National Institute of 

Allergy and Infectious 

Diseases

CONGRESSIONAL JUSTIFICATION 

FY 2022

Department of Health and Human Services

National Institutes of Health

NIAID-1 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH 

National Institute of Allergy and Infectious Diseases (NIAID) 

FY 2022 Budget Table of Contents Page No.

Director’s Overview.........................................................................................................................3 

IC Fact Sheet ....................................................................................................................................7 

Major Changes in Budget Request .................................................................................................9 

Budget Mechanism Table ..............................................................................................................10 

Appropriations Language ..............................................................................................................11 

Summary of Changes .....................................................................................................................12 

Budget Graphs ..............................................................................................................................13 

Organization Chart ........................................................................................................................14 

Budget Authority by Activity .......................................................................................................15 

Justification of Budget Request .....................................................................................................16 

Program Descriptions ....................................................................................................................16 

Appropriations History ..................................................................................................................27 

Authorizing Legislation .................................................................................................................28 

Amounts Available for Obligation ................................................................................................29 

Budget Authority by Object Class ................................................................................................30 

Salaries and Expenses ...................................................................................................................31 

Detail of Full-Time Equivalent Employment (FTE) ....................................................................32 

Detail of Positions .........................................................................................................................33 
NIAID-2 
NIAID-3 

Director’s Overview 

In 2020, the emergence of the novel coronavirus SARS-CoV-2 and 

the disease it causes, COVID-19, highlighted the importance of the 

dual mandate of the National Institute of Allergy and Infectious 

Diseases (NIAID). This mandate, to enable research on infectious, 

immunologic, and allergic diseases and respond to emerging public 

health threats, positioned NIAID at the forefront of research efforts 

to address the pandemic. 

 

As the spread of SARS-CoV-2 and the increase in cases of COVID19 continue globally, so too have NIAID’s efforts to help control the outbreak. In leading the 

U.S. government’s biomedical research response to the pandemic, the Institute is engaged in a 

multitude of activities focused on characterization of the virus and the disease it causes and the 

development of vaccines, therapeutics, and diagnostics. 

Although SARS-CoV-2 emerged as a novel virus, prior NIAID-supported research on related 

viruses, including the viruses that cause severe acute respiratory syndrome (SARS) and Middle 

East respiratory syndrome (MERS), provided a pivotal foundation for critical early studies on the 

SARS-CoV-2 virus. One study elucidated a key feature of the virus structure called the spike 

protein, which is expressed on the viral surface and initiates infection and may inform future 

treatment strategies. Research on the interaction between the virus and host target cells and in 

newly developed animal models has been complemented by observational studies to understand 

who is at higher risk of infection or disease and how the body responds to infection, particularly

in vulnerable populations such as pregnant women, infants, the elderly, and people in high-risk 

occupations. Many of these studies require extensive collaborations across the federal 

government and with scientists in academia and pharmaceutical and biotechnology companies to 

address the breadth of clinical and public health issues posed by the current pandemic. The 

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),

the National Heart, Lung, and Blood Institute (NHLBI), and NIAID are launching a multifaceted 

program to study the multi-system inflammatory syndrome (MIS-C) seen in some children 

following SARS-CoV-2 infection. These collaborations are critical for developing public health 

interventions to minimize the impact of the current pandemic and pave the way for preparedness 

efforts for future pandemics. 

Basic information about SARS-CoV-2 and the immune response informs the development of 

rapid, accurate, and easy-to-administer diagnostics to mitigate the spread of COVID-19, such as 

those supported by the trans-NIH Rapid Acceleration of Diagnostics (RADx) initiative. In 

addition, NIAID is bringing together clinicians, scientists, and other federal agencies to improve 

and validate blood tests that detect antibodies to the virus. These tests are used in communitybased and large-scale surveillance efforts—such as the RESPONSE study co-sponsored with 

NHLBI—to identify how many people have recovered from SARS-CoV-2 infection, providing 

data crucial for epidemiological models and public health decision-making. 

Early on, the growing public health threat posed by SARS-CoV-2 underscored the need for rapid 

identification and testing of potential treatments for COVID-19. This includes identifying 

Anthony S. Fauci, M.D. 
NIAID-4 

existing licensed drugs that can be repurposed to treat COVID-19 and testing novel antiviral 

drugs, antibody-based therapies, and strategies to target an individual’s immune response to the 

virus. In February 2020, NIAID launched the Adaptive COVID-19 Treatment Trial (ACTT), the 

first clinical trial in the United States to evaluate an experimental treatment for COVID-19. The 

adaptive trial design enables multiple therapies to be tested more efficiently and rapidly. The 

first iteration of ACTT demonstrated that remdesivir, an experimental broad-spectrum antiviral, 

accelerated the recovery of hospitalized patients with advanced COVID-19 disease. Subsequent 

iterations of ACTT are examining whether additional treatment strategies paired with remdesivir 

improve the body’s response to infection. NIAID is coordinating the conduct of multiple clinical 

trials, including the trans-NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines 

(ACTIV) public-private partnership trials to examine monoclonal antibodies and other 

experimental therapeutics for diverse populations with varying severity of disease. Data from 

these studies will continue to inform the NIH COVID-19 Treatment Guidelines developed in 

collaboration with physicians, statisticians, public health experts, and community 

representatives. 

NIAID is investigating multiple SARS-CoV-2 vaccine strategies, including technologies that 

have shown promise against coronaviruses that cause SARS and MERS. Based on encouraging 

results from early-stage clinical testing, NIAID and industry partner Moderna initiated Phase 3 

clinical testing in late July of the mRNA-1273 vaccine candidate. The trial, which is being 

conducted at U.S. clinical research sites, enrolled approximately 30,000 adult volunteers who do 

not have COVID-19. NIAID also is supporting many other vaccine development studies with 

multiple partners in both industry and academia with the goal of creating a safe and effective 

vaccine. In response to this growing need for large-scale COVID-19 clinical trials, NIAID 

quickly leveraged its established research infrastructure and formed the NIH Coronavirus 

Prevention Network (CoVPN), a clinical trials network that aims to enroll thousands of 

volunteers in large-scale clinical trials testing a variety of investigational vaccines and treatments

to protect people from COVID-19. The CoVPN was established by merging four existing 

NIAID-funded clinical trials networks that are focused on the prevention of HIV and other 

infectious diseases. 

The emergence of COVID-19 as a global pandemic underscored the value of NIAID biomedical 

research preparedness efforts. NIAID-supported foundational research on related coronaviruses 

was pivotal in the rapid response to prevent and treat COVID-19. In addition, the experience in 

developing rapidly deployable vaccine platform technologies was critical to advancement of 

novel SARS-CoV-2 vaccine candidates at an unprecedented pace. However, one of the most 

effective preparedness strategies is detecting threats early and stopping them before they evolve 

into pandemics. As part of this effort, NIAID recently expanded its infrastructure to include the 

Centers for Research in Emerging Infectious Diseases, a global network dedicated to 

investigating how and where viruses and other pathogens emerge from wildlife and spillover to 

cause disease in people. Knowledge gained from research conducted by this network of 

investigators will support early warnings of emerging diseases wherever they occur and increase 

preparedness for future infectious disease outbreaks. Along with maintaining a flexible research 

infrastructure, NIAID will continue to advance its mission of protecting public health by 

preparing for and responding to emerging and re-emerging threats. 
NIAID-5 

Overall Budget Policy: 

As noted above, the importance of executing NIAID’s dual mandate is underscored by its 

ongoing response to the COVID-19 pandemic. NIAID continues to support research and clinical 

trials to develop diagnostics, therapeutics and vaccines against COVID-19. Prior investments 

made through annual appropriations have positioned NIAID with the capability to rapidly 

respond to emerging and re-emerging disease threats such as COVID-19, Ebola, and Zika. 

The FY 2022 President’s Budget request seeks annual funding to continue support of NIAID’s 

dual mandate to conduct and support basic and applied research to better understand, treat, and 

ultimately prevent infectious, immunologic, and allergic diseases, while also supporting an 

infrastructure to respond to emerging and re-emerging public health and disease threats. The 

Institute dedicates its annual resources to support scientific opportunities that align with its 

mission and address domestic and global health problems and diseases. 

The FY 2022 President’s Budget request is $6,245.9 million, an increase of $178.9 million or 2.9 

percent compared with the FY 2021 Enacted level. Within the President’s Budget request, 

noncompeting grants will be funded at committed levels. The average cost of competing RPGs 

will be comparable to the FY 2021 level. 

