CONGRESSIONAL JUSTIFICATION 

FY 2023

Department of Health and Human Services

National Institutes of Health

National Institute of 

Allergy and Infectious 

Diseases
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases (NIAID)

FY 2023 Budget Table of Contents 

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

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 ............................................................................................................. 28 

Authorizing Legislation ............................................................................................................ 29 

Amounts Available for Obligation............................................................................................ 30 

Budget Authority by Object Class ............................................................................................ 31 

Salaries and Expenses............................................................................................................... 32 

Detail of Full-Time Equivalent Employment (FTE) ................................................................ 33 

Detail of Positions..................................................................................................................... 34
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Director’s Overview

The National Institute of Allergy and Infectious Diseases 

(NIAID) has been at the forefront of research to address the 

COVID-19 pandemic while continuing to lead research on 

other diseases. NIAID is actively preparing for the 

emergence of new public health threats, including variants of 

SARS-CoV-2, the virus that causes COVID-19. These 

efforts reflect the dual mandate of NIAID, to enable research 

on infectious, immunologic, and allergic disease and respond 

to emerging public health threats with the overall goal of 

enhancing human health. 

NIAID responded rapidly to the COVID-19 pandemic by 

mobilizing existing research programs, especially research on 

related coronaviruses, including those that cause severe acute respiratory syndrome (SARS) and 

Middle East respiratory syndrome (MERS). Coronaviruses have a spike protein on their surface 

that plays an essential role in infection. NIAID scientists designed a stabilized spike antigen 

based on their previous research on coronavirus spike structures. NIAID and the biotechnology 

company Moderna then developed a messenger RNA (mRNA) vaccine, which directs the body’s 

cells to express the spike in its prefusion conformation to elicit an immune response. The PfizerBioNTech, Janssen, Novavax, and Sanofi vaccines are also based on the stabilized version of the 

spike protein. 

Building on successes in the fight against COVID-19, NIAID is expanding on its already robust 

basic research portfolio to plan for emerging infectious disease threats. To mitigate risks 

associated with these yet unknown pathogens, NIAID is prioritizing preparedness research on 

prototype-pathogens, representative pathogens from viral families known to infect humans. 

Prototype pathogen research can be used to inform the development of medical countermeasures 

(MCMs), such as therapeutics, vaccines, and monoclonal antibodies (mAbs), for related viruses. 

In addition, NIAID continues to characterize and conduct preclinical testing of high priority 

pathogens most likely to threaten human health and advance platform technologies that also can 

be leveraged to develop MCMs. To further pandemic preparedness, NIAID established a global 

network of research centers to study how and when viruses and other pathogens emerge from 

wildlife and spillover into humans. The Centers for Research in Emerging Infectious Diseases 

(CREID) will enable early warnings of emerging diseases, facilitating a rapid response and 

potentially curbing potential disease threats before they develop into widespread pandemics. 

Additionally, NIAID continues the Pandemic Response Repository through Microbial and 

Immune Surveillance and Epidemiology (PREMISE) program that pairs virologic and 

immunologic surveillance of viruses and facilitate the development of diagnostic tests and 

MCMs in anticipation of potential pandemic threats.

Despite the challenges posed by COVID-19, NIAID’s work to address the ongoing HIV 

epidemic has not wavered. Achieving a durable end to the HIV pandemic will require research 

on the optimal implementation of diagnosis, treatment, and prevention methods, as well as 

continued development of new and improved prevention and treatment tools suited to those 

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

populations most affected by HIV. In 2020, NIH awarded approximately $10 million to advance 

the goals of Ending the HIV Epidemic: A Plan for America, which aims to reduce new HIV 

diagnoses in the United States by at least 90 percent by 2030. NIAID expanded the existing 

collaborative, multidisciplinary NIH-wide Centers for AIDS Research (CFARs) and AIDS 

Research Centers (ARCs) programs to stimulate new and improved diagnostics, prevention, and 

treatment options, particularly for populations in areas highly impacted by HIV. Stark disparities 

in HIV outcomes exist not only regionally, but also between certain age, racial, and ethnic 

groups, as well as among sexual and gender identities. Accordingly, NIAID is continuing efforts 

to include diverse populations at all stages of clinical research to develop culturally appropriate, 

tailored interventions that may help communities respond to the unique needs of people in—or at 

the intersections of—these groups. 

The emergence of SARS-CoV-2 variants underscores the challenges of viral evolution. Like 

SARS-CoV-2, influenza viruses can evolve quickly. As such, current influenza vaccines must be 

reformulated annually in anticipation of the changing viral strains predicted to circulate during 

the upcoming influenza season. In the hopes of one day eliminating the need for annual 

vaccination, universal flu vaccines are being developed to generate long-lasting immune 

responses protective against many existing or emerging influenza strains. For example, NIAID 

scientists have begun clinical trials with an experimental universal flu vaccine, FluMos-v1. 

NIAID is investing in research to inform other vaccine approaches, such as a whole avian 

influenza virus cocktail, BPL-1357, as well as novel delivery mechanisms utilizing a new vector 

for a broadly protective intranasal vaccine and a vaccine targeting different influenza surface 

proteins than current vaccines do. 

Pan-pathogen vaccines that protect against most variants of a pathogen are a promising strategy 

for vector-borne and parasitic diseases, where both vector and pathogen vary widely over time or 

across regions. For example, leishmaniasis is caused by a parasite carried by sandflies, but the 

subtypes of both the parasite and sandfly vary greatly across regions. Tick-borne diseases are 

similarly varied and increasingly prevalent in the United States. As a result of climate change, 

more people are at risk for contracting mosquito-borne diseases such as malaria, Zika, and West 

Nile. NIAID scientists are studying the mechanisms that enable mosquitoes, sandflies, and ticks 

to evade our immune system by masking the presence of pathogens. An examination of the role 

of proteins in the insect’s saliva and the interactions between the vector, pathogen, and our 

immune system and microbiome is informing the development of broadly protective vaccine 

candidates for mosquito-borne diseases (see program portrait below), leishmaniasis, and tickborne diseases. Broad protection provided by pan-pathogen vaccines may hinder the 

development of resistance to existing prevention and treatment approaches, and knowledge of 

the mechanisms involved will have further implications for other emerging and re-emerging 

pathogens. 
NIAID-5 

CR
NIAID-6 
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Major Changes in the Fiscal Year 2023 President’s Budget Request

Major changes by selected budget mechanism are briefly described below. The FY 2023 

President’s Budget request is $6,268.3 million, an increase of $198.7 million or 3.3 percent 

compared with the FY 2022 Continuing Resolution (CR) 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) (+$129.7 million; total $3,736.2 million): 

NIAID will support a total of 5,496 Research Project Grant (RPG) awards in FY 2023. The 

increased 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 increase by $131.6 million or 19.2 percent in FY 2023, while 

noncompeting RPG funding will decrease by $11.6 million or 0.4 percent. Overall RPG funding 

will increase by 3.6 percent. 

Research and Development Contracts (+$62.8 million; total $1,054.7 million): 

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

well as other HHS-wide initiatives. 

