f 

National Institute of 

Allergy and Infectious 

Diseases

CONGRESSIONAL JUSTIFICATION 

FY 2024

Department of Health and Human Services

National Institutes of Health
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NIAID-1 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases (NIAID) 

FY 2024 Budget Table of Contents 

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

IC Fact Sheet ............................................................................................................................... 5 

Major Changes in the Budget Request ........................................................................................ 7 

Budget Mechanism Table ........................................................................................................... 8 

Appropriations Language ............................................................................................................ 9 

Summary of Changes ................................................................................................................ 10 

Budget Graphs .......................................................................................................................... 11 

Organization Chart .................................................................................................................... 12 

Budget Authority by Activity Table ......................................................................................... 13 

Justification of Budget Request ................................................................................................ 14 

Appropriations History ............................................................................................................. 26 

Authorizing Legislation ............................................................................................................ 27 

Amounts Available for Obligation............................................................................................ 28 

Budget Authority by Object Class ............................................................................................ 29 

Salaries and Expenses ............................................................................................................... 30 

Detail of Full-Time Equivalent Employment (FTE) ................................................................ 31 

Detail of Positions ..................................................................................................................... 32 

General Notes

1. FY 2023 Enacted levels cited in this document include the effects of the FY 2023 

HIV/AIDS transfer, as shown in the Amounts Available for Obligation table.

2. Detail in this document may not sum to the subtotals and totals due to rounding.
NIAID-2 

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NIAID-3 

DIRECTOR’S OVERVIEW

Director’s Overview

The National Institute of Allergy and Infectious Diseases (NIAID) conducts 

and supports biomedical research to develop and improve medical 

countermeasures to protect public health. As part of its dual mandate, NIAID 

also leads the research response to emerging disease threats that have a global 

impact. Together with other federal agencies, and with collaborators in 

industry, academia, and international research partners, NIAID continues to be 

at the forefront of biomedical science in addressing the research gaps in 

vaccine and therapeutic development for emerging infectious agents and 

diseases. 

NIAID Acting 

Director

Hugh Auchincloss, Jr., M.D.

NIAID is dedicated to ensuring the translation of basic research advances into 

candidate vaccines and therapeutics to address public health needs for all. 

These efforts include the continued investment to maintain active partnerships 

and clinical infrastructure across the globe and facilitating diverse 

representation in clinical trials to ensure the medical countermeasures being 

developed will be safe and effective broadly. NIAID supports community 

engagement activities to increase the number of underrepresented minorities in clinical trials. 

For example, the HIV Vaccine Treatment Network (HVTN) established relationships with 

Black, African American, and Latinx communities to boost participation in trials of HIV 

interventions. These relationships proved critical during the COVID-19 pandemic when the 

HVTN rapidly enrolled participants from different ethnic groups across the country in clinical 

trials of COVID-19 vaccines. NIAID values the importance of a diverse workforce, both within 

the Institute and among the researchers that it supports, to advance its mission. With 

representatives across the Institute, the NIAID Diversity, Equity, Inclusion, and Accessibility 

(DEIA) Council is charged with fostering a diverse and inclusive workforce at NIAID and 

enhancing the diversity of the extramural workforce. 

As the effects of the COVID-19 pandemic continue and as we monitor for emerging SARS-CoV2 variants of concern, mitigating the impact of some existing medical countermeasures, 

advancing next-generation vaccines, diagnostics, and therapeutics is a priority. NIAID scientists 

and funded investigators are developing novel vaccine candidates with the goal of providing 

broad immunity against multiple coronavirus variants. One approach using mosaic nanoparticles 

displaying antigens derived from SARS-CoV-2 and other coronaviruses has demonstrated 

protection against multiple related viruses in animal models. Additionally, NIAID recently 

awarded several large program project grants to support a multidisciplinary approach to COVID19 vaccines incorporating expertise in coronavirus biology, immunology, immunogen design, 

and innovative vaccine and adjuvant platform technologies. These resources will be applied to 

the development of vaccine candidates that provide broad immunity to multiple coronaviruses. 

To increase the effectiveness of SARS-CoV-2 vaccines, researchers are advancing nasal vaccines 

that elicit rapid protection at the mucosal surfaces to prevent or limit infection and transmission. 

Recently, NIAID intramural investigators used modified vaccinia virus Ankara (MVA) as a 

vector to deliver the spike protein of SARS-CoV-2 intranasally in mice to generate a faster and 
NIAID-4 

broader antibody response than traditional intramuscular vaccine administration methods. 

NIAID researchers also have developed a pediatric nasal vaccine that targets both SARS-CoV-2 

and human parainfluenza virus type 3 (HPIV3), a common pediatric disease agent. This vaccine 

was safe and effective at preventing SARS-CoV-2 from spreading in the nose and lungs in 

animal models. Plans are currently underway to evaluate this vaccine candidate in a Phase 1 

clinical trial in young children. 

In addition to safe and effective vaccines, there remains a critical need to develop safe and 

effective antiviral drugs to prevent and treat COVID-19. NIAID, along with the National Center 

for Advancing Translational Sciences (NCATS), the NIH Office of Research Infrastructure 

Programs (ORIP), and the Administration for Strategic Preparedness and Response’s Biomedical 

Advanced Research and Development Authority (BARDA), established the Antiviral Program 

for Pandemics (APP) to speed development of therapeutics for SARS-CoV-2 and other viruses 

with pandemic potential. As part of this effort, NIAID established nine Antiviral Drug 

Discovery (AViDD) Centers for Pathogens of Pandemic Concern. These centers will conduct 

research on early-stage identification and validation of novel viral targets that can inform the 

development of small molecule drugs and biotherapeutics. 

The spread of mpox in the United States remains a concern as the need for vaccines for at-risk 

individuals has outpaced the available supply. Building on data from previous research studies, 

NIAID is evaluating the immunogenicity and safety of different administration routes of the 

currently approved JYNNEOS vaccine. Intradermal administration of this vaccine uses a lower 

dose to induce a similar immune response and can expand the number of available vaccine doses. 

This clinical trial is enrolling healthy volunteers and at-risk individuals, including those with 

controlled HIV infection, to ensure that any changes to the dosing strategy will be applicable to 

those who will benefit the most. 

Currently, no approved treatments for human mpox disease are available, highlighting a gap in 

the need for interventions that may curb the current increase in cases of non-endemic and 

endemic mpox. Tecovirimat (TPOXX), approved by the U.S. Food and Drug Administration 

(FDA) for the treatment of human smallpox disease, has shown promise in animal models of 

mpox and in small numbers of human patients. NIAID is pursuing two separate clinical trials to 

evaluate the effectiveness of this drug in humans. Taking advantage of established infrastructure 

for the conduct of clinical trials for HIV interventions, the Study of Tecovirimat for Human 

mpox virus (STOMP) was launched in September 2022 in the United States to evaluate safety in 

an outpatient setting for both adults and children and determine if tecovirimat reduces the time to 

clinical resolution of disease. It is also critical to study drug efficacy in areas where the disease 

is endemic to ensure it is safe and effective in populations where the drug may be needed 

routinely. In this regard, NIAID has a longstanding and active collaboration with the National 

Institute for Biomedical Research (INRB) and the Ministry of Health in the Democratic Republic 

of the Congo (DRC). In October 2022, NIAID and IRNB launched a clinical trial in the DRC to 

detect whether adding tecovirimat to the standard of care will decrease time to disease resolution. 
FACT SHEET

ABOUT NIAID

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 60 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 Acting Director

Hugh Auchincloss, Jr., M.D.

RESEARCH HIGHLIGHTS

It is important to 

understand the safety 

and immunogenicity of 

COVID-19 vaccine 

boosters of either the 

identical primary 

vaccine or one that is 

different. A study using 

the Moderna, J&J, and 

Pfizer vaccines as 

boosters showed that 

all had acceptable 

safety profiles and 

were immunogenic in 

adults who had 

completed a different 

primary vaccine series. 

Preventing SARSCoV-2 from 

establishing infection 

at the mucosal 

surfaces is the focus of 

next generation 

COVID-19 vaccines. 

NIAID supports the 

development of 

several nasal vaccine 

candidates that have 

shown promise in preclinical animal models. 

Efforts are underway 

to advance these into 

Phase 1 clinical trials.