NIAID will continue to support basic and applied research to prevent, diagnose, and treat 

infectious and immune-mediated diseases and illnesses. Key research areas include emerging 

infectious diseases, agents with bioterrorism potential, HIV/AIDS, influenza, Ebola, 

tuberculosis, malaria, autoimmune disorders, drug-resistant microbes, asthma, and allergies. In 

FY 2022, NIAID will continue efforts to conduct foundational research on viruses and pathogens 

and to strengthen its infrastructure for investigating the origins of emerging infectious diseases 

and how they cause disease and illness. NIAID will also support opportunities for new 

researchers to receive R01 funding equivalent to those of established investigators who submit 

new R01 applications. 

NIAID will continue support for trans-NIH initiatives, including a new cybersecurity effort, as 

well as other HHS-wide initiatives through the Research and Development contract mechanism. 

The Intramural Research Program will receive an increase to support critical long-range 

priorities with resources aligned to key research on infectious diseases such as HIV/AIDS, 

malaria, and influenza, as well as on combatting antibiotic-resistant bacteria (CARB). 
NIAID-6 
NIAID-7 

NIAID OVERVIEW 

NIAID supports research to better understand, treat, and 

prevent infectious, immunologic, and allergic diseases 

while continuing in its unique dual mandate to respond 

rapidly to emerging and re-emerging diseases. For more 

than 65 years, NIAID research has led to new therapies, 

vaccines, diagnostics, and other technologies that have 

improved the health of millions of people in the United 

States and around the world. 

NIAID APPROPRIATIONS HISTORY FACTS AND 

FIGURES* 

!m 1,945 Full-Time 

Equivalents 

le 1,289 Funded Principal 

Investigators 

FY 2022 President's Budget request is $6,245.9 million. 

*averages FYI 7-FY20 

Research Highlights 

I 

NIAID is leading the U.S. government research response to COVID-19, including 

advancing basic research on SARS-Co V-2, diagnostics, and the development and 

testing of promising treatments and vaccines. 

Researchers confirmed that reducing viral loads in people with HIV to undetectable 

levels with antiretroviral therapy (ART) can prevent the sexual transmission of the 

virus to others. Optimization and implementation of targeted treatment and prevention 

strategies in geographic "hot spots" could theoretically end the HIV epidemic in the 

United States. 

The PALM (Pamoja Tulinde Maisha) trial in the Democratic Republic of the Congo 

revealed that two therapeutic agents improved survival in patients with Ebola virus 

disease. 

NIAID researchers conducted the first-in-human clinical trial of a promising universal 

influenza vaccine. 

Scientists identified a new approach to prevent the development of peanut- and 

possibly other- food allergies. 
NIAID-8 

ID~ 

National Institute of 

Allergy and 

Infectious Diseases Research Advances

LONG-ACTING PREVENTION OF HIV/AIDS 

• Decades ofNIAID-led research established effectiveness of preexposure prophylaxis (PrEP) to prevent HIV infection. 

• NIAID is investing in research on long-acting forms of HIV 

prevention which are easy to access and use consistently for 

diverse populations. 

• Several promising long-lasting prevention methods are being 

explored including: 

o A vaginal ring that releases the drug dapivirine over the 

course of 1 month. 

o Injectable drug cabotegravir, given once every 8 weeks, more 

effective than daily PrEP regimen 

• Additional strategies being investigated: Implants, multi-purpose 

products that include contraception, broadly neutralizing 

antibodies, and others 

CELL THERAPIES FOR IMMUNE-MEDIATED DISORDERS 

Scanning electron micrograph of a 

human T cell from the immune 

system of a healthy donor. In 

multiple sclerosis, T cells are 

involved in the immune system's 

attack on the central nervous system. 

• Cell therapy: Using stem cells or more specialized cells to treat disease 

• Bone marrow transplants are standard lifesaving treatment for infants 

born with severe combined immunodeficiency, a rare genetic disorder 

• Cell therapies could treat severe immune-mediated disorders 

• Recent results show infusing hematopoietic (blood-forming) stem cells 

to reprogram a patient's immune system is an effective and durable 

treatment for people with severe relapsing-remitting multiple sclerosis 

(MS) 

• Current large trial comparing this treatment to the best available MS 

therapies could not only provide a new treatment for this severe form of 

MS but also open doors for treating other autoimmune disorders, such as 

lupus. 

PANDEMIC PREPAREDNESS 

• Pandemic response relies on extensive NIAID biomedical research preparedness efforts 

• Foundational research on coronaviruses pivotal to rapid response to prevent and treat COVID-19 

• Recently established Centers for Research in Emerging Infectious Disease: a global network to 

investigate how and where viruses and other pathogens emerge from wildlife and spillover to cause 

disease in people, and enable early warnings of emerging diseases 

• NIAID research and flexible infrastructure crucial to protect public health by preparing for and 

responding to emerging and re-emerging infectious diseases 
NIAID-9 

Major Changes in the Fiscal Year 2022 President’s Budget Request

Major changes by selected budget mechanism are briefly described below. The FY 2022 

President’s Budget is $6,245.9 million, an increase of $178.9 million or 2.9 percent compared 

with the FY 2021 Enacted level. Within this request level, NIAID will pursue its highest research 

priorities through strategic investments and careful stewardship of appropriated funds. 

Research Project Grants (RPGs) (+$75.5 million; total $3,709.0 million):

NIAID will support a total of 5,654 Research Project Grant (RPG) awards in FY 2022. The 

increased funding will support research in NIAID’s Biodefense and Emerging Infectious 

Diseases, Infectious and Immunologic Diseases, and HIV/AIDS program areas. The FY 2022 

request reflects a resource shift from competing to noncompeting RPGs because of the FY 2021 

re-competition of the HIV/AIDS Clinical Trials Networks (CTNs), which involve large-scale, 

multi-site clinical research activities. The HIV/AIDS CTNs continue as noncompeting grants in 

FY 2022. Funding for competing RPGs is expected to decrease by $191.6 million or 17.7 percent 

in FY 2022, while noncompeting RPG funding will increase by $263.3 million or 11.0 percent. 

Overall RPG funding will increase by 2.1 percent. 

Research Centers (+$13.8 million; total $93.7 million):

The FY 2022 budget request provides an additional $10.0 million for the NIH Centers for AIDS 

Research (CFARs) to support the U.S. Department of Health and Human Services initiative, 

“Ending the HIV Epidemic in the U.S.” (EHE). The initiative seeks to reduce new HIV 

transmissions by 75 percent over the next 5 years and by 90 percent within the next 10 years. 

Other Research (-$36.5 million, total $94.4 million): 

NIAID will reduce Other Research funding by 27.9 percent compared with the FY 2021 Enacted 

level. NIAID’s FY 2021 resources included a one-time $40.0 million investment in Regional 

Biocontainment Laboratories (RBL), which was divided evenly among 12 RBLs to support 

efforts to prevent, prepare for, and respond to infectious disease outbreaks. 

Research Training (+$4.4 million; total $69.7 million):

NIAID’s FY 2022 budget request provides $4.4 million to support anticipated increases in 

training costs. The Ruth L. Kirschstein NRSA budget reflects a 2.0 percent stipend increase to

cover cost of living expenses and additional resources for childcare allowances. NIH began 

providing childcare support to recipients of NRSA fellowships in FY 2021 and will introduce 

childcare allowances for NRSA-supported trainees in FY 2022. 

Research and Development Contracts (+$85.8 million; total $1,072.8 million): 

NIAID will continue to support trans-NIH initiatives, including a new cybersecurity effort, as 

well as other HHS-wide initiatives. 

