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Biomedical Advanced Research and Development Authority
Biomedical Advanced Research and Development Authority
Biomedical Advanced Research and Development Authority
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Biomedical Advanced Research and Development Authority
Agency overview
FormedDecember 2006
JurisdictionFederal Government of the United States
HeadquartersHubert H. Humphrey Building, Washington, D.C.
Employees150
Annual budget$1.6 billion USD (2020)
Agency executive
  • Gary Disbrow, Acting Director
Parent agencyOffice of the Assistant Secretary for Preparedness and Response
Websitewww.medicalcountermeasures.gov/barda

The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response[1] (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases.[2]: 140  BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA). The ASPR center manages 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.[2]: 140 

In addition to preparing and maintaining bioterrorism responses and countermeasures, HHS, through 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 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 U.S. federal government and the biomedical industry.[2]: 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.[2]: 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).[3]

History

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Creation and legislative history

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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.[4] 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, 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, 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

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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.[5] 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).[6] 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

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BARDA's 2011–2016 Strategic plan described its composition as the Office of the Director plus seven functional divisions:[7]

  • 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).[8] DRIVe is a business accelerator to fund and support the development of a portfolio of healthcare products.

Roles and purpose

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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 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".[9][7] In this respect, BARDA provides services similar to those offered by venture capitalists or business accelerators in private industry, although BARDA takes no financial stake in the final product once approved by the FDA.[10]

BARDA acts in concert with the PHEMCE. These activities (see below) include:

  • 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

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During public health emergencies, BARDA’s budget may be increased by additional congressional appropriations.

In FY 2020, the annual budget of BARDA was approximately $1.6 billion depending on the precise allocation of costs, including the costs of projects overseen or managed by BARDA on behalf of the ASPR.[11][12][13] The proposed budget in FY 2020, not reflecting any additional congressional appropriations due to the COVID-19 crisis, was an increase from $1.27 billion in FY 2019, and $1.02 billion in FY 2018. This figure included $512 million in medical countermeasures including $192 million for combating antibiotic-resistant bacteria[14] and $260 million USD for advanced research and development (ARD).

Major initiatives

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  • Research and development
    • Medical countermeasures[15]
      • Vaccines
      • Antimicrobial drugs
      • Therapeutic products
      • Diagnostics
      • Non-pharmaceutical medical supplies
  • Stockpiling programs (see below)
  • Manufacturing infrastructure

Setting requirements

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BARDA sets the requirements for medical countermeasures in order to reduce the threats of public health emergencies such as pandemic influenza, 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

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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. [18]

Pandemic influenza

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Pandemic Influenza requirements are defined by strategic objectives established in the "National Strategy for Pandemic Influenza"[19] and the "HHS Pandemic Influenza Plan".[20]

Advanced research and development

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Overview

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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).[21]

Influenza and emerging infectious diseases

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One of BARDA's key activities includes the Influenza and Emerging Infectious Diseases Division.[22] This program aims to support the advanced development of vaccines, therapeutic and diagnostic medical countermeasures that address emerging infectious disease threats.

Nerve agents

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Nerve agents and other chemical weapons are a priority for fighting CBRN threats. VX gas, which was the nerve agent that reportedly killed the half-brother of North Korean 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.[23]

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 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.[24]

Antibiotic resistant bacteria

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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.[25][26][27] In April 2019, Achaogen declared bankrupt.[28]

Stockpile programs

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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:

  1. Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak.
  2. 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

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In FY 2004, the US Congress appropriated $5.6 billion 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.[23] As of January 2020, BARDA had helped obtain FDA approval for at least 50 products.[29][30]

Pandemic influenza stockpile programs

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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 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.[31]

Strategic national stockpile

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The Public Health Security and Bioterrorism Preparedness Act of 2002 directed the Secretary of 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.[32]

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.[33] 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.[34]

Emergent BioSolutions manufactures the only FDA licensed vaccine against anthrax disease, called BioThrax, which is recommended by the CDC as a post-exposure prophylactic for anthrax infection.[35]

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.[v] Canada also approved BAT.[36]

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. [23]

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).[23]

Manufacturing and building infrastructure

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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. [37] [38]

Advancing innovation

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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. 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.[39] 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 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.”[40] 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.[40]

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.”[41] 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.[41]

In 2017, BARDA signed a three-year $8.1 million contract with InBios International, Inc. of Seattle, Washington to develop a “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.”[42]

In September 2017, BARDA awarded Velico Medical $15.5 million for development of a technology that uses spray drying of human plasma for transfusions. The current industry standard is to freeze plasma. Frozen plasma can take 40 or more minutes to defrost and deliver.[43] 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 rooms, operating suites and intensive care units--as well as in a military or field hospital setting.”[44]

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").[45][46]

Pandemic and emerging disease responses

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Anthrax

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Since the 2001 anthrax attacks in the United States, BARDA has supported the research and development [47] of diagnostics, therapeutics and vaccines for anthrax. Therapeutics include the antibiotics XERAVA Of Tetraphase Pharmaceuticals, ZEMDRI of Achaogen (rights ex-Greater China bought by Cipla USA) Gepotidacin of GlaxoSmithKline and SPR994 of Spero Therapeutics. In July 2018, Spero was jointly awarded [48] 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 multi-drug resistant (MDR) bacteria.

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

Botulism

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Botulism is caused by the botulinum toxin, one of the deadliest known toxins. While the bacteria that cause botulism [49] [50] occur naturally, botulism outbreaks are considered rare and unlikely by the US CDC, except as the result of a bioterrorism attack. BARDA maintains a supply of botulism antitoxins through the Strategic National Stockpile (SNS).

COVID-19

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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, Vaxart, and Inovio.[51][52] 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.[51]

In June 2020, BARDA and the 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.[53]

Ebola

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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, ERVEBO, by BioProtection Systems, a subsidiary of NewLink Genetics Inc. (now Lumos Pharma). The vaccine was announced [54] by the ASPR on December 19, 2019; ERVEBO ,[55] a vaccine for the Zaire ebola virus was licensed from NewLink Genetics in 2014 and produced and taken to market by Merck. It was successfully used in the 2018 Ebola virus epidemic in the Democratic Republic of the Congo (DRC).

Influenza

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Smallpox

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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 [56] [57] 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. [58] [59] By 2018, BARDA had procured millions of doses of TPOXX, of SIGA Technologies, by then the first (and only) FDA-approved [60] antiviral smallpox drug therapy, for the SNS. [61] In 2019, BARDA announced a partnership with BioFactura to develop a second therapeutic, a monoclonal antibody smallpox treatment. [62]

Zika

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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 [63]

  • Prevention (vaccines)
  • Detection (diagnostics)
  • Ensuring a safe blood supply (screening)
  • National Countermeasure Response Activation (developer assistance)

Medical countermeasure portfolio

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Threat Product Development Stage
Smallpox TPOXX (SIGA Technologies)[64] Procured
Botulism Botulism therapeutic product Procured
Anthrax Nuthrax (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:[23]

Integrated national biodefense medical countermeasures portfolio

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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

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On April 20, 2020, during the COVID-19 pandemic in the United States, in an action that led to the filing of a US whistleblower complaint and testimony before the US House of Representatives,[65][66] 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."[67] 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 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.”[68][69]

The investigation by the HHS Office of Inspector General (OIG) substantiated whistleblower claims that “ASPR did not always comply with Federal fiscal law when managing BARDA appropriations.”[70] 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

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References

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Revisions and contributorsEdit on WikipediaRead on Wikipedia

Biomedical Advanced Research and Development Authority

View on Grokipedia
from Grokipedia
The Biomedical Advanced Research and Development Authority (BARDA) is a division of the U.S. Department of Health and Human Services' Administration for Strategic and Response, established in 2006 to accelerate the , development, and procurement of medical countermeasures against chemical, biological, radiological, nuclear threats, pandemic , and emerging infectious diseases. BARDA operates through public-private partnerships, providing grants, contracts, and technical assistance to industry to advance vaccines, therapeutics, diagnostics, and other products from late-stage to regulatory approval and stockpiling, thereby addressing gaps in private-sector incentives for high-risk projects. Key achievements include supporting the development of over 60 FDA-approved or cleared medical countermeasures, such as the mRNA through , which demonstrated BARDA's capacity for rapid scaling of manufacturing and procurement during national . The agency has faced scrutiny for financial mismanagement, including a 2021 investigation revealing the diversion of at least $10 million in congressionally appropriated funds for and to unrelated expenditures like office renovations and subscriptions. Further controversies arose from whistleblower claims by former BARDA director , who alleged political interference in contracting decisions and retaliation for opposing the expedited promotion of unproven treatments like amid the , highlighting tensions between scientific rigor and administrative pressures.