Current typhoid 

vaccines are difficult to 

manufacture, making 

global implementation 

challenging. Addition of 

the Advax-CpG 

adjuvant, created 

within the NIAID 

Adjuvant Discovery 

Program, to the newly 

developed, low-cost 

Typhax vaccine elicited 

strong immune 

responses in animal 

studies. Early-stage 

clinical trials are 

planned in Australia. 

Understanding the risk 

factors for COVID-19 

disease is important for 

implementation of public 

health measures. The 

NIAID Human 

Epidemiology and 

Response to SARSCoV-2 (HEROS) study 

found that people with 

food allergies are less 

likely to become infected 

with the virus. Asthma 

does not increase the 

risk of infection, but 

obesity and high body 

mass index do.

FACTS AND FIGURES 

Malaria affects 

approximately 200 to 

400 million people 

worldwide per year, 

making interventions to 

reduce morbidity and 

mortality a critical 

public health need. 

NIAID evaluated the 

safety and efficacy of 

two monoclonal 

antibodies, CIS43LS 

and L9LS, and 

demonstrated strong 

efficacy in experimental 

human challenge and 

field studies.

2,017

1,328

FULL TIME 

EQUIVALENT

EMPLOYEES

Averaged over FY 2019-FY 2022 

FUNDED PRINCIPAL 

INVESTIGATORS

FUNDING HISTORY

5,876 6,049 6,322 6,562 6,562

2020 2021 2022 2023 2024*

Fiscal Year 

$ (in millions)

*President’s budget request
RESEARCH ADVANCES

The mRNA platform technology used to develop the successful COVID-19 vaccines is 

now being applied to develop several candidate vaccines against HIV. 

► In 2021, NIAID scientists showed that an experimental HIV mRNA vaccine was safe

and prompted the desired antibody and cellular immune responses in mice and nonhuman primates.

► In 2022, NIAID launched a clinical trial to examine whether three additional

experimental HIV mRNA vaccines are safe and can induce immune responses in

people. These investigational vaccine candidates are designed to induce immune

responses against the surface HIV proteins that facilitate entry into human cells.

Valley fever lifecycle Valley fever, caused by the soil-dwelling fungi Coccidioides immitis and Coccidiodes

posadasii, is endemic in parts of southwestern U.S. Infection with Coccidioides can 

cause fatigue, cough, fever, and rashes. Each year, thousands of people in the United 

States experience severe cases, which can lead to long-term respiratory symptoms. 

► In 2022, NIAID awarded four grants to establish a network of Coccidioidomycosis

Collaborative Research Centers to advance diagnostics, therapeutics, and

vaccines for this fungal disease.

► In September 2022, NIAID published the Strategic Plan for Research to Develop

a Valley fever Vaccine.

To address the shortage of human organs for transplantation, NIAID established The 

Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP), which 

aims to develop preclinical porcine to non-human primate (NHP) models of islet, kidney, 

heart, lung, and liver xenotransplantation. 

► NIAID investigators have overcome many obstacles to successful xenotransplantation

with survival and function of pig kidney, and heart xenotransplants in NHPs extending

up to 500 days and 6 months, respectively.

► These achievements are paving the way toward a xenotransplantation clinical trial.

 Selected Future Research Initiatives 

► HIV CURE. Projects focused on cure interventions

administered during HIV infection near the start of

antiretroviral therapy (ART) to achieve a sustained ARTfree remission.

► DURABLE PROTECTIVE IMMUNITY. Research to

improve understanding of how vaccines against infectious

agents lead to durable protective immunity.

► BACTERIAL VACCINES. Research to develop vaccines

against E. coli, Salmonella, and Shigella, which together

cause a high burden of diarrheal disease globally.

► DEIA. Supporting new, early-stage, and at-risk

investigators from diverse backgrounds, including groups

underrepresented in the health sciences, to enhance the

diversity of NIAID R01-funded investigators.

NIAID Commitment to DEIA 

Foster a workplace that embodies and 

values the perspectives of a diverse staff

Fund an extramural research portfolio 

inclusive of the populations it serves

Prioritize health equity in all research 

that NIAID conducts and supports
NIAID-7 

MAJOR CHANGES

Major Changes in the Budget Request

Major changes by selected budget mechanism are briefly described below. The FY 2024 

President’s Budget request is $6,561.7 million, which is the same as the FY 2023 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) (-$7.5 million; total $3,842.4 million): 

NIAID will support a total of 5,367 Research Project Grant (RPG) awards in FY 2024. The 

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

Diseases, Infectious and Immunologic Diseases, and HIV/AIDS program areas. Funding for 

competing RPGs is expected to decrease by $83.6 million or 10.5 percent in FY 2024, while 

noncompeting RPG funding will increase by $76.1 million or 2.7 percent. Overall RPG funding 

will decrease by 0.2 percent.

Research and Development Contracts (-$5.2 million; total $1,117.4 million): 

NIAID will continue to support trans-NIH initiatives, including ongoing cybersecurity efforts, as 

well as other HHS-wide initiatives. 

Intramural Research (+$8.5 million; total $861.5 million): 

NIAID will continue to support critical long-range priorities with funds carefully aligned to key 

research on infectious diseases, such as HIV/AIDS, malaria, influenza, antimicrobial 

resistance/combatting antibiotic-resistant bacteria (CARB), and vector-borne diseases. The 

increased funding supports pay cost increases for intramural staff. 
NIAID-8 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Mechanism*

(Dollars in Thousands)

Mechanism FY 2022 Final FY 2023 Enacted FY 2024 President's

Budget FY 2024 +/- FY 2023

Number Amount Number Amount Number Amount Number Amount

Research Projects:

Noncompeting 3,671 $2,751,320 3,577 $2,864,434 3,749 $2,940,559 172 $76,126

Administrative Supplements (158) $59,493 (92) $24,878 (92) $24,878 (0) $0

Competing:

Renewal 145 $124,976 165 $148,567 161 $129,249 -4 -$19,318

New 1,085 $564,156 1,228 $651,206 1,210 $586,875 -18 -$64,331

Supplements 0 $0 0 $0 0 $0 0 $0

Subtotal, Competing 1,230 $689,132 1,393 $799,774 1,371 $716,124 -22 -$83,649

Subtotal, RPGs 4,901 $3,499,945 4,970 $3,689,086 5,120 $3,681,562 150 -$7,524

SBIR/STTR 251 $160,414 247 $160,819 247 $160,819 0 $0

Research Project Grants 5,152 $3,660,359 5,217 $3,849,905 5,367 $3,842,381 150 -$7,524

Research Centers

Specialized/Comprehensive 34 $99,167 35 $101,713 35 $101,713 0 $0

Clinical Research 0 $0 0 $0 0 $0 0 $0

Biotechnology 0 $0 0 $0 0 $0 0 $0

Comparative Medicine 0 $770 0 $770 0 $770 0 $0

Research Centers in Minority Institutions 0 $0 0 $0 0 $0 0 $0

Research Centers 34 $99,938 35 $102,483 35 $102,483 0 $0

Other Research:

Research Careers 327 $54,876 337 $57,291 337 $57,291 0 $0

Cancer Education 0 $0 0 $0 0 $0 0 $0

Cooperative Clinical Research 0 $0 0 $0 0 $0 0 $0

Biomedical Research Support 0 $0 0 $0 0 $0 0 $0

Minority Biomedical Research Support 0 $0 0 $232 0 $232 0 $0

Other 111 $78,677 115 $85,566 115 $85,566 0 $0

Other Research 438 $133,553 452 $143,089 452 $143,089 0 $0

Total Research Grants 5,624 $3,893,849 5,704 $4,095,477 5,854 $4,087,953 150 -$7,524

Ruth L Kirschstein Training Awards: FTTPs FTTPs FTTPs FTTPs

Individual Awards 261 $12,225 264 $12,763 257 $12,763 -7 $0

Institutional Awards 954 $57,404 962 $59,930 942 $59,930 -20 $0

Total Research Training 1,215 $69,629 1,226 $72,693 1,199 $72,693 -27 $0

Research & Develop. Contracts 227 $1,134,291 122 $1,122,544 120 $1,117,358 -2 -$5,186

SBIR/STTR (non-add) (28) ($31,185) (27) ($32,185) (26) ($31,385) -(1) -($800)

Intramural Research 954 $821,744 991 $852,970 991 $861,500 0 $8,530

Res. Management & Support 1,145 $402,667 1,189 $417,968 1,189 $422,148 0 $4,180

SBIR Admin. (non-add) ($1,137) ($2,900) ($2,900) ($0)

