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February 2021

This six-part fact sheet series examines the contributions of US government agencies to advancing global health R&D. The series includes the US Agency for International Development, National Institutes of Health, Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority, Department of Defense, and Food and Drug Administration.

Global Health R&D at the US Agency for International Development

What does USAID do for global health R&D? What does USAID do for global health R&D?

The US Agency for International Development (USAID) supports the development, introduction, and scale-up of urgently needed drugs, vaccines, and other technologies to address unmet health needs of people in the world’s poorest places. The agency specializes in late-stage clinical research and implementation research and operates Grand Challenges to identify and advance promising health innovations from around the world.

Why is USAID’s role in global health R&D important??Why is USAID’s role in global health R&D important?

USAID is the only US agency with a mandate to focus on global health and development, which means it is uniquely positioned to support product development and innovation to advance global health. The agency’s deep international footprint, combined with its in-depth understanding of community needs and culture, makes it critical for developing new health tools that are appropriate, affordable, and accessible for widespread uptake in low-resource settings.

Impact of investment Impact of investment

USAID support has helped advance:

22

new global health technologies since 2000

36

promising products in late-stage development

R&D investment by health area R&D investment by health area

Contributions to global health R&D

USAID R&D success stories: Saving lives, saving money

GLOBAL HEALTH SECURITY

GLOBAL HEALTH SECURITY

Creation of a low-cost, battery-operated tool used during both the Ebola and COVID-19 responses that manages the flow rate of IV treatments with a simple gravity system, replacing the need for expensive, difficult-to-use infusion pumps.

HIV/AIDS

HIV/AIDS

Development of a woman-controlled microbicide vaginal ring, the first long-acting HIV prevention method to receive a positive regulatory opinion.

MALARIA

MALARIA

Development of a child-friendly malaria medicine, which has been distributed in over 50 nations and has saved an estimated 840,000 child lives since its introduction in 2009.

TB

TB

Development of child-friendly tuberculosis (TB) medicines, which have now been adopted in over 116 countries with enough treatment courses ordered to meet the needs of more than 75 percent of the world’s children reported to have TB.

NEWBORN HEALTH

NEWBORN HEALTH

Adaptation of the antiseptic chlorhexidine for umbilical cord care, which is projected to save the lives of more than 1 million babies by 2030 at a cost of fewer than US$.50 per dose.

MENINGITIS

MENINGITIS

Development of a low-cost meningitis A vaccine, which has been delivered to more than 340 million people in 24 countries, virtually eliminating meningitis A wherever it has been used.

Global Health R&D at the National Institutes of Health

What does NIH do for global health R&D? What does NIH do for global health R&D?

The National Institutes of Health (NIH) excels at basic biomedical research, which unlocks early scientific discoveries that can later be translated into lifesaving global health technologies by the private sector, nonprofits, and other US agencies. NIH facilitates research for global health through in-house programs and grants to universities, nonprofits, and other organizations, and operates clinical trial networks which serve as the backbone for clinical trials taking place across America and the world.

Why is NIH’s role in global health R&D important??Why is NIH’s role in global health R&D important?

NIH is the United States’ leading medical research institution and a respected, world-class scientific powerhouse. Its work to advance research for global infectious diseases, through the National Institute of Allergy and Infectious Diseases; to coordinate crosscutting HIV/AIDS research, through the Office of AIDS research; and to strengthen international research capacity, through the Fogarty International Center, forms the building blocks for future drugs, vaccines, diagnostics, and other tools that save and improve lives around the world.

Impact of investment Impact of investment

NIH support has helped advance:

22

new global health technologies since 2000

99

promising products in late-stage development

R&D investment by health area R&D investment by health area

Contributions to global health R&D

NIH R&D success stories: Saving lives, saving money

HIV/AIDS

HIV/AIDS

Development of the first antiretroviral drugs and other subsequent therapies, which have collectively averted an estimated 12.1 million AIDS-related deaths since 2010.

TB

TB

Development of a new drug for highly drug-resistant tuberculosis (TB), which is part of a combination regimen that has reduced treatment time from up to two years to six months while dramatically improving outcomes.

NTDs

NTDs

Development of drugs to treat neglected tropical diseases (NTDs), including a low-cost treatment for visceral leishmaniasis and novel drugs for sleeping sickness and Chagas disease.

DIARRHEAL DISEASE

DIARRHEAL DISEASE

Creation of two low-cost rotavirus vaccines manufactured in India, ROTAVAC and ROTASIIL, that are now in use in several countries worldwide.

CAPACITY STRENGTHENING

CAPACITY STRENGTHENING

The Fogarty International Center has provided research training to more than 6,000 US and foreign scientists working in low- and middle-income countries, including alumni who have played vital roles in the Ebola, Zika, COVID-19, and HIV/AIDS responses.