Other Research (-$37.6 million; total $95.0 million):

NIAID will reduce Other Research funding, reflecting the completion of upgrades to existing 

facilities and building systems across 12 Regional Biocontainment Laboratories. 

Intramural Research (+$25.8 million; total $818.7 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, influenza, antimicrobial 

resistance/combatting antibiotic-resistant bacteria (CARB), and tick-borne diseases. Funding 

will also support the proposed FY 2023 pay raise for intramural research employees. 
NIAID-8 

MECHANISM FY 2021 Final FY 2022 CR FY 2023 President's Budget

FY 2023

+/-

FY 2022 CR

Research Projects:

Noncompeting

Administrative Supplements 

Competing:

Renewal

New

Supplements

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

3,574

(99)

215

1,366

1

$2,247,458

32,977

538,452

651,084

478

3,823

(80)

185

1,102

1

$2,729,400

27,947

239,378

446,126

408

3,723

(80)

209

1,292

1

$2,717,824

27,947

271,409

545,520

532

-100

(0)

24

190

0

-$11,576

0

32,031

99,395

124

Subtotal, Competing 1,582 $1,190,014 1,288 $685,911 1,502 $817,461 214 $131,550

Subtotal, RPGs 5,156 $3,470,450 5,111 $3,443,257 5,225 $3,563,231 114 $119,974

SBIR/STTR 268 165,230 262 163,230 271 172,924 9 9,694

Research Project Grants 5,424 $3,635,680 5,373 $3,606,488 5,496 $3,736,155 123 $129,668

Research Centers:

Specialized/Comprehensive

Clinical Research

Biotechnology

Comparative Medicine

Research Centers in Minority Institutions

27

0

0

0

0

$78,096

0

0

743

0

27

0

0

0

0

$80,342

0

0

743

0

28

0

0

0

0

$82,993

0

0

767

0

1

0

0

0

0

$2,651

0

0

25

0

Research Centers 27 $78,838 27 $81,085 28 $83,760 1 $2,676

Other Research:

Research Careers

Cancer Education

Cooperative Clinical Research

Biomedical Research Support

Minority Biomedical Research Support

Other

317

0

0

0

0

102

$53,881

0

0

0

232

80,136

304

0

0

0

0

107

$54,129

0

0

0

232

78,271

320

0

0

0

0

82

$55,915

0

0

0

240

38,872

16

0

0

0

0

-25

$1,786

0

0

0

8

-39,400

Other Research 419 $134,250 411 $132,632 402 $95,027 -9 -$37,606

Total Research Grants 5,870 $3,848,767 5,811 $3,820,205 5,926 $3,914,942 115 $94,738

Ruth L Kirschstein Training Awards:

Individual Awards

Institutional Awards

FTTPs

272

904

$12,665

52,458

FTTPs

273

911

$12,843

53,192

FTTPs

278

931

$13,266

54,948

FTTPs

5

20

$424

1,755

Total Research Training 1,176 $65,123 1,184 $66,035 1,209 $68,214 25 $2,179

Research & Develop. Contracts

(SBIR/STTR) (non-add)

Intramural Research

Res. Management & Support

SBIR Admin. (non-add)

Construction 

Buildings and Facilities

226

(34)

948

1,130

(0)

$965,164

(19,639)

782,679

387,116

(806)

0

0

242

(27)

983

1,197

(0)

$991,887

(15,639)

792,879

398,613

(1,600)

0

0

268

(27)

983

1,197

(0)

$1,054,724

(11,639)

818,666

411,767

(1,600)

0

0

26

(0)

0

0

(0)

$62,837

(-4,000)

25,786

13,154

(0)

0

0

Total, NIAID 2,078 $6,048,849 2,180 $6,069,619 2,180 $6,268,313 0 $198,694

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-9 

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, $6,268,313,000.
NIAID-10 

FY 2022 CR $6,069,619

FY 2023 President's Budget $6,268,313

Net change $198,694

CHANGES

FY 2022 CR FY 2023 President's Budget Built-In Change from FY 2022 CR

FTEs Budget Authority FTEs Budget Authority FTEs Budget Authority

A. Built-in:

1. Intramural Research:

a. Annualization of January 2022 pay increase & benefits $212,949 $224,348 $1,412

b. January FY 2023 pay increase & benefits 212,949 224,348 7,209

c. Paid days adjustment 212,949 224,348 -809

d. Differences attributable to change in FTE 212,949 224,348 0

e. Payment for centrally furnished services 109,776 111,971 2,196

f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs 470,154 482,347 10,196

Subtotal $20,203

2. Research Management and Support:

a. Annualization of January 2022 pay increase & benefits $221,405 $230,341 $1,466

b. January FY 2023 pay increase & benefits 221,405 230,341 7,487

c. Paid days adjustment 221,405 230,341 -841

d. Differences attributable to change in FTE 221,405 230,341 0

e. Payment for centrally furnished services 31,124 31,746 622

f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs 146,084 149,680 3,105

Subtotal $11,839

Subtotal, Built-in $32,042

CHANGES

FY 2022 CR FY 2023 President's Budget Program Change from FY 2022 CR

No. Amount No. Amount No. Amount

B. Program:

1. Research Project Grants:

a. Noncompeting 3,823 $2,757,347 3,723 $2,745,771 -100 -$11,576

b. Competing 1,288 685,911 1,502 817,461 214 131,550

c. SBIR/STTR 262 163,230 271 172,924 9 9,694

Subtotal, RPGs 5,373 $3,606,488 5,496 $3,736,155 123 $129,668

2. Research Centers 27 $81,085 28 $83,760 1 $2,676

3. Other Research 411 132,632 402 95,027 -9 -37,606

4. Research Training 1,184 66,035 1,209 68,214 25 2,179

5. Research and development contracts 242 991,887 268 1,054,724 26 62,837

Subtotal, Extramural $4,878,127 $5,037,880 $159,753

FTEs FTEs FTEs

6. Intramural Research 983 $792,879 983 $818,666 0 $5,583

7. Research Management and Support 1,197 398,613 1,197 411,767 0 1,315

8. Construction 0 0 0

9. Buildings and Facilities 0 0 0

Subtotal, Program 2,180 $6,069,619 2,180 $6,268,313 0 $166,652

Total built-in and program changes $198,694

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Summary of Changes

(Dollars in Thousands)
NIAID-11 

Fiscal Year 2023 Budget Graphs

History of Budget Authority and FTEs: 

 

Distribution by Mechanism: 

Change by Selected Mechanisms: 
NIAID-12 
NIAID-13 

Extramural Research

FY 2021 Final FY 2022 CR FY 2023 President's 

Budget 

FY 2023 

+/-

 FY 2022 CR 

FTE Amount FTE Amount FTE Amount FTE Amount

Detail

2 HIV/AIDS $1,433,521 $1,437,588 $1,434,426 -$3,162

Biodefense & Emerging Infectious Diseases 3 2,016,196 2,018,663 2,130,912 112,248

Infectious & Immunological Diseases 1,429,338 1,421,876 1,472,543 50,667

Subtotal, Extramural $4,879,054 $4,878,127 $5,037,880 $159,753

Intramural Research 948 $782,679 983 $792,879 983 $818,666 0 $25,786

Research Management & Support 1,130 $387,116 1,197 $398,613 1,197 $411,767 0 $13,154

TOTAL 2,078 $6,048,849 2,180 $6,069,619 2,180 $6,268,313 0 $198,694

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) $1,783,470 in FY 2021; $1,791,391 in FY 2022; and $1,798,843 in FY 2023.