Construction $0 $0 $0 $0

Buildings and Facilities $0 $0 $0 $0

Total, NIAID 2,099 $6,322,180 2,180 $6,561,652 2,180 $6,561,652 0 $0 *

All items in italics and brackets are non-add entries.
NIAID-9 

APPROPRIATIONS LANGUAGE

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, [$6,562,279,000]$6,561,652,000. 
NIAID-10 

Summary of Changes

(Dollars in Thousands)

FY 2023 Enacted $6,561,652

FY 2024 President's Budget $6,561,652

Net change $0

CHANGES

FY 2023 Enacted FY 2024 President's 

Budget

Built-In Change from 

FY 2023 Enacted

FTEs Budget 

Authority FTEs Budget Authority FTEs Budget Authority

A. Built-in:

1. Intramural Research:

a. Annualization of FY 2023 pay and benefits increase $224,157 $236,143 $2,488

b. FY 2024 pay and benefits increase $224,157 $236,143 $8,592

c. Paid days adjustment $224,157 $236,143 $863

d. Differences attributable to change in FTE $224,157 $236,143 $0

e. Payment for centrally furnished services $115,251 $117,095 $1,844

f. Cost of laboratory supplies, materials, other expenses, and 

non-recurring costs $513,562 $508,262 $12,141

Subtotal $25,928

2. Research Management and Support:

a. Annualization of FY 2023 pay and benefits increase $232,881 $245,315 $2,577

b. FY 2024 pay and benefits increase $232,881 $245,315 $8,915

c. Paid days adjustment $232,881 $245,315 $897

d. Differences attributable to change in FTE $232,881 $245,315 $0

e. Payment for centrally furnished services $21,593 $21,938 $345

f. Cost of laboratory supplies, materials, other expenses, and 

non-recurring costs $163,494 $154,895 $3,703

Subtotal $16,437

Subtotal, Built-in $42,365

CHANGES

FY 2023 Enacted FY 2024 President's 

Budget

Program Change from 

FY 2023 Enacted

No. Amount No. Amount No. Amount

B. Program:

1. Research Project Grants:

a. Noncompeting 3,577 $2,889,312 3,749 $2,965,438 172 $76,126

b. Competing 1,393 $799,774 1,371 $716,124 -22 -$83,649

c. SBIR/STTR 247 $160,819 247 $160,819 0 $0

Subtotal, RPGs 5,217 $3,849,905 5,367 $3,842,381 150 -$7,524

2. Research Centers 35 $102,483 35 $102,483 0 $0

3. Other Research 452 $143,089 452 $143,089 0 $0

4. Research Training 1,226 $72,693 1,199 $72,693 -27 $0

5. Research and development contracts 122 $1,122,544 120 $1,117,358 -2 -$5,186

Subtotal, Extramural $5,290,714 $5,278,004 -$12,709

6. Intramural Research 991 $852,970 991 $861,500 0 -$17,398

7. Research Management and Support 1,189 $417,968 1,189 $422,148 0 -$12,257

8. Construction $0 $0 $0

9. Buildings and Facilities $0 $0 $0

Subtotal, Program 2,180 $6,561,652 2,180 $6,561,652 0 -$42,365

Total built-in and program changes $0
NIAID-11 

History of Budget Authority and FTE:

5,876.2 6,048.8 6,322.2 6,561.7 6,561.7

Funding Levels by Fiscal Year (Dollars in Millions)

2020 2021 2022 2023 2024

$0

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

$7,000

1969

2078 2099 2180 2180

FTEs by Fiscal Year

2020 2021 2022 2023 2024

0

500

1000

1500

2000

2500

Distribution by Mechanism:

Research Project

Grants

$3,842,381

59%

Research Centers

$102,483

2%

Other Research

$143,089

2%

Research Training

$72,693

1%

R&D Contracts

$1,117,358

17%

Intramural Research

$861,500

13%

RMS

$422,148

6%

FY 2024 Budget Mechanisms

(Dollars in Thousands)

Change by Selected Mechanisms:

-0.20%

0.00%

0.00%

0.00%

-0.46%

1.00%

1.00%

FY 2024 Estimated Percent Change from FY 2023 Mechanism

Research Project Grants

Research Centers

Other Research

Research Training

R&D Contracts

Intramural Research

RMS

-0.60% -0.40% -0.20% 0.00% 0.20% 0.40% 0.60% 0.80% 1.00% 1.20%
NIAID-12 
NIAID-13 

Budget Authority by Activity *

(Dollars in Thousands)

Extramural Research

FY 2022 Final FY 2023 Enacted FY 2024 President's 

Budget

FY 2024 +/- FY 

2023 Enacted

FTE Amount FTE Amount FTE Amount FTE Amount

Detail

HIV/AIDS 1 $1,488,163 $1,535,408 $1,531,649 -$3,760

Biodefense & Emerging Infectious Diseases 2 $2,147,097 $2,236,369 $2,231,341 -$5,028

Infectious & Immunological Diseases $1,462,509 $1,518,937 $1,515,015 -$3,922

Subtotal, Extramural $5,097,769 $5,290,714 $5,278,004 -$12,709

Intramural Research 954 $821,744 991 $852,970 991 $861,500 0 $8,530

Research Management & Support 1,145 $402,667 1,189 $417,968 1,189 $422,148 0 $4,180

TOTAL 2,099 $6,322,180 2,180 $6,561,652 2,180 $6,561,652 0 $0

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

 1 Reflects NIAID extramural total for HIV/AIDS. NIAID-wide totals are (in thousands) $1,779,113 in FY 2022; $1,788,843 in FY 2023; and $1,798,843 in FY 2024.

 2 Reflects NIAID extramural total for Biodefense. NIAID-wide totals are (in thousands) $2,371,416 in FY 2022; $2,495,748 in FY 2023; and $2,594,251 in FY 2024.
NIAID-14 

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 2022 Final

FY 2023 

Enacted

FY 2024 

President's 

Budget

FY 2024 +/- 

FY 2023

BA $6,322,180,000 $6,561,652,000 $6,561,652,000 0

FTE 2,099 2,180 2,180 0

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

Contracts; Direct Federal/Intramural and Other.

Overall Budget Policy:

The FY 2024 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 FY 2024 President’s Budget request is $6,561.7 million, which is equal to the FY 2023 

enacted level. The Institute dedicates its annual resources to support biomedical research that 

aligns with its mission and addresses domestic and global health issues, such as the recent 

COVID-19 pandemic. 

The Institute remains focused on high priority areas of research such as other emerging 

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

tuberculosis, malaria, drug-resistant microbes, vector-borne diseases, autoimmune disorders, 

asthma, and allergies and continues to fund research to understand and develop medical 

countermeasures to address the COVID-19 pandemic. In FY 2024, 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. 

Additionally, NIAID will continue efforts to develop 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-15 

Program Descriptions

HIV/AIDS

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

treatment of people with HIV/AIDS. Optimization of antiretroviral drug regimens and the 

establishment of treatment paradigms, including stressing early treatment and adherence, have 

transformed HIV infection from an almost uniformly fatal infection into a manageable chronic 

condition. Capitalizing on progress in the treatment of HIV/AIDS, the HHS initiative “Ending 

the HIV Epidemic in the United States” (EHE) aims to reduce new HIV infections in the United 

States by 90 percent by 2030. To support this goal, NIAID supports research that pairs 

researchers with community partners to pursue creative, locally defined, and culturally sensitive 

concepts relevant to their region to diagnose, treat, prevent, and respond to HIV infection. 

Additionally, the Centers for AIDS Research (CFARs) are investigating how to best deliver 

evidence-based interventions and services in regions of the country with the highest rates of 

HIV, focusing on individuals with a disproportionate risk of HIV infection, such as Black and 

Latinx populations. 

Unlike current antiretroviral treatment (ART) regimens that require daily dosing, long-acting 

antiretrovirals would revolutionize the control and prevention of HIV. A recent NIAID Phase 1 

study demonstrated that a therapeutic approach using two broadly neutralizing antibodies 

(bNAbs) against HIV was effective in suppressing HIV viral loads for extended periods of time 

in the absence of ART. Unfortunately, this treatment was not effective for participants infected 

with a form of HIV that is resistant to either bNAb. Results of this research are paving the way 

for new alternatives to daily ART for people living with HIV. For example, NIAID scientists 

and their collaborators isolated a naturally occurring bNAb, dubbed VRC07, and developed a 

drug-delivery system that uses adeno-associated virus serotype 8 (AAV8) to deliver the gene 

encoding this bNAb to a person with HIV, giving the patient the ability to produce their own 

anti-HIV therapeutic. A Phase 1 clinical trial of AAV8-VRC07 showed that it was safe when 

administered intramuscularly, and participants produced sustained levels of VRC07. Efforts to 

characterize the factors that determine how much bNAb is produced by human cells are 

underway as participants in this study continue to be monitored. 