Intramural Research (+$24.7 million; total $807.5 million): 

NIAID will increase funding to support critical long-range priorities with funds carefully aligned 

to key research on infectious diseases, such as HIV/AIDS, malaria, and influenza, as well as on 

CARB. Funding will also support the proposed FY 2022 pay raise for intramural research 

employees. 
NIAID-10 

MECHANISM FY 2020 Final FY 2021 Enacted FY 2022 President's Budget

FY 2022

+/-

FY 2021 Enacted

Research Projects:

Noncompeting

Administrative Supplements 

Competing:

Renewal

New

Supplements

No. Amount No. Amount No. Amount No. Amount

3,441

(63)

188

1,470

2

$2,556,855

6,860

134,439

669,795

637

3,675

(63)

183

1,422

2

$2,386,571

6,811

184,607

894,481

516

3,619

(64)

203

1,561

2

$2,649,684

7,037

149,148

738,178

683

-56

(1)

20

139

0

$263,112

227

-35,459

-156,303

167

Subtotal, Competing 1,660 $804,871 1,607 $1,079,604 1,766 $888,010 159 -$191,594

Subtotal, RPGs 5,101 $3,368,586 5,282 $3,472,986 5,385 $3,544,730 103 $71,745

SBIR/STTR 278 160,491 273 160,536 269 164,301 -4 3,765

Research Project Grants 5,379 $3,529,077 5,555 $3,633,521 5,654 $3,709,031 99 $75,510

Research Centers:

Specialized/Comprehensive

Clinical Research

Biotechnology

Comparative Medicine

Research Centers in Minority Institutions

26

0

0

0

0

$70,652

931

0

765

0

25

0

0

0

0

$79,464

0

0

500

0

29

0

0

0

0

$93,218

0

0

512

0

4

0

0

0

0

$13,755

0

0

12

0

Research Centers 26 $72,348 25 $79,964 29 $93,730 4 $13,767

Other Research:

Research Careers

Cancer Education

Cooperative Clinical Research

Biomedical Research Support

Minority Biomedical Research Support

Other

302

0

0

0

0

87

$51,134

0

0

0

390

34,440

305

0

0

0

0

107

$52,668

0

0

0

232

77,980

311

0

0

0

0

83

$54,247

0

0

0

242

39,911

6

0

0

0

0

-24

$1,579

0

0

0

9

-38,070

Other Research 389 $85,965 412 $130,881 394 $94,399 -18 -$36,482

Total Research Grants 5,794 $3,687,390 5,992 $3,844,366 6,077 $3,897,160 85 $52,794

Ruth L Kirschstein Training Awards:

Individual Awards

Institutional Awards

FTTPs

252

902

$11,748

51,723

FTTPs

254

920

$12,100

53,275

FTTPs

254

920

$12,522

57,208

FTTPs

0

0

$422

3,933

Total Research Training 1,154 $63,471 1,174 $65,375 1,174 $69,730 0 $4,355

Research & Develop. Contracts

(SBIR/STTR) (non-add)

Intramural Research

Res. Management & Support

SBIR Admin. (non-add)

Construction 

Buildings and Facilities

198

(24)

911

1,058

(0)

$992,998

(19,691)

760,016

372,320

(907)

0

0

194

(26)

951

1,100

(0)

$987,024

(20,590)

782,817

387,489

(2,370)

0

0

211

(30)

951

1,100

(0)

$1,072,791

(22,141)

807,519

398,726

(2,370)

0

0

17

(4)

0

0

(0)

$85,767

(1,551)

24,702

11,237

(0)

0

0

Total, NIAID 1,969 $5,876,195 2,051 $6,067,071 2,051 $6,245,926 0 $178,855

1 All items in italics and brackets are non-add entries.

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Mechanism - Total1

(Dollars in Thousands)
NIAID-11 

NATIONAL INSTITUTES OF HEALTH

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

For carrying out section 301 and title IV of the PHS Act with respect to allergy and infectious 

diseases, [$6,069,619,000]$6,245,926,000. 
NIAID-12 

FY 2021 Enacted $6,067,071

FY 2022 President's Budget $6,245,926

Net change $178,855

CHANGES

FY2021 Enacted FY 2022 President's Budget Built-In Change from FY 2021 

Enacted

FTEs Budget Authority FTEs Budget Authority FTEs Budget Authority

A. Built-in:

1. Intramural Research:

a. Annualization of January 2021 pay increase & benefits $199,937 $205,925 $545

b. January FY 2022 pay increase & benefits 199,937 205,925 5,443

c. Paid days adjustment

d. Differences attributable to change in FTE

199,937

199,937

205,925

205,925

0

0

e. Payment for centrally furnished services 108,484 113,908 5,424

f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs 474,397 487,686 10,343

Subtotal $21,755

2. Research Management and Support:

a. Annualization of January 2021 pay increase & benefits $200,406 $206,502 $553

b. January FY 2022 pay increase & benefits 200,406 206,502 5,543

c. Paid days adjustment 200,406 206,502 0

d. Differences attributable to change in FTE

e. Payment for centrally furnished services

200,406

31,930

206,502

33,526

0

1,596

f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs 155,153 158,698 4,358

Subtotal $12,050

Subtotal, Built-in $33,806

CHANGES

Program Change from FY 2021 FY2021 Enacted FY 2022 President's Budget Enacted

No. Amount No. Amount No. Amount

B. Program:

1. Research Project Grants:

a. Noncompeting 3,675 $2,393,382 3,619 $2,656,721 -56 $263,339

b. Competing 1,607 1,079,604 1,766 888,010 159 -191,594

c. SBIR/STTR 273 160,536 269 164,301 -4 3,765

Subtotal, RPGs 5,555 $3,633,521 5,654 $3,709,031 99 $75,510

2. Research Centers 25 $79,964 29 $93,730 4 $13,767

3. Other Research 412 130,881 394 94,399 -18 -36,482

4. Research Training 1,174 65,375 1,174 69,730 0 4,355

5. Research and development contracts 194 987,024 211 1,072,791 17 85,767

Subtotal, Extramural $4,896,765 $5,039,681 $142,916

FTEs FTEs FTEs

6. Intramural Research 951 $782,817 951 $807,519 0 $2,946

7. Research Management and Support 1,100 387,489 1,100 398,726 0 -813

8. Construction 0 0 0

9. Buildings and Facilities 0 0 0

Subtotal, Program 2,051 $6,067,071 2,051 $6,245,926 0 $145,049

Total built-in and program changes $178,855

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Summary of Changes

(Dollars in Thousands)
NIAID-13 

Fiscal Year 2022 Budget Graphs 

History of Budget Authority and FTEs: 

Distribution by Mechanism: 

Change by Selected Mechanisms:
NIAID-14 
NIAID-15 

Extramural Research

FY 2020 Final FY 2021 Enacted FY 2022 President's 

Budget 

FY 2022 

+/-

 FY 2021 Enacted 

FTE Amount FTE Amount FTE Amount FTE Amount

Detail

2 HIV/AIDS $1,429,914 $1,432,164 $1,431,821 -$344

Biodefense & Emerging Infectious Diseases 3 1,924,809 2,029,781 2,114,771 84,990

Infectious & Immunological Diseases 1,389,136 1,434,820 1,493,090 58,270

Subtotal, Extramural $4,743,859 $4,896,765 $5,039,681 $142,916

Intramural Research 911 $760,016 951 $782,817 951 $807,519 0 $24,702

Research Management & Support 1,058 $372,320 1,100 $387,489 1,100 $398,726 0 $11,237

TOTAL 1,969 $5,876,195 2,051 $6,067,071 2,051 $6,245,926 0 $178,855

1 Includes FTEs whose payroll obligations are supported by the NIH Common Fund. 2 Reflects NIAID extramural total for HIV/AIDS. NIAID-wide totals are (in thousands) $1,779,113 in FY 2020; $1,788,843 in FY 2021; and $1,798,843 in FY 2022.

3 Reflects NIAID extramural total for Biodefense. NIAID-wide totals are (in thousands) $2,371,416 in FY 2020; $2,495,748 in FY 2021; and $2,594,251 in FY 2022.

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Authority by Activity1

(Dollars in Thousands)
NIAID-16 

Justification of Budget Request

National Institute of Allergy and Infectious Diseases 

Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.

Budget Authority (BA): 

FY 2020 

Final

FY 2021 

Enacted

FY 2022 

President’s 

Budget 

FY 2022 + / - 

FY 2021 

BA $5,876,195,000 $6,067,071,000 $6,245,926,000 +$178,855,000 

FTE 1,969 2,051 2,051 0 

Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; 

Contracts; Direct Federal/Intramural and Other.

Program Descriptions

HIV/AIDS

Decades of basic science and clinical research sponsored by NIAID have revolutionized the 

treatment of people with HIV/AIDS. With effective antiretroviral therapy (ART), a person with 

HIV now can expect a near-normal lifespan. Furthermore, individuals who receive ART and 

maintain an undetectable viral load (the amount of HIV in the blood) cannot sexually transmit 

the virus to others, a concept known as Undetectable = Untransmittable, or U=U. A single ART 

pill used daily as pre-exposure prophylaxis (PrEP) also can protect people who are at risk of 

acquiring HIV. 

Implementing evidence-based treatment and prevention tools could theoretically end the HIV 

epidemic in the United States. The U.S. Department of Health and Human Services initiative, 

“Ending the HIV Epidemic in the U.S.” (EHE), aims to reduce new HIV transmissions by 75 

percent over the next 5 years and by 90 percent within the next 10 years. The strategy is 

focusing first on geographic and demographic “hot spots” where more than 50 percent of new 

HIV infections are concentrated. As part of the EHE initiative, NIAID is supporting research to 

optimize diagnosis, linkage to care, and treatment and prevention approaches for specific at-risk 

groups. This requires adapting implementation strategies to account for gender, cultural, and 

socioeconomic differences. In addition, NIAID provided supplemental and new funding to 

institutions participating in the trans-NIH Centers for AIDS Research and AIDS Research 

Centers programs. These awards will support pilot and exploratory studies aimed at enhancing 

knowledge needed for future implementation activities related to the EHE plan. In 2020, NIH 

added a program to include a focus on reducing HIV incidence by developing methods to 

improve PrEP uptake in cisgender women. 
NIAID-17 

NIAID is investing in multiple approaches to 

prevent HIV, with the goal of delivering new 

options that are safe and effective, appeal to 

diverse populations, and are scalable 

worldwide to help end the global pandemic. 