COVID-19

COVID-19

Development of leading COVID-19 vaccines, including those from AstraZeneca/Oxford, Johnson & Johnson, and Moderna.

Global Health R&D at the US Centers for Disease Control and Prevention

What does CDC do for global health R&D? What does CDC do for global health R&D?

The US Centers for Disease Control and Prevention (CDC) protects people at home and abroad through disease surveillance, rapid outbreak response, and research and development (R&D) of diagnostics, drugs, and other technologies to combat infectious diseases. Not only does CDC’s research advance new diagnostic, prevention, and surveillance technologies, it also evaluates the effectiveness of tools already in use to determine future R&D needs. CDC’s Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases leads much of the agency’s global health R&D work.

Why is CDC’s role in global health R&D important??Why is CDC’s role in global health R&D important?

CDC has unique expertise and capacity to detect, track, and contain infectious disease outbreaks and develop the right technologies to advance these efforts. CDC’s work is critical to protecting Americans and people around the world from emerging epidemics, as well as monitoring the impact of current tools and global health programs to maximize future investments.

Impact of investment Impact of investment

CDC support has helped advance:

6

new global health technologies since 2000

9

promising products in late-stage development

R&D investment by health area R&D investment by health area

Contributions to global health R&D

CDC R&D success stories: Saving lives, saving money

MALARIA

MALARIA

Evaluation of the efficacy of insecticide-treated bednets and the level of damage they can sustain before requiring replacement, which is increasing the impact of bednet programs while also reducing costs.

TB

TB

Development of simplified, better-tolerated tuberculosis (TB) treatments through the Tuberculosis Trials Consortium, which have dramatically reduced TB treatment times and costs.

EBOLA

EBOLA

Development, evaluation, and distribution of rapid diagnostics for Ebola during the 2014–2015 outbreak, including a test that can provide results from a finger prick in just four minutes.

RABIES

RABIES

Creation of a rapid diagnostic technique for rabies that provides results within an hour, requires no refrigeration, and reduces costs by 90 percent; and development of safer, more effective rabies vaccine candidates for humans and animals.

CAPACITY STRENGTHENING

CAPACITY STRENGTHENING

Training of more than 18,000 disease detectives in over 80 countries through its flagship global Field Epidemiology Training Program.

COVID-19

COVID-19

Ongoing validation of COVID-19 diagnostic tests and surveillance activities to detect and characterize new variants of the virus, including by leveraging cutting-edge advanced molecular detection capabilities.

Global Health R&D at the Biomedical Advanced Research and Development Authority

What does BARDA do for global health R&D? What does BARDA do for global health R&D?

The Biomedical Advanced Research and Development Authority (BARDA) supports the development of vaccines, drugs, and other medical countermeasures (MCMs) to protect Americans against threats to public health, including emerging infectious diseases, pandemic influenza, and antimicrobial resistance (AMR).

Why is BARDA’s role in global health R&D important??Why is BARDA’s role in global health R&D important?

BARDA works with industry and other partners to bridge the “valley of death” between basic research and product development, where research and development (R&D) efforts most often fail. Through unique contracting and incentive mechanisms, BARDA’s partnerships ensure promising research is translated into urgently needed medical products by creating commercial incentives for developers that would otherwise not exist. During the COVID-19 pandemic, BARDA’s prominence and funding has grown exponentially as the agency was charged with leading the US government’s MCM R&D portfolio, demonstrating how—with sufficient, sustained funding—BARDA is uniquely equipped to advance products against a range of other global health threats.

Impact of investment Impact of investment

BARDA support has helped advance:

8

FDA-approved products for Ebola & Zika

75+

products in development for COVID-19

78

projects to advance innovations for AMR

BARDA R&D success stories: Saving lives, saving money

COVID-19

COVID-19

Led US COVID-19 product development efforts for vaccines, diagnostics, and therapeutics, supporting dozens of innovations, including all vaccines approved by the US Food and Drug Administration (FDA).

EBOLA

EBOLA

Development of the world’s first Ebola vaccine, as well as two Ebola treatments and one rapid diagnostic test approved by the FDA.

AMR

AMR

Accelerating antibacterial research through the CARB-X public-private partnership, which has supported 78 projects in ten countries, to build the world’s largest early development pipeline of antibacterial innovations. Ongoing development of a genetic sequencing platform to detect pathogens in patient samples in hours, rather than days, and anticipate AMR patterns, enabling clinicians to more effectively treat drug-resistant infections.

ZIKA

ZIKA

Development of six FDA-approved diagnostics, including tests to identify infection and screen blood supplies, and several Zika vaccine candidates in development.

INFLUENZA

INFLUENZA

Strengthening manufacturing capacity in low- and middle-income countries to enable rapid production of seasonal and pandemic influenza vaccines.

