BARDA’s First 15 Years

2022 marks the start of the Biomedical Advanced Research and Development Authority’s (BARDA’s) 16th year. The office was established after the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, became law on December 19, 2006, following a series of health security threats and incidents in the early 2000s.

PAHPA amended the Public Health Service Act, which was enacted in 1944, to create BARDA within the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health Human Services (HHS). BARDA’s mission includes using unique contracting authorities and other resources to support the development of medical countermeasures (MCMs). These include products such as vaccines, therapeutics and diagnostic tools that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. 

BARDA’s mandate is to develop technologies in a preparedness posture so that they are available during public health emergencies. BARDA works with the private sector in a true partnership to facilitate the development of MCMs and brings not only funding but a vast array of subject matter expertise to these partnerships. 

Since its inception, BARDA has responded to and developed MCMs for endemic and pandemic threats as well as fostered novel partnering opportunities. Previous investment in pandemic influenza preparedness and response proved to be critical in the fights against the H1N1 pandemic in 2009, the Ebola outbreak in West Africa in 2014 and subsequent Ebola outbreaks in Africa, the Zika virus in 2015-2016, and COVID-19.

BARDA’s results in its first 15 years include:

• Sixty-one U.S. Food and Drug Administration (FDA) approvals, licensures or clearances for BARDA-supported medical countermeasures.
• Support for the development of products used to stop Ebola outbreaks in western Africa since 2014, including a rapid antigen test, a vaccine and two treatments that are FDA approved, licensed or cleared.
• Established a robust TechWatch program to support industry engagement with the USG.
• BARDA supported all four of the FDA 510(k) cleared diagnostic tests for detecting Zika virus antibodies and both FDA-licensed blood-screening tests used in response to the 2016 Zika public health emergency.
• Over $1.6 billion invested in products to treat drug-resistant bacteria, through advanced research and development appropriations and Project BioShield. This includes projects funded via the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), advanced research and development, and Project BioShield programs.
• Procured 22 products under Project BioShield authorities to address chemical, biological, radiological or nuclear threats.
• The first FDA-licensed cell-based and recombinant protein-based influenza vaccines.
• A first-of-its-kind facility to manufacture influenza vaccines. Capable of manufacturing cell-based vaccines without fertilized chicken eggs, this BARDA-supported facility in 2011 marked the first major advancement in domestic influenza vaccine manufacturing in 50 years. The facility provides for domestic manufacturing capability for pandemic influenza vaccine and produces seasonal influenza vaccine.
• Our efforts under pandemic influenza preparedness have increased domestic capacity from 60 million doses of antigen to now over 600 million doses of antigen.
• The creation of the Division of Research, Innovation and Ventures (DRIVe), which stimulates innovation through both non-dilutive and dilutive funding.
  • Within DRIVe, BARDA Ventures uses the private sector’s venture capital approach to deploy needed capital so that inventors, innovators, and entrepreneurs can help combat complex, evolving health security threats. 
  • DRIVe’s Accelerator Network and Blue Knight initiative also establish novel partnerships and invest in transformative technologies.

The same unique authorities that enabled these accomplishments also allowed BARDA to rapidly respond to COVID-19 immediately after reports of the first SARS-CoV-2 outbreak in Wuhan, China, emerged. Even though the SARS-CoV-2 virus was recognized for the first time in January 2020, many of the vaccines, therapeutics and diagnostic tools used to help combat COVID-19 resulted from BARDA’s work that began years before.

BARDA’s role also includes facilitating collaborations both with private sector partners and across U.S. government science, health and emergency response organizations. This has enabled BARDA to serve as an entry point, through our TechWatch program, for the many companies that want to support the U.S. response to COVID-19.