Several long-lasting prevention methods are 

being explored, such as broadly neutralizing 

antibodies (bNAbs), vaginal rings containing 

an antiretroviral drug, and injectable 

therapeutics (see HIV Program Portrait), as 

well as implants and multi-purpose products 

that offer contraception along with HIV 

prevention. NIAID also is capitalizing on 

foundational investments and focusing on 

entirely new approaches to develop HIV 

vaccine candidates that elicit bNAbs, which 

usually develop in people years after HIV 

infection is established. These approaches 

use detailed knowledge of the structure of 

HIV proteins to create special immunogens—

proteins that elicit an immune response. 

Identifying the fusion peptide—the section of 

the “spike” on the HIV surface that the virus 

uses to bind to and infect cells—and 

discovering that it is a target for bNAbs has 

led to the development of a vaccine candidate 

now being tested in humans for safety. 

Another vaccine in early testing uses a 

version of the HIV spike protein stabilized as 

a trimer—three proteins bound together—as it 

normally exists on the viral surface. A 

vaccine using a “mosaic” immunogen, created 

by stitching together multiple sections of the 

HIV genome, is being tested in two late-stage, multinational human clinical trials. Finally, 

NIAID scientists used a viral vector to deliver the gene for a bNAb. This technology can lead to 

the sustained production of that antibody for more than a year, as shown in a recent clinical trial. 

With further development, such a strategy could be applied to prevent, treat, and possibly induce 

a sustained remission in people with HIV. 

Better treatment approaches are being tested that would facilitate long-term control of HIV. The 

long-acting antiretroviral drug cabotegravir has shown promise in clinical trials when given in 

conjunction with the antiretroviral rilpivirine. NIAID also is testing cabotegravir along with 

infusions of a newly designed bNAb given every 8 weeks. Treatment of HIV during pregnancy 

is particularly complicated, due to metabolic changes in the mother and the possibility that 

therapy will be toxic to the developing fetus. A large, NIAID-sponsored international trial 

recently demonstrated that ART regimens containing dolutegravir were more effective in 

LONG-ACTING APPROACHES FOR HIV 

PREVENTION

Currently, the only licensed PrEP regimen for 

people at risk of HIV infection is a daily pill 

regimen. Long-acting prevention methods may 

be more discreet, easier to use consistently, and 

easier to access and thus may increase the 

global uptake of PrEP. Two NIAID-supported 

clinical trials recently demonstrated that the drug 

cabotegravir, injected once every 8 weeks, was 

safe and more effective than a daily PrEP 

regimen in preventing HIV acquisition in men 

who have sex with men, transgender women, 

and cisgender women.

Large clinical trials are testing whether the bNAb 

VRC01, injected intravenously every 8 weeks, 

could provide long-lasting protection. Several 

other bNAbs developed by NIAID scientists also 

are being evaluated. A collaboration between 

NIAID and the nonprofit International AIDS 

Vaccine Initiative was created to systematically 

identify and assess bNAb combinations that can 

protect against a wide range of HIV strains. 

Finally, clinical trials demonstrated that a vaginal 

ring that releases the drug dapivirine over the 

course of 1 month reduced women’s risk of 

acquiring HIV. Further studies are examining the 

safety of the dapivirine ring during adolescence 

and pregnancy, when the risk of HIV acquisition 

is heightened. Long term, vaginal rings or 

implants could deliver drugs to prevent both 

pregnancy and HIV acquisition, thereby providing 

additional convenient choices for women.
NIAID-18 

suppressing HIV and safer for the unborn infant than a different, commonly used regimen. This 

finding further supports the recently updated World Health Organization guidelines for HIV 

treatment during pregnancy. Further analyses of data from the trial will aid in understanding the 

factors affecting outcomes for both mother and infant. 

Curing HIV is a major NIAID priority. This will require eradicating or otherwise controlling the 

HIV reservoir—pockets of virus that lie dormant in a small number of cells in the body and are 

activated when ART is interrupted. Studies in animal models recently identified two compounds 

that can activate these reservoirs. This activation could then enable the reservoir cells to be 

destroyed, an approach known as “kick and kill.” NIAID also has partnered with NHLBI and the 

Bill & Melinda Gates Foundation to develop accessible gene-based cures for HIV as well as 

sickle cell disease. 

Budget Policy: 

The FY 2022 President’s Budget request for the extramural component of the HIV/AIDS 

research is $1,431.8 million, which is $0.3 million below the FY 2021 Enacted level. NIAID will 

continue to support research from basic discovery through clinical trials on vaccine candidates as 

well as other treatment approaches that would facilitate long-term control of HIV. The FY 2022 

request includes an increase of $10.0 million to prioritize the critical role of NIAID’s Centers for 

AIDS Research program in the Department’s efforts to end the HIV epidemic. As part of the 

EHE initiative, NIAID will continue research to optimize diagnosis, linkage to care, and

treatment and prevention approaches for specific at-risk groups. 

Biodefense and Emerging Infectious Diseases

The emergence and re-emergence of infectious diseases, accelerated by globalization and rapidly 

evolving microbes, continues to threaten the health of people worldwide. NIAID continues to 

conduct and support research to better understand viruses, bacteria, and other infectious agents 

that cause diseases of public health concern.

When Ebola virus disease (EVD) re-emerged in the Democratic Republic of Congo (DRC) in 

2018, NIAID mobilized its flexible infrastructure and extensive experience establishing 

international collaborative research partnerships to advance several promising agents for 

preventing EVD, including the now-approved vaccine VSV-EBOV. As Ebola continues to reemerge, with a new outbreak reported in June 2020 in the DRC, NIAID is continuing to advance 

the use, development, and testing of EVD vaccine candidates. In one study, NIAID scientists 

found that a single dose of a highly diluted VSV-EBOV vaccine remains fully protective against 

EVD in experimentally infected monkeys. These findings mean that VSV-EBOV may be 

effective at protecting against EVD at a much lower dose than anticipated, enabling more 

widespread availability of the vaccine. In addition, the lower dose could reduce the number of 

adverse reactions to vaccination, promoting its use. NIAID also is supporting the advancement 

of additional vaccine candidates against EVD, including vaccine platforms that provide 

protection against additional strains of filovirus as well as other hemorrhagic fevers endemic to 

overlapping regions in Africa. 

The use of a single vaccine for a single virus has been a long-standing strategy to combat 

continually re-emerging threats, including seasonal influenza. However, each year, seasonal 
NIAID-19 

influenza sickens millions and causes thousands of hospitalizations and flu-related deaths.

1

 A

NIAID high priority is the development of a safe and effective “universal” influenza vaccine that

would provide long-lasting protection against multiple strains of the virus, including strains with 

the potential to cause a pandemic. NIAID is advancing several promising universal influenza 

vaccine candidates into clinical trials. One approach used by NIAID scientists is a combination 

of whole inactivated avian influenza viruses, which enables researchers to change virus 

components to optimize the mixture for a broadly protective immune response. Phase 1 studies 

of one such vaccine candidate will begin by late 2020 or early 2021. Another experimental 

vaccine candidate developed by NIAID researchers, called H1ssF_3928, displays part of the 

influenza hemagglutinin (HA) protein on the surface of a microscopic nanoparticle made of 

nonhuman ferritin. The HA protein consists of two regions, called the head and the stem. This 

vaccine utilizes the stem region, which does not vary much between influenza strains and is 

likely to generate immune responses that will be broader and long-lasting. Ferritin, a natural 

protein found in cells of all living species, is useful as a vaccine platform because it forms selfassembling nanoparticles that can display multiple influenza HA spikes on its surface, 

mimicking the natural organization of HA on the influenza virus. H1ssF_3928 displays HA 

molecules from group 1 influenza strains, one of two primary groups of influenza virus subtypes 

known to infect humans. Recently, H1ssF_3928 was tested in a Phase 1 clinical trial. In FY

2021, a counterpart to this nanoparticle vaccine for group 2 HA molecules will be similarly

tested. Nanoparticle technology also is being leveraged by NIAID researchers in a separate

universal influenza vaccine candidate. In this approach, HA molecules from multiple influenza

strains are incorporated into nanoparticles. This vaccine strategy, called a “mosaic 

nanoparticle,” may induce a broader immune response than current influenza vaccines.