History

Establishment and Initial Mandate

The Biomedical Advanced Research and Development Authority (BARDA) was established by Title IV of the Pandemic and All-Hazards Preparedness Act (PAHPA), which was signed into law by President George W. Bush on December 19, 2006. This legislation created BARDA as a component of the Department of Health and Human Services (HHS) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), aiming to address gaps in the advanced development and procurement of medical countermeasures following the and broader concerns over vulnerabilities. PAHPA authorized BARDA to leverage public-private partnerships, providing flexible funding mechanisms such as advance market commitments and milestone-based payments to incentivize industry investment in high-risk projects that traditional markets might overlook. BARDA's initial mandate focused on accelerating the transition of promising technologies from late-stage into deployable products, specifically targeting s against chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. This included supporting the development of vaccines, therapeutics, diagnostics, and platforms for rapid response, with an emphasis on bridging the "valley of death" between basic funded by entities like the and full-scale manufacturing. Unlike earlier efforts limited to , BARDA was empowered to fund advanced directly, incorporating risk-sharing models to mitigate the financial uncertainties inherent in . Complementing the 2004 Project BioShield Act, which had established a special reserve fund for purchasing approved countermeasures but lacked robust development authorities, BARDA assumed oversight of BioShield procurements while expanding into proactive R&D. Initial appropriations under PAHPA included $415 million for BARDA's advanced development activities and access to BioShield's $5.6 billion over 10 years, enabling early investments in products like next-generation vaccines and broad-spectrum antimicrobials. This structure prioritized needs over commercial profitability, reflecting a causal recognition that market failures in low-volume, high-stakes products necessitated government intervention.

Legislative Expansions and Reauthorizations

The Biomedical Advanced Research and Development Authority (BARDA) received its first significant legislative reauthorization and expansion through the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (P.L. 113-5), signed into law on March 13, 2013. This act extended BARDA's core authorities under Section 319L of the for five years, through fiscal year 2017, and authorized $2.8 billion in procurement funding via Project BioShield for medical countermeasures against chemical, biological, radiological, and nuclear threats. It also expanded BARDA's flexible procurement tools by authorizing the use of other transaction authorities (OTAs) for rapid development and acquisition of countermeasures, bypassing traditional federal contracting constraints to accelerate public-private partnerships. Subsequent expansions occurred via the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA; P.L. 116-22), enacted on June 24, 2019. This legislation reauthorized BARDA's programs through fiscal year 2023 and broadened its mandate to prioritize platform technologies for scalable manufacturing, broad-spectrum antimicrobials, and diagnostics for s. PAHPAIA enhanced BARDA's OTA authorities by increasing flexibility for advanced contracts up to $1.25 billion over five years and required the development of a five-year strategic plan integrating with emerging infectious disease threats. It also established new incentives, such as extended exclusivity periods for certain countermeasures and expanded BARDA's role in sustaining domestic manufacturing capacity post-development. BARDA's authorities have been further supported by supplemental legislation, including the (P.L. 114-255, December 13, 2016), which introduced priority review vouchers transferable for MCM development, indirectly bolstering BARDA-funded projects by incentivizing private investment in late-stage countermeasures. During the response, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136, March 27, 2020) provided BARDA with $3.2 billion in emergency funding for vaccines and therapeutics but did not alter core statutory authorities. As of September 2023, many PAHPA provisions, including BARDA's, expired but have been temporarily extended through continuing resolutions, with the latest extension running until September 30, 2025, amid ongoing congressional efforts for a multi-year reauthorization incorporating lessons from recent pandemics.

Key Organizational Milestones

The Biomedical Advanced Research and Development Authority (BARDA) was established on December 19, 2006, through enactment of the Pandemic and All-Hazards Preparedness Act (PAHPA; P.L. 109-417), which directed the Department of Health and Human Services to accelerate advanced research, development, procurement, and stockpiling of medical countermeasures against chemical, biological, radiological, nuclear threats, and emerging infectious diseases. This legislation integrated BARDA into the Office of the Assistant Secretary for Preparedness and Response, building on the 2004 Project BioShield Act by addressing gaps in late-stage development and flexible procurement authorities. PAHPA's first reauthorization in 2013 via the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA; P.L. 113-5) expanded BARDA's operational toolkit, including broader use of "other transaction authority" for rapid contracting outside traditional federal acquisition rules, authority to enter advance market commitments, and enhanced coordination with the . These changes, prompted by events like the 2009 H1N1 influenza pandemic, enabled BARDA to fund more agile public-private partnerships for countermeasures. The 2019 reauthorization under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) further broadened BARDA's scope by authorizing international research collaborations, sustainable manufacturing incentives, and dedicated funding streams for platform technologies applicable to multiple threats. This built on prior expansions to emphasize innovation in diagnostics, therapeutics, and vaccines amid rising and risks. In 2021, BARDA launched of Research, Innovation, and Ventures (DRIVe) to prioritize disruptive technologies, such as rapid diagnostics and next-generation manufacturing, complementing its core advanced development focus. By fiscal year 2022, BARDA had supported FDA approval or clearance of over 100 medical countermeasures, reflecting scaled operations under successive PAHPA frameworks.

Organizational Structure and Leadership

Internal Divisions and Programs

The Biomedical Advanced Research and Development Authority (BARDA) organizes its operations through specialized divisions that oversee the advanced development of medical countermeasures for threats, including chemical, biological, radiological, nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases. These divisions coordinate preclinical and , regulatory affairs, and innovative ventures to bridge gaps between early-stage research and procurement for the . The Division of Research, Innovation, and Ventures (DRIVe), established in , employs entrepreneurial strategies to accelerate breakthrough technologies against health threats, utilizing networks of accelerators and venture funding mechanisms such as BARDA Ventures. DRIVe supports programs like Type to Treat, which develops tools for patient stratification to optimize therapeutic efficacy, and IMMUNECHIP+, aimed at advancing 3D human tissue models for improved drug testing. Additional DRIVe initiatives include efforts in rapid pandemic response platforms and agnostic diagnostics to enable flexible countermeasures for novel pathogens. The and Emerging Infectious Diseases (IEID) Division focuses on , therapeutics, and diagnostics for and priority pathogens, managing portfolios that address threats like strains and coronaviruses through partnerships and funding awards. Complementing this, the Clinical Development Division and Non-Clinical Development Division handle late-stage product advancement, including human trials and animal model studies to generate data for regulatory approval. The Division of Regulatory and Quality Affairs (RQA) provides expertise in navigating (FDA) requirements, ensuring compliance with good manufacturing practices and supporting emergency use authorizations during crises. BARDA also maintains cross-cutting programs through strategic partnerships, such as CARB-X for antibiotic resistance countermeasures and the Blue Knight program for early-stage venture scouting, which integrate external innovation into divisional workflows. These structures enable BARDA to allocate resources across threat-specific pipelines while prioritizing scalable, sustainable solutions.

Leadership Transitions and Influences

The Biomedical Advanced Research and Development Authority (BARDA) saw its first permanent director appointed in April 2008, when Robin A. Robinson, Ph.D., previously the deputy director of BARDA's and Emerging Diseases Program, was named to lead the agency. Robinson served in this role until November 14, 2016, overseeing early expansions in biodefense countermeasures, including support for vaccines and therapeutics against chemical, biological, radiological, and nuclear threats, as well as preparedness. Rick Bright, Ph.D., succeeded Robinson on November 15, 2016, after serving internally at BARDA since 2010 as director of its Influenza and Emerging Infectious Diseases Division. Bright's tenure emphasized accelerating development of medical countermeasures for pandemics and emerging threats, but it ended abruptly on April 20, 2020, amid the COVID-19 response. Gary L. Disbrow, Ph.D., Bright's former deputy, assumed acting directorship immediately following Bright's departure and was later confirmed as permanent director and Deputy Assistant Secretary for BARDA within the Administration for Strategic Preparedness and Response (ASPR). Disbrow, who held the position as of September 2025, led BARDA's massive investments in vaccines, therapeutics, and diagnostics, including partnerships that supported over $10 billion in funding for platforms like mRNA technology. Bright's removal drew significant scrutiny, with Bright filing a whistleblower complaint alleging retaliation for resisting political pressure from HHS leadership to prioritize unproven treatments like for , despite limited evidence of efficacy and potential safety risks. He claimed directives from HHS Secretary and others sought to override scientific assessments, leading to his reassignment to a less influential role. The complaint settled in August 2021 without admission of wrongdoing by HHS, but it highlighted tensions between BARDA's mandate for evidence-based countermeasures and executive branch influences during emergencies. Senate Democrats expressed concerns that such changes could reflect undue political interference in agency operations. Leadership shifts have been shaped by broader administrative priorities, with transitions often aligning with changes in HHS secretaries and national security focuses—such as post-2006 biodefense emphasis under Robinson, pandemic acceleration under Bright and Disbrow, and sustained countermeasure procurement amid evolving threats. No further director changes occurred through 2025, reflecting stability under Disbrow despite ongoing debates over BARDA's independence from political directives.

Mission and Strategic Objectives

The Biomedical Advanced Research and Development Authority (BARDA) was established within the Department of Health and Human Services by section 319L of the Public Health Service Act (42 U.S.C. § 247d-7e), as added by the Pandemic and All-Hazards Preparedness Act (Public Law 109-417), signed into law on December 19, 2006. This foundational legislation mandates BARDA to accelerate the research, development, production, and procurement of medical countermeasures—such as vaccines, therapeutics, diagnostics, and devices—targeted at chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases and pandemic influenza. BARDA's core functions, as outlined in subsection (c)(2) of the , include coordinating advanced activities across federal agencies, entities, and academic institutions to reduce development timelines and mitigate risks for countermeasures that lack sufficient commercial incentives. The authority emphasizes an integrated, systematic approach to building and sustaining domestic manufacturing surge capacity for these products, ensuring availability during emergencies. Activities are guided by a five-year strategic plan, updated biennially, which prioritizes threats based on assessments of risks and needs. Key authorities enabling these mandates include the power to enter into contracts, grants, cooperative agreements, and other transactions on a broad basis of , bypassing certain standard federal restrictions to facilitate rapid and partnerships. BARDA is also authorized to expedite hiring of up to 100 personnel or 50% of its workforce without standard procedures during emergencies, and it manages the Biodefense Medical Countermeasure Development Fund, appropriated at $611.7 million annually from fiscal years 2019 through 2023 to support these efforts. These provisions underscore a focus on bridging the "valley of death" between and licensed products, particularly for threats unlikely to attract private investment absent government intervention.