Curing HIV, a major NIAID priority, will require eradicating or otherwise controlling the HIV 

reservoir – pockets of virus that lie dormant in cells in the body until they are activated when 

ART is interrupted. NIAID is evaluating several bNAbs for HIV eradication, to be used either 

by themselves or in combination with compounds that reactivate latent, or non-replicating, HIV, 

allowing ART and the body’s immune system to attack the virus. An observational study, 

conducted through the International Maternal Pediatric Adolescent AIDS Clinical Trial 

(IMPAACT) network, is following people living with HIV who undergo stem cell transplants 

because of a cancer diagnosis. Prior to transplant, scientists genetically remove the CCR5 coreceptor from the patient’s stem cells, which HIV uses to infect cells, ultimately preventing 

descendants of those stem cells from expressing CCR5. In one study, an individual with HIV 

who stopped ART 37 months after receiving a transplant has no detectable HIV 14 months later. 

This example, taken together with similar data from two previously reported cases from other 

countries, provides evidence that although not a universal cure, CCR5-deleted stem cell 
NIAID-16 

transplantation should be considered to achieve HIV remission and cure for people living with 

HIV who require such a transplant for other diseases. 

While rates of mother-to-child transmission of HIV have fallen in the last decade, research is 

ongoing to optimize prevention of HIV transmission from mother to child and to evaluate the 

factors that impact ART efficacy during pregnancy. Recent studies indicate that pregnancy may 

affect the way antiretroviral drugs are metabolized, rendering ART less effective. In one NIAIDsupported study, the combination of two antiretroviral drugs – darunavir and cobicistat – was 

tested in pregnant women with HIV in the United States. Researchers found that levels of both 

drugs were much lower during the second and third trimesters when compared with postpartum 

levels, suggesting that standard dosing of ART during pregnancy may increase the risk of 

treatment failure and mother-to-child transmission. In addition, a recent Phase 3 clinical trial 

was conducted across nine countries to 

examine the safety and efficacy of 

three different ART regimens in 

pregnant women. The study showed 

that when started during pregnancy, 

dolutegravir-containing regimens were 

superior at suppressing viral levels 

compared with other regimens. The 

study also identified ART regimens 

that resulted in the lowest frequency of 

adverse pregnancy outcomes and 

neonatal deaths. NIAID research 

continues to pave the way for the 

development of optimized strategies to 

prevent perinatal HIV transmission in 

the United States and around the 

world. 

Along with advancing HIV prevention 

strategies, such as microbicides, the 

development of a safe and effective 

HIV vaccine remains key to realizing 

an end to the HIV epidemic. One 

approach to vaccine development is 

identifying novel HIV vaccine 

immunogens, or proteins that induce a 

protective immune response. NIAID 

scientists developed a vaccine candidate, called Trimer 4571, composed of a stabilized HIV-1 envelope protein trimer. A Phase 

1 clinical trial of Trimer 4571 with alum (a common vaccine adjuvant) showed that it was safe 

and well-tolerated, but it produced low levels of neutralizing antibodies. Animal model studies 

suggest that the addition of a priming molecule may overcome this and clinical trials to validate 

this finding are in development. NIAID continues to investigate additional strategies for 

mRNA VACCINES FOR HIV

Building on the discoveries that enabled the remarkable 

success of COVID-19 mRNA vaccines, researchers are 

applying mRNA platform technology to develop candidate 

HIV vaccines. For example, one vaccine candidate 

evaluated in mice and nonhuman primates (NHPs) 

provides instructions for making two key HIV proteins, 

envelope (Env) and Gag. The study showed that the Env 

protein produced by the experimental HIV vaccine closely 

resembled the Env protein of the whole HIV virus, 

mimicking natural infection, and likely playing a role in 

generating the desired immune response to protect 

against HIV. Furthermore, this candidate vaccine was 

well-tolerated and prompted the desired antibody and 

cellular immune responses. Studies are underway to 

optimize the vaccine to increase its efficacy and reduce 

the number of booster vaccinations required to produce a 

robust immune response.

After nearly four decades of effort by a global research 

community, an effective vaccine to prevent HIV remains 

an elusive goal. The application of mRNA platform 

technology towards this goal represents a promising path 

forward. NIAID recently launched a Phase 1 clinical trial 

to examine whether three experimental HIV mRNA 

vaccines are safe and can induce an immune response 

in people (the HVTN 302 study). Each investigational 

vaccine candidate is designed to present the surface HIV 

proteins that facilitate entry into human cells. This study, 

which will enroll adults at 11 U.S. sites, is expected to be 

completed in July 2023. 
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developing an HIV vaccine, including mRNA vaccines (see HIV program portrait) with multiple 

candidates in various stages of development. 

Budget Policy:

The FY 2024 President’s Budget request for the extramural component of NIAID HIV/AIDS 

research is $1,531.6 million, which is a reduction of $3.8 million or 0.2 percent from the FY 

2023 enacted level. NIAID will continue to support basic, translational, and clinical research 

aimed at reducing incidence of infection. Research priorities will focus on development of an 

effective vaccine and biomedical prevention strategies, development of novel approaches for the 

treatment and cure of HIV infection, and development of interventions to treat and/or prevent coinfections and co-morbidities. The FY 2024 request includes $26.0 million, unchanged from the 

FY 2023 enacted level, to support ongoing research under the Ending the HIV Epidemic in the 

U.S. (EHE) initiative. NIAID will continue to support the Centers for AIDS Research (CFAR) 

activities and related efforts, which offer evidence-based practices on prevention and treatment 

to initiative partners and support for evaluating the initiative. 

Biodefense and Emerging Infectious Diseases 

The emergence and re-emergence of infectious diseases, accelerated in part by factors such as 

human encroachment into, and modification of, wildlife habitats, climate change, and declines in 

biodiversity, threatens the health of people worldwide. As part of its dual mandate, NIAID 

continues to conduct and support research to better understand viruses, bacteria, and other 

infectious agents of public health concern. This has been underscored during the COVID-19 

pandemic. NIAID continues to lead the U.S. government biomedical research response in 

developing safe and effective COVID-19 countermeasures, including assessing booster vaccine 

strategies for healthy adults and those with compromised immune systems. 

For example, the COVID-19 Variant Immunologic Landscape (COVAIL) trial is aiming to 

understand whether different vaccine regimens, including vaccines targeting SARS-CoV-2 

variants, can broaden immune responses in adults who already have received their primary series 

plus one booster shot. Additionally, the NIAID Infectious Diseases Clinical Research 

Consortium conducted a “mix and match” clinical trial in which investigators administered 

COVID-19 booster vaccines to adults in the United States who had previously received a 

primary COVID-19 vaccination series from one manufacturer. Some participants received the 

same brand of vaccine as their primary series, and others received a vaccine from a different 

manufacturer. Results showed that for all combinations of primary and booster vaccines, 

immune responses over time resulted in increased neutralizing antibody levels in the recipients. 

For some individuals with suppressed or compromised immune systems, the standard vaccine 

dosing regimen may not be sufficient to elicit a protective immune response. To address this 

issue, NIAID is sponsoring two Phase 2 trials: the first is assessing the immune response to a 

booster dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients, either 

alone or with a transient reduction in immunosuppressive medication; and the second is 

assessing the immune response to booster doses of COVID-19 vaccines in people with 

autoimmune diseases, with or without a brief cessation of the immunosuppressive drugs. 

Pediatric populations have been hit hard by the COVID-19 pandemic – both with acute 

infections and with longer lasting impacts such as multisystem inflammatory syndrome in 
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children (MIS-C) and post-acute sequelae of SARS-CoV-2 (PASC; also known as Long 

COVID). Several ongoing NIAID studies are focused on understanding the outcomes and longterm impacts of this virus on children’s health. The Pediatric Research Immune Network on 

SARS-CoV-2 and MIS-C (PRISM) study enrolled 244 children and young adults ages 20 years 

or younger from diverse racial and ethnic backgrounds at approximately 20 sites nationwide to 

observe short- and long-term outcomes of children infected with SARS-CoV-2 and characterize 

the immunologic pathways leading to those outcomes. Another study, which is part of NIH’s 

Researching COVID to Enhance Recovery (RECOVER) Initiative, will track up to 1,000 

children and young adults who previously tested positive for COVID-19 to evaluate the impact 

of COVID-19 on their physical and mental health over three years. Results from a recently 

completed study evaluating immune responses in children with SARS-CoV-2 or MIS-C indicate 

that children’s immune systems respond differently to the two conditions, assisting physicians in 

properly treating children with MIS-C. 