Researchers are planning a trial of this vaccine candidate in 2021. 

In addition to nanoparticles, NIAID researchers recently tested a novel peptide-based candidate 

vaccine that is designed to prompt a different type of immune response to influenza viruses than 

most vaccines. The experimental vaccine, called FLU-v, targets several influenza proteins that

tend to be similar across influenza strains. A Phase 2 trial of FLU-v showed that volunteers who 

received the investigational vaccine were less likely to develop mild to moderate influenza 

disease than volunteers who received a placebo. Advancement of these promising vaccine 

candidates underscores how NIAID-supported research in the areas of influenza virology, 

structural biology, protein engineering, immunology, and vaccinology have made possible the 

goal of advancing beyond strain-specific vaccines toward a universal influenza vaccine. In 2019, 

NIAID bolstered this effort by establishing the multidisciplinary Collaborative Influenza Vaccine 

Innovation Centers to advance the development of improved seasonal influenza vaccines and 

broadly protective universal influenza vaccine candidates. In the first year of the program, 

NIAID has advanced four novel influenza vaccine candidates into manufacturing for future 

clinical trials.

Another ongoing threat to public health is the growing presence of antibiotic-resistant infections. 

Each year, more than 35,000 people die in the United States alone from antibiotic-resistant 

infections.2

 Overuse and misuse of antibiotics drives the emergence and spread of resistance,

1 CDC influenza information: www.cdc.gov/flu/about/burden/index.html 2 CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and 

Human Services, CDC; 2019. 
NIAID-20 

resulting in bacterial infections that are difficult—and sometimes impossible—to treat. Under a 

seven-year grant renewal, the Antibacterial Resistance Leadership Group (ARLG), a global 

consortium that leads a comprehensive clinical research agenda, will place renewed emphasis on 

developing better countermeasures against antibiotic-resistant bacteria. ARLG also will support 

the development and evaluation of improved diagnostic tests to identify antibiotic-resistant 

microbes and studies to optimize use of existing antibiotics. A recent ARLG clinical study 

showed that a rapid antibiotic susceptibility testing method enabled markedly faster adjustments 

in antibiotic therapy for bloodstream infections with Gram-negative bacteria such as E. coli when 

compared to conventional testing. These tests could help physicians provide timely, effective 

therapy while supporting antibiotic stewardship to mitigate the development of antibiotic 

resistance.

The emergence of multidrug-resistant tuberculosis (MDR-TB), which is resistant to the two most 

effective anti-TB drugs, is a growing concern. However, recent progress in improved TB 

diagnostics, therapeutic regimens, and prevention approaches offer promise against this bacterial 

disease, which remains the leading infectious cause of death globally. A NIAID-supported 

macaque study using BCG, the only licensed TB vaccine, given intravenously (IV) instead of by 

the standard route of a needle placed just under the skin, resulted in a dramatic increase in 

vaccine efficacy. These data provide a model to better understand the immune markers and 

mechanisms of protection and support further investigation of IV BCG in clinical trials. Other 

TB vaccine candidates are advancing as well, and vaccines will be a powerful tool against drugresistant strains. Current MDR-TB treatment regimens take 9 months or longer and may have 

substantial toxicity. Therefore, efforts to prevent latent TB infection from progressing to active 

MDR-TB are essential. To that end, a clinical trial is being conducted to compare the safety and 

efficacy of a new drug, delamanid, with that of the decades-old TB drug isoniazid for preventing 

active MDR-TB disease in people at high risk who are exposed to adult household members with 

MDR-TB. NIAID also is supporting a clinical trial to determine the optimal duration of an alloral regimen for treating MDR-TB that may be better tolerated than current treatment strategies. 

TB also is the leading cause of death for people living with HIV. Although TB mainly affects 

those of reproductive age, pregnant women often are excluded from clinical trials, leaving gaps 

in our understanding of the impact of TB drugs on mothers and newborns. A recent NIAIDsponsored clinical study evaluated treatment with isoniazid in women with HIV during 

pregnancy or 12 weeks after delivery and compared outcomes for the mothers, fetuses, and 

newborns. Findings from this study helped inform strategies to safely prevent TB in women 

with HIV who are pregnant or have recently given birth. 

Within the past decade, biennial spikes of a rare and sometimes serious condition called acute 

flaccid myelitis (AFM) have occurred in the United States. AFM is marked by sudden muscle 

weakness and paralysis, primarily in children. Many cases of AFM appear to be linked with 

non-polio enteroviruses, especially enterovirus D-68 (EV-D68), which usually causes only mild 

disease or asymptomatic infections. However, much about the disease remains unclear. In 2020, 

NIAID held a workshop to address the gaps in knowledge about AFM, including its possible 

cause(s) and the best avenues for developing therapies or preventive measures such as vaccines. 

A large, international study is ongoing to learn more about the incidence and distribution of this 

condition and to better understand how it develops and progresses in children. NIAID also is 
NIAID-21 

supporting efforts to develop an effective

EV-D68 vaccine candidate to combat the 

burden of this debilitating disease. 

Tick-borne diseases remain a serious and 

growing public health problem in the 

United States. NIAID continues its 

commitment to research on Lyme disease 

and other tick-borne diseases through 

advancing research priorities outlined in the 

NIH Strategic Plan for Tick-Borne Disease 

Research. Among the key priorities is the 

improvement of diagnostics for tick-borne 

diseases, which are critical for optimal 

treatment. Results from a recent NIAIDsupported study revealed that a new, rapid 

test for Lyme disease was more sensitive 

than current lab-based tests. These findings 

could translate into a faster, simpler, and 

more accurate point-of-care diagnostic for 

Lyme disease. NIAID also is advancing 

strategies to prevent the acquisition of tickborne diseases. Along with human vaccines

against tick-borne pathogens, this includes 

strategies that focus on reducing 

populations of ticks in the environment, as 

well as vector- and reservoir-targeted 

preventive approaches that can disrupt the 

transmission cycle of the pathogen. To 

advance these efforts, several new research 

projects focusing on the development of 

novel vaccine candidates and other 

innovative approaches for preventing Lyme 

and/or other tick-borne diseases were 

recently funded. For some tick-borne 

diseases, patients report long-term 

symptoms following treatment or in the 

absence of prompt treatment. Along with 

efforts to improve diagnosis and treatment, 

basic and clinical research projects will 

address key questions regarding why 

symptoms persist in some individuals, even 

after completion of treatment. NIAID will 

continue its efforts to bolster research and 

facilitate progress on this critical disease. 

 

PREPARING FOR A PANDEMIC RESPONSE

Preparedness for emerging and re-emerging 

diseases requires an existing research 

infrastructure to enable a rapid and effective 

response. Critical to these efforts are networks 

that provide research and response capacity 

against emerging threats. In 2021, NIAID will 

establish the Centers of Excellence for Influenza 

Research and Response (CEIRR). The CEIRR 

program will focus on the study of influenza in 

humans and at the human-animal interface and 

will address knowledge gaps that can advance 

universal influenza vaccine research. The 

CEIRR also will provide international research 

infrastructure needed to address zoonotic 

influenza outbreaks in humans or a pandemic. In 

addition to known threats, the COVID-19 

pandemic is a stark reminder of the ongoing 

threat of newly emerging pathogens. 

When SARS-CoV-2 emerged as a public health 

threat, NIAID foundational research on 

“prototype” pathogens—the related 

coronaviruses causing SARS and MERS—

provided critical background information to 

enable the rapid development of vaccines and 

therapies for this new coronavirus. In addition, 

existing research infrastructure, including the 

Centers for Translational Research, supported 

studies of the antiviral drug remdesivir, which 

was the first therapeutic demonstrated to 

improve outcomes for patients with severe 

COVID-19 disease. 

For large-scale vaccine trials, NIAID built on 

existing HIV clinical research networks to 

establish the COVID Prevention Network. In FY 

2020, in response to the growing number of 

threats spilling over from animal hosts, NIAID 

established the new Centers for Research in 

Emerging Infectious Diseases (CREID). This 

global network will advance our understanding of 

how and where viruses and other pathogens 

emerge from wildlife and cause disease in 

humans. The CREID network also will enable 

early warnings of emerging diseases, facilitating 

a rapid response and potentially curbing potential 

disease threats before they develop into 

widespread pandemics. 
NIAID-22 

Budget Policy: 

The FY 2022 President’s Budget request for the extramural component of Biodefense and 

Emerging Infectious Diseases research supported by NIAID is $2,114.8 million, an increase of 

$85.0 million or 4.2 percent above the FY 2021 Enacted level. NIAID will continue to conduct 

and support research to better understand viruses, bacteria, and other infectious agents that cause 

diseases of public health concern. NIAID will promote basic and clinical research aimed at the 

development of vaccines, therapeutics and diagnostics for emerging and re-emerging infectious 

diseases including advancing a universal influenza vaccine and therapeutics against emerging 

infectious diseases and antibiotic resistant bacteria. FY 2022 resources will also support the 

development of medical countermeasures and new platform technologies against biodefense and 

emerging infectious disease pathogens. 