Prioritization of Threats and Countermeasures

The prioritization of threats and countermeasures by the Biomedical Advanced Research and Development Authority (BARDA) occurs within the broader Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) framework, which integrates assessments from the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS). DHS conducts Material Threat Determinations (MTDs) for chemical, biological, radiological, and nuclear (CBRN) agents deemed capable of posing a severe threat to national security through weaponization, evaluating factors such as likelihood of use, potential impact on civilian populations, and feasibility of delivery. HHS then combines these threat characterizations with medical and public health consequence assessments—considering morbidity, mortality, transmission dynamics, and gaps in existing countermeasures—to establish requirements for medical countermeasures (MCMs). This process ensures focus on agents with catastrophic potential, such as anthrax, smallpox, botulinum toxin, and radiological dispersal devices. PHEMCE employs a risk-based prioritization framework with three primary criteria and three moderating factors to allocate resources efficiently amid finite budgets. Primary criteria include the severity of the threat (prioritizing high-consequence CBRN and emerging natural threats like pandemic ), multi-functionality of MCMs (favoring broad-spectrum products usable against multiple agents or in routine care), and operational capacity (emphasizing ease of storage, distribution, and administration under emergency conditions). Moderating criteria adjust for at-risk populations (e.g., , elderly, immunocompromised), time to product availability (balancing rapid-response needs with sustained development), and lifecycle costs (encompassing , , , and ). This framework guides BARDA's investments in advanced development, via Project BioShield, and sustainment of the . BARDA's 2022–2026 Strategic Plan reinforces these priorities by emphasizing CBRN threats alongside pandemic and emerging infectious diseases (EIDs), incorporating threat-agnostic platforms for rapid adaptation to novel like "." Key focus areas include next-generation vaccines, therapeutics, and diagnostics for pandemics, antimicrobial-resistant bacteria, and high-priority biological agents, with investments in manufacturing surge capacity to enable scalable responses. For EIDs, BARDA utilizes a dedicated threat assessment tool to evaluate risks alongside portfolio gaps, facilitating decisions on platform technologies over agent-specific products when broader utility exists. Unpredictable for non-CBRN threats, such as certain EIDs, has historically constrained partnerships, prompting calls for stable appropriations to address natural outbreaks alongside deliberate attacks.

Funding and Resource Allocation

BARDA's funding originates from congressional appropriations directed to the U.S. Department of Health and Human Services (HHS), primarily through the Administration for Strategic Preparedness and Response (ASPR), which oversees the agency as its principal component for medical countermeasures development. These appropriations support base activities in , advanced development, and procurement, with allocations specified in annual Labor-HHS-Education spending bills. Additional dedicated comes from the Project BioShield program, authorized under the Project BioShield Act of 2004, which maintains a special reserve for acquiring approved countermeasures against chemical, biological, radiological, and nuclear threats, with appropriations drawn from general revenues and managed separately from BARDA's core budget. Base appropriations for BARDA's innovation and development programs have exhibited a modest upward trend in recent fiscal years, reflecting legislative priorities for and preparedness amid reauthorizations of the Pandemic and All-Hazards Preparedness Act. In 2023, funding stood at approximately $935 million, rising to $1 billion in 2024—an increase of $65 million—to bolster countermeasures against emerging threats. For 2026, the Alliance for Biosecurity recommended $1.4 billion for BARDA's core account, alongside $1 billion for Project BioShield procurement and $410 million for pandemic influenza initiatives, underscoring ongoing advocacy for expanded baseline capacity. Current annual spending execution approximates $1.7 billion, encompassing contracts and grants for ongoing programs. Supplemental appropriations during public health emergencies represent a significant but episodic funding stream, often dwarfing base levels. For instance, the response under acts like the and American Rescue Plan provided BARDA with billions in additional resources—totaling over $10 billion in awards by mid-2021 for , therapeutics, and diagnostics—enabling rapid scaling but highlighting reliance on crisis-driven boosts rather than sustained peacetime . The Emergency Medical Countermeasures Enterprise (PHEMCE) multiyear budgets project aggregate needs exceeding $70 billion from 2023 to 2027 across ASPR programs, including BARDA, with identified shortfalls emphasizing that annual appropriations cover only a fraction of long-term requirements for stockpiling and . This structure prioritizes flexible response capabilities but has drawn criticism for underfunding proactive R&D relative to reactive surges.

Procurement Models and Financial Incentives

BARDA employs flexible procurement models tailored to the rapid development and acquisition of medical countermeasures, prioritizing speed over rigid federal acquisition rules. The cornerstone is its Other Transaction Authority (OTA), codified in 42 U.S.C. § 247d-7e, which permits agreements for research, prototyping, and production that deviate from the (FAR) to engage innovative or non-traditional partners. This authority, initially granted under the Project BioShield Act of 2004 and broadened by acts like the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, supports vehicles such as the Rapid Response Partnership Vehicle (RRPV) consortium, launched to streamline awards for pandemic preparedness technologies. OTAs facilitate milestone-based funding and arrangements that encourage private-sector participation in high-risk areas like chemical, biological, radiological, and nuclear (CBRN) threats. BARDA supplements OTAs with traditional instruments, including cost-reimbursement contracts, grants, and cooperative agreements, primarily solicited through competitive Broad Agency Announcements (BAAs). The EZ-BAA process, outlined in BARDA's 2022–2026 Strategic Plan, enables quick initial awards—often within months—for proof-of-concept work, with provisions for rapid scaling to larger production contracts upon success. Under Project BioShield, BARDA executes contracts to acquire countermeasures for the , authorizing purchases of unapproved products with up to 10-year shelf lives if deemed necessary for national security. Financial incentives focus on mitigating market failures where private investment lags due to limited commercial returns. Push incentives involve direct of development costs, with BARDA often covering 100% in early, high-risk phases via cost-reimbursement mechanisms; cost-sharing is encouraged but not required under BAAs to align incentives without deterring applicants. Cost-plus-incentive-fee (CPIF) contracts tie payments to performance metrics, such as regulatory milestones, providing bonuses for efficiency and on-time delivery. Pull incentives derive from guaranteed procurement under BioShield, where BARDA commits to buying specified volumes—e.g., multi-year contracts for vaccines or therapeutics—creating assured revenue streams backed by the program's Special Reserve Fund. This model de-risks late-stage investment by simulating market demand, as evidenced in BARDA's acquisition of countermeasures despite negligible civilian use. OTA terms further enhance incentives by allowing flexible cost-sharing ratios, often escalating private contributions in advanced development to promote fiscal responsibility. These structures collectively bridge the "valley of death" between research and commercialization, though their efficacy depends on precise threat prioritization to avoid inefficient allocation.

Research and Development Initiatives

Biodefense and CBRN Focus Areas

The Biomedical Advanced Research and Development Authority (BARDA) prioritizes the development and of medical countermeasures (MCMs) to mitigate threats from chemical, biological, radiological, and nuclear (CBRN) agents, with efforts centering on biological agents that could be weaponized, such as Category A priority pathogens. BARDA's Division of CBRN Medical Countermeasures oversees these initiatives, aiming to ensure at least one FDA-approved or cleared MCM for each identified CBRN threat through public-private partnerships, advanced research, and late-stage clinical development. This focus addresses potential mass-casualty scenarios from or accidental releases, integrating with broader objectives under the Project BioShield Act of 2004, which provides BARDA with authority for procurement guarantees and emergency use authorizations. In biodefense, BARDA supports vaccines, antivirals, and targeting high-consequence biological threats like (), (Variola major), and . For , BARDA has procured millions of doses of (anthrax vaccine adsorbed) and funded next-generation candidates, including contracts awarded to in September 2025 for additional stockpiling. countermeasures include the ACAM2000 vaccine and investigational therapeutics like (Tpoxx), with BARDA facilitating procurement of 1.7 million doses of ACAM2000 by 2010 and ongoing support for . Against , BARDA acquired 107,560 doses of heptavalent by 2012 under Project BioShield, expanding to full 200,000-dose contracts for rapid deployment in exposure events. These programs emphasize broad-spectrum antivirals and monoclonal antibodies to counter engineered or naturally occurring variants, with BARDA funding late-stage trials for antivirals like . For chemical threats, BARDA invests in MCMs against nerve agents (e.g., , VX), vesicants (e.g., ), and blood agents (e.g., ), including atropine auto-injectors, reactivators, and novel bioscavengers to neutralize organophosphates before symptoms manifest. Radiological and nuclear countermeasures target (ARS) and combined injury, with BARDA procuring granulocyte colony-stimulating factors like (Neupogen) for recovery—stockpiling over 4 million doses by 2016—and advancing decorporation agents like Ca-DTPA for internal contamination. Burn and blast injury MCMs address secondary effects from nuclear detonations, supporting dermal regeneration therapies and fluid resuscitation devices. BioShield funding, totaling over $5.6 billion since 2004, has enabled these acquisitions, though critics note uneven coverage across threat categories, with biological agents receiving disproportionate emphasis due to historical precedents like the .

