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RSV Vaccine

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In 2023, due in part to over 60 years of NIH-supported research, FDA approved a safe and effective vaccine for respiratory syncytial virus (RSV), which reduces the risk of severe disease by 94.1% in people over 60. RSV causes up to 160,000 adults over the age of 65 to be hospitalized per year in the U.S.

Image credit: �����鶹��Ƶ Institute of Allergy and Infectious Diseases, NIH

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• RSV usually causes mild symptoms similar to a common cold. However, up to 10,000 adults over 65 die as a result of the virus each year in the U.S.
• In 1957, NIH researchers identified RSV as a virus associated with respiratory illness in children, and through subsequent decades of research, NIH scientists discovered how to help the body elicit a stronger protective immune response against the virus.
• This vaccine is approved for adults over 60 years of age and pregnant people. Vaccines are in development for children and younger adults.

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Lupus and Pregnancy

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Findings from NIH-supported research showing that people with lupus can have safe and healthy pregnancies resulted in a change in CDC guidance for people with lupus who are planning to become pregnant. Previously, patients with lupus were counseled to avoid becoming pregnant.

Image credit: istock

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• NIH-supported researchers identified key factors that may put patients with lupus at risk for complications during pregnancy, so physicians are able to better counsel and monitor high-risk patients.
• Now patients with lupus who are planning pregnancies have NIH-informed resources from CDC to help guide conversations with their physicians.
• These findings are expected to significantly impact prenatal care and allocation of health care resources for the 1.5 million people in the U.S. with lupus, of which 90% are women.

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Vaccines

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NIH has led the world in the identification of viral pathogens and subsequent development and testing of vaccines. NIH researchers have played an integral role in the development of roughly half of all FDA-approved vaccines currently in use, collectively saving millions of lives each year.

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• Vaccines stimulate the immune system to produce immune responses that protect against infection. 
• Vaccines provide a safe, cost-effective, and efficient means of preventing illness, disability, and death from infectious diseases.���� 
• NIH has supported vaccine development to address numerous diseases including, most recently COVID-19, and also historically, diphtheria, smallpox, Rocky Mountain spotted fever, rubella, hepatitis A, whooping cough, Type B Haemophilus (Hib), human papillomavirus (HPV), and many more.

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HPV Vaccine

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Decades of NIH research showed how to prevent Human Papillomavirus (HPV) infection through the development of vaccines that are 100% effective against two forms of HPV that cause cervical cancer. Governments across the globe now recommend routine HPV vaccination for all children 11 or 12 years old.

Image credit: Ewa Krawczyk/�����鶹��Ƶ Cancer Institute \ Georgetown Lombardi Comprehensive Cancer Center

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• The first commercially available vaccines that protect against HPV—including the two forms that cause cervical cancer and most HPV-associated cancers—became available in 2006.
• HPV is associated with almost all cases of cervical cancer and some types of other cancers including head and neck, anal, penile, vulvar, and vaginal.
• Most treatments in the field of cancer aim to cure the disease, but this advance is designed to prevent it.

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COVID-19 Diagnostics

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NIH played a large role in responding to the COVID-19 pandemic by supporting the rapid development of accurate and reliable testing on an enormous scale, leading to the production of more than 1 billion COVID-19 tests and test products in under 1.5 years.

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• NIH launched the Rapid Acceleration of Diagnostics (RADx®) initiative to speed the manufacture of COVID-19 diagnostic technologies in response to the pandemic, increasing testing capacity by 100s of millions in the U.S. in less than 1.5 years. 
• Support from RADx has led to more than 45 emergency use authorizations (EUAs) from FDA, including the first EUA for over-the-counter COVID-19 testing.
• Several COVID-19 testing technologies supported by RADx are available to the American public and can be purchased at pharmacies or online for at-home use.

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COVID-19 Vaccine

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NIH-supported research led to the development of mRNA COVID-19 vaccines in record time. As a result, by March 2022, over 577 million vaccine doses had been administered in the U.S., saving an estimated 2.4 million lives and preventing 17 million hospitalizations.

Image credit: NIH

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• Decades of NIH-supported research provided the platform to jumpstart development of mRNA vaccines targeting SARS-CoV-2, the virus that causes COVID-19, ensuring a rapid response to the pandemic.
• Community engagement approaches and infrastructure developed for HIV vaccine clinical trials ensured that COVID-19 vaccine trials included people who represent the diversity of the U.S. 
• As of July 2022, two vaccines had been approved by FDA, and two had been authorized for emergency use. 
• Research shows that COVID-19 vaccines are effective in preventing fully vaccinated people from developing serious disease.