The devastation of the COVID-19 pandemic affirmed the impact that outbreaks of emerging and 

re-emerging infectious disease can have on human health globally. As such, NIAID has taken 

great strides to prepare for future outbreaks by developing its Pandemic Preparedness Plan.

1

 The 

Plan aligns with both the American Pandemic Preparedness Plan: Transforming our Capabilities 

and the National Biodefense Strategy and Implementation Plan on the development of vaccines, 

therapeutics, and diagnostics for pathogens that could cause significant disease and lead to a 

future pandemic. The Plan’s goals are to characterize pathogens of concern, shorten timelines 

between pathogen emergence and authorization/approval of medical countermeasures (MCMs), 

and eliminate gaps in research, infrastructure, and technology. Within the Plan, biomedical 

research is prioritized on prototype pathogens, representative viruses from 10 families of 

pandemic potential. The in-depth characterization of these prototype pathogens offers a viable 

pathway to gain knowledge and develop MCMs that may be applicable to other viruses in the 

same family. NIAID hosted a workshop that brought together experts in virology to discuss 

prioritizing prototype pathogens within these families for MCM development. NIAID will 

continue to invest in the Pandemic Preparedness Plan to expand these activities to their full 

potential.

1 https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf
NIAID-19 

NIAID also has a commitment to advance research on vector-borne diseases, including those 

transmitted by mosquitos and ticks. For example, NIAID scientists designed a virus-like particle 

(VLP) vaccine candidate (abbreviated WEVEE) that expresses proteins from the outer shells of 

three related alphaviruses, western equine encephalitis virus (WEEV), eastern equine 

encephalitis virus (EEEV), and Venezuelan equine encephalitis virus (VEEV) to prompt a 

protective immune response. WEEV, EEEV, and VEEV are spread to humans through the bites 

of infected mosquitoes and can lead to flu-like symptoms and in some cases to severe 

neurological damage or death. A Phase 1 study testing WEVEE vaccine showed that it was safe, 

well-tolerated, and induced an antibody response. NIAID also has developed a promising VLP 

vaccine for the mosquito-borne Chikungunya virus, which generates an immune response lasting 

at least 16 months. Lyme disease, 

transmitted by blacklegged ticks, 

accounted for 82 percent of all tickborne disease cases in the United 

States from 2004 to 2016. Current 

antibiotics to treat Lyme disease are 

broadly acting and disrupt the 

patient’s microbiome. NIAID-funded 

researchers have discovered a specific 

antibiotic that in mice can selectively 

clear Borrelia burgdorferi, the 

bacterium that causes Lyme disease. 

This finding holds potential as an 

alternative therapeutic option. NIAID 

also is investigating therapies for 

people with Lyme disease who do not 

respond well to initial treatment and 

continue to suffer symptoms. 

Food- and water-borne bacterial 

pathogens, including Escherichia coli, 

Salmonella enterica serotype 

Paratyphi A, Shigella flexneri, and 

Shigella sonnei, significantly impact 

public health and often lead to lifelong 

consequences that negatively impact 

physical health and cognitive 

development, especially for infants 

and children. In FY 2023, NIAID will 

award research grants for projects to 

advance development of vaccine 

candidates against these bacteria. 

NIAID’s Antibacterial Resistance 

Leadership Group (ARLG), a global 

consortium that leads a comprehensive 

clinical research agenda, is also 

VACCINE RESEARCH TO COMBAT VALLEY FEVER

Valley fever, a disease caused by the soil-dwelling fungi 

Coccidioides immitis and Coccidioides posadasii, is 

endemic in parts of the southwestern United States, as 

well as in Mexico and Central and South America. 

Infection with Coccidioides is often asymptomatic in 

people, but some suffer from fatigue, cough, shortness of 

breath, fever, and rashes. Each year, thousands of 

people in the United States experience severe 

Coccidioides infections, which can lead to long-term 

respiratory symptoms. In rare instances, the infection 

can spread outside of the lungs and cause meningitis, 

skin lesions, and even death. 

In February 2022, NIAID established a network of

Coccidioidomycosis Collaborative Research Centers to 

advance diagnostics, therapeutics, and vaccines for this 

fungal disease. Scientists supported within this network 

will work collaboratively by pooling resources and 

expertise. To accelerate progress where obstacles and 

significant gaps in scientific knowledge exist for Valley 

fever research, NIAID published the Strategic Plan for 

Research to Develop a Valley Fever Vaccine in 

September 2022. This plan is organized around three 

interdependent strategic priorities to advance research 

on a Valley fever vaccine: 1) understanding Coccidioides 

pathogenesis and host responses, 2) developing tools 

and resources to support Coccidioides vaccine research, 

and 3) advancing strategies to prevent Valley fever. 

Ongoing NIAID research aims to characterize 

disseminated coccidioidomycosis (DCM), when the 

fungus infects other body parts, and refractory 

coccidioidomycosis (RCM), when the fungus stays in the 

lungs for longer than six months. NIAID researchers are 

examining multiple immune factors, characterizing the 

demographics of patients afflicted with DCM and RCM, 

and examining the genetic similarities of the infecting 

organisms. This information will reveal pathways that 

might be targets for therapeutic intervention and vaccine 

development.
NIAID-20 

prioritizing the development of better countermeasures against antibiotic-resistant bacteria. 

ARLG researchers initiated a Phase 2b trial to test the antibiotic dalbavancin for safety and 

efficacy in treating complicated Staphylococcus aureus blood infections. This trial will ascertain 

whether dalbavancin is better than standard antibiotics for the treatment of complicated S. aureus

bacteremia.

Most bacteria, viruses, and other microbes multiply rapidly and can evolve and develop 

resistance to antimicrobial drugs, making them increasingly difficult -- and sometimes 

impossible -- to treat. Accurately diagnosing the type of pathogen causing infection is one step 

in curbing the threat of antimicrobial resistance. In FY 2023, NIAID will support research 

projects that focus on developing diagnostics that can rapidly and accurately identify the culprit 

microbe and provide clinicians with information for the most effective treatment. NIAID also is 

supporting research using bacteriophages, or phages, to treat antibiotic-resistant infections. 

Phages are viruses that can directly infect and destroy bacteria, bypassing bacterial antibiotic 

resistance mechanisms. ARLG scientists are conducting a clinical trial assessing the safety and 

microbiological activity of a single dose of a bacteriophage cocktail to treat Pseudomonas 

aeruginosa infections in cystic fibrosis patients. Additionally, a NIAID-funded clinical trial will 

evaluate the clinical safety and efficacy of ShigActive, a bacteriophage cocktail, to treat Shigella

infections. Shigella bacteria are the causative agents for shigellosis and dysentery. 

Tuberculosis (TB) is the second leading cause of death after SARS-CoV-2 among infectious 

diseases globally.2 Additional research is needed to discover and improve diagnostics, 

therapeutics, and vaccines to alleviate the global burden of TB. In FY 2024, NIAID will 

establish a consortium of TB preclinical and clinical experts to systematically refine preclinical 

models with clinical data and identify the most efficacious drug combination regimens for future 

clinical trials. A notable advance in TB prevention supported by NIAID is a three-month course 

of weekly isoniazid and rifapentine, referred to as 3HP. The IMPAACT network recently 

conducted a clinical study that found 3HP is well-tolerated and safe in pregnant women with 

latent TB who are also living with HIV. These promising results pave the way for larger studies 

to address maternal safety, increase diversity in study participants, and understand the influence 

of ART on the TB drug levels in pregnant women living with HIV. NIAID-funded researchers 

also are advancing novel TB vaccination strategies, including a spray-dried TB vaccine that was 

effective in controlling TB in mice. Spray-dried vaccines could be more easily shipped globally 

and have dosage and administration route flexibility. 