3 Reflects NIAID extramural total for Biodefense. NIAID-wide totals are (in thousands) $2,488,252 in FY 2021; $2,495,748 in FY 2022; and $2,622,309 in FY 2023.

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Budget Authority by Activity1

(Dollars in Thousands)
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 2021 

Final

$6,048,849,000 

2,078 

FY 2022 

CR

$6,069,619,000 

2,180 

FY 2023 

President's 

Budget 

$6,268,313,000 

2,180 

FY 2023 +/- 

FY 2022 

+$198,694,000 

0 

BA

FTE

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

Contracts; Direct Federal/Intramural and Other.

Overall Budget Policy: 

The FY 2023 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 

importance of executing NIAID’s dual mandate is underscored by the ongoing response to the 

COVID-19 pandemic. 

The FY 2023 President’s Budget request is $6,268.3 million, an increase of $198.7 million or 3.3 

percent compared with the FY 2022 CR 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. 

While NIAID continues to fund research to understand and develop medical countermeasures to 

address the COVID-19 pandemic, the Institute also remains focused on other high priority areas 

of research such as other emerging infectious diseases, agents with bioterrorism potential, 

HIV/AIDS, influenza, tuberculosis, malaria, drug-resistant microbes, tick-borne diseases, 

autoimmune disorders, asthma, and allergies. In FY 2023, 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 

opportunities provided to established investigators who submit new R01 applications. 

The FY 2023 request includes specific increases over the FY 2022 CR level, which include 

$40.0 million to continue efforts to develop a universal influenza vaccine, $20.0 million for 
NIAID-15 

health disparities research, and $10.0 million to support the Ending the HIV Epidemic in the U.S.

(EHE) initiative1

. The request also continues 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 research on CARB and tick-borne diseases.

Program Descriptions

HIV/AIDS

Decades of basic 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) do not 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 vulnerable to HIV. 

Despite this progress, an estimated 1.2 million Americans were living with HIV in 2020, 

although 13 percent of them were aware of their HIV status. While an end to the HIV epidemic 

is theoretically possible, it will require new prevention approaches and treatments that must be 

refined, developed, and tested. 

A universal test and treat approach—testing all members of a community and treating anyone 

with HIV to improve their health and prevent transmission—has proven very effective at 

decreasing HIV spread in areas with high levels of HIV. Despite overall efficacy, a subset of 

people still have unsuppressed virus. A recent NIAID study showed that these people tended to 

be younger, male, and mobile. Knowing this can inform strategies targeted at reducing the 

stigma of HIV that may lead to suboptimal prevention and treatment in these populations. 

NIAID-supported investigators have been working to develop a long-acting alternative to oral 

PrEP that would be more desirable than taking a daily pill. Two clinical trials recently showed 

that the long-acting injectable drug cabotegravir outperformed daily PrEP in men and 

transgender women who have sex with men, as well as in cisgender women in Africa. The U.S. 

Food and Drug Administration (FDA) has moved this intervention to fast-track approval. Earlier 

NIAID trials had shown that a vaginal ring containing the drug dapivirine could protect women 

from acquiring HIV. Following its approval by the European Medicines Agency and a 

recommendation from the World Health Organization (WHO), some countries in Africa are 

starting to approve it for use, providing a convenient and discreet option for women to 

complement other prevention tools. 

The development of a safe and effective HIV vaccine has proven to be a formidable scientific 

challenge. In addition to attacking the immune system, HIV mutates rapidly and has many 

strains. One approach to vaccine development is the identification of novel immunogens, 

1 Details on the PrEP Delivery Program to End the HIV Epidemic are included in the Mandatory Proposals section 

of the Departmental Management Congressional Justification. 
NIAID-16 

proteins that elicit an immune response. Two studies were launched to examine an 

investigational vaccine based on “mosaic” immunogens—vaccine components comprising 

elements from multiple HIV subtypes. An interim analysis of the trial examining the mosaic 

vaccine in women recently found the vaccine to be safe but not sufficiently effective at 

protecting women from HIV. However, the trial in transgender women and men who have sex 

with men is ongoing. Another HIV vaccine strategy involves harnessing the potential of broadly 

neutralizing antibodies (bNAbs), which, laboratory studies indicate, can prevent a wide variety 

of HIV strains from infecting cells. Results reported in January 2021 from the AMP (AntibodyMediated Protection) studies demonstrated that passive administration of a bNAb can prevent a 

person from acquiring HIV strains susceptible to that antibody. Currently, early-stage clinical 

trials are testing several next-generation bNAbs, individually and in combination, for HIV 

prevention. In parallel, scientists are working to develop candidate vaccines that can elicit 

bNAbs in healthy people. 
NIAID-17 

ART can suppress viral load to 

undetectable and untransmittable levels; 

however, this requires regular monitoring, 

and viral levels can rebound if treatment is 

stopped. NIAID supports substantial 

efforts to develop better treatments, 

including bNabs. Multiple bNAbs are 

being developed, including N6LS, which 

was first tested by NIAID scientists and is 

now being advanced for clinical use by a 

company. Unfortunately, HIV resistance to 

bNAbs (i.e., continued viral replication 

despite the presence of bNAbs) can emerge 

during treatment. NIAID is seeking to 

better understand how resistance emerges 

and if different combinations of bNAbs can 

alleviate this phenomenon. For example, 

resistance may result from pre-existing 

bNAb-resistant viruses, or from the de novo

evolution of newly resistant viruses during 

bNAb treatment. These results will help 

identify optimal bNAbs combinations for 

therapeutic use. 

To accelerate HIV cure research, NIAID 

expanded its Martin Delaney 

Collaboratories for HIV Cure Research 

program, including a new Collaboratory 

specifically focused on developing a 

pediatric cure. A variety of concepts are 

being examined by the Collaboratories, 

including exploring compounds to either 

flush out latent HIV or prevent its 

activation, inhibit latency establishment 

upon starting ART, studying correlates of control of HIV rebound, and using genetically 

engineered viruses to identify viral reservoirs. New therapeutic technologies include engineering 

immune cells to express broadly neutralizing antibodies, mRNA vaccines, and nanoparticle 

vaccines. Another important new concept is the use of gene therapy for a cure. Gene-editing 

technology could be used to inactivate or remove dormant HIV, enhance immune responses, and 

engineer immune cells to be resistant to HIV infection. In collaboration with the Bill & Melinda 

Gates Foundation, NIAID is stimulating research into new technologies for anti-HIV gene 

therapy that could one day replace the need for ART. 

SYNERGISTIC IMPACT OF HIV RESEARCH ON 

COVID-19 RESPONSE

To rapidly address the COVID-19 pandemic, 

NIAID built on many of the lessons learned from 

responding to the HIV pandemic. Four decades of 

NIAID-supported HIV research demonstrated the 

promise of monoclonal antibodies as treatment, 

prevention, and post-exposure prophylaxis, and 

several monoclonal antibodies have now been 

developed to treat and prevent COVID-19. 