NIAID will continue to prioritize the development of a safe and effective “universal” influenza 

vaccine that would provide long-lasting protection against multiple strains of the virus, including 

strains with the potential to cause a pandemic. NIAID is advancing several promising universal 

influenza vaccine candidates into clinical trials and is also advancing the use, development, and 

testing of EVD vaccine candidates to address the reemergence of Ebola. In addition, NIAID will 

continue research on Lyme disease and other tick-borne diseases through advancing research 

priorities as outlined in the NIH Strategic Plan for Tick-Borne Disease Research.

Infectious and Immunologic Diseases 

NIAID conducts and supports basic and clinical research to better understand, diagnose, treat, 

and prevent infectious diseases and immune-mediated disorders—many of which have farreaching global consequences—including malaria, neglected tropical diseases, hepatitis, TB, 

sexually transmitted infections (STIs), fungal diseases, autoimmune diseases, asthma, and 

allergic diseases. 

Food allergy affects approximately 11 percent of adults and 8 percent of children in the United 

States, and many are allergic to more than one food.3,4 Oral immunotherapy (OIT)—the 

repeated exposure to small, increasing amounts of an allergen in a controlled setting—can 

desensitize individuals, decreasing the likelihood of a severe allergic reaction. Based on 

promising results from a small study, NIAID recently launched the Omalizumab as Monotherapy 

and as Adjunct Therapy to Multi-Allergen Immunotherapy in Food Allergic Children and 

Adults, or OUtMATCH, study. This large clinical trial is testing whether the drug omalizumab 

injected every 2 or 4 weeks, either alone or with multi-allergen OIT, can increase a person’s 

ability to tolerate multiple foods to which they are allergic. Sesame allergies, which often lead to 

severe reactions in children, are difficult to diagnose with standard allergy tests. Using data from 

antibody tests in children with food allergies combined with results of an oral food challenge, 

Scientists at NIAID developed a mathematical model to predict the probability that a child with 

food allergy also is allergic to sesame. Further studies will need to validate the model so that it 

3 Gupta RS, et al. JAMA Netw Open 2019 Jan 4;(2)1:e185630 4 Gupta RS, et al. Pediatrics 2018 Dec;(142)6:e20181235.
NIAID-23 

can eventually be applied to clinical practice, which will allow doctors to better guide treatment 

for children with food allergies. Allergies are more likely to develop in people with atopic 

dermatitis, an immune disorder that causes red, itchy skin. However, some food allergy tests are 

less accurate in people with atopic dermatitis. To improve diagnosis, a new study aims to 

identify threshold levels of IgE (an allergic antibody) in blood samples from people with atopic 

dermatitis that would indicate an allergy to milk or peanut. Finally, two national surveys to 

assess awareness of and adherence to NIAID-led guidelines for peanut allergy prevention 

showed strong use of the guidelines by allergists and identified barriers to greater use by 

pediatricians. 

STIs are a global public health challenge, with one million new cases of gonorrhea, syphilis, 

chlamydia, and trichomoniasis diagnosed each 

day worldwide.5

 Left untreated, STIs can 

result in serious health complications and often 

increase the risk of HIV transmission and 

acquisition. Additionally, increasing 

antimicrobial resistance will make STIs more 

difficult to treat as existing drugs become less 

effective. To facilitate the development of new 

and improved public health interventions, 

NIAID funded six new STI Cooperative 

Research Centers focusing on vaccine 

development for syphilis, gonorrhea, and 

chlamydia. NIAID also is translating results 

from basic research into clinical trials needed 

to move new interventions into clinical 

practice. For example, a large clinical trial was 

initiated to examine whether the antibiotic 

doxycycline taken soon after sexual contact 

without a condom is safe and effective against 

gonorrhea, chlamydia, and syphilis. Although 

doxycycline is approved by the U.S. Food and 

Drug Administration for other indications, this 

would expand its application to disease 

prevention in individuals at high risk of 

acquiring STIs. A recent Phase 2 clinical trial 

demonstrated that the investigational antibiotic 

zoliflodacin is effective against uncomplicated 

gonorrhea, which has progressively developed 

resistance to each of the current antibiotics 

used to treat it. Zoliflodacin is undergoing 

further testing against gonorrhea in a large, 

multicenter Phase 3 clinical trial sponsored by 

the Global Antibiotic Research and 

Development Partnership. 

5 Rawley J, et al. Bull World Health Organ 2019 Aug 1;(97)8:548-62. 

ADVANCING THERAPIES FOR MULTIPLE 

SCLEROSIS

Multiple sclerosis (MS) is an autoimmune 

disease in which a person’s own immune cells 

attack the central nervous system, causing 

neurological problems such as weakness, lack of 

coordination, vision loss, and problems with 

cognitive functioning or memory. Approved 

medicines for MS vary in effectiveness, safety, 

and cost. Advances in cell-based therapies have 

paved the way for their application in 

autoimmune diseases such as MS. In an 

approach called autologous hematopoietic stem 

cell transplantation (AHSCT), blood-forming stem 

cells are collected from the patient and the 

patient is then given high-dose chemotherapy to 

destroy their immune system. The person’s own 

stem cells are then infused back to repopulate 

the individual’s immune system, allowing a reset 

in which the new immune cells no longer attack 

the central nervous system. Previous 

studies supported by NIAID and others have 

suggested that AHSCT may be an effective and 

durable treatment for individuals with severe 

relapsing-remitting MS. A NIAID-supported 

clinical trial, called Best Available Therapy versus 

Autologous Hematopoietic Stem Cell Transplant 

for Multiple Sclerosis (BEAT-MS), will compare 

AHSCT to the best available biologics and other 

therapies for people with severe relapsingremitting MS. Participants will be monitored for 6 

years to assess disease severity and quality of 

life, and the newly developed immune system in 

participants undergoing AHSCT will be compared 

to the immune features of participants receiving 

best available (non–stem cell) therapies.
NIAID-24 

Chronic infection with hepatitis B virus (HBV) can cause serious health problems, such as 

cirrhosis, liver failure, and liver cancer. Despite a highly effective preventive vaccine, 

approximately 257 million people worldwide are chronically infected.6

 NIAID recently led the 

development of a trans-NIH strategic plan to cure HBV 7and reduce its sizable public health 

burden. The plan, released in fall 2019, includes strategic priorities to advance the understanding 

of HBV biology, develop needed tools and resources, and develop cure strategies. 

Fungal infections such as coccidioidomycosis (Valley fever), histoplasmosis, and blastomycosis 

are particularly common in certain regions of the United States and can cause severe disease in 

healthy individuals. NIAID is addressing this growing health threat by encouraging fundamental 

research on fungal pathogens and the development and evaluation of therapies and diagnostics 

for these diseases. Currently, a Phase 1 clinical trial is enrolling healthy volunteers to evaluate 

the safety of various oral doses of the experimental anti-fungal drug VT-1598 and to understand 

how the drug is processed in the body. 

Malaria, a mosquito-borne disease caused by Plasmodium parasites, causes symptoms including 

high fever, chills, and flu-like illness, and can be fatal. Approximately 2,000 cases of malaria are 

diagnosed each year in the United States. Worldwide in 2018, an estimated 228 million cases of 

malaria occurred and 405,000 people died of the disease, mostly children in Africa.8 NIAID has 

a long-standing commitment to conduct and support research to reduce morbidity and mortality 

due to malaria and, ultimately, to eradicate the disease. Researchers at NIAID discovered and 

isolated a monoclonal antibody (mAb) against malaria, called CIS43, from a volunteer who 

received an investigational malaria vaccine. A Phase 1 clinical trial is assessing the safety and 

efficacy of a modified, more potent version of this mAb, CIS43LS, in healthy volunteers. 

Pregnant women are highly susceptible to malaria infection, which has substantial health risks 

for the woman, her fetus, and the newborn. However, no malaria vaccine trials have been 

conducted specifically in pregnant women or women of childbearing potential thus far. The 

PfSPZ malaria vaccine candidate has been shown to be safe in previous studies and will be tested 

in a Phase 2 clinical trial in women of childbearing potential during malaria transmission season 

in Mali. Women who become pregnant will be monitored for the duration of their pregnancy 

and babies and their mothers will be followed for one year after birth.