Pandemic and Emerging Infectious Disease Programs

The Biomedical Advanced Research and Development Authority (BARDA) maintains dedicated programs to develop medical countermeasures (MCMs) against influenza and (EIDs), emphasizing platform technologies for rapid , therapeutic, and diagnostic production to bridge gaps between and deployment. These efforts align with the U.S. Department of Health and Human Services (HHS) Influenza Plan and National Influenza Modernization Strategy, focusing on end-to-end including detection, treatment, prevention, and domestic surge capacity. BARDA has invested in recombinant platforms, adjuvants to expand supply, novel antivirals, and diagnostics since at least , with over $2 billion allocated to biopharmaceutical infrastructure to support production scalability. In pandemic influenza initiatives, BARDA prioritizes faster production technologies, such as RNA-based systems including mRNA and self-amplifying mRNA, alongside alternative delivery methods like intranasal formulations, patches, and oral vaccines to improve accessibility across age groups. Efforts include modernizing potency assays and reducing sterility testing timelines from 14 to 7 days to accelerate regulatory approval by the (FDA), while stockpiling antigens and adjuvants for surge response. These programs have yielded FDA-licensed countermeasures, including vaccines with enhanced efficacy against seasonal and potential strains, and supported U.S.-based manufacturing to mitigate vulnerabilities. For broader EIDs, BARDA employs flexible funding mechanisms and partnerships with industry to address threats like , Zika, and novel pathogens, funding platform technologies for quick pivots—such as the February 2020 shift to countermeasures. Key achievements include support for the sole FDA-licensed (Ervebo, approved 2019), approved therapeutics like and monoclonal antibodies, and the only FDA-cleared point-of-care Zika diagnostic in 2016. The 2022–2026 Strategic Plan introduces expanded efforts for EID threat assessment tools and proven technologies, prioritizing sustainable production and delivery innovations to counter unpredictable outbreaks without relying on ad-hoc emergency funding. These programs integrate with broader by fostering domestic capacity and regulatory efficiencies, though outcomes depend on validated platform performance in real-world threats.

Innovation Acceleration Efforts

The Biomedical Advanced Research and Development Authority (BARDA) established the Division of Research, Innovation, and Ventures (DRIVe) in to accelerate the development of transformative medical countermeasures for health security threats, focusing on high-risk, high-reward technologies that traditional funding mechanisms often overlook. DRIVe emphasizes , iterative development, and public-private partnerships to bridge gaps between early-stage and advanced product candidates, targeting areas such as novel manufacturing platforms, diagnostics, and therapeutics for chemical, biological, radiological, nuclear, and threats. A core component of DRIVe's efforts is the BARDA Accelerator Network (BAN), launched in 2018, which connects BARDA with regional accelerators to scout, nurture, and advance early-stage innovations in , life sciences, and medical devices. By 2024, the network had expanded to include thirteen accelerators across the , fostering a pipeline of health security products through , funding access, and technical assistance, with an emphasis on underserved regions and underrepresented innovators. The initial BAN phase concluded in 2024, transitioning to next-generation hubs, including the Vaccine Innovation and Therapeutic Acceleration Launchpad (VITAL) Hub led by Start2 Group, announced on May 7, 2024, to expedite and therapeutic prototypes against threats. BARDA has also deployed challenge-based programs to spur innovation, such as the Blue Knight QuickFire Challenge under Project NextGen, launched in 2023 to identify rapid diagnostic and manufacturing solutions for respiratory viruses, awarding contracts to multiple developers including Innovation partners on August 24, 2023. Complementary initiatives include the Rapid Response Partnership Vehicle (RRPV), which streamlines procurement for advanced development of countermeasures, and specialized accelerators like the pediatric medical countermeasures program funded in October 2024 to address age-specific gaps in tools. Additionally, BARDA Ventures and partnerships with entities like CARB-X provide seed funding and de-risking for antibiotic and innovations, as outlined in BARDA's 2022–2026 Strategic Plan. These efforts prioritize scalable platforms over single-use products, with DRIVe allocating resources to modular technologies that can adapt to multiple threats, evidenced by investments exceeding $1 billion in innovative R&D by 2023. While effective in populating BARDA's pipeline—such as advancing tools through the MATTER-led accelerator selected in September 2024—critics note potential overlaps with broader HHS programs and calls for enhanced metrics on commercialization success to ensure taxpayer returns.

Medical Countermeasures Portfolio

Vaccine and Therapeutic Development

The Biomedical Advanced Research and Development Authority (BARDA) supports the advancement of vaccines and therapeutics as critical medical countermeasures against public health threats, including chemical, biological, radiological, nuclear (CBRN) agents and emerging infectious diseases, through funding, technical assistance, and partnerships with industry and academia. This includes bridging gaps in late-stage development where private sector investment is often insufficient due to market risks, focusing on products that can be rapidly scaled for emergencies. BARDA's efforts emphasize platform technologies for accelerated manufacturing and deployment, such as those under the Division of Research, Innovation, and Ventures (DRIVe) initiative launched to enable countermeasures within months of threat identification. In vaccine development, BARDA prioritizes next-generation platforms for and emerging pathogens, aiming for universal or rapidly adaptable with robust domestic production capacity. Notable successes include BARDA's funding contributions to the licensure of Ervebo, the only FDA-approved vaccine, with ongoing support for label expansion to broader age groups and filovirus as of 2023-2027 strategic plans. BARDA also awarded a $10 million in 2019 to Vaccines LLC for early-stage Marburg virus vaccine development, targeting prototype pathogens for fast-response capabilities. For , BARDA committed billions through , funding mRNA and other platforms that led to emergency use authorizations, though post-pandemic evaluations prompted shifts. In August 2025, HHS terminated 22 BARDA-funded mRNA vaccine projects totaling approximately $500 million, citing clinical data demonstrating inadequate against upper respiratory infections from diverse coronaviruses, halting new mRNA initiatives to redirect resources toward more effective alternatives. BARDA's therapeutic development focuses on antivirals, monoclonal antibodies, and broad-spectrum agents for threats like pandemic influenza, acute respiratory distress syndrome (ARDS), and bacterial agents such as anthrax. Programs target small-molecule antivirals and nucleic acid therapies compatible with rapid platform adaptation, as outlined in target product profiles specifying efficacy metrics like survival rates and administration timelines. Examples include support for Ebola therapeutics like remdesivir, which advanced through BARDA partnerships and demonstrated efficacy in clinical trials, contributing to outbreak responses. BARDA also funds antibacterial and antifungal therapeutics for sepsis and resistant infections, integrating them into the Strategic National Stockpile for immediate deployment. These efforts incorporate lessons from prior emergencies, emphasizing empirical validation of efficacy in human challenge models or Phase 2 trials to ensure regulatory pathways under emergency use authorities.

Diagnostics, Devices, and Platform Technologies

The (BARDA) supports the advancement of diagnostics, medical devices, and platform technologies as critical components of medical countermeasures against chemical, biological, radiological, (CBRN), and emerging infectious disease threats. Through its Detection, Diagnostics, and Devices Infrastructure (DDDI) Division, BARDA funds projects aimed at developing rapid, scalable testing solutions and supportive devices to enable early detection and response in public health emergencies. These efforts prioritize technologies that address gaps in biothreat identification, such as multiplex assays for multiple pathogens, and extend to point-of-care and at-home systems for decentralized use. In diagnostics, BARDA has invested in molecular and platforms for biothreat agents, including a $27 million allocation announced on November 27, 2024, to accelerate development and manufacturing of tests targeting priority biologic threats like and . Notable examples include BARDA-backed support for the T2Biothreat Panel by T2 Biosystems, a fully automated, direct-from-blood test detecting six biothreat pathogens, which received FDA 510(k) clearance on September 19, 2023. Similarly, in July 2025, BARDA awarded Medical Systems $9 million to develop the Metrix Filovirus Panel, a rapid molecular diagnostic for ebolaviruses and viruses. BARDA's Division of Research, Innovation, and Ventures (DRIVe) further drives early-stage diagnostic innovation, including the Lab At Home program for at-home biochemical marker detection and the September 2025 ReadyDetect competition offering $10 million for low-cost, decentralized pathogen diagnostics. Programs like DxR2 Rapid Prototype Partnership focus on scalable biothreat diagnostics for six key agents, emphasizing just-in-time manufacturing over stockpiling. For medical devices, BARDA targets countermeasures such as ventilatory support systems and enhancements, integrated with diagnostic workflows for emergency deployment. In May 2024, BARDA launched an accelerator network hub dedicated to diagnostics and medical devices, fostering startups to prototype devices for health security threats. Initiatives like I-CREATE provide up to $200,000 in milestone-based funding for innovative devices bridging to . Platform technologies under BARDA's purview emphasize reusable, adaptable systems for broad-spectrum threat response, including multiplex PCR and amplification platforms for simultaneous detection. DRIVe supports disruptive platforms like TrueDx for rapid biothreat manufacturing scalability. BARDA's portfolio invests in diagnostic platforms to expedite responses, such as home-use molecular tests initiated in 2018 for lab-quality results outside clinical settings. These platforms aim to reduce development timelines and enhance surge capacity, with funding mechanisms like BARDA Ventures channeling resources to high-potential technologies.