Similarly, the search for effective antivirals to treat 

COVID-19 is modelled on the success of HIV 

antivirals. 

New technologies have evolved over the last 

decade driven largely from efforts to develop an 

HIV vaccine. In 2020, NIAID leveraged HIV 

research expertise to rapidly launch critical clinical 

prevention trials, including the successful mRNA 

vaccines for COVID-19. Conversely, the mRNA 

vaccine technology that proved effective for SARSCoV-2 is now being applied to develop a candidate

HIV vaccine. NIAID also leveraged existing HIV 

research infrastructure, merging four HIV and 

infectious disease clinical trials networks to create 

the COVID-19 Prevention Network (CoVPN). The 

CoVPN rapidly enrolled more than 90,000 

volunteers in trials while ensuring diverse 

populations were represented in these studies. 

While answering the call to test COVID-19 

vaccines and therapeutics, these networks 

continued to perform clinical trials and test 

prevention strategies for HIV and other infectious 

diseases. 

People with HIV are also at high risk for severe 

COVID-19, highlighting the importance of 

community interaction and education to foster trust 

and uptake of vaccines, therapeutics, and 

preventive strategies for both COVID and HIV. 

 

 

 

 

 

 
NIAID-18 

Budget Policy: 

The FY 2023 President’s Budget request for the extramural component of the HIV/AIDS 

research is $1,434.4 million, a decrease of $3.2 million or 0.2 percent compared with the FY 

2022 CR 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 co-infections 

and co-morbidities. The FY 2023 request includes $10.0 million of additional funding over the 

FY 2022 CR level for the EHE initiative to expand implementation research activities conducted 

by CFARs and ARCs. 

Biodefense and Emerging Infectious Diseases

The COVID-19 pandemic has reminded us of the global havoc that can be caused by an 

emerging infectious disease. As part of NIAID’s mandate to respond rapidly to emerging 

disease threats and outbreaks, NIAID developed the NIAID Strategic Plan for COVID-19 

Research in 2020 and updated it in 2021 to coordinate research efforts on fundamental research 

on SARS-CoV-2, diagnostics, therapeutics, vaccines, and the long-term effects of infection.

To rapidly test therapeutics and vaccines against COVID-19, NIH, with significant NIAID 

participation, developed an unprecedented public-private partnership called Accelerating 

COVID-19 Therapeutics and Vaccines (ACTIV). Since its establishment, 25 therapeutic agents 

have been prioritized for testing in rigorous clinical trials for COVID-19 patients in both 

inpatient and outpatient trials. The results of the ACTIV clinical trials are reflected in regular 

updates to the NIH COVID-19 Treatment Guidelines. 

In addition, NIAID launched the Adaptive COVID-19 Treatment Trial (ACTT) to evaluate 

promising therapeutics for treating adults hospitalized with COVID-19. The adaptive nature of 

ACTT enabled NIAID to rapidly launch trials. The first study, ACTT-1, demonstrated the safety 

and efficacy of the antiviral remdesivir in shortening the time to recovery in hospitalized 

patients, resulting in FDA licensure. ACTT-2 improved on those results, showing the additional 

benefit of baricitinib, a drug designed to reduce inflammation, for hospitalized patients receiving 

remdesivir. The FDA subsequently issued an Emergency Use Authorization (EUA) for the 

combination of baricitinib and remdesivir for treating hospitalized patients with COVID-19. To 

continue efforts to develop safe and effective antivirals to combat SARS-CoV-2, NIAID, in 

conjunction with other NIH Institutes and Centers, launched the Antiviral Program for 

Pandemics (APP). In 2022, as part of the APP, NIAID will establish Antiviral Drug Discovery 

(AViDD) Centers for Pathogens of Pandemic Concern. These multidisciplinary research centers 

will create platforms that will target coronaviruses and one or more additional RNA viruses with 
NIAID-19 

pandemic potential – helping to better prepare the nation for future viral threats. Oral drug 

candidates for broad use in outpatient settings are the primary focus of this effort. 

Even though several effective vaccines 

against COVID-19 are now available, 

additional studies are needed to maximize 

their real-world utility. One priority is 

understanding the safety and effectiveness 

of employing heterologous prime-boost 

strategies, that is using different 

combinations of COVID vaccines for the 

prime and booster doses. NIAID 

completed a trial that demonstrated the 

safety and efficacy of such an approach 

and the FDA approved the use of 

heterologous or ‘mix and match’ booster 

doses in October 2021. After reports of 

severe allergic reactions to the mRNA 

vaccines surfaced, NIAID quickly 

responded by launching a Phase 2 trial to 

examine whether people with allergies or 

certain immune disorders are at increased 

risk for severe allergic reactions like 

anaphylaxis. A complementary study was 

launched at the NIH Clinical Center to 

assess the safety of a second dose in 

patients who had an allergic reaction to 

the first dose with the goal of determining 

the mechanisms underlying these 

reactions.

To ensure that all people benefit from 

COVID-19 vaccination, NIAID supports clinical trials in special populations such as pregnant 

and immunocompromised people. Pregnant people infected with COVID-19 are more likely to 

be hospitalized and severely ill than their non-pregnant peers. The MOMI-Vax study is 

characterizing the immune responses elicited by vaccination of pregnant and postpartum people. 

The study will evaluate the transfer of vaccine-induced antibodies across the placenta and 

through breast milk to protect the infant. NIAID researchers are comparing immune system 

responses to COVID-19 vaccines in people with and without immune deficiencies to gain a 

comprehensive understanding of the variety of immune responses to these vaccines. In another 

study, NIAID researchers are evaluating an extra vaccine dose in kidney transplant recipients 

who did not develop protective antibodies after two doses of either the Moderna or PfizerBioNTech mRNA vaccines. Like transplant recipients, people with autoimmune diseases take 

medication to suppress their immune systems, and as such, may require an extra vaccine dose. 

PAN-CORONAVIRUS VACCINES

The emergence and re-emergence of infectious 

diseases continues to threaten the health of 

Americans and people worldwide. In the past two 

decades, three novel coronaviruses – SARS-CoV-1, 

MERS-CoV, and most recently SARS-CoV-2 – have 

caused major disease outbreaks. The 2020 global 

pandemic caused by SARS-CoV-2 underscores the 

devastation that this family of viruses can inflict and 

the critical need to develop vaccines capable of broad 

protection against multiple coronavirus strains, 

including newly emerging viruses and variants. The 

aim of pan-coronavirus vaccines is to elicit protection 

against the coronaviruses we already know, such as 

SARS-CoV-2, and related coronaviruses that could 

potentially cause the next pandemic. To that end, 

NIAID established a multidisciplinary research 

program specifically to design and advance pancoronavirus vaccine candidates. These projects aim 

to assess the diversity and infectious potential of 

coronavirus family members, test vaccine 

approaches that can elicit strong and long-lasting 

pan-coronavirus immunity and evaluate pancoronavirus vaccine candidates in cellular and animal 

models. Such an approach builds on pre-clinical 

success seen with the development of experimental 

pan-influenza vaccines, BPL-1357 and FluMos-v1. 