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COVID-19 Treatments

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NIH-supported research has enabled the rapid development of treatments for COVID-19, including the antiviral Paxlovid. Paxlovid, which has been authorized by FDA for those with mild-to-moderate symptoms, can be taken at home and has been shown to reduce the risk of hospitalization and death by 89%.

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• Paxlovid is an antiviral combination therapy of nirmatrelvir and ritonavir, and it targets specific parts of the virus to stop it from multiplying in the body.
• NIH has developed treatment guidelines for healthcare providers to help them work with their patients and determine the best treatment options for them. Several options, including Paxlovid, are now available for treating COVID-19 at home or in an outpatient setting. 
• As of August 2022, FDA had issued Emergency Use Authorization for three COVID-19 treatments: monoclonal antibodies, Paxlovid, and molnupiravir.

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HIV and Pregnancy

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Since the mid-1990s, NIH research has informed implementation of HIV testing and preventive interventions. HIV testing and interventions have resulted in a more than 90% decrease in the number of children with perinatally acquired HIV in the U.S.

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• HIV can be transmitted during pregnancy, birth, or infant feeding. Perinatal transmission, also known as mother-to-child transmission, is the most common way that children get HIV. 
• NIH-supported research showed that a three-drug regimen—called HAART, or highly active antiretroviral therapy—was shown to be better than the drug azidothymidine (AZT) at preventing mother-to-child transmission of HIV. 
• HAART was shown to reduce the risk of perinatal transmission to 1.2%, and because of this and related interventions, an estimated 21,956 perinatally-acquired HIV cases have been prevented in the U.S. since 1994.

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HIV Prevention

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An NIH-supported clinical trial was the first to establish the efficacy of pre-exposure prophylaxis (PrEP) to prevent infection by HIV, the virus that causes AIDS. PrEP reduces the risk of getting HIV from sex by 99% and reduces the risk of getting HIV from injection drug use by at least 74%.

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• Since the first AIDS cases were reported in 1981, HIV/AIDS has been one of humanity’s deadliest and most persistent epidemics. 
• In 2015, WHO recommended oral PrEP for people at substantial risk of HIV infection, paving the way for widespread adoption of PrEP.
• PrEP is currently available in oral pill form that must be taken daily and in a long-acting injectable form. 
• HIV prevention efforts have contributed to averting more than 350,000 HIV infections in the U.S.

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HIV Treatment

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NIH research led to the development of medications such as antiretroviral therapy (ART) to prevent people with HIV from developing AIDS, resulting in nearly normal life expectancy.

Image credit: Office of AIDS Research, NIH

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• Over 40 million people with HIV have died worldwide since 1981.
• NIH research led to the development of ART. By taking ART as prescribed, most people with HIV will not develop AIDS and will have improved life expectancy.
• NIH research demonstrated that people living with HIV who achieve and maintain undetectable levels of virus in their blood—by taking and adhering to ART as prescribed—cannot sexually transmit the virus to others, known as U=U (Undetectable = Untransmittable).

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Hepatitis C

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NIH research played a major role in the discovery of the hepatitis C virus, resulting in the development of drugs that can cure almost all infected individuals and blood donor screening programs that have decreased the incidence of transfusion-transmitted hepatitis to near zero.

Image credit: CDC

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• Hepatitis C affects millions of people in the U.S. and around the world.
• It is a viral infection that spreads through contact with an infected person’s blood and causes liver inflammation and damage. It is one of the most common causes of liver cancer.
• In 2020, an NIH researcher received a Nobel Prize for his contribution to the discovery of the virus.
• This work was instrumental in leading to the development of new diagnostic and therapeutic agents for hepatitis C and for providing the scientific basis for instituting blood donor screening programs.

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Hepatitis A Vaccine

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NIH researchers played a crucial role in developing the first licensed hepatitis A vaccine in 1995, contributing to a 92% decline in hepatitis A rates since then.

Image credit: CDC/ Betty Partin

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• The hepatitis A virus causes acute inflammation of the liver. 
• Prior to the discovery of a vaccine, an estimated 100 people died from hepatitis A every year in the U.S. 
• NIH intramural researchers played a crucial role in developing the first licensed hepatitis A vaccine, from initial identification and characterization of the virus to the clinical trials that demonstrated the effectiveness of the vaccine.

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Hepatitis B Vaccine

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Hepatitis B infection causes inflammation of the liver that can lead to life-threatening health issues. Due to intensive vaccination programs based on NIH research, the rate of acute hepatitis B has fallen by more than 80% since the late 1980s.