Each year, seasonal influenza sickens millions and causes thousands of hospitalizations and flurelated deaths.3

 In the hopes of eliminating the need for annual vaccination, universal or broadly 

protective flu vaccines are being developed to generate long-lasting immune responses against 

many existing or emerging influenza strains. For example, a Phase 1 clinical trial, now 

completely enrolled, is testing the safety of a novel influenza candidate vaccine, BPL-1357, and 

its ability to prompt immune responses. BPL-1357 is a whole-virus vaccine made up of four 

strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. NIAID 

researchers also are utilizing a ferritin-based and computationally designed self-assembling 

nanoparticle vaccine platform to make next-generation vaccines against influenza. Advantages 

2 www.who.int/news-room/fact-sheets/detail/tuberculosis 3 www.cdc.gov/flu/about/burden/index.html
NIAID-21 

of these approaches include the ability to target the unchanging stem region of the influenza 

virus, eliminating the need to reformulate a seasonal vaccine each year, and the fact that they do 

not require growing live influenza virus like traditional vaccines. The results of the clinical trial 

of a ferritin nanoparticle-based vaccine showed that neutralizing antibodies were detected in all 

participants that were durable up to six months after the second injection, indicating that this is a 

potential strategy for universal influenza vaccine development. NIAID is also assessing alternate 

administration routes, including a recent candidate vaccine administered intranasally together 

with an immune-boosting adjuvant. 

Budget Policy: 

The FY 2024 President’s Budget request for the extramural component of Biodefense and 

Emerging Infectious Diseases research supported by NIAID is $2,231.3 million, which is $5.0 

million or 0.2 percent lower than the FY 2023 enacted level. NIAID will continue to conduct and 

support research to better understand, prevent, and treat infectious diseases of public health 

concern. 

The FY 2024 request will support the development of medical countermeasures and new 

platform technologies as part of a strategy to address emerging and re-emerging infectious 

disease pathogens. The budget includes $270.0 million, equal to the FY 2023 enacted level, to 

sustain development of a safe and effective universal influenza vaccine that would provide longlasting 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. 

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. Such diseases include malaria, neglected tropical diseases, 

hepatitis, sexually transmitted infections (STIs, including herpes simplex virus), fungal diseases, 

autoimmune diseases, asthma, and allergic diseases. Support for collaborative, multidisciplinary 

research on developing vaccines for STIs, identifying immune cells that drive celiac disease, and 

advancing research on hepatitis B and C viruses are only a few examples of how NIAID will 

begin to address the magnitude of disease burden imposed by infectious and immune-mediated 

diseases.

The prevalence of food allergy among children under 18 has been increasing, and today peanut 

allergy affects about 2 percent of children in the United States, or nearly 1.5 million individuals. 

NIAID’s Immune Tolerance Network completed a clinical trial, called IMPACT, that 

investigated whether giving gradually increasing doses of peanut protein could lead to allergy 

remission in young children with severe peanut allergy. The clinical trial found that peanut 

protein, given orally, safely desensitized most children and led to remission of peanut allergy in 

one-fifth of the participants. The results also pointed to a window of opportunity in early 

childhood when oral immunotherapy may be successful. NIAID also is advancing similar 

tolerization strategies for those suffering from other allergies. In another approach, the CATNIP 

study tested cat immunotherapy together with a monoclonal antibody against TSLP, an immune 

factor that plays an important role in allergy. The results demonstrated that adding antibody 
NIAID-22 

improved the response while on immunotherapy and extended the response after immunotherapy 

was stopped. This study supports the concept that allergen-specific immunotherapy can be 

enhanced by combination with other immune-modulating agents. 

Asthma is a chronic lung disease that reduces the quality of life, is a major reason for school 

absenteeism, and causes life-threatening attacks leading to numerous emergency department 

visits and hospitalizations. In the United States, severe asthma disproportionately affects Black 

and Hispanic children in low-income urban environments. To address this disparity, a NIAIDsupported study recently found that a monoclonal antibody, mepolizumab, decreased asthma 

attacks by 27 percent in Black and Hispanic children and adolescents who are prone to asthma 

attacks and live in low-income urban neighborhoods. NIAID also launched the Prevention of 

Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) trial to 

examine if dupilumab, another monoclonal antibody, can reduce asthma attacks and improve 

lung function and asthma symptoms in children with poorly controlled allergic asthma. 

Malaria, a mosquito-borne disease caused by Plasmodium parasites, remains a major global 

public health problem and a priority area of NIAID research. NIAID continues to support basic 

and clinical research to accelerate malaria vaccine discovery. In pregnant women, malariainfected red blood cells collect in vascular spaces of the placenta. This can result in 

inflammatory immune responses leading to various adverse pregnancy outcomes, including 

severe maternal anemia, fetal growth restriction, premature delivery, and maternal and/or 

perinatal mortality. NIAID scientists identified a protein highly expressed on the surface of 

Plasmodium parasites called PfCSAL that is a potential target for vaccine 

development. A new and promising 

approach to prevent malaria is 

administering a monoclonal antibody 

against the sporozoite, the infectious 

form of the parasite. NIAID 

conducted a Phase 1 clinical trial to 

evaluate a single injection of a 

candidate monoclonal antibody 

known as L9LS, developed by 

scientists at the NIAID Vaccine 

Research Center (VRC). L9LS was 

found to be safe and highly protective 

in U.S. adults following controlled 

human challenge with malaria. It is 

now being evaluated for malaria 

prevention in infants and children in 

Mali and Kenya, where the disease is 

endemic. L9LS is highly potent, 

allowing for subcutaneous injection, a 

more cost-effective and feasible route 

of administration than intravenous 

injection and could potentially be 

XENOTRANSPLANTATION RESEARCH TO ADDRESS 

ORGAN DONATION SHORTAGES

Since 2016, approximately 28,000 new people have been 

added to the heart transplant wait-list and 1,687 have died

while waiting. To address transplant needs and shortages

of human organs, NIAID established The Immunobiology 

of Xenotransplantation Cooperative Research Program 

(IXCRP). Xenotransplantation is a transplant from one 

species to another. The goal of this program is to develop

preclinical pig to NHP models of islet, kidney, heart, lung, 

or liver transplantation. Genetically modified (GM) pigs 

offer unique benefits as xenograft donors because they 

are anatomically and physiologically similar to humans. 

These GM pigs are developed through an iterative 

process of gene editing to ensure each gene modification 

dampens the recipient immune response to the 

transplanted organ, thus increasing xenograft survival. 

Research supported by the IXCRP laid the foundation for 

the first pig-to-human heart transplant that took place in 

2022. Following the surgery, the 57-year-old male 

recipient had excellent cardiac function. This initial 

success has encouraged expansion of both preclinical 

and clinical research activities. NIAID has supported 

xenotransplantation research since 2003 and will continue 

to ensure high scientific, regulatory, and ethical standards 

in this rapidly evolving field.
NIAID-23 

used as a single dose to prevent malaria in infants, young children, and pregnant individuals. In 

a study focused on the mosquito vector, an engineered symbiotic bacterium protected mosquitos 

from Plasmodium falciparum infection by secreting a substance that selectively kills 

Plasmodium parasites. This bacterium disseminates through mosquito populations, rendering 

them resistant to malaria infection and providing a potential tool for blocking malaria 

transmission to humans if disseminated in the field.

Sexually transmitted infections (STIs) are an important global health priority because of their 

potentially devastating impact on long-term health. When left untreated, STIs can cause longterm health problems, including infertility and neurological impairment, making prevention a 

critical public health need. NIAID conducted a clinical trial to evaluate the use of doxycycline 

post-exposure prophylaxis (or DoxyPEP). DoxyPEP is a targeted intervention in which an 

antibiotic is given to high-risk individuals within three days of having sex without a condom as a 

method to prevent STIs. During a planned safety oversight meeting, it was recommended that 

everyone in the control arm be offered active therapy because the treatment effectively reduced 

the number of gonorrhea, chlamydia, and syphilis infections in men who have sex with men and 

transgender women who are living with HIV or are taking HIV pre-exposure prophylaxis (PrEP). 

While this study indicates DoxyPEP may be an effective strategy to prevent STIs in high-risk 

individuals, further investigation into the impact of this treatment on the development of 

antimicrobial resistance is warranted. 

Hepatitis C is one of the most common bloodborne infections in the United States, and infections 

are on the rise among young adults. NIAID researchers and their collaborators recently 

characterized the interactions of a hepatitis C virus (HCV) protein with a host cell protein that 

facilitates viral entry into the host cell. The results of this work may provide the foundation for 

an HCV vaccine. Hepatitis B virus (HBV) infection may cause short-term illness; however some 

individuals may develop a chronic infection, particularly those infected early in life. Chronic 

infection may lead to serious complications, such as cirrhosis, liver cancer, and liver failure. 

Left untreated, these complications can be life-threatening. While there is no cure for hepatitis 

B, highly effective vaccines can prevent HBV infection, and oral antiviral agents and other 

therapeutics can slow the progression of hepatitis B complications. NIAID recently led the 

trans-NIH effort to update the Strategic Plan for NIH Research to Cure Hepatitis B4

, a roadmap 

for ending the hepatitis B epidemic, to incorporate lessons learned from the COVID-19 

pandemic and recent advances in technology. The plan aligns with the HHS Viral Hepatitis 

National Strategic Plan5

 and is designed to be a part of NIH’s ongoing response to the effects of 

this disease. 

Budget Policy: 

The FY 2024 President’s Budget request for the extramural component of Infectious and 

Immunologic Diseases research is $1,515.0 million, which is a reduction of $3.9 million or 0.3 

percent compared with the FY 2023 enacted level. NIAID will continue to advance long-range 

research priorities in infectious and immunologic diseases. The FY 2024 request will support 

NIAID’s commitment and long-term interest in fundamental immunology, as well as research on 

4 https://www.niaid.nih.gov/sites/default/files/Trans-NIH-Hep-B-Strategic-Plan-2019.pdf 5 https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf
NIAID-24 

malaria, neglected tropical diseases, hepatitis, TB, sexually transmitted infections (STIs), fungal 

diseases, autoimmune diseases, organ transplantation, asthma, and allergic diseases. 

Intramural Research Program

The NIAID Intramural Research Program (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, located in Maryland and at the 

Rocky Mountain Laboratories (RML) in Montana, who lead a wide range of basic, translational, 

and clinical research efforts; 2) the NIAID VRC, which conducts basic and translational research 

to facilitate the development of effective vaccines and biologic therapies for human 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 breadth 

of activities and the ability to pivot research projects to focus on emerging infectious threats as 

they arise ensures that the NIAID IRP can immediately fill the gaps in knowledge required to 

inform public health measures to prevent the spread of disease. 

NIAID researchers utilize animal models to evaluate concepts critical to the implementation of 

public health measures. Understanding how a virus predominately spreads is important to reduce 

transmission between humans. For example, researchers at RML used a Syrian hamster animal 

model to evaluate the efficiency of airborne and contaminated surface contact to transmit SARSCoV-2. Results from these studies showed that although SARS-CoV-2 replicated in the lungs 

regardless of exposure route, aerosol-exposed animals had more severe lung damage than their 

counterparts exposed only to contaminated surfaces. Additionally, airborne transmission was 

much more efficient at infecting animals, providing critical information to support guidance on 

reducing indoor airborne transmission of SARS-CoV-2 through masking, increased air filtration, 

and social distancing. As the effects of the COVID-19 pandemic endure and variants of concern 

continue to emerge, scientists in the NIAID IRP are continuing to inform and enhance 

vaccination and treatment strategies. VRC scientists and their collaborators completed a study in 

rhesus macaques to determine the impact on protection from COVID-19 of a booster shot of the 

mRNA-1273 vaccine six months after the primary series. Results showed that a booster of the 

original version of the vaccine or a slightly modified version targeting the beta variant of SARSCoV-2 led to an increase in neutralizing antibody levels and provided protection against 

infection. The knowledge gained from this work supported the implementation of vaccine 

boosters to protect individuals from severe COVID-19. To support the development and 

optimization of COVID-19 treatment strategies, researchers at the NIAID Integrated Research 

Facility at Ft. Detrick are supporting efforts, sponsored by the HHS COVID Therapeutics 

Response Team, to test antibody therapeutics, small-molecule clinical candidates, and products 

with FDA Emergency Use Authorization (EUA) in cellular assays and in hamster infection 

models. These experimental and EUA therapies are tested against selected SARS-CoV-2 

variants of concern to inform pharmacokinetic analysis and clinical efficacy. Data from these 

studies are shared with the manufacturers for inclusion in regulatory reporting and with the HHS 

COVID Therapeutics Response Team for internal decision-making and risk assessment as the 

variant landscape evolves. 
As the effects of the COVID-19 pandemic continue to evolve, strategies are needed to assess the 

burden of disease across populations. To support this effort, NIAID researchers developed an 

algorithm to differentiate individuals who had a previous infection, a vaccination, or were 

unexposed to SARS-CoV-2. This algorithm proved very sensitive and specific and was used to 

evaluate seroprevalence and vaccination status trends among emergency department patients in 

an urban area over time. The results showed differences among ethnic groups and genders in 

both disease burden and vaccination status and could be applied to help address health 

disparities.

Budget Policy: 

The FY 2024 President’s Budget request for Intramural Research is $861.5 million, an increase 

of $8.5 million or 1.0 percent compared with the FY 2023 enacted level. The FY 2024 

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

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

all aspects of research on infectious diseases such as HIV/AIDS, malaria, and influenza, with a 

focus 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 for the 

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

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

programs, such as the NIAID International Centers of Excellence in Malaria Research (ICEMR)

program. ICEMR is a global network of independent research centers in malaria-endemic

settings that generates knowledge, tools, and evidence-based strategies crucial to understanding, 

controlling, and ultimately preventing malaria. NIAID’S Policy, Planning, and Evaluation 

(PP&E) Branch performed a multi-method evaluation of ICEMR to assess program outcomes 

and identify areas of improvement. The key findings of this evaluation included identifying 

substantial contributions made to malaria research by ICEMR, benefits of the program to junior 

investigators, and benefits and challenges of data sharing and collaborations for participating 

investigators; as well as capturing suggested emerging research trends to focus on in the future to 

advance the field. This information was incorporated into the development of the next iteration 

of the ICEMR program to optimize research outcomes. RMS activities also encompass 

regulatory compliance, international coordination, and liaison activities with other federal 

agencies, Congress, and the public. 

Budget Policy: 

The FY 2024 President’s Budget request for RMS is $422.1 million, an increase of $4.2 million 

or 1.0 percent compared with the FY 2023 enacted level. This budget increase will mostly 

maintain the overall level of program management and administrative support. 

 
NIAID-26 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Appropriations History

Fiscal Year Budget Estimate

to Congress

House

Allowance

Senate

Allowance Appropriation

2015 $4,423,357,000 $4,358,841,000

Rescission $0

2016 $4,614,779,000 $4,512,918,000 $4,710,342,000 $4,629,928,000

Rescission $0

2017 1 $4,715,697,000 $4,738,883,000 $4,961,305,000 $4,906,638,000

Rescission $0

2018 $3,782,670,000 $5,005,813,000 $5,127,866,000 $5,260,210,000

Rescission $0

2019 $4,761,948,000 $5,368,029,000 $5,506,190,000 $5,523,324,000

Rescission $0

2020 $4,754,379,000 $5,811,268,000 $5,937,816,000 $5,885,470,000

Rescission $0

Supplemental $1,542,000,000

2021 $5,885,470,000 $6,013,087,000 $6,142,540,000 $6,069,619,000

Rescission $0

2022 $6,245,926,000 $6,557,803,000 $6,342,756,000 $6,322,728,000

Rescission $0

2023 $6,268,313,000 $6,642,608,000 $6,449,804,000 $6,562,279,000

Rescission $0

2024 $6,561,652,000

1 Budget Estimate to Congress includes mandatory financing.
NIAID-27 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Authorizing Legislation

PHS Act/

Other Citation

U.S. Code

Citation

2023 Amount 

Authorized

F acted Y 2023 En 2024 Amount 

Authorized

FY 2024 President's 

Budget

Research and Investigation Section 301 42§241 Indefinite

National Institute of Allergy and Infectious Diseases Section 401(a) 42§281 Indefinite

$6,561,652,000

IndefiniteIndefinite

$6,561,652,000

Total, Budget Authority $6,561,652,000 $6,561,652,000
NIAID-28 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Amounts Available for Obligation 1

(Dollars in Thousands)

Source of Funding FY 2022 Final FY 2023 

Enacted

FY 2024 

President's 

Budget

Appropriation $6,322,728 $6,562,279 $6,561,652

Secretary's Transfer $0 $0 $0

OAR HIV/AIDS Transfers -$548 -$627 $0

Subtotal, adjusted budget authority $6,322,180 $6,561,652 $6,561,652

Unobligated balance, start of year $0 $0 $0

Unobligated balance, end of year (carryover) $0 $0 $0

Subtotal, adjusted budget authority $6,322,180 $6,561,652 $6,561,652

Unobligated balance lapsing -$100 $0 $0

Total obligations $6,322,080 $6,561,652 $6,561,652

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

 FY 2022 - $32,914 FY 2023 - $40,000 FY 2024 - $40,000
NIAID-29 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Authority by Object Class 1