NIAID maintains a robust transplantation research program to improve the long-term success of 

organ, tissue, and cell transplantation. People with HIV have a growing prevalence of end-stage 

kidney disease and are nearly three times more likely to die while on kidney dialysis than people 

without HIV. Recently, a clinical trial supported by NIAID and the National Cancer Institute

found that people with HIV who received a kidney transplant from a deceased donor with HIV 

had high overall survival and survival of the transplanted organ after 5 years. This study 

demonstrates that the pool of available kidneys for people with HIV can be expanded by 

including donors with HIV, making more kidneys available for all who are awaiting a 

transplant. 

6 WHO hepatitis B fact sheet: www.who.int/news-room/fact-sheets/detail/hepatitis-b 7 https://www.niaid.nih.gov/sites/default/files/Trans-NIH-Hep-B-Strategic-Plan-2019.pdf 8 CDC malaria information: www.cdc.gov/parasites/malaria/index.html
NIAID-25 

Budget Policy: 

The FY 2022 President’s Budget estimate for the extramural component of Infectious and 

Immunologic Diseases research is $1,493.1 million, an increase of $58.3 million or 4.1 percent 

above the FY 2021 Enacted level. NIAID will continue to advance long-range research priorities 

in infectious and immunologic diseases and to support basic and clinical research aimed at the 

development of countermeasures, such as therapeutics, vaccines, and diagnostics for emerging 

and re-emerging infectious diseases, including antibiotic resistant bacteria. The FY 2022 request 

will support NIAID’s commitment and long-term interest in fundamental immunology and fund 

research on organ transplantation, malaria, neglected tropical diseases, hepatitis, TB, sexually 

transmitted infections (STIs), fungal diseases, autoimmune diseases, asthma, and allergic 

diseases. 

Intramural Research Program (IRP)

The IRP remains at the forefront of efforts to translate basic science discoveries into new tools 

and strategies to improve human health and address urgent public health needs. The program has 

three components: 1) the Division of Intramural Research, comprising more than 125 principal 

investigators in Maryland and at the Rocky Mountain Laboratories in Montana who lead a wide 

range of basic, translational, and clinical research efforts; 2) the Vaccine Research Center, which 

applies fundamental advances to design and develop vaccines and biologic therapies against 

infectious diseases; and 3) the Division of Clinical Research, which plays an integral role in 

facilitating the efficient and effective performance of NIAID clinical research programs, both 

domestically and internationally, and in managing special projects as directed by the NIAID 

director.

 

The unique nature of the IRP, along with access to the NIH Clinical Center and longstanding 

U.S. and international partnerships, allows NIAID to execute high-risk and long-term studies and

rapidly respond to global public health emergencies such as the recent Ebola outbreaks and the 

COVID-19 pandemic. Early during the COVID-19 response, studies conducted by NIAID 

researchers provided fundamental knowledge about SARS-CoV-2 structure, stability, and how 

the virus causes disease. Building on these studies, NIAID researchers, in collaboration with 

biotechnology company Moderna, based in Cambridge, Massachusetts, and researchers from the 

University of North Carolina at Chapel Hill, Vanderbilt University Medical Center in Nashville, 

and the University of Texas at Austin, conducted the preclinical research on a promising vaccine 

candidate, mRNA-1273. The mRNA-1273 vaccine is 94.1 percent efficacious in preventing 

symptomatic COVID-19 and was issued an Emergency Use Authorization (EUA) in December 

2020. The vaccine has been administered to millions of people and is a critical tool for ending 

the COVID-19 pandemic. The rapid mobilization of this critical research infrastructure 

highlights the unique capacity and preparedness of the NIAID intramural research program to 

respond to public health emergencies. 

In addition to responding to the COVID-19 pandemic, NIAID researchers continue to advance 

research with broad health impact, including studies targeted against diseases spread by vectors 

such as mosquitoes. Recently, NIAID scientists conducted a Phase 1 clinical trial of a promising 

candidate vaccine that targets components of mosquito saliva to prevent transmission of multiple 

mosquito-borne infections. In contrast to traditional vaccination strategies that are directed 

toward specific parasites, bacteria, or viruses, this strategy of targeting mosquito saliva could 
NIAID-26 

provide broader protection against a variety of pathogens spread by mosquitoes. Intramural 

scientists also are leading research on the role of the microbiota—the community of microbes 

that colonize the human body in human health. Recent advances include new insights on the 

long-term effects of the microbiota in wound repair and an international study showing that a 

beneficial bacterium commonly found in probiotic digestive supplements helps eliminate 

Staphylococcus aureus, a type of bacteria that can cause serious antibiotic-resistant infections. 

Another study is investigating the possibility that immune responses to specific types of bacteria 

in the gut may predict which patients develop severe COVID-19 disease while others remain 

asymptomatic. 

Basic research conducted by NIAID investigators provides the foundational knowledge that can 

be applied to the development of novel interventions to treat disease. In a highly collaborative 

study, NIAID scientists and their colleagues recently found that when the immune system first 

responds to infectious agents such as viruses or bacteria, a natural brake on the response prevents 

overactivation. This brake, a molecule called CD47, is turned on by certain pathogens including 

SARS-CoV-2 and is a potential target for broad-spectrum immunotherapies for infectious 

diseases. NIAID IRP researchers also collaborate with their NIH partners on a range of 

initiatives to advance groundbreaking discoveries, such as the trans-NIH Blood and Immune 

Deficiency–Cellular Therapy Program, launched in 2019, to systematically assess, treat, and 

monitor outcomes for patients with rare blood and immune disorders. 

Budget Policy: 

The FY 2022 President’s Budget request for Intramural Research is $807.5 million, an increase

of $24.7 million or 3.2 percent compared with the FY 2021 Enacted level. The FY 2022 

Intramural Research plan supports NIAID’s critical long-range research priorities with funding 

carefully aligned to support key research activities. These include continued support for all 

aspects of research on infectious diseases such as AIDS, malaria, and influenza, as well as 

research on causative agents, vectors, and the human host. In addition, NIAID is developing 

countermeasures against bioterrorism through basic research and its strong clinical research 

component, allowing vital lab discoveries to be rapidly translated into methods to prevent, 

diagnose, or treat disease. 

Research Management and Support (RMS) 

RMS activities provide administrative, budgetary, logistical, and scientific support in the review, 

award, and monitoring of research grants, training awards, and research and development 

contracts. RMS activities include strategic planning, facilitation, and evaluation of Institute 

programs, as well as regulatory compliance, international coordination, and liaison activities with 

other federal agencies, Congress, and the public. 

Budget Policy: 

The FY 2022 President’s Budget request for RMS is $398.7 million, an increase of $11.2 million 

or 2.9 percent compared with the FY 2021 Enacted level. The budget increase will support 

ongoing administrative efforts and cover the FY 2022 proposed pay increase. 
NIAID-27 

Fiscal Year Budget Estimate to 

Congress House Allowance Senate Allowance Appropriation

2013

Rescission

Sequestration

$4,495,307,000 $4,508,932,000 $4,490,711,484

$8,981,423

($225,402,837)

2014

Rescission

$4,578,813,000 $4,548,383,000 $4,358,841,000

$0

2015

Rescission

$4,423,357,000 $4,358,841,000

$0

2016

Rescission

$4,614,779,000 $4,512,918,000 $4,710,342,000 $4,629,928,000

$0

20171

Rescission

$4,715,697,000 $4,738,883,000 $4,961,305,000 $4,906,638,000

$0

2018

Rescission

$3,782,670,000 $5,005,813,000 $5,127,866,000 $5,260,210,000

$0

2019

Rescission

$4,761,948,000 $5,368,029,000 $5,506,190,000 $5,523,324,000

$0

2020

Rescission

Supplemental

$4,754,379,000 $5,811,268,000 $5,937,816,000 $5,885,470,000

$0

$1,542,000,000

2021

Rescission

$5,885,470,000 $6,013,087,000 $6,142,540,000 $6,069,619,000

$0

2022 $6,245,926,000

1 Budget Estimate to Congress includes mandatory financing.

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Appropriations History
NIAID-28 

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NIAID-29 

Source of Funding FY 2020 Final FY 2021 Enacted FY 2022 President's 

Budget

Appropriation $5,885,470 $6,069,619 $6,245,926

Secretary's Transfer 0 0 0

Subtotal, adjusted appropriation $5,885,470 $6,069,619 $6,245,926

OAR HIV/AIDS Transfers -9,275 -2,548 0

Subtotal, adjusted budget authority $5,876,195 $6,067,071 $6,245,926

Unobligated balance, start of year 0 0 0

Unobligated balance, end of year 0 0 0

Subtotal, adjusted budget authority $5,876,195 $6,067,071 $6,245,926

Unobligated balance lapsing -21 0 0

Total obligations $5,876,174 $6,067,071 $6,245,926

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Amounts Available for Obligation1

(Dollars in Thousands)

1 Excludes the following amounts (in thousands) for reimbursable activities carried out by this account:

 FY 2020 - $42,877 FY 2021 - $44,592 FY 2022 - $45,885 
NIAID-30 

FY 2021 Enacted FY 2022 President's 

Budget

FY 2022

+/-

FY 2021 Enacted

Total compensable workyears:

Full-time equivalent

Full-time equivalent of overtime and holiday hours

Average ES salary

Average GM/GS grade

Average GM/GS salary

Average salary, Commissioned Corps (42 U.S.C. 