Image credit: Photographer: Alain Grillet; Copyright Sanofi Pasteur

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• Hepatitis B infection causes inflammation of the liver. 
• It occurs through contact with infected blood, semen, or other bodily fluid through sex, sharing needles or other drug-injection equipment, or from mother to baby at birth. 
• For many people, hepatitis B is a short-term illness. For others, it can become a long-term, chronic infection that can lead to serious, even life-threatening health issues like cirrhosis or liver cancer.
• The best way to prevent hepatitis B is to get vaccinated.

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Autoimmune Disorders

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NIH-supported basic research on the immune system in the 1990s led to the development of Janus kinase (JAK) inhibitors—a class of drugs routinely used to treat a wide range of autoimmune disorders. To date, eight JAK inhibitors have been FDA-approved for treatment of a range of disorders.

Image credit: Illustration by Emw - Own work, based on PyMOL rendering of PDB 1yvj. CC BY-SA 3.0, sh.wikipedia.org/wiki/Janus_kinaza_3#/media/Datoteka:Protein_JAK3_PDB_1yvj.png

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• NIH researchers discovered the importance of the JAK family of proteins as regulators of the human immune system, leading to the development of a class of drugs that block JAK activity to suppress the immune system and protect against damaging inflammation. 
• To date, JAK inhibitors have been FDA-approved for treatment of rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile arthritis, ulcerative colitis, atopic dermatitis, graft-versus-host disease, myeloproliferative neoplasms, alopecia areata, vitiligo, COVID-19 pneumonia, and counting.

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Rotavirus Vaccine

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Because of NIH research, the introduction of a vaccine for rotavirus—the most common cause of childhood diarrhea worldwide—has resulted in the prevention of up to 50,000 child hospitalizations each year.

Image credit: Ethan Tyler and Nihal Altan-Bonnet

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• NIH intramural scientists were the first to identify rotavirus in 1974, and they partnered with the pharmaceutical industry to create the first rotavirus vaccine in 1998. This paved the way for the creation of second-generation rotavirus vaccines in 2006 and 2008.
• Prior to vaccine introduction in the U.S., rotavirus caused up to 70,000 children to be hospitalized and 60 deaths annually. 
• After the introduction of rotavirus vaccine in 2006, rotavirus activity in the U.S. decreased up to 90%, with up to 50,000 child hospitalizations prevented annually.

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References

RSV Vaccine

1. RSV in Older Adults and Adults with Chronic Medical Conditions:
2. NIAID Research Journeys: Safe and Effective RSV Protein Vaccines:
3. Article: FDA Approves First Respiratory Syntical (RSV) Vaccine:
4. Article: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants:

Lupus and Pregnancy

1. Having a Healthy Pregnancy with Lupus:
2. Breacher G, et al. Am J Clin Path. 1956;26: 1439-49. PMID: .
3. Lupus facts and stats:

Vaccines

1. Article: A Long Tradition of Vaccine Breakthroughs: IRP Vaccine Research Stretches Back to the NIH’s Birth: ;
2. Producing Novel Vaccines: 

HPV Vaccine

1. Article: NIH Technology Licensed to Merck for HPV Vaccine: 
2. Human Papillomavirus (HPV) Vaccines: 
3. Article: The HPV vaccine: Two decades of research pays off: 
4. Article: Protecting Against HPV: Common Viruses Can Lead to Cancer: 

COVID-19 Diagnostics

1. Rapid Acceleration of Diagnostics (RADx®): /research-training/medical-research-initiatives/radx
2. RADx® Tech and ATP Programs: 
3. RADx® Tech/ATP/ITAP Dashboard: 
4. RADx® Tech and ATP Programs: Phase 2 Awards: 
5. Article: RADx One Year Later – A Sea Change for Diagnostics: 
6. Radical solutions. Nat Biotechnol. 2021;39(4):391. PMID: .
7. Roback JD, et al. Nat Biotechnol. 2021;39(9):1060-1062. PMID: .
8. Barat B, et al. J Clin Microbiol. 2021;59(3):e02486-20. PMID: .
9. Article: One Year of Rapid Acceleration of Diagnostics, and Anticipating New Challenges: 

COVID-19 Vaccine

1. COVID-19 Vaccines: 
2. COVID-19 mRNA Vaccine Development: 
3. CDC COVID Data Tracker: 
4. Article: Impact of U.S. COVID-19 Vaccination Efforts: An Update on Averted Deaths, Hospitalizations, and Health Care Costs Through March 2022: 
5. Benefits of Getting A COVID-19 Vaccine: 
6. COVID-19 after Vaccination: Possible Breakthrough Infection: 

COVID-19 Treatments

1. Hammond J, et al. N Engl J Med. 2022;386(15):1397-1408. PMID: .
2. COVID-19 Treatments NIH Page: 
3. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines: 
4. COVID-19 Treatments HHS Page: 
5. COVID-19 Treatments and Medications: 

HIV and Pregnancy

1. NICHD Contributions to Society: Nearly Eliminating Perinatal Transmission of HIV: 
2. Tuomala RE, et al. N Engl J Med. 2002;346(24):1863-70. PMID: .
3. Cooper ER, et al. J Acquir Immune Defic Syndr. 2002;29(5):484-94. PMID: .
4. How is HIV passed from one person to another?: 
5. Little KM, et al. Pediatr Infect Dis J. 2017;36(1):66-71. PMID: .
6. Connor EM, et al. N Engl J Med. 1994 Nov 3;331(18):1173-80. PMID: .