Stockpile and Preparedness Programs

Integration with Strategic National Stockpile

The Biomedical Advanced Research and Development Authority (BARDA) integrates its portfolio of medical countermeasures (MCM) with the (SNS) primarily through advanced development, , and sustainment activities that ensure rapid deployment of drugs, vaccines, diagnostics, and other supplies during emergencies. BARDA, operating under the Assistant Secretary for Preparedness and Response (ASPR), leads these efforts by funding late-stage research and acquisition, particularly for chemical, biological, radiological, and nuclear (CBRN) threats, with products transitioning into SNS storage managed by the Centers for Disease Control and Prevention (CDC). This integration supports the SNS's mandate to maintain a 12-hour push capability for delivery to any U.S. jurisdiction upon request. A core mechanism is Project BioShield, established by the Project BioShield Act of 2004, which authorizes BARDA to procure MCM using a special $5.6 billion reserve fund (as of 2023) for threats lacking commercial viability, even prior to full FDA approval via (EUA) provisions. Under this program, BARDA collaborates with industry partners to advance candidates through clinical trials and manufacturing scale-up, followed by bulk procurement for SNS inclusion once efficacy and safety thresholds are met. BARDA must brief the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Executive Committee and Senior Council prior to acquisitions, ensuring alignment with national threat assessments. As of 2023, Project BioShield has facilitated the addition of 15 products to the SNS, including antivirals, antibiotics, and radioprotectants, with 10 achieving full FDA licensure. For pandemic preparedness, BARDA's programs exemplify integration by supporting the development and stockpiling of pre-pandemic and therapeutics, such as H5N1 countermeasures, which are procured in sufficient quantities (e.g., millions of doses) for SNS rotation and shelf-life management. BARDA employs contracts with performance milestones to incentivize manufacturers for surge capacity, ensuring SNS holdings can expand from baseline levels during outbreaks. Recent plans outline transitioning 13 additional MCM candidates from Project BioShield into SNS by 2027, focusing on emerging threats like antitoxins and therapies. This process includes establishing deployment strategies with interagency partners, such as the Department of Defense and FDA, to optimize usability and distribution. Sustainment challenges arise from product expiration and evolving threats, prompting BARDA to implement warm-base manufacturing contracts that maintain production readiness without full-scale operations. For instance, BARDA has procured and rotated anthrax vaccines like BioThrax (anthrax vaccine adsorbed), ensuring over 10 million doses remain viable in SNS as of 2022. Integration also extends to non-CBRN areas, such as therapeutics post-2020, where BARDA-funded products like monoclonal antibodies were rapidly assessed for SNS incorporation under EUA. Overall, this framework has enabled SNS to hold BARDA-procured assets valued in billions, though audits highlight needs for better requirements definition to avoid waste from unrotated stock.

Specific Threat-Oriented Stockpiling

The Biomedical Advanced Research and Development Authority (BARDA) conducts specific threat-oriented stockpiling by procuring targeted medical countermeasures (MCMs) for defined chemical, biological, radiological, and nuclear (CBRN) threats, primarily through the Project BioShield program established under the 2004 Project BioShield Act. This approach prioritizes agents identified as high-priority risks by the Department of Homeland Security, such as Category A pathogens including (), (Variola major), plague (), ( toxin), (), and viral hemorrhagic fevers like . BARDA funds late-stage development and guaranteed procurement of FDA-approved MCMs lacking commercial viability, ensuring their availability in the (SNS) for rapid deployment in the event of an attack or outbreak. By fiscal year 2019, Project BioShield had supported 27 projects, resulting in 15 MCMs added to the SNS, with ongoing transitions of 13 additional candidates planned through fiscal year 2027. For biological threats, BARDA has stockpiled anthrax countermeasures including the BioThrax vaccine (anthrax vaccine adsorbed) and antibiotics such as ciprofloxacin, sufficient to treat up to 10 million people in a mass exposure scenario, reflecting historical emphasis on this agent due to its weaponization potential. Smallpox stockpiles include the ACAM2000 and JYNNEOS vaccines, alongside therapeutics like tecovirimat (TPOXX), with BARDA procuring doses to cover the U.S. population and transitioning additional smallpox products to SNS by fiscal year 2025 at a cost of $1.56 billion. Other examples encompass botulinum antitoxin for botulism and ERVEBO vaccine for Ebola, with $3.24 billion allocated for Ebola therapeutic transitions by fiscal year 2027. Recent solicitations, such as a July 2025 request for proposals under Project BioShield, target antibiotics effective against biothreat pathogens including anthrax and plague, aiming to replenish and expand stocks against antimicrobial-resistant strains. Radiological and nuclear threats receive focused attention through countermeasures like for cesium/radiocesium decontamination and for , with BARDA supporting procurement for treatment. Chemical threat stockpiling includes atropine auto-injectors and for exposure under the Chemical MCM program. These efforts address gaps where commercial markets are insufficient, with SNS allocations historically concentrating most resources on and between fiscal years 2015 and 2021. BARDA's strategy integrates threat assessments from interagency processes, ensuring stockpiles align with evolving risks while maintaining shelf-life monitoring and replenishment protocols.

Emergency Response Operations

Pre-2020 Public Health Emergencies

Prior to 2020, the Biomedical Advanced Research and Development Authority (BARDA) played a pivotal role in accelerating the development and procurement of medical countermeasures during several public health emergencies, including the 2009 H1N1 influenza pandemic, the 2014-2016 outbreak, and the 2015-2016 epidemic. Established in 2006, BARDA leveraged its authority under the Project BioShield Act to fund advanced research, manufacturing scale-up, and emergency use authorizations for vaccines, therapeutics, and diagnostics, often in coordination with the FDA and CDC. These efforts focused on bridging gaps in private-sector incentives for high-risk product development, enabling rapid deployment to mitigate domestic and global threats. During the 2009 H1N1 swine flu pandemic, which emerged in April 2009 and led to over 60 million cases and 12,000 deaths in the United States, BARDA supported the rapid production and procurement of seasonal and pandemic vaccines from licensed manufacturers. BARDA's pre-existing investments in preparedness, dating back to 2005, facilitated the adaptation of manufacturing processes for H1N1-specific s, resulting in the delivery of over 100 million doses of monovalent H1N1 vaccine by late 2009. This included contracts for adjuvanted vaccines to enhance and stretch limited supplies, demonstrating BARDA's end-to-end strategy from research to stockpiling. In response to the 2014 West African virus disease outbreak—the largest in history, with over 28,000 cases and 11,000 deaths—BARDA expedited funding for experimental therapeutics and . BARDA awarded contracts to advance treatments like ZMapp, providing up to $42 million to Mapp Biopharmaceutical for scale-up and clinical testing, and supported repurposed antivirals such as for potential use. Additionally, BARDA contributed to candidates, including a $200 million award to in 2015 to accelerate production of an adenovirus-based , which entered phase III trials amid the crisis. These interventions emphasized speed, with BARDA serving as Incident Coordinator to prioritize procurement needs. BARDA's Zika response targeted the 2015-2016 Americas outbreak, linked to over 1.5 million suspected cases and risks in newborns, by funding and diagnostic platforms. In June 2016, BARDA issued a task order worth up to $21.9 million to for a Zika candidate using its DNA-based platform, aiming for phase I trials. Separately, BARDA granted $43.2 million to in September 2016 to advance the Zika purified inactivated virus (ZPIV) into phase II, building on U.S. for and studies. BARDA also supported blood screening assays, such as Hologic's Procleix Zika test, to prevent transfusion transmission. These actions underscored BARDA's focus on vector-borne threats, though no Zika achieved full licensure by 2020.

COVID-19 Mobilization and Outcomes

In early 2020, BARDA initiated a rapid mobilization of resources in response to the emerging , establishing a dedicated response team and conducting market assessments to identify promising medical countermeasures across diagnostics, therapeutics, and vaccines. This effort intensified with the launch of (OWS) in May 2020, a public-private partnership led by the Department of Health and Human Services (HHS) and the Department of Defense, where BARDA served as the primary funding and project management entity for vaccine and therapeutic development. BARDA committed billions in federal funds to support advanced research, clinical trials, manufacturing scale-up, and procurement, prioritizing technologies with potential for rapid deployment. BARDA's vaccine portfolio under OWS included funding for six candidates, with significant investments in mRNA platforms; for instance, it provided up to $1.5 billion to on August 11, 2020, for large-scale manufacturing and delivery of its investigational following an initial $483 million grant for earlier development. Additional awards supported partners like ($2 billion announced July 31, 2020) and . For therapeutics, BARDA backed development with contributions including up to $483 million, leading to its (EUA) by the FDA on May 1, 2020, for hospitalized patients. Investments also extended to monoclonal antibodies, such as those from Regeneron, with later funding like $326 million in 2023 for next-generation variants under Project NextGen. Overall, BARDA facilitated over 130 partnerships, enabling procurement of countermeasures for national distribution. These efforts yielded rapid regulatory milestones, including EUAs for Pfizer-BioNTech and vaccines in December 2020, with phase 3 trials demonstrating 95% against symptomatic for Pfizer-BioNTech up to six months post-second dose. Real-world data confirmed high against severe outcomes, such as 87% vaccine against hospitalization among U.S. veterans in 2021 and sustained protection against critical illness through 2025. BARDA-supported countermeasures contributed to reduced mortality, though subsequent variants and waning immunity against infection prompted adaptations; by August 2025, HHS terminated 22 projects totaling about $500 million, citing insufficient protection against upper respiratory infections based on empirical performance data.

Post-2020 Threats and Adaptations

Following the , BARDA shifted focus to emerging infectious disease threats, including the 2022 global outbreak and ongoing highly pathogenic (HPAI) H5N1 surveillance, while advancing countermeasures against (AMR). In response to , BARDA facilitated the release of stockpiled JYNNEOS vaccine doses—previously developed with BARDA support for smallpox/ indications—and the antiviral (TPOXX), also BARDA-funded, from the for treatment of severe cases. BARDA exercised contract options worth $144 million with in May 2025 to manufacture additional freeze-dried JYNNEOS doses, replenishing supplies depleted during the 2022-2023 outbreak response. For HPAI H5N1, which has caused outbreaks in , wild birds, and increasingly mammals including U.S. since 2022, BARDA maintained an end-to-end preparedness strategy encompassing platforms, adjuvants, and manufacturing surge capacity. This included awards to CSL Seqirus for adjuvanted H5N1 pre-pandemic and H5N8 antigens to expand the portfolio against evolving strains, building on prior investments in rapid-response technologies. BARDA's and emerging infectious diseases program emphasized partnerships to achieve delivery within months of a declaration, informed by lessons from prior H5N1 and H7N9 responses. Amid rising AMR threats, BARDA's 2022-2026 Strategic Plan prioritized broad-spectrum antimicrobials effective against high-consequence bacterial pathogens, including support for next-generation antifungals and therapies for Clostridium difficile. Through the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), co-led by BARDA, four candidates advanced to Phase 1 trials between October 2020 and September 2021, targeting priority pathogens per CDC threat assessments. Adaptations post-2020 included the 2023 launch of Project NextGen, a $5 billion initiative to develop next-generation vaccines and therapeutics via public-private partnerships, incorporating platform technologies for faster variant adaptation and broader respiratory virus coverage. The strategic plan emphasized agility in uncertain environments, enhanced international coordination, and diversified manufacturing to mitigate vulnerabilities exposed by . These efforts extended to Sudan virus disease responses in 2022, underscoring BARDA's pivot toward integrated, multi-threat readiness.

Achievements and Measured Impacts

Successful Countermeasure Deployments

BARDA has facilitated the deployment of several medical countermeasures during public health emergencies, leveraging public-private partnerships to accelerate development, manufacturing, and distribution. Notable examples include pandemic influenza vaccines during the 2009 H1N1 outbreak, where BARDA entered response mode to support production and procurement, resulting in the delivery of approximately 186 million doses to mitigate widespread transmission. In the 2014-2016 virus disease outbreak, BARDA-funded efforts contributed to the advancement of therapeutics such as REGN-EB3 (Inmazeb), which received FDA approval in October 2020 for treating in adults and children, demonstrating improved survival rates in clinical trials compared to standard care. Similarly, , initially developed with BARDA support for , showed antiviral efficacy in preclinical models and was later repurposed. BARDA also backed the (Ervebo), approved by the FDA in December 2019, which was deployed in outbreak responses and provided protective efficacy in ring vaccination trials. For chemical, biological, radiological, and nuclear threats, BARDA-supported (TPOXX), approved by the FDA in July 2018 as the first antiviral for , was deployed from the during the 2022 outbreak to treat severe cases, with expanded EUA authorizing its use for infections in high-risk patients. Anthrax countermeasures, including vaccines like BioThrax and monoclonal antibodies such as raxibacumab, have been procured and stockpiled under BARDA oversight for rapid deployment in potential aerosolized attack scenarios, ensuring availability without prior widespread use in confirmed events. The represented BARDA's largest-scale deployment, with investments supporting over 130 partnerships that yielded FDA approvals or EUAs for six vaccines—including Moderna's mRNA-1273 and Janssen's Ad26.COV2.S—and 23 therapeutics, such as (EUA March 2020) and , enabling billions of doses administered and reducing hospitalization rates in . These efforts underscored BARDA's in scaling to meet demands, though outcomes varied by in real-world settings.

Contributions to National Security and Health

The Biomedical Advanced Research and Development Authority (BARDA) has significantly advanced U.S. national security by funding the research, development, and procurement of medical countermeasures (MCMs) tailored to chemical, biological, radiological, and nuclear (CBRN) threats, thereby enabling rapid response to deliberate attacks or accidents. Established under the Project BioShield Act of 2004 and expanded through subsequent legislation, BARDA's CBRN portfolio prioritizes achieving at least one FDA-approved MCM per major threat category, including vaccines, antivirals, antitoxins, and diagnostics. These investments deter potential adversaries by signaling credible defensive capabilities, as stockpiled MCMs mitigate the lethality of bioweapons and reduce post-attack societal disruption. Key achievements include BARDA's support for countermeasures, such as the BioThrax vaccine (Anthrax Vaccine Adsorbed), which has been procured in quantities exceeding 50 million doses for the since the early 2000s, providing against inhalation —a primary bioterrorism concern following the 2001 Amerithrax attacks. Similarly, BARDA has driven advancements in vaccines, including ACAM2000 and the third-generation Jynneos vaccine, with over 300 million doses stockpiled by 2020 to counter variola virus reemergence via laboratory accident or intentional release. For chemical threats like nerve agents, BARDA-funded antitoxins such as enhance treatment efficacy, while radiological/nuclear programs yield decorporation agents like those addressing cesium and isotopes. In burn and —a common of CBRN events—BARDA's dedicated program has developed novel therapeutics and diagnostics to manage mass casualties, integrating them into federal response frameworks for improved survival rates. These MCMs not only fortify but also contribute to broader health security by fostering dual-use technologies applicable to or emerging pathogens, as evidenced by BARDA's role in sustaining capacity for scalable production during crises. Overall, BARDA's systematic approach has transitioned nascent innovations into deployable assets, with annual appropriations enabling over $1 billion in CBRN-related funding as of 2023, underscoring a causal link between sustained investment and enhanced national resilience.

Criticisms, Controversies, and Reforms

Efficiency and Waste in Funding

The Biomedical Advanced Research and Development Authority (BARDA) has managed billions in federal funding for medical countermeasures, but audits and investigations have revealed instances of misuse and inefficient allocation that diverted resources from intended purposes. In fiscal year 2019, approximately $25 million was misappropriated from BARDA's programs for unrelated administrative expenses, including office furniture removal, salaries for non-BARDA personnel, news subscriptions, and legal services, violating the Purpose Statute and potentially the . Additionally, from fiscal years 2007 to 2016, $517.8 million in BARDA administrative expenditures lacked proper accounting, contributing to broader concerns over fiscal controls within the Department of Health and Human Services (HHS). These findings prompted HHS to initiate an internal review and engage an external accounting firm, though systemic vulnerabilities persisted due to inadequate segregation of funds between research and overhead activities. BARDA's high-risk investment model, which funds advanced-stage development with anticipated failure rates, has led to significant terminations of projects that did not yield viable products, amplifying perceptions of waste. In August 2025, HHS terminated 22 BARDA-funded development projects totaling nearly $500 million, citing data showing ineffectiveness against upper respiratory infections, as part of a broader reevaluation under Project NextGen—a $5 billion initiative launched in 2023 to advance countermeasures. Critics, including subsequent HHS leadership, characterized aspects of Project NextGen as wasteful, noting $1.63 billion spent on vaccines that underperformed, prompting a shift toward alternative platforms like nasal vaccines. Such outcomes reflect the inherent risks of BARDA's portfolio approach, where rapid deployment needs clash with uncertain R&D success, but also underscore limited pre-investment scrutiny on and real-world . Infrastructure investments have similarly suffered from underutilization and oversight gaps, eroding efficiency. The Continuity of Industry for Domestic Advanced Manufacturing (CIADM) program, with $400 million invested in facilities for production, experienced chronic underuse due to insufficient task orders and sustained funding—averaging only $4 million annually pre-pandemic against $30–60 million needed—resulting in wasted capacity and one site closure at following cross-contamination issues. BARDA's oversight, including audits and site visits, was curtailed by this inactivity, relying heavily on COVID-19-era escalations rather than routine monitoring, which GAO attributed to staffing shortages and contracting complexities under other transaction authorities. These lapses highlight broader GAO-identified vulnerabilities in preparedness programs to waste, fraud, and mismanagement, exacerbated by BARDA's expedited funding mechanisms that prioritize speed over rigorous fiscal accountability.