Global Health R&D at the Department of Defense

What does DoD do for global health R&D? What does DoD do for global health R&D?

The Department of Defense (DoD) supports research and development (R&D) for infectious diseases, antimicrobial resistance, and other health conditions that pose a risk to US national security and service members stationed abroad.

Why is DoD’s role in global health R&D important??Why is DoD’s role in global health R&D important?

While DoD research first and foremost aims to protect service members overseas from local diseases, it also helps generate vaccines, drugs, and other health tools to combat diseases that are endemic in the world’s poorest places. Additionally, because DoD focuses on producing health tools for austere settings like the battlefield, the tools it advances are often well-suited for use in low-resource communities worldwide.

DoD research is unique in spanning across all stages of R&D, from basic research to late-stage clinical development and manufacturing, making it the only US agency that can single-handedly advance a single technology from early research to end-stage product.

Impact of investment Impact of investment

DoD support has helped advance:

13

new global health technologies since 2000

18

promising products in late-stage development

R&D investment by health area R&D investment by health area

Contributions to global health R&D

DoD R&D success stories: Saving lives, saving money

MALARIA

MALARIA

Development of nearly every antimalarial drug approved by the US Food and Drug Administration and the world’s first approved malaria vaccine, which is undergoing pilot implementation in sub-Saharan Africa.

HIV/AIDS

HIV/AIDS

Supporting two ongoing late-stage clinical trials evaluating promising mosaic HIV/AIDS vaccine regimens, which aim to protect against a wide variety of global HIV strains.

DIARRHEAL DISEASE

DIARRHEAL DISEASE

Ongoing development of affordable vaccines against E. coli and Shigella, and creation of technology used in a water chlorinator device, which gives low-resource communities access to safe, affordable drinking water.

EBOLA

EBOLA

Development of the world’s first approved Ebola vaccine, which has been used to successfully quell recent outbreaks of the disease.

COVID-19

COVID-19

Supporting ongoing development of several COVID-19 vaccine candidates, including a candidate developed at DoD labs and a temperature-stable needleless vaccine; therapeutics; and diagnostics.

CAPACITY STRENGTHENING

CAPACITY STRENGTHENING

Operates a network of overseas labs and medical research facilities, which provide bases for infectious disease R&D, disease surveillance, and capacity-strengthening in partner nations.

Global Health R&D at the US Food and Drug Administration

What does FDA do for global health R&D? What does FDA do for global health R&D?

The US Food and Drug Administration (FDA) regulates the safety and efficacy of drugs, vaccines, and other medical products marketed in the United States, which can include products also designed for use overseas. The FDA also works with international regulators in lowand middle-income countries (LMICs) to strengthen their regulatory capacity and provide technical assistance.

Why is FDA’s role in global health R&D important??Why is FDA’s role in global health R&D important?

FDA approval of a product serves as a “gold standard” that can expedite regulatory review in LMICs. This effect, combined with the agency’s work in regulatory capacity strengthening, helps ensure new global health technologies are safe, effective, and accessible in low-resource settings.

Impact of investment Impact of investment

The FDA has approved more than 75 drugs, vaccines, and diagnostics for neglected diseases.

The FDA has 208 formal arrangements for information sharing and technical assistance with regulatory authorities in 49 countries.

Contributions to global health R&D

Contributions to global health R&D

FDA R&D success stories: Saving lives, saving money

CAPACITY STRENGTHENING

CAPACITY STRENGTHENING

Development of partnerships to strengthen regulatory capacity in LMICs, including collaborations with the World Health Organization (WHO) African Vaccine Regulatory Forum and the WHO Developing Country Vaccine Regulators Network to share expertise and provide training and mentoring.

HIV/AIDS

HIV/AIDS

Creation of a “tentative approval” process allowing the President’s Emergency Plan for AIDS Relief (PEPFAR) to purchase generic antiretroviral (ARV) drugs for use outside the United States. Through the program, the FDA has approved more than 200 ARVs, which have helped support treatment for more than 15 million people worldwide.

HEALTH EMERGENCIES

HEALTH EMERGENCIES

Granted emergency use authorization for more than 350 medical products for COVID-19, 18 diagnostics for Zika, and 11 diagnostics for Ebola, facilitating their use during these crises.

MENINGITIS

MENINGITIS

Development of critical technology used in a low-cost meningitis A vaccine, which has been delivered to more than 340 million people in 24 countries, virtually eliminating meningitis A wherever it has been used.

NTDs

NTDs

Release of guidance documents to aid organizations in developing drugs for neglected tropical diseases (NTDs) and issuance of 11 priority review vouchers (PRVs) as part of the NTD PRV program intended to stimulate private-sector investment in NTD R&D.

TB

TB

Use of an accelerated approval pathway to speed review and approval of two new drugs to treat drug-resistant tuberculosis (TB).