207)

Average salary of ungraded positions

2,051

0

$200

12.6

$121

$104

$162

2,051

0

$205

12.6

$124

$107

$165

0

0

$5

0.0

$3

$2

$4

OBJECT CLASSES FY 2021 Enacted FY 2022 President's 

Budget

FY 2022

+/-

FY 2021

11.1

11.3

11.5

11.7

11.8

Personnel Compensation

Full-Time Permanent

Other Than Full-Time Permanent

Other Personnel Compensation

Military Personnel

Special Personnel Services Payments

180,599

77,930

11,024

4,488

25,820

184,708

79,703

11,274

4,612

26,408

4,109

1,773

251

125

587

11.9 Subtotal Personnel Compensation $299,860 $306,705 $6,844

12.1

12.2

13.0

Civilian Personnel Benefits

Military Personnel Benefits

Benefits to Former Personnel

96,714

3,769

0

101,849

3,874

0

5,136

105

0

Subtotal Pay Costs $400,343 $412,427 $12,084

21.0

22.0

23.1

23.2

23.3

24.0

25.1

25.2

25.3

25.4

25.5

25.6

25.7

25.8

Travel & Transportation of Persons

Transportation of Things

Rental Payments to GSA

Rental Payments to Others

Communications, Utilities & Misc. Charges

Printing & Reproduction

Consulting Services

Other Services

Purchase of goods and services from government 

accounts

Operation & Maintenance of Facilities

R&D Contracts

Medical Care

Operation & Maintenance of Equipment

Subsistence & Support of Persons

4,483

1,749

6

68

2,284

0

203,536

168,795

617,358

16,671

683,336

6,016

28,999

0

4,565

1,783

6

69

2,301

0

212,389

176,058

648,297

16,896

748,378

6,238

29,609

0

82

34

0

1

17

0

8,853

7,263

30,939

225

65,041

223

610

0

25.0 Subtotal Other Contractual Services $1,724,711 $1,837,865 $113,153

26.0

31.0

32.0

33.0

41.0

42.0

43.0

44.0

Supplies & Materials

Equipment

Land and Structures

Investments & Loans

Grants, Subsidies & Contributions

Insurance Claims & Indemnities

Interest & Dividends

Refunds

49,991

41,467

959

0

3,841,001

0

8

0

51,309

42,492

976

0

3,892,125

0

8

0

1,318

1,024

17

0

51,124

0

0

0

Subtotal Non-Pay Costs $5,666,728 $5,833,499 $166,771

Total Budget Authority by Object Class $6,067,071 $6,245,926 $178,855

1 Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Authority by Object Class1

(Dollars in Thousands)
NIAID-31 

OBJECT CLASSES FY 2021 Enacted FY 2022 President's 

Budget

FY 2022

+/-

FY 2021

Personnel Compensation

Full-Time Permanent (11.1)

Other Than Full-Time Permanent (11.3)

Other Personnel Compensation (11.5)

Military Personnel (11.7)

Special Personnel Services Payments (11.8)

$180,599

77,930

11,024

4,488

25,820

$184,708

79,703

11,274

4,612

26,408

$4,109

1,773

251

125

587

Subtotal Personnel Compensation (11.9) $299,860 $306,705 $6,844

Civilian Personnel Benefits (12.1)

Military Personnel Benefits (12.2)

Benefits to Former Personnel (13.0)

$96,714

3,769

0

$101,849

3,874

0

$5,136

105

0

Subtotal Pay Costs $400,343 $412,427 $12,084

Travel & Transportation of Persons (21.0)

Transportation of Things (22.0)

Rental Payments to Others (23.2)

Communications, Utilities & Misc. Charges (23.3)

Printing & Reproduction (24.0)

Other Contractual Services:

Consultant Services (25.1)

Other Services (25.2)

Purchases from government accounts (25.3)

Operation & Maintenance of Facilities (25.4)

Operation & Maintenance of Equipment (25.7)

Subsistence & Support of Persons (25.8)

$4,483

1,749

68

2,284

0

203,536

168,795

466,544

16,671

28,999

0

$4,565

1,783

69

2,301

0

212,389

176,058

492,149

16,896

29,609

0

$82

34

1

17

0

8,853

7,263

25,604

225

610

0

Subtotal Other Contractual Services $884,545 $927,100 $42,555

Supplies & Materials (26.0) $49,991 $51,309 $1,318

Subtotal Non-Pay Costs

Total Administrative Costs

$943,121

$1,343,464

$987,128

$1,399,555

$44,007

$56,091
NIAID-32 

OFFICE/DIVISION

FY 2020 Final FY 2021 Enacted FY 2022 President's Budget

Civilian Military Total Civilian Military Total Civilian Military Total

Division of Acquired Immunodeficiency

Direct:

Reimbursable:

Total:

Division of Allergy, Immunology, and Transplantation

Direct:

Reimbursable:

Total:

Division of Clinical Research

Direct:

Reimbursable:

Total:

Division of Extramural Activities

Direct:

Reimbursable:

Total:

Division of Intramural Research

Direct:

Reimbursable:

Total:

Division of Microbiology and Infectious Diseases

Direct:

Reimbursable:

Total:

Office of the Director

Direct:

Reimbursable:

Total:

Vaccine Research Center

Direct:

Reimbursable:

Total:

151

-

151

99

-

99

91

-

91

211

-

211

691

-

691

176

-

176

390

-

390

119

-

119

8

-

8

-

-

-

9

-

9

-

-

-

13

-

13

8

-

8

2

-

2

1

-

1

159

-

159

99

-

99

100

-

100

211

-

211

704

-

704

184

-

184

392

-

392

120

-

120

155

-

155

103

-

103

90

-

90

233

-

233

725

-

725

181

-

181

412

-

412

116

-

116

7

-

7

-

-

-

8

-

8

-

-

-

11

-

11

7

-

7

2

-

2

1

-

1

162

-

162

103

-

103

98

-

98

233

-

233

736

-

736

188

-

188

414

-

414

117

-

117

155

-

155

103

-

103

90

-

90

233

-

233

725

-

725

181

-

181

412

-

412

116

-

116

7

-

7

-

-

-

8

-

8

-

-

-

11

-

11

7

-

7

2

-

2

1

-

1

162

-

162

103

-

103

98

-

98

233

-

233

736

-

736

188

-

188

414

-

414

117

-

117

Total 1,928 41 1,969 2,015 36 2,051 2,015 36 2,051

Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

FTEs supported by funds from Cooperative Research and 

Development Agreements. 0 0 0 0 0 0 0 0 0

FISCAL YEAR Average GS Grade

2018 12.6

2019 12.7

2020 12.6

2021 12.6

2022 12.6
NIAID-33 

GRADE FY 2020 Final FY 2021 Enacted FY 2022 President's 

Budget

Total, ES Positions

Total, ES Salary

2

394,600

2

400,618

2

409,732

General Schedule

GM/GS-15 197 181 181

GM/GS-14 427 434 434

GM/GS-13 388 387 387

GS-12 229 243 243

GS-11 114 121 121

GS-10 1 1 1

GS-9 67 71 71

GS-8 26 28 28

GS-7 53 56 56

GS-6 5 5 5

GS-5 8 8 8

GS-4 8 8 8

GS-3 8 8 8

GS-2 0 0 0

GS-1 1 1 1

Subtotal 1,532 1,552 1,552

Commissioned Corps (42 U.S.C. 207)

Assistant Surgeon General 0 0 0

Director Grade 12 11 11

Senior Grade 12 11 11

Full Grade 9 9 9

Senior Assistant Grade 4 4 4

Assistant Grade 0 0 0

Subtotal 37 35 35

Ungraded 467 467 467

Total permanent positions 1,556 1,612 1,612

Total positions, end of year 2,038 2,056 2,056

Total full-time equivalent (FTE) employment, end of year 1,969 2,051 2,051

Average ES salary

Average GM/GS grade

Average GM/GS salary

197,300

12.6

119,355

200,309

12.6

121,175

204,866

12.6

123,932