Political and Bureaucratic Influences

The ouster of BARDA Director Rick Bright in April 2020 exemplified political pressures on agency decision-making during the COVID-19 response. Bright, who led BARDA since December 2016, alleged that he was removed after resisting directives from HHS political leadership to expedite approval and funding for hydroxychloroquine and chloroquine as COVID-19 treatments, despite insufficient evidence of efficacy and safety concerns. He filed a whistleblower complaint claiming that such efforts prioritized "politics and cronyism" over scientific rigor, including steering contracts to politically favored entities rather than those with rigorous proposals. However, colleagues provided mixed assessments of Bright's tenure, noting internal disputes predating COVID-19 and questioning the extent of external political interference. BARDA's role in (OWS), launched in May 2020, further highlighted tensions between accelerated timelines and political oversight. As the primary funder for vaccine candidates like those from and , BARDA committed billions in research, manufacturing, and procurement support under OWS, enabling Use Authorizations by December 2020. Critics raised concerns about potential commercial and political conflicts, including limited transparency in contract awards and influence from industry stakeholders on prioritization. Democratic senators, including , inquired about mechanisms to prevent ideological or political sway in BARDA's processes following Bright's departure, underscoring broader apprehensions over executive branch directives shaping countermeasure selections. Bureaucratic constraints have persistently affected BARDA's efficiency, including non-compliance in contract awards and fund allocation. A 2024 HHS Office of Inspector General (OIG) found that ASPR, BARDA's parent organization, failed to consistently adhere to federal requirements when awarding research contracts under programs like BARDA DRIVe, such as inadequate documentation and competition processes. Similarly, fiscal years 2018-2019 appropriations for BARDA were not always used as intended, with accounting irregularities diverting funds from congressionally mandated pandemic preparedness. These issues stem from inter-agency coordination challenges with FDA and CDC, as well as rigid rules that delay agile responses to emerging threats. Regulatory bureaucracy, including FDA's stringent approval pathways, has compounded operational hurdles for BARDA-supported projects. High compliance costs and protracted reviews have deterred private-sector partnerships, leading to underutilization of facilities despite available . Congressional observers have noted that while BARDA's mandate promotes innovation, entrenched federal processes often prioritize over rapid deployment, as seen in pre-COVID efforts where countermeasures languished due to validation delays. Reforms to streamline these elements remain debated, with calls for greater autonomy to mitigate both political whims and administrative inertia.

Ethical and Oversight Challenges

The Biomedical Advanced Research and Development Authority (BARDA) has faced scrutiny over inadequate oversight mechanisms, particularly during rapid-response scenarios like the , where billions in federal funds were allocated with limited monitoring. A 2023 Government Accountability Office (GAO) report identified limited BARDA oversight of manufacturing sites due to underutilization during the crisis, resulting in fewer on-site inspections and risk assessments than planned, which potentially compromised for countermeasures. Similarly, a 2021 GAO analysis of contracting highlighted challenges in BARDA's processes, including reliance on sole-source awards and delays in documenting justifications, exacerbating risks of inefficiency and waste in distributing over $10 billion for and therapeutics. Ethical concerns have arisen from allegations of political interference in funding decisions, as detailed in a 2020 whistleblower complaint by former BARDA Director Rick Bright, who claimed HHS leadership pressured him as early as 2017 to prioritize contracts based on political connections rather than scientific merit, including efforts to expedite unproven treatments like hydroxychloroquine despite safety risks. Bright's ouster in April 2020, shortly after resisting such directives, underscored tensions between expediency and evidence-based allocation, with critics arguing it reflected broader vulnerabilities to bureaucratic and partisan influences in biodefense priorities. Transparency deficits have compounded oversight issues, such as instances where BARDA-funded entities failed to disclose public investments in filings; for example, omitted BARDA's contributions in a patent application for its antibody therapy REGN-COV2, potentially obscuring taxpayer-supported innovations from public scrutiny. A 2021 analysis further noted insufficient disclosure of U.S. public R&D costs for vaccines, with BARDA's investments—exceeding $18 billion across platforms like mRNA—lacking detailed breakdowns, hindering accountability for outcomes like the 2025 termination of 22 mRNA projects totaling $500 million due to demonstrated inefficacy against respiratory infections. In vaccine development, ethical challenges include balancing accelerated timelines under Emergency Use Authorizations with rigorous safety data, as BARDA's support for platforms like Moderna's mRNA technology involved compressed Phase 3 trials amid public health urgency, raising questions about long-term risk disclosure and equitable access mandates. Broader biodefense ethics, such as informed consent for stockpiled countermeasures potentially used in compulsory scenarios, remain underexplored in BARDA's framework, with experts noting conflicts between national security imperatives and individual autonomy in pathogen research funding. These issues highlight the need for enhanced independent audits and conflict-of-interest safeguards to mitigate risks of biased prioritization in future emergencies.