NIAID is exploring the development of pan-pathogen 

vaccines for other diseases as well (see Director’s 

Overview and IID Program Portrait). Developing 

successful pan-pathogen vaccines could prevent a 

disease outbreak from becoming the next pandemic. 
NIAID-20 

To examine this question, NIAID-supported researchers are administering an extra vaccine dose 

to people with one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid 

arthritis, systemic lupus erythematosus, or systemic sclerosis. Some of the subjects will 

discontinue their immune-suppression medication for a short period before and after receiving an 

extra dose to see if this will elicit better antibody production. Finally, NIAID is collaborating 

with Moderna to utilize the Vaccine and Treatment Evaluation Units (VTEUs) for the KidCOVE 

study, which is evaluating 3 different doses of the Moderna mRNA-1273 vaccine in healthy 

children 6 months to less than 12 years of age. 

To support the development of effective vaccines against many diseases, NIAID has an extensive 

program to develop adjuvants, ingredients in vaccines that boost immune responses and enhance 

a vaccine’s effectiveness. For example, alhydroxiquim-II, an adjuvant developed with NIAID 

funding, was included as an essential component of COVAXIN, a COVID-19 vaccine developed 

in India. COVAXIN is currently approved for use in 9 countries. 

NIAID also rapidly launched cohort studies that use cutting-edge approaches to better understand 

the immune response to SARS-CoV-2 infection. The Immunophenotype Assessment in a 

COVID-19 Cohort (IMPACC) study is collecting clinical samples from adults hospitalized with 

COVID-19 for detailed analysis of various aspects of the human immune response to the virus. 

This knowledge will lead to a better understanding of how this disease affects people, including 

risk factors for disease severity and long-COVID complications, and to optimal treatment 

strategies. Additionally, the Human Epidemiology and Response to SARS-CoV-2 (HEROS) 

study followed children and their families for six months to determine who became infected with 

SARS-CoV-2, whether the virus was transmitted to other household members, and which 

household members with the virus developed COVID-19. NIAID also is participating in 

RECOVER (Researching COVID to Enhance Recovery), a large NIH effort to delineate and 

characterize the long-term impacts of Post-Acute Sequelae of SARS-CoV-2 (PASC), including 

long-COVID, in both children and adults (see more in the Crosscutting Initiatives section of the 

NIH Congressional Justification Overview volume).

In addition to responding to the global COVID-19 pandemic, NIAID has responded to several 

Ebola virus disease (EVD) outbreaks by mobilizing its flexible infrastructure and collaborating 

through established clinical research partnerships. One such research collaboration, the PALM 

(Pamoja Tulinde Maisha) trial, resulted in FDA approval of two monoclonal antibody (mAb) 

treatments for EVD – Inmazeb and Ebanga. The mAb that comprises Ebanga was first isolated 

from an EVD survivor by NIAID scientists. To limit and stop EVD outbreaks, NIAID also is 

investing in the development of EVD vaccines. NIAID leads the Partnership for Research on 

Ebola Vaccination (PREVAC), a research collaboration testing three different vaccine strategies 

to prevent EVD in children and adults. Separate, ongoing clinical trials are examining the safety 

of two additional vaccine candidates for EVD and Marburg, a disease caused by a close viral 

relative of Ebola. Both use the vaccine vector cAd3, a delivery system developed by NIAID 

scientists and are currently being advanced by the Sabin Vaccine Institute. To mitigate EVD 

spread, NIAID scientists developed two new rapid diagnostic tests. One recognizes certain 
NIAID-21 

Ebola virus proteins in the blood only four days after infection. The other is a portable field 

assay that tests for Ebola virus in wildlife carcasses to rapidly identify possible new outbreaks. 

Resistance to antibiotics and other antimicrobial drugs is also a growing public health concern, 

causing 2.8 million infections and 35,000 deaths in the United States each year.2

 Antimicrobial 

resistance occurs when pathogens change over time and no longer respond to treatment. NIAID

continues to make significant investments into basic, translational, and clinical research on 

antimicrobial resistance, including supporting the government-wide National Action Plan for 

Combatting Antibiotic-Resistant Bacteria (CARB). NIAID works to identify promising 

countermeasures to accelerate the fight against antimicrobial resistance and works closely with 

the Biomedical Advanced Research and Development Authority (BARDA) to further develop 

them. NIAID and BARDA supported the Antimicrobial Resistance Diagnostic Challenge to 

develop innovative, rapid, point-of-care diagnostics that identify drug-resistant pathogens and 

treatment strategies. Such targeted treatment approaches reduce the risk of developing drug 

resistance. The test that won this challenge can diagnose gonorrhea and determine the best 

treatment in less than 30 minutes.

In FY 2020, NIAID established several new programs related to antimicrobial resistance, 

including the Chemistry Center for Combatting Antibiotic-Resistant Bacteria (CC4CARB), to 

design, synthesize and deliver novel compounds to the scientific community; and the Combatting 

Antibiotic-Resistant Bacteria Interdisciplinary Research Units (CARBIRUs) which are exploring 

bacterial and human factors that influence drug resistance. NIAID also renewed the 

Antibacterial Research Leadership Group (ARLG), which designs and implements the clinical 

research agenda to address antibacterial resistance. ARLG advances research by developing 

transformational clinical trials that aim to change clinical practice and reduce the impact of 

antibacterial resistance. For example, a recent ARLG study of community-acquired pneumonia 

in children showed that a 5-day antibiotic course was better than the standard 10-day treatment, 

reducing both side effects and the risk of antibiotic resistance. 

Bacteriophages, or phages, also can be used to treat antibiotic resistant infections. These viruses 

directly infect and destroy bacteria, bypassing bacterial antibiotic resistance mechanisms. 

NIAID scientists tested phage therapy in mice infected with multidrug-resistant Klebsiella 

pneumoniae, a bacterium that can lead to pneumonia, bloodstream infections, meningitis, or 

urinary tract infections. When treated with either of two different phages, P1 or P2, all mice 

recovered from K. pneumoniae infection. In 2021, NIAID prioritized this area of research, 

funding its first set of projects to address key knowledge gaps in the development of phages as 

preventative and therapeutic tools for bacterial infections. ARLG scientists will also test a 

bacteriophage cocktail for the treatment of cystic fibrosis patients with treatment-resistant 

Pseudomonas aeruginosa infections. 

The spread of drug resistance is also an ongoing concern for tuberculosis (TB), which remains 

the leading cause of death among infectious diseases and one of the top 10 causes of death 

2 cdc.gov/drugresistance/index.html
NIAID-22 

worldwide. In a recent clinical trial, investigators showed that a 4-month drug treatment regimen 

was as efficient as the standard 6-month regimen, with fewer side effects, and less risk of drug 

resistance, while allowing for better patient adherence to treatment. In collaboration with 

private-sector partners, the PredictTB program is evaluating markers of disease in patients with 

drug-sensitive TB to determine if they could benefit from a shorter treatment course. To prevent 

the spread of multidrug resistant-TB in households, NIAID’s Protecting Households On 

Exposure to Newly Diagnosed Index trial is testing whether the anti-TB drug delamanid is better 

than the standard isoniazid treatment for preventing TB disease in at-risk household members. 

Additionally, NIAID is evaluating how anti-TB drugs are absorbed, distributed, and metabolized 

in the body during and after pregnancy to better understand how best to treat pregnant people 

without harming their fetuses. To characterize immune responses to TB, NIAID launched 

IMPAc-TB in FY 2019. Results from the program have identified early immune responses that 

predict the ability to control the infection, which are helping to inform new candidate vaccines 

and treatments.

Vaccines that either prevent infection or transition to active TB are urgently needed to decrease 

the global burden of TB. A NIAID initiative, the Innovation in TB Vaccine Discovery, 

emphasizes high risk/high impact strategies for vaccine design that incorporate novel 

technologies. NIAID is supporting the comparison of different adjuvants in combination with 

tuberculosis immunogens to develop effective vaccines. Finally, NIAID is establishing 

Tuberculosis Research Advancement Centers to foster multidisciplinary TB research, mentor 

new TB investigators, and strengthen TB clinical research whether related to vaccines or 

treatment. Ending the TB pandemic will depend on identifying the millions of individuals with 

TB who are undiagnosed. NIAID launched Feasibility of Novel Diagnostics for TB in Endemic 

Countries (FEND for TB) in 2020, to evaluate and improve TB diagnostics for both drugsusceptible and drug-resistant TB with a special emphasis on diagnostics for point of care 

settings as well as in children and adults with HIV.

NIAID is committed to addressing the threat to public health posed by the rising incidence of 

tickborne diseases (TBDs), such as Lyme disease, in the United States. Current strategies to 

address TBDs are hindered by suboptimal diagnostics, a paucity of treatment options for viral 

and other TBDs, and a lack of vaccines. The NIH Strategic Plan for Tickborne Disease Research 

proposes additional research to better understand the complex interplay among host, tick, and 

pathogen factors that contribute to TBDs and the body’s defenses against them. NIAID will 

leverage this knowledge to develop new tools to effectively prevent, diagnose, and treat TBDs 

for all stages of disease and across diverse populations and age groups. 

Budget Policy: 

The FY 2023 President’s Budget request for the extramural component of Biodefense and 

Emerging Infectious Diseases research supported by NIAID is $2,130.9 million, an increase of 

$112.2 million or 5.6 percent compared with the FY 2022 CR level. NIAID will continue to 

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

health concern. 
NIAID-23 

The FY 2023 request will also support the development of medical countermeasures and new 

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

disease pathogens. An increase of $40.0 million over the FY 2022 CR level will support NIAID 

efforts to continue 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. 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, and will also support development of therapeutics against 

antibiotic-resistant bacteria. 

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. Support for collaborative, multidisciplinary research on developing vaccines 

for STIs, identifying immune cells that drive celiac disease, addressing endemic fungal disease 

such as Valley fever, and advancing research on hepatitis B and C viruses will begin to address 

the magnitude of burden imposed by these diseases.

The prevalence of food allergy among children under 18 has been increasing. NIAID 

researchers have identified several risk factors for developing food allergy, but the reasons food 

allergy has been increasing remain unknown. Allergic reactions to foods can range from mild, 

such as gastrointestinal symptoms or skin rashes, to severe, including the life-threatening allergic 

reaction called anaphylaxis. In March 2021, NIAID launched the observational Systems Biology 

of Early Atopy, or SUNBEAM study to identify prenatal and early childhood biomarkers of high 

risk for the development of food allergy and atopic dermatitis, as well as biological pathways 

that lead to these conditions. The study is enrolling children from birth to age three and will 

examine the roles and interrelationships between clinical, environmental, biologic, and genetic 

factors in the development of allergic diseases. Results from the study will help guide the 

implementation of current prevention strategies and facilitate new approaches to the prevention 

and treatment of food allergy. 

Atopic dermatitis, or eczema, is a chronic inflammatory skin disease characterized by dry, itchy 

skin and rashes. Most common in children, atopic dermatitis increases the risk of developing 

asthma, hay fever, and food allergy and can require costly and cumbersome treatments. In 

addition to the SUNBEAM study, NIAID researchers are exploring the numerous genetic and 

environmental factors that contribute to eczema, including the role of the skin’s microbiota—the 

community of bacteria and other microbes living on the skin. NIAID investigators found that 

treatment with Roseomonas mucosa, a bacterium of the skin’s microbiota, can safely reduce 

eczema disease severity and increase quality of life. Additionally, new research supported by 

NIAID has delineated how two relatively common variations of a gene called KIF3A impair skin 

barrier function, leading to increased water loss and the potential development of eczema. With 
NIAID-24 

the identification of these gene variations, infants could be screened for them potentially. 

Furthermore, therapies addressing water loss from the skin might prevent eczema in these 

children, thereby preventing a cascade of additional allergic diseases later in life. 

More than 25 million people in the United 

States have asthma, including 5.1 million 

children.3

 This chronic lung disease can 

reduce quality of life, and severe asthma 

attacks can be life-threatening and lead to 

numerous emergency room visits and 

hospitalizations. In 2021, NIAID 

supported the establishment of the 

Childhood Asthma in Urban Settings 

(CAUSE) network. This nationwide 

network will conduct observational studies 

and clinical trials to improve the 

understanding of asthma and develop 

treatment and prevention approaches 

tailored to children of low-income 

families living in urban communities. 

This initiative extends and expands 

NIAID’s long-standing efforts to better 

understand and address health disparities 

in asthma prevalence and treatment. 

Respiratory syncytial virus (RSV) 

infection in infants hospitalized with 

bronchiolitis, a severe childhood lung 

infection, is the most impactful risk factor 

for developing asthma later in childhood. 

Recently, the MARC-35 (35th Multicenter 

Airway Research Collaboration) study 

identified which infants hospitalized with 

RSV were at highest risk for developing 

asthma by age five. These findings will 

be expanded to help target prevention 

strategies. RSV vaccine candidates based 

on vaccine prototypes developed by 

NIAID scientists are in advanced 

development by industry. Another clinical 

trial, Preventing Asthma in high-Risk Kids 

(PARK), is evaluating whether blocking IgE, an antibody critical in the development of allergies 

3 cdc.gov/vitalsigns/asthma/index.html

MALARIA AND MOSQUITO VACCINES

Mosquito-borne diseases are widespread and 

difficult to treat, with malaria having the greatest 

global impact. Roughly 3.2 billion people—almost 

half the world’s population—are at risk of malaria 

and there is a pressing need for a highly effective 

malaria vaccine. NIAID supported two recent 

clinical trials for vaccines that have shown 

promising protection against malaria. 

 

In collaboration with a small business, NIAID 

scientists developed a chemoprophylaxis 

vaccination (PfSPZ-CVac) approach that 

combines vaccination with live parasites and one 

of two antimalarial drugs, pyrimethamine or 

chloroquine. Initial tests in humans suggest that 

higher doses of the vaccine-antimalarial drug 

combination had very strong protective results; the 

combination with chloroquine showed a 

remarkable 100 percent protection. Larger Phase 

2 studies are currently under development and, if 

successful, suggest that chemoprophylaxis 

vaccination could be a promising preventative 

strategy for those living in or traveling to endemic 

areas.

NIAID scientists also developed another vaccine, 

Anopheles gambiae saliva vaccine (AGS-v), which 

elicits an immune response to mosquito-derived 

substances rather than any specific parasite, virus, 

or bacteria. Instead of targeting the pathogen 

itself, the AGS-v vaccine elicited immune 

responses against four mosquito salivary proteins. 

In animal models, immunity to mosquito salivary 

proteins protected animals from many different

mosquito-borne diseases. A clinical trial of this 

vaccine was the first “universal mosquito vaccine” 

in humans and demonstrated that the vaccine is 

safe and produced significant immune responses. 

Both the PfSPZ-CVac and AGS-v candidates, if 

shown to be effective in larger clinical trials, could 

help reverse stalled global progress against 

malaria.
NIAID-25 

and asthma, can prevent asthma in high-risk children ages 2-4 years old. The PARK trial results 

will advance our understanding of the pathogenesis, treatment, and prevention of asthma. 

Many mutations in immune system genes affect the development and function of infectionfighting immune cells, causing rare immune deficiencies such as severe combined 

immunodeficiency (SCID). This condition is fatal, usually within the first two years of life, 

unless the infants’ immune system is restored by a transplant of blood-forming stem cells, gene 

therapy, or enzyme therapy. The SCID newborn screening test, originally developed at NIH, has 

made it possible to detect SCID before symptoms appear, helping ensure that affected infants 

receive life-saving treatments. NIAID researchers have now developed an investigational gene 

therapy that safely restores the immune systems of infants and children who have one version of 

this rare, life-threatening disorder. XMEN disease, another disorder of the immune system, was 

first described by NIAID investigators in 2011 and is characterized by low levels of infectionfighting immune cells. Existing treatment options are associated with high mortality, so 

alternative therapeutic options are needed. Using gene editing technology, NIAID researchers 

were able to genetically alter the cells in mice responsible for creating new immune cells, fix the 

mouse counterpart of the defective gene associated with XMEN disease, and restore cellular 

function. This treatment approach is now poised for testing in humans with XMEN disease. 

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

devastating impact on women and infants and their interrelationships with HIV/AIDS. Infection 

with certain STIs can increase the risk of getting and transmitting HIV as well as alter the way 

the disease progresses. When left untreated, STIs can cause long-term health problems including 

infertility and neurological impairments. Cases of syphilis, gonorrhea, and chlamydia have 

increased in the United States. NIAID established four STI Cooperative Research Centers to 

advance the development of vaccines against the pathogens that cause these STIs. 

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

public health problem and an important topic of NIAID research (see Program Portrait). In a 

first-in-human study, NIAID researchers have evidence that one dose of an antimalarial 

monoclonal antibody (mAb) can prevent infection. Researchers at NIAID discovered and 

isolated a mAb against malaria from a volunteer who received an investigational malaria vaccine 

and then modified it to extend the amount of time the mAb would remain in the bloodstream, 

creating mAb CIS43LS. In a Phase 1 clinical trial, one dose of CIS43LS was safe and prevented 

malaria in a controlled human challenge up to nine months after administration. A larger Phase 

2 clinical trial is underway in Mali—where malaria is endemic—to evaluate the safety and 

efficacy of this mAb at preventing malaria infection in adults. 

Budget Policy: 

The FY 2023 President’s Budget request for the extramural component of Infectious and 

Immunologic Diseases research is $1,472.5 million, an increase of $50.7 million or 3.6 percent 

compared with the FY 2022 CR level. NIAID will continue to advance long-range research 

priorities in infectious and immunologic diseases. The FY 2023 request will support NIAID’s 

commitment and long-term interest in fundamental immunology, as well as research on malaria, 
NIAID-26 

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

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

Intramural Research Program (IRP)

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 (DIR), 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 research 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 

domestic and international partnerships, allows NIAID to execute high-risk and long-term 

studies, conduct research on rare diseases, and rapidly respond to global public health 

emergencies.

A recent collaboration between DIR and academic researchers identified a mechanism where 

organisms living in or on our body surfaces—called the microbiota—communicate with each 

other and with the human immune system. Pieces of viruses that were previously infectious can 

integrate in the human host’s DNA and influence how the host immune system and microbiota 

interact. This communication can affect tissue repair and antimicrobial defenses. In another 

highly collaborative study of the body’s natural defenses against bacterial infection, NIAID IRP 

investigators along with researchers from four other NIH Institutes identified a nutrient—

taurine—that helps the gut recall prior infections and kill invading bacteria, such as Klebsiella 

pneumoniae. This finding could aid efforts seeking alternatives to antibiotics and reduce 

antimicrobial resistance. Additionally, IRP researchers identified an antimicrobial substance 

called micrococcin P1 (MP1) found in a species of bacteria from the skin’s microbiota. Topical 

application of MP1 reduced infection and accelerated healing of wounds in mice with 

methicillin-resistant Staphylococcus aureus infection. 

Finally, the IRP plays an essential role in rapidly responding to public health emergencies across 

the globe. Intramural investigators created the mRNA for the stabilized SARS-CoV-2 spike 

protein within 3 days of the publication of the virus’ genome, enabling the rapid generation and 

testing of a vaccine. NIAID scientists also conducted the first-in-human COVID-19 vaccine trial 

and provided scientific expertise and leadership for the U.S. Government’s COVID-19 effort, 

including expert clinical trial and immunologic support for phase 3 clinical trials, such as assays 

that measure immune responses to COVID-19 vaccines. The pandemic response involved 

intense discussion and close collaborations with global entities such as the WHO, as well as 

coordination with many local and foreign governments. Similarly, NIAID staff members 

advised the Indian government in responding to the 2021 Nipah virus outbreak. 
NIAID-27 

Budget Policy: 

The FY 2023 President’s Budget request for Intramural Research is $818.7 million, an increase 

of $25.8 million or 3.3 percent compared with the FY 2022 CR level. The FY 2023 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 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 2023 President’s Budget request for RMS is $411.8 million, an increase of $13.2 million 

or 3.3 percent compared with the FY 2022 CR level. The budget increase will support ongoing 

administrative efforts and cover the FY 2023 proposed pay increase. 
NIAID-28 

Fiscal Year Budget Estimate to 

Congress House Allowance Senate Allowance Appropriation

2014

Rescission

2015

Rescission

2016

Rescission

20171

Rescission

2018

Rescission

2019

Rescission

2020

Rescission

Supplemental

2021

Rescission

2022

Rescission

2023

$4,578,813,000

$4,423,357,000

$4,614,779,000

$4,715,697,000

$3,782,670,000

$4,761,948,000

$4,754,379,000

$5,885,470,000

$6,245,926,000

$6,268,313,000

$4,512,918,000

$4,738,883,000

$5,005,813,000

$5,368,029,000

$5,811,268,000

$6,013,087,000

$6,557,803,000

$4,548,383,000

$4,710,342,000

$4,961,305,000

$5,127,866,000

$5,506,190,000

$5,937,816,000

$6,142,540,000

$6,342,756,000

$4,358,841,000

$0

$4,358,841,000

$0

$4,629,928,000

$0

$4,906,638,000

$0

$5,260,210,000

$0

$5,523,324,000

$0

$5,885,470,000

$0

$1,542,000,000

$6,069,619,000

$0

$6,069,619,000

$0

1

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Appropriations History

Budget Estimate to Congress includes mandatory financing.
NIAID-29 PHS Act/ Other Citation U.S. Code Citation FY 2022 CR FY 2023 President's Budget Section 301