Much of the work was done in partnership with other federal partners, including Operation Warp Speed and its successors, the Countermeasures Acceleration Group (CAG) and the HHS Coordination Operations and Response Element (H-CORE,) as well as the Department of Defense (DOD). BARDA, in partnership with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), made 290 COVID-19 awards totaling nearly $48 billion through the end of FY2021 for the advanced development and/or procurement of COVID-19 vaccines, therapeutics, and diagnostics. More than 140 public-private partnerships supported through these awards yielded:

• 98 products supported (seven vaccine candidates, five therapeutics, 55 diagnostics, 15 rapidly deployable technologies, and five other technologies).
• 37 FDA EUAs of products to combat COVID-19 (27 diagnostics, three vaccines, and seven therapeutics –14 new in 2021 alone).
• 651M+ vaccines, 4.4M+ therapeutics and 195M+ diagnostic tests shipped across America.
• More than $3B in Industrial Base Expansion (IBx) efforts through investments in manufacturing capacity for raw materials, critical ingredients, consumables and facilities.

Although the COVID-19 pandemic spotlighted both new and known challenges in the nation’s pandemic preparedness and response strategy, the intrinsic flexibility of BARDA’s comprehensive portfolio approach allowed a rapid pivot and acceleration in the development of vaccines, diagnostics, and therapeutics against COVID-19. BARDA investments since its inception have also helped to improve the manufacturing and fill-finish capacity for influenza vaccines, demonstrating that sustained investment in the pandemic influenza strategy will equip BARDA with the ability to rapidly respond to emerging and reemerging pandemic pathogens.

BARDA continues to work with partners to secure the public health domestic supply chain by enabling new manufacturing lines and facilities for the syringes, vials, and active pharmaceutical ingredients (API) that are crucial during a public health emergency, while also supporting alternative technologies to prepare for future response that could make vaccines and therapeutics easier to administer and more widely available without the need for needles, syringes, vials or cold-chain distribution.

In response to COVID-19, BARDA also leveraged proven platform technologies that not only accelerated the development of MCMs for COVID-19 but can also be adapted for future emergencies - both known and unknown. Building on previous partnerships – with Moderna to accelerate their mRNA vaccine technology, and with Regeneron to leverage the company’s monoclonal antibody discovery platform – BARDA has successfully shortened the development timeline for vaccines and therapeutics to months instead of years. This approach is a cornerstone of BARDA’s strategy and is made possible through the collaboration of the dedicated professionals at BARDA, and across ASPR, as well as federal, state, territorial, and tribal public health officials, and private industry sectors.

While SARS-CoV-2 has proven to be a serious health security threat, BARDA staff continues its work against other threats, including other viral pathogens, both domestically and abroad. BARDA’s Chemical, Biological, Radiological and Nuclear Medical Countermeasures Division (CBRN) supported the response to recent Ebola outbreaks in the Democratic Republic of the Congo and Guinea, monkeypox cases in the U.S. and the United Kingdom, and a Marburg virus case in Guinea. All of these efforts - while still responding to COVID-19.

In addition to supporting the advanced research and development of MCMs, BARDA has supported products through every stage of the pipeline, from development, to testing, authorization, manufacturing, and procurement. Among BARDA’s latest FDA approvals are a therapeutic for treatment of acute radiation syndrome, a portable ultrasound to detect lung injuries, an antiviral to treat smallpox, and a product to reduce or eliminate autografting in adults with deep-partial thickness burns. BARDA also procured six products in 2021 under PBS, including an anthrax vaccine and an antibiotic, an Ebola vaccine and therapeutic, and a smallpox vaccine and antiviral. These products have been manufactured and stockpiled and are now able to be deployed during a public health emergency.

BARDA has a team of federal staff and contractors who are experts in the fields of physical, chemical and biological sciences, engineering, clinical medicine, public health, product development, regulatory affairs, contracting, and program management. Together, they have worked with more than 500 private-sector partners to address a wide range of health security threats. Looking to the future, BARDA continues to build its workforce so that the BARDA organization can continue to respond to public health challenges of the 21st century.

Even though the COVID-19 pandemic is not yet over, BARDA has continued its work to maintain readiness for other potential public health emergencies. Building on accomplishments and learnings from the last 15 years, BARDA aims to be able to rapidly develop vaccines, therapeutics and diagnostics for any new public health threat, with the goal of having readily available manufacturing capacity and capability to get MCMs widely deployed within weeks, not months or years. Together with its partners, BARDA remains committed to ensuring that the nation is prepared to respond immediately to any future health security threat.