HIV Prevention

1. Pre-exposure Prophylaxis (PrEP) to Reduce HIV Risk: ��������������
2. HIV Prevention Trials Network: HPTN 083 Summary: 
3. HIV Prevention Trials Network: HPTN 084 Summary: 
4. Article: Global data shows increasing PrEP use and widespread adoption of WHO PrEP recommendations: 
5. Pre-Exposure Prophylaxis (PrEP): 
6. CDC’s HIV Prevention Progress in the United States: 
7. Fauci AS, et al. JAMA. 2012;308(4):343-4. PMID: .
8. Harden, Victoria A. AIDS at 30: A History. Potomac Books. 2012.
9. In Their Own Words..NIH Researchers Recall the Early Years of AIDS: 
10. HIV Undetectable=Untransmittable (U=U), or Treatment as Prevention: 
11. Article: Final HIV Prevention & Treatment Research Highlights from CROI 2021: 
12. �����/�����ٳ�:��
13. Article: FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention: 
14. Landovitz RJ, et al. N Engl J Med. 2021;385(7):595-608. PMID: .
15. Delany-Moretlwe S, et al. Lancet. 2022;399(10337):1779-1789. PMID: .

HIV Treatment

1. Global HIV & AIDS statistics — Fact sheet: 
2. HIV/AIDS Treatment: 
3. Antiretroviral Drug Discovery and Development: ����
4. HIV Undetectable=Untransmittable (U=U), or Treatment as Prevention: 
5. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection: 
6. Orkin C, et al. N Engl J Med. 2020;382(12):1124-1135. PMID: .
7. Wandeler G, et al. Curr Opin HIV AIDS. 2016;11(5):492-500. PMID: .
8. Teeraananchai S, et al. HIV Med. 2017;18(4):256-266. PMID: .
9. Eisinger RW, et al. JAMA. 2019;321(5):451-452. PMID: .
10. Cohen MS, et al. N Engl J Med. 2016;375(9):830-9. PMID: .
11. Rodger AJ, et al. Lancet. 2019;393(10189):2428-2438. PMID: .
12. Article: The science is clear: with HIV, undetectable equals untransmittable: /news-events/news-releases/science-clear-hiv-undetectable-equals-untransmittable

Hepatitis C

1. Article: Harvey Alter, M.D., Wins the 2020 Nobel Prize in Physiology or Medicine: /harvey-alter-md-wins-2020-nobel-prize-physiology-or-medicine
2. Hepatitis C NIH Page: 
3. Liang TJ, et al. N Engl J Med. 2014;370(21):2043-7. PMID: .
4. Marinho RT, et al. World J Gastroenterol. 2013;19(40):6703-9. PMID: .
5. Video: CC Grand Rounds: 1) Hepatitis C Virus Infection: A Disease Cured but Not Conquered and 2) Update on Management and the Road to a Cure for Chronic Hepatitis B: 
6. Hepatitis C CDC Page: 
7. Alter HJ, et al. Clin Liver Dis (Hoboken). 2020;15(Suppl 1):S64-S71. PMID: .
8. Nobel Prize 2020 Press Release: 

Hepatitis A Vaccine

1. Article: In the fight against viral hepatitis A, vaccines save lives: 
2. Hepatitis A Vaccine: 
3. CDC Pink Book: Hepatitis A Vaccine (Chapter 9). 2021: 

Hepatitis B Vaccine

1. ���貹�پ��پ���:��
2. Hepatitis B: 
3. Kim WR. Hepatology. 2009;49(5 Suppl):S28-34. PMID: .
4. Surveillance for Acute Viral Hepatitis—United States, 2007: 

Autoimmune Disorders

1. Liu C, et al. Arthritis Rheumatol. 2021;73(12):2166-2178. PMID: .
2. Shawky AM, et al. Pharmaceutics. 2022;14(5):1001. PMID: .
3. Philips RL, et al. Cell. 2022;185(21):3857-3876. PMID: .

Rotavirus Vaccine

1. Article: Developing the first rotavirus vaccine: 
2. Rotavirus in the U.S.: 
3. Rotavirus Surveillance Reports: