preparedness.html | archive-date=September 3, 2019 | archive-url=https://web.archive.org/web/20190903184841/https://www.hhs.gov/about/news/2019/09/03/hhs-purchases-smallpox-vaccine-to-enhance-biodefense-preparedness.html | url-status=live }}</ref>
By 2018, BARDA had procured millions of doses of 
[[Tecovirimat|TPOXX]], of [[SIGA Technologies]], by then 
the first (and only) FDA-approved
<ref>{{Cite web | website=www.investor.siga | date=July 13, 2018 | access-date=May 22, 2020 | title="US Food and Drug Administration Approves SIGA Technologies' TPOXX (tecovirimat) for the Treatment of Smallpox" | url=https://investor.siga.com/news-releases/news-release-details/us-food-and-drug-administration-approves-siga-technologies | archive-date=September 21, 2018 | archive-url=https://web.archive.org/web/20180921045623/http://investor.siga.com/news-releases/news-release-details/us-food-and-drug-administration-approves-siga-technologies | url-status=dead }}</ref>
antiviral smallpox drug therapy, for the SNS.
<ref>{{Cite web | website=www.phe.gov | title="ASPR Blog" | date=July 13, 2018 | access-date=May 22, 2020 | url=https://www.phe.gov/ASPRBlog/Lists/Posts/Post.aspx?ID=313 | archive-date=May 14, 2020 | archive-url=https://web.archive.org/web/20200514115114/https://www.phe.gov/ASPRBlog/Lists/Posts/Post.aspx?ID=313 | url-status=dead }}</ref>
In 2019, BARDA announced a partnership with [[BioFactura]] to develop a second therapeutic, a monoclonal antibody smallpox treatment. 
<ref>{{Cite web | website=www.phe.gov | date=September 26, 2019 | access-date=May 22, 2020 | title="HHS spurs development of smallpox therapeutic to enhance health security" | url=https://www.phe.gov/Preparedness/news/Pages/smallpox-26sept19.aspx | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613112047/https://www.phe.gov/Preparedness/news/Pages/smallpox-26sept19.aspx | url-status=live }}</ref>

=== Zika ===
As of early 2020, there were no publicly acknowledged BARDA biomedical collaborations (diagnostics, therapies or vaccines) for the 
[[Zika virus]]. 
However BARDA has an announced (general) four-part Zika strategy
<ref>{{Cite web | website=www.phe.gov | access-date=May 21, 2020 | url=https://www.phe.gov/about/barda/zika/Pages/default.aspx | title="BARDA's Medical Countermeasure Response to Zika" | archive-date=May 14, 2020 | archive-url=https://web.archive.org/web/20200514114557/https://www.phe.gov/about/barda/zika/Pages/default.aspx | url-status=dead }}</ref>
{{bulleted list | Prevention (vaccines) | Detection (diagnostics) | Ensuring a safe blood supply (screening) | National Countermeasure Response Activation (developer assistance)}}

== Medical countermeasure portfolio ==

{| class="wikitable"
!Threat
!Product
!Development Stage
|-
|Smallpox
|TPOXX ([[SIGA Technologies]])<ref>{{Cite web |url=https://www.in-pharmatechnologist.com/Article/2018/09/21/Siga-signs-629m-multiyear-contract-with-BARDA-for-smallpox-drug-stockpiling |title=Siga signs $629m contract with BARDA for smallpox drug stockpiling |last=in-pharmatechnologist.com |website=in-pharmatechnologist.com |date=21 September 2018 |language=en-GB |access-date=2019-06-13}}</ref>
|Procured
|-
|Botulism
|Botulism therapeutic product
|Procured
|-
|Anthrax
|Nuthrax ([[Emergent BioSolutions|Emergent Biosolutions]])
|Late stage development and procurement (2017)
|-
|Anthrax
|BioThrax (Emergent Biosolutions)
|Stockpiled
|-
|Ebola virus
|Ebola therapeutic and Ebola vaccine 
|Late stage development (2017)
|-
|Nerve agents 
(such as VX)
|Midazolam in an autoinjector (Meridian Medical Technologies)
|Preparing to stockpile (2017)
|-
|Mustard gas
|In process (2017)
|Future development
|-
|Chlorine gas
|In process (2017)
|Future development
|-
|Improvised nuclear device or dirty bomb
|[[Cytokine]] products
|Procured
|-
|Burn injuries
|Silverlon, a metallic silver-based antimicrobial wound dressing (Argentum Medical)
|Stockpiled
|}
Table source:<ref name=":1" />

== Integrated national biodefense medical countermeasures portfolio ==

{{unreferenced section|date=April 2020}}
The Department of Defense (DoD) and HHS each identify medical countermeasure requirements to address their different missions and focus. DoD's focus is on protecting the armed forces prior to exposure, whereas HHS's focus is on response to threats to the civilian population after exposure in a CBRN event.

However, there are areas of common requirements or interest where medical countermeasure candidates, resources and information can be appropriately shared to maximize opportunities for success in the development of medical countermeasures for the highest priority threats. BARDA, in partnership with other HHS and DoD partners, is leading an Integrated National Biodefense Medical Countermeasure Portfolio to leverage resources and programs across the agencies that develop and acquire CBRN medical countermeasures to more effectively address the broad range of common threats and requirements. Members of this Integrated Portfolio include BARDA, biodefense programs in the [[National Institute of Allergy and Infectious Diseases]] (NIAID), which also oversees all biodefense activities across the other Institutes of the [[National Institutes of Health]] (NIH), and multiple elements of the DoD Chemical and Biological Defense Program.

== Controversies ==

On April 20, 2020, during the [[COVID-19 pandemic in the United States]], in an action that led to the filing of a 
[[Whistleblower Protection Act|US whistleblower]]
complaint and testimony before the US House of Representatives,<ref>{{Cite news | website=www.cnn.com | url=https://www.cnn.com/politics/live-news/rick-bright-testimony-05-14-20/index.html | title= "Coronavirus whistleblower Rick Bright testifies" | date=May 14, 2020 | access-date=May 20, 2020}}</ref><ref>{{Cite news | website=www.cnn.com | url=https://www.cnn.com/2020/05/05/politics/rick-bright-full-complaint/index.html | title="Rick Bright's Full Whistleblower Complaint" | date=May 5, 2020 | access-date=May 20, 2020 | archive-date=May 16, 2020 | archive-url=https://web.archive.org/web/20200516085542/https://www.cnn.com/2020/05/05/politics/rick-bright-full-complaint/index.html | url-status=live }}</ref> 
[[Rick Bright]] was asked to step down as Director of BARDA. Bright claimed he had been removed from his post because he had insisted that “the billions of dollars allocated by Congress to address the [[COVID-19]] pandemic” be invested “into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit."<ref name=":5">{{Cite web|url=https://www.cnbc.com/2020/04/22/coronavirus-treatment-vaccine-doctor-says-worry-about-trump-idea-led-to-ouster.html|title=Top vaccine doctor says his concern about Trump's coronavirus treatment theory led to ouster from federal agency|website=CNBC|date=22 April 2020|access-date=2020-04-22|archive-date=2021-02-15|archive-url=https://web.archive.org/web/20210215173920/https://www.cnbc.com/2020/04/22/coronavirus-treatment-vaccine-doctor-says-worry-about-trump-idea-led-to-ouster.html|url-status=live}}</ref> Bright was reassigned to the [[National Institutes of Health]] (NIH). The Assistant Secretary for Preparedness and Response (ASPR) at the time, who was implicated in the complaint, was [[Robert Kadlec]].

On January 27, 2021, the [[United States Office of Special Counsel|U.S. Office of Special Counsel]] transmitted an investigative report to President Biden confirming whistleblower allegations that ASPR “misappropriated millions of dollars that Congress appropriated for [BARDA] to respond to public health emergencies like outbreaks of Ebola, Zika, and—now—COVID-19.”<ref>{{Cite web | website=osc.gov | date=January 27, 2021 | access-date= January 28, 2021 | title="HHS Misused Millions of Dollars Intended for Vaccine Research, Emergency Preparedness" | url=https://osc.gov/News/Pages/21-08-HHS-Misused-Millions-Emergency-Preparedness.aspx}}</ref><ref>{{Cite news | website=www.washingtonpost.com | url=https://www.washingtonpost.com/health/2021/01/27/barda-health-funds-misappropiated/ | title=" Millions earmarked for public health emergencies were used to pay for unrelated projects, inspector general says" | date=January 27, 2021 | access-date=January 28, 2021 | archive-date=January 28, 2021 | archive-url=https://web.archive.org/web/20210128000258/https://www.washingtonpost.com/health/2021/01/27/barda-health-funds-misappropiated/ | url-status=live }}</ref>

The investigation by the [[Office of Inspector General, U.S. Department of Health and Human Services|HHS Office of Inspector General (OIG)]] substantiated whistleblower claims that “ASPR did not always comply with Federal fiscal law when managing BARDA appropriations.”<ref>{{Cite web | website=osc.gov | date=January 27, 2021 | access-date= January 28, 2021 | title="Investigation into the Assistant Secretary for Preparedness and Response for Misuse of Congressional Appropriations, H-18-0-1183-8" | url=https://osc.gov/Documents/Public%20Files/FY21/DI-16-3098/Subject%20Agency%20Report%3b%20DI-16-3098.pdf}}</ref> In his transmittal letter, Special Counsel Henry Kerner wrote the President that he was “deeply concerned about ASPR’s apparent misuse of millions of dollars in funding meant for public health emergencies like the one our country is currently facing with the COVID-19 pandemic. Equally concerning is how widespread and well-known this practice appeared to be for nearly a decade.”

== See also ==
*[[Advanced Research Projects Agency for Health]] (ARPA-H)
* [[Public Health Security and Bioterrorism Preparedness and Response Act]] (H.R.3448, 107th Congress; Public Law 107-188) - original 2002 law revised and extended by PAHPA
* [[Pandemic and All-Hazards Preparedness Act]] (PAHPA) (S.3678, 109th Congress; Public Law 109-417) - 2006 law (PAHPA) authorizing BARDA
* [[Pandemic and All-Hazards Preparedness Reauthorization Act of 2013]] (PAHPRA) (H.R. 307, 113th Congress; Public Law 113-5) - 2013 law reauthorizing BARDA
* [[Pandemic and All-Hazards Preparedness and Advancing Innovation Act]] (PAHPAI Act) (S.1379, 116th Congress; Public Law 116-22) - 2019 law reauthorizing BARDA

== References ==

<references/>

== External links ==
* {{official website| https://www.medicalcountermeasures.gov/}}
* [https://www.medicalcountermeasures.gov/barda/cbrn CBRN, BARDA, Project BioShield Overview]
* [https://www.phe.gov/about/pages/default.aspx Public Health Emergencies (United States) - HHS public health emergency website including information on BARDA]

{{U.S. biological defense}}
{{United States research agencies}}
{{Authority control}}

{{DEFAULTSORT:Biomedical Advanced Research And Development Authority}}
[[Category:Administration for Strategic Preparedness and Response]]
[[Category:Counterterrorism in the United States]]
[[Category:2006 establishments in the United States]]