References

  1. https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx
  2. https://www.law.cornell.edu/uscode/text/42/247d-7e
  3. https://ifp.org/why-barda-deserves-more-funding/
  4. https://medicalcountermeasures.gov/barda/
  5. https://osc.gov/News/Pages/21-08-HHS-Misused-Millions-Emergency-Preparedness.aspx
  6. https://www.nytimes.com/2021/01/27/us/politics/barda-public-health-watchdog.html
  7. https://medcitynews.com/2020/05/the-eye-popping-allegations-in-ousted-barda-director-rick-brights-whistleblower-complaint/
  8. https://www.science.org/content/article/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
  9. https://www.govinfo.gov/app/details/STATUTE-120/STATUTE-120-Pg2831
  10. https://grants.nih.gov/grants/guide/rfa-files/rfa-ai-07-037.html
  11. https://www.medicalcountermeasures.gov/media/745/bardastrategicplan9-28--508.pdf
  12. https://medicalcountermeasures.gov/barda/cbrn/project-bioshield/
  13. https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/Project-Bioshield.aspx
  14. https://www.csis.org/analysis/twenty-years-project-bioshield
  15. https://www.congress.gov/bill/116th-congress/senate-bill/1379
  16. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation
  17. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions
  18. https://aspr.hhs.gov/legal/pahpa/Pages/default.aspx
  19. https://www.congress.gov/crs-product/IF12683
  20. https://www.congress.gov/crs-product/R42349
  21. https://drive.hhs.gov/resources.html
  22. https://medicalcountermeasures.gov/barda/fdaapprovals/
  23. https://www.hhs.gov/about/agencies/orgchart/aspr/barda/index.html
  24. https://drive.hhs.gov/
  25. https://medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/
  26. https://medicalcountermeasures.gov/barda/rqa/
  27. https://www.fiercehealthcare.com/healthcare/hhs-names-first-director-biomedical-advanced-research-development-authority
  28. https://www.nasdaq.com/press-release/renovacare-appoints-founding-director-of-barda-dr.-robin-a.-robinson-to-chief
  29. https://globalbiodefense.com/2016/11/15/rick-bright-selected-new-barda-director/
  30. https://www.statnews.com/2020/04/21/rick-bright-out-at-barda/
  31. https://www.reuters.com/article/us-health-coronavirus-usa-barda/u-s-replaces-director-of-agency-overseeing-covid-19-vaccines-drugs-idUKKCN223306/
  32. https://www.kff.org/global-health-policy/key-u-s-government-agency-positions-and-officials-in-global-health-policy-related-areas/
  33. https://servicetoamericamedals.org/honorees/gary-disbrow-ph-d-robert-johnson-ph-d-kimberly-armstrong-ph-d-rodney-wallace/
  34. https://osc.gov/News/Pages/20-21-Settlement-Rick-Bright.aspx
  35. https://www.biopharmadive.com/news/bright-barda-azar-retaliation/580640/
  36. https://www.nytimes.com/2021/08/09/us/politics/rick-bright-whistleblower.html
  37. https://homelandprepnews.com/stories/48481-senate-democrats-increase-investigative-pressure-over-removal-of-bardas-director/
  38. https://www.pharmamanufacturing.com/coronavirus-updates/news/11297919/hhs-replaces-director-charged-with-covid-19-vaccines-and-drug-development
  39. https://aspr.hhs.gov/AboutASPR/LeadershipBiographies/Pages/Leadership-Disbrow.aspx
  40. https://www.medicalcountermeasures.gov/barda/documents/phemce_implplan_041607final.pdf
  41. https://www.medicalcountermeasures.gov/media/13962/2012-phemce-implementation-plan.pdf
  42. https://aspr.hhs.gov/PHEMCE/Documents/2023-2027-PHEMCE-MYB-508.pdf
  43. https://faolex.fao.org/docs/pdf/us218400.pdf
  44. https://www.liebertpub.com/doi/full/10.1089/hs.2024.0076
  45. https://www.ghtcoalition.org/documents/pdf/Bolstering-BARDAs-role-in-combatting-naturally-occuring-threats-and-emerging-infectious-diseases.pdf
  46. https://www.naccho.org/blog/articles/congress-releases-labor-hhs-bill-in-final-fy2024-package
  47. https://allianceforbiosecurity.com/wp-content/uploads/2025/04/03.24.25-Alliance-for-Biosecurity-FY2026-Appropriations-Request.pdf
  48. https://www.citizen.org/article/barda-funding-tracker/
  49. https://aspr.hhs.gov/PHEMCE/Pages/2023-2027-PHEMCE-MYB.aspx
  50. https://www.rrpv.org/ota/
  51. https://medicalcountermeasures.gov/barda/project-bioshield/
  52. https://imlive.s3.amazonaws.com/Federal%2520Government/ID65671589122942988393789121444629984676/FINAL_BAA-16-100-SOL-00001_CBRN_20160108.pdf
  53. https://drive.hhs.gov/files/ezbaa_files/Amendment%2520041%2520-%2520ImmuneChip.pdf
  54. https://arpa-h.gov/sites/default/files/2024-06/HHS%2520-%2520OTA%2520at%2520HHS.pdf
  55. https://medicalcountermeasures.gov/barda/cbrn/
  56. https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Documents/PBS-Infographic-508.pdf
  57. https://globalbiodefense.com/2025/09/23/us-biodefense-contracts-emergent-anthrax-smallpox/
  58. https://www.congress.gov/crs_external_products/R/HTML/R42349.web.html
  59. https://www.cidrap.umn.edu/anthrax/bioshield-report-shows-growth-biodefense-stockpile
  60. https://medicalcountermeasures.gov/barda/cbrn/antivirals-antitoxins/
  61. https://medicalcountermeasures.gov/barda/cbrn/radiological-and-nuclear-countermeasures/
  62. https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/PI.aspx
  63. https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/EID.aspx
  64. https://medicalcountermeasures.gov/barda/pci/
  65. https://medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/vaccine-development/
  66. https://pubmed.ncbi.nlm.nih.gov/39812164/
  67. https://www.ffvcnc.org/drive
  68. https://drive.hhs.gov/BAN1.html
  69. https://drive.hhs.gov/accelerators.html
  70. https://www.cidrap.umn.edu/pandemic-influenza/barda-announces-first-next-generation-countermeasure-accelerator-hubs
  71. https://jnjinnovation.com/news/press-releases/johnson--johnson-innovation-and-the-biomedical-advanced-research-and-development-authority-barda-names-awardees-in-the-blue-knight-quickfire-challenge-accelerating-project-nextgen
  72. https://medicalcountermeasures.gov/barda/preparedness-partnerships/
  73. https://array.aami.org/content/news/advancing-pediatric-medical-countermeasures-through-newly-barda-funded-accelerator
  74. https://matter.health/posts/MATTER-Selected-to-Lead-the-Digital-Health-Accelerator-in-the-Next-Generation-of-the-BARDA-Accelerator-Network/
  75. https://jamanetwork.com/journals/jama/fullarticle/2731155
  76. https://medicalcountermeasures.gov/barda/barda-covid-19-response/covid-19-portfolio/
  77. https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
  78. https://www.fiercebiotech.com/biotech/hhs-cancels-all-mrna-vaccine-development-funded-barda
  79. https://medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/therapeutics/
  80. https://medicalcountermeasures.gov/barda/tpp/
  81. https://pmc.ncbi.nlm.nih.gov/articles/PMC9746534/
  82. https://medicalcountermeasures.gov/barda/dddi/
  83. https://www.cidrap.umn.edu/biosecurity-issues/hhs-aspr-announces-new-funding-fill-gaps-biothreat-diagnostics
  84. https://globalbiodefense.com/2023/09/19/molecular-diagnostic-test-for-six-biothreat-pathogens-receives-fda-clearance/
  85. https://www.biospace.com/press-releases/aptitude-secures-9m-partnership-with-barda-to-develop-rapid-molecular-diagnostic-for-ebolaviruses-and-marburg-viruses
  86. https://drive.hhs.gov/homediagnostics.html
  87. https://www.universitylabpartners.org/blog/ulp-barda-launches-readydetect-a-10-million-competition-to-accelerate-next-generation-diagnostics
  88. https://everglade.com/bardas-dxr2-rpp-scaling-biothreat-diagnostic-readiness/
  89. https://www.360dx.com/business-news/barda-launches-diagnostics-medical-devices-accelerator
  90. https://www.universitylabpartners.org/blog/applications-open-for-i-create-offering-up-to-200k-in-funding-and-a-50k-cash-prize?hsLang=en
  91. https://www.rrpv.org/portfolio-items/biothreat-diagnostic-rapid-response/
  92. https://aspr.hhs.gov/legal/Pandemic-Influenza-Strategy/Pages/Objective-4.aspx
  93. https://www.ncbi.nlm.nih.gov/books/NBK396384/
  94. https://www.congress.gov/crs-product/R47400
  95. https://www.ncbi.nlm.nih.gov/books/NBK396378/
  96. https://aspr.hhs.gov/newsroom/video-alt-text-descriptions/Pages/default.aspx
  97. https://aspr.hhs.gov/H5N1/Pages/default.aspx
  98. https://www.gao.gov/assets/gao-23-106210.pdf
  99. https://www.nature.com/articles/nbt0207-179
  100. https://globalbiodefense.com/2019/08/05/project-bioshield-building-a-better-medical-countermeasure-pipeline/
  101. https://academic.oup.com/cid/article/64/10/1430/2967925
  102. https://everglade.com/barda-launches-new-rfp-to-bolster-antibiotic-stockpiles-against-drug-resistant-and-biothreat-pathogens/
  103. https://medicalcountermeasures.gov/barda/cbrn/chemical-medical-countermeasures/
  104. https://medicalcountermeasures.gov/barda/barda-responds/
  105. https://www.ncbi.nlm.nih.gov/books/NBK349047/
  106. https://obamawhitehouse.archives.gov/the-press-office/2014/12/02/fact-sheet-update-ebola-response
  107. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-barda-funding-award-to-accelerate-ebola-vaccine-program
  108. https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-receives-barda-task-order-valued-219
  109. https://www.news.sanofi.us/press-releases?item=137143
  110. https://www.medicalcountermeasures.gov/media/36975/33_bright_zika.pdf
  111. https://medicalcountermeasures.gov/barda/barda-covid-19-response/timeline/
  112. https://www.gao.gov/assets/gao-21-319.pdf
  113. https://pmc.ncbi.nlm.nih.gov/articles/PMC9975718/
  114. https://www.genengnews.com/news/u-s-raises-to-2-5b-its-warp-speed-bet-on-modernas-covid-19-vaccine/
  115. https://covid19.nihb.org/wp-content/uploads/2020/08/Fact-sheet-operation-warp-speed.pdf
  116. https://www.fiercepharma.com/marketing/gilead-s-covid-19-therapy-remdesivir-worth-4-460-per-course-says-pricing-watchdog
  117. https://www.fiercebiotech.com/biotech/regeneron-secures-326m-barda-funds-work-next-gen-covid-antibody-therapy
  118. https://www.nejm.org/doi/full/10.1056/NEJMoa2110345
  119. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e3.htm
  120. https://www.cdc.gov/covid/php/surveillance/vaccine-effectiveness.html
  121. https://aspr.hhs.gov/SNS/Pages/Mpox.aspx
  122. https://www.bavarian-nordic.com/investor/news/news.aspx?news=7133
  123. https://www.cslseqirus.us/news/csl-seqirus-announces-sixth-barda-award-in-response-to-avian-influenza
  124. https://medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/pandemic-vaccines-adjuvants/
  125. https://hdiac.dtic.mil/articles/barda-support-protects-against-drug-resistant-threats/
  126. https://www.aspe.hhs.gov/sites/default/files/documents/4bbf9137edb9e3c978039e0ce26fcdef/FY21-CARB-Report-Formatted-508C.pdf
  127. https://medicalcountermeasures.gov/nextgen/
  128. https://www.youtube.com/watch?v=FH5POnsojUA
  129. https://www.ncbi.nlm.nih.gov/books/NBK349039/
  130. https://www.fiercepharma.com/pharma/amid-covid-19-effort-regeneron-wins-first-fda-approval-for-ebola-treatment
  131. https://www.congress.gov/crs-product/R46427
  132. https://www.researchamerica.org/wp-content/uploads/2023/05/ResearchAmerica-BARDA-Fact-Sheet.pdf
  133. https://pmc.ncbi.nlm.nih.gov/articles/PMC3167589/
  134. https://files.asprtracie.hhs.gov/documents/burn-and-blast-medical-countermeasures-program-the-federal-perspective.pdf
  135. https://www.fiercebiotech.com/biotech/hhs-unveils-500m-universal-vaccine-initiative-calls-biden-era-covid-vax-accelerator
  136. https://www.gao.gov/assets/gao-23-105713.pdf
  137. https://www.gao.gov/products/gao-24-107198
  138. https://www.nytimes.com/2020/05/05/us/politics/rick-bright-coronavirus-whistleblower.html
  139. https://www.biopharmadive.com/news/barda-director-depart-rick-bright-coronavirus/576471/
  140. https://www.npr.org/sections/coronavirus-live-updates/2020/05/05/850960344/rick-bright-former-top-vaccine-scientist-files-whistleblower-complaint
  141. https://www.citizen.org/article/what-the-bright-complaint-reveals-about-the-trump-administrations-covid-19-response/
  142. https://www.politico.com/news/2020/05/13/rick-bright-vaccine-chief-coronavirus-254127
  143. https://www.congress.gov/crs_external_products/IN/PDF/IN11560/IN11560.7.pdf
  144. https://pmc.ncbi.nlm.nih.gov/articles/PMC7393415/
  145. https://www.help.senate.gov/dem/newsroom/press/murray-and-colleagues-ask-about-political-interference-in-covid-19-response-following-ouster-of-vaccine-development-head
  146. https://oig.hhs.gov/reports/all/2024/aspr-did-not-consistently-comply-with-federal-requirements-for-awarding-research-and-development-contracts/
  147. https://oig.hhs.gov/reports/all/2024/fiscal-year-2018-and-2019-biomedical-advanced-research-and-development-authority-appropriations-may-not-have-been-used-for-their-intended-purpose-in-accordance-with-federal-requirements/
  148. https://www.gao.gov/products/gao-23-105713
  149. http://cole.house.gov/media/weekly-columns/value-barda
  150. https://www.acq.osd.mil/asda/dpc/cp/policy/docs/ia/GAO-21-528_COVID19_Contracting_Final_Report.pdf
  151. https://www.keionline.org/34258
  152. https://msfaccess.org/sites/default/files/2021-01/COVID_Technical_Brief_RandD_US-cost-transparency_ENG_Jan2021.pdf
  153. https://www.congress.gov/crs-product/R46399
  154. https://pmc.ncbi.nlm.nih.gov/articles/PMC2831650/
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