(Dollars in Thousands)

FY 2023 Enacted FY 2024 President's

Budget FY 2024 +/- FY 2023

Total compensable workyears:

Full-time equivalent 2,180 2,180 0

Full-time equivalent of overtime and holiday hours 0 0 0

Average ES salary $212 $223 $11

Average GM/GS grade 12.7 12.7 0.0

Average GM/GS salary $129 $136 $7

Average salary, Commissioned Corps (42 U.S.C. 207) $108 $114 $5

Average salary of ungraded positions $168 $176 $8

OBJECT CLASSES FY 2023 Enacted FY 2024 President's

Budget

FY 2024 +/- FY 2023

Personnel Compensation

11.1 Full-Time Permanent $208,131 $219,484 $11,352

11.3 Other Than Full-Time Permanent $86,493 $91,210 $4,718

11.5 Other Personnel Compensation $14,703 $15,505 $802

11.7 Military Personnel $4,511 $4,757 $246

11.8 Special Personnel Services Payments $27,876 $29,396 $1,520

11.9 Subtotal Personnel Compensation $341,714 $360,353 $18,639

12.1 Civilian Personnel Benefits $113,795 $119,492 $5,697

12.2 Military Personnel Benefits $1,529 $1,612 $83

13.0 Benefits to Former Personnel $0 $0 $0

Subtotal Pay Costs $457,038 $481,457 $24,419

21.0 Travel & Transportation of Persons $4,598 $4,397 -$201

22.0 Transportation of Things $1,976 $1,922 -$55

23.1 Rental Payments to GSA $0 $0 $0

23.2 Rental Payments to Others $0 $0 $0

23.3 Communications, Utilities & Misc. Charges $1,922 $1,763 -$159

24.0 Printing & Reproduction $11 $11 $0

25.1 Consulting Services $208,252 $208,449 $197

25.2 Other Services $192,604 $187,651 -$4,953

25.3 Purchase of Goods and Services from Government

Accounts $634,431 $631,461 -$2,970

25.4 Operation & Maintenance of Facilities $10,463 $9,889 -$574

25.5 R&D Contracts $824,254 $821,094 -$3,161

25.6 Medical Care $6,786 $6,700 -$86

25.7 Operation & Maintenance of Equipment $32,138 $30,222 -$1,916

25.8 Subsistence & Support of Persons $2 $3 $0

25.0 Subtotal Other Contractual Services $1,908,931 $1,895,469 -$13,462

26.0 Supplies & Materials $57,103 $55,690 -$1,413

31.0 Equipment $30,974 $29,211 -$1,763

32.0 Land and Structures $6,595 $6,753 $158

33.0 Investments & Loans $0 $0 $0

41.0 Grants, Subsidies & Contributions $4,092,429 $4,084,905 -$7,524

42.0 Insurance Claims & Indemnities $0 $0 $0

43.0 Interest & Dividends $74 $74 $0

44.0 Refunds $0 $0 $0

Subtotal Non-Pay Costs $6,104,614 $6,080,195 -$24,419

Total Budget Authority by Object Class $6,561,652 $6,561,652 $0 1 Includes FTEs whose payroll obligations are supported by the NIH Common Fund.
NIAID-30 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Salaries and Expenses

(Dollars in Thousands)

Object Classes FY 2023

Enacted

FY 2024

President's

Budget

FY 2024 +/- FY

2023

Personnel Compensation

Full-Time Permanent (11.1) $208,131 $219,484 $11,352

Other Than Full-Time Permanent (11.3) $86,493 $91,210 $4,718

Other Personnel Compensation (11.5) $14,703 $15,505 $802

Military Personnel (11.7) $4,511 $4,757 $246

Special Personnel Services Payments (11.8) $27,876 $29,396 $1,520

Subtotal, Personnel Compensation (11.9) $341,714 $360,353 $18,639

Civilian Personnel Benefits (12.1) $113,795 $119,492 $5,697

Military Personnel Benefits (12.2) $1,529 $1,612 $83

Benefits to Former Personnel (13.0) $0 $0 $0

Subtotal Pay Costs $457,038 $481,457 $24,419

Travel & Transportation of Persons (21.0) $4,598 $4,397 -$201

Transportation of Things (22.0) $1,976 $1,922 -$55

Rental Payments to Others (23.2) $0 $0 $0

Communications, Utilities & Misc. Charges

(23.3) $1,922 $1,763 -$159

Printing & Reproduction (24.0) $11 $11 $0

Other Contractual Services

Consultant Services (25.1) $208,252 $208,449 $197

Other Services (25.2) $192,604 $187,651 -$4,953

Purchase of Goods and Services from

Government Accounts (25.3) $469,456 $466,486 -$2,970

Operation & Maintenance of Facilities (25.4) $10,463 $9,889 -$574

Operation & Maintenance of Equipment (25.7) $32,138 $30,222 -$1,916

Subsistence & Support of Persons (25.8) $2 $3 $0

Subtotal Other Contractual Services $912,916 $902,701 -$10,215

Supplies & Materials (26.0) $57,103 $55,690 -$1,413

Subtotal Non-Pay Costs $978,527 $966,484 -$12,044

Total Administrative Costs $1,435,565 $1,447,941 $12,376
NIAID-31 

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Detail of Full-Time Equivalent Employment (FTE)

Office

FY 2022 Final FY 2023 Enacted FY 2024 President's Budget

Civilian Military Total Civilian Military Total Civilian Military Total

Division of Clinical Research

Direct: 94 5 99 95 5 100 95 5 100

Total: 94 5 99 95 5 100 95 5 100

Division of Extramural Activities

Direct: 241 2 243 262 2 264 262 2 264

Total: 241 2 243 262 2 264 262 2 264

Division of Intramural Research

Direct: 744 8 752 765 8 773 765 8 773

Total: 744 8 752 765 8 773 765 8 773

Office of the Director

Direct: 431 1 432 446 1 447 446 1 447

Total: 431 1 432 446 1 447 446 1 447

Division of Allergy, Immunology, and

Transplantation

Direct: 101 1 102 101 1 102 101 1 102

Total: 101 1 102 101 1 102 101 1 102

Division of Microbiology and Infectious Diseases

Direct: 185 7 192 199 7 206 199 7 206

Total: 185 7 192 199 7 206 199 7 206

Division of Acquired Immunodeficiency

Direct: 155 4 159 166 4 170 166 4 170

Total: 155 4 159 166 4 170 166 4 170

Vaccine Research Center

Direct: 118 2 120 116 2 118 116 2 118

Total: 118 2 120 116 2 118 116 2 118

Total 2,069 30 2,099 2,150 30 2,180 2,150 30 2,180

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

2020 12.6

2021 12.6

2022 12.7

2023 12.7

2024 12.7
NIAID-32 

GRADE FY 2022 Final FY 2023 Enacted FY 2024 

President's Budget

Total, ES Positions 2 2 2

Total, ES Salary $407,400 $424,205 $445,628

General Schedule

GM/GS-15 210 215 218

GM/GS-14 429 448 445

GM/GS-13 424 431 435

GS-12 250 264 259

GS-11 126 126 134

GS-10 1 1 1

GS-9 71 79 74

GS-8 24 26 26

GS-7 43 52 49

GS-6 11 11 12

GS-5 5 4 4

GS-4 5 8 8

GS-3 6 6 6

GS-2 0 1 1

GS-1 2 3 3

Subtotal 1,607 1,675 1,675

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

Assistant Surgeon General 0 0 0

Director Grade 9 9 9

Senior Grade 7 8 8

Full Grade 7 9 8

Senior Assistant Grade 6 4 4

Assistant Grade 0 0 0

Co-Step 1 0 1

Subtotal 30 30 30

Ungraded 490 509 509

Total permanent positions 1,627 1,620 1,620

Total positions, end of year 2,129 2,216 2,216

Total full-time equivalent (FTE) 

employment, end of year 2,099 2,180 2,180

Average ES salary $203,700 $212,103 $222,814

Average GM/GS grade 12.7 12.7 12.7

Average GM/GS salary $124,105 $129,225 $135,751

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Detail of Positions 1