Section 401(a) 42§281 Indefinite

Total, Budget Authority $6,069,619,000 $6,268,313,000

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Authorizing Legislation

2022 Amount

Authorized

2023 Amount

Authorized

Research and Investigation 42§241 Indefinite Indefinite

National Institute of Allergy and Infectious Diseases

$6,268,313,000 $6,069,619,000

Indefinite
NIAID-30 

Source of Funding FY 2021 Final FY 2022 CR FY 2023 President's 

Budget

Appropriation $6,069,619 $6,069,619 $6,268,313

Secretary's Transfer -18,222 0 0

Subtotal, adjusted appropriation $6,051,397 $6,069,619 $6,268,313

OAR HIV/AIDS Transfers -2,548 0 0

Subtotal, adjusted budget authority $6,048,849 $6,069,619 $6,268,313

Unobligated balance, start of year 0 0 0

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

Subtotal, adjusted budget authority $6,048,849 $6,069,619 $6,268,313

Unobligated balance lapsing -11 0 0

Total obligations $6,048,838 $6,069,619 $6,268,313

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 2021 - $19,351 FY 2022 - $20,125 FY 2023 - $20,930 
NIAID-31 

FY 2022 CR FY 2023 President's 

Budget

FY 2023

+/-

FY 2022 CR

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

2,180

0

$204

12.6

$123

$105

$158

2,180

0

$212

12.6

$128

$110

$162

0

0

$9

0.0

$5

$4

$4

OBJECT CLASSES FY 2022 CR FY 2023 President's 

Budget

FY 2023

+/-

FY 2022

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

196,859

82,689

13,551

3,541

26,409

205,702

87,028

14,177

3,713

27,844

8,844

4,339

627

173

1,435

11.9 Subtotal Personnel Compensation $323,048 $338,465 $15,417

12.1

12.2

13.0

Civilian Personnel Benefits

Military Personnel Benefits

Benefits to Former Personnel

107,609

3,698

0

112,353

3,870

0

4,744

173

0

Subtotal Pay Costs $434,355 $454,688 $20,334

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

1,001

1,681

47

0

1,825

18

202,167

180,998

592,744

9,774

693,046

6,662

32,905

0

1,028

1,727

48

0

1,884

19

206,714

188,443

606,799

9,878

744,308

6,977

33,871

0

27

46

1

0

59

1

4,547

7,444

14,055

103

51,262

315

965

0

25.0 Subtotal Other Contractual Services $1,718,297 $1,796,989 $78,692

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

62,696

29,752

2,438

0

3,817,505

0

3

0

64,408

30,604

2,492

0

3,914,422

0

3

0

1,712

853

54

0

96,917

0

0

0

Subtotal Non-Pay Costs $5,635,264 $5,813,625 $178,360

Total Budget Authority by Object Class $6,069,619 $6,268,313 $198,694

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-32 

OBJECT CLASSES FY 2022 CR FY 2023 President's 

Budget

FY 2023

+/-

FY 2022

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)

$196,859

82,689

13,551

3,541

26,409

$205,702

87,028

14,177

3,713

27,844

$8,844

4,339

627

173

1,435

Subtotal Personnel Compensation (11.9) $323,048 $338,465 $15,417

Civilian Personnel Benefits (12.1)

Military Personnel Benefits (12.2)

Benefits to Former Personnel (13.0)

$107,609

3,698

0

$112,353

3,870

0

$4,744

173

0

Subtotal Pay Costs $434,355 $454,688 $20,334

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)

$1,001

1,681

0

1,825

18

202,167

180,998

440,305

9,774

32,905

0

$1,028

1,727

0

1,884

19

206,714

188,443

454,360

9,878

33,871

0

$27

46

0

59

1

4,547

7,444

14,055

103

965

0

Subtotal Other Contractual Services $866,150 $893,265 $27,115

Supplies & Materials (26.0) $62,696 $64,408 $1,712

Subtotal Non-Pay Costs

Total Administrative Costs

$933,372

$1,367,727

$962,332

$1,417,020

$28,959

$49,293

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Salaries and Expenses

(Dollars in Thousands)
NIAID-33 

OFFICE/DIVISION

FY 2021 Final FY 2022 CR FY 2023 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:

158

-

158

103

-

103

94

-

94

236

-

236

734

-

734

181

-

181

421

-

421

117

-

117

5

-

5

1

-

1

6

-

6

-

-

-

11

-

11

8

-

8

2

-

2

1

-

1

163

-

163

104

-

104

100

-

100

236

-

236

745

-

745

189

-

189

423

-

423

118

-

118

171

-

171

113

-

113

96

-

96

260

-

260

749

-

749

193

-

193

444

-

444

120

-

120

5

-

5

1

-

1

6

-

6

-

-

-

11

-

11

8

-

8

2

-

2

1

-

1

176

-

176

114

-

114

102

-

102

260

-

260

760

-

760

201

-

201

446

-

446

121

-

121

171

-

171

113

-

113

96

-

96

260

-

260

749

-

749

193

-

193

444

-

444

120

-

120

5

-

5

1

-

1

6

-

6

-

-

-

11

-

11

8

-

8

2

-

2

1

-

1

176

-

176

114

-

114

102

-

102

260

-

260

760

-

760

201

-

201

446

-

446

121

-

121

Total 2,044 34 2,078 2,146 34 2,180 2,146 34 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

2019 12.7

2020 12.6

2021 12.6

2022 12.6

2023 12.6

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Detail of Full-Time Equivalent Employment (FTE)
NIAID-34 

GRADE FY 2021 Final FY 2022 CR FY 2023 President's 

Budget

Total, ES Positions

Total, ES Salary

2

390,600

2

407,668

2

424,688

General Schedule

GM/GS-15 210 215 215

GM/GS-14 433 448 448

GM/GS-13 414 431 431

GS-12 243 264 264

GS-11 117 126 126

GS-10 1 1 1

GS-9 77 79 79

GS-8 26 26 26

GS-7 51 52 52

GS-6 11 11 11

GS-5 4 4 4

GS-4 8 8 8

GS-3 6 6 6

GS-2 1 1 1

GS-1 3 3 3

Subtotal 1,605 1,675 1,675

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

Assistant Surgeon General 0 0 0

Director Grade 9 9 9

Senior Grade 8 8 8

Full Grade 9 9 9

Senior Assistant Grade 4 4 4

Assistant Grade 0 0 0

Subtotal 30 30 30

Ungraded 509 509 509

Total permanent positions 1,619 1,620 1,620

Total positions, end of year 2,146 2,216 2,216

Total full-time equivalent (FTE) employment, end of year 2,078 2,180 2,180

Average ES salary

Average GM/GS grade

Average GM/GS salary

195,300

12.6

120,056

203,834

12.6

122,788

212,344

12.6

127,914

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

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy and Infectious Diseases

Detail of Positions1