R&D across health areas | Emerging Infectious Diseases
R&D for Emerging Infectious Diseases
How new tools can transform the fight
In a world experiencing increasing human mobility and ecological change, emerging infectious diseases (EIDs) pose a growing threat to health security. As we saw with COVID-19, an outbreak in one corner of the world can quickly become a global pandemic with devastating human and economic costs. New vaccines, treatments, diagnostics, and other tools are urgently needed to outsmart epidemics. However, research and development (R&D) for EIDs is particularly challenging.
The market potential for tools against EIDs is too uncertain to drive commercial investment, and testing these products is especially difficult. Strong government support and smart collaboration between nations are vital to overcome these barriers and develop the tools needed to prevent, detect, and respond to these threats.
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$12.5 trillionglobal economic cost of COVID-19
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11,000+ liveslost from 2014-16 West Africa Ebola outbreak
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3x projected increasein annual probability of extreme epidemics in coming decades
Key missing tools
We are without essential tools to combat many EIDs considered most likely to cause the next epidemic:
| Vaccines | Treatments | Diagnostics | |
|---|---|---|---|
| COVID-19 | Several vaccines are approved but will require routine updates for variants. | Oral and intravenous treatments are approved, but continued innovation is needed to optimize treatment and address variants. | Several rapid, point-of-care (POC) tests and laboratory-based tests are available, but continued validation is needed for new variants. |
| Crimean-Congo Haemorrhagic fever (CCHF) | No FDA-approved vaccine is available. A Bulgarian-licensed vaccine exists, but its efficacy is unclear | No specific licensed treatment is available. An existing antiviral has been used during outbreaks, but its efficacy remains unclear. | Commercial tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Ebola Sudan | No licensed vaccine. | No specific licensed treatment. | Confirmatory tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Ebola Zaire | Two vaccines are approved by stringent regulators. | Two licensed treatments are FDA-approved and in use globally. | Several rapid POC tests and laboratory-based tests are in use globally, including FDA-approved and -authorized options. |
| Lassa fever | No licensed vaccine. | No specific licensed treatment. The IV-administered antiviral ribavirin is effective if used early, but more robust research is needed, as are oral antivirals. | Confirmatory tests are available but require sophisticated laboratory infrastructure, and validation is needed for different lineages. Rapid POC tests are needed. |
| Marburg | No licensed vaccine. | No specific licensed treatment. | Commercial tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Middle East respiratory syndrome (MERS) | No licensed vaccine. | No specific licensed treatment. | Commercial tests are available, including FDA-authorized options, but they require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Mpox | Three vaccines are approved by stringent regulators, two of which are FDA-approved. | No specific licensed treatment. An FDA-approved smallpox drug that has been used on a compassionate use basis was found ineffective. | Commercial tests are available, including FDA-authorized options, but they require sophisticated laboratory infrastructure or specialized testing systems. Further validation is needed for different clades, as are additional rapid POC tests. |
| Nipah | No licensed vaccine. | No specific licensed treatment. | Commercial tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Rift Valley fever (RVF) | No licensed human vaccine. | No specific licensed treatment. | Commercial tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Severe Acute Respiratory Syndrome (SARS) | No licensed vaccine. | No specific licensed treatment. | Commercial tests are available but require sophisticated laboratory infrastructure. Rapid POC tests are needed. |
| Zika | No licensed vaccine. | No specific licensed treatment. | Rapid POC tests and laboratory-based tests are available, including FDA-approved or -authorized options. |
| Pandemic influenza | No licensed universal vaccine. Existing flu vaccines may offer some cross protection. | Existing antivirals may be effective. Additional broad-spectrum antivirals are needed. | Confirmatory tests are available but not all commercially. Rapid POC tests will be needed. |
Research progress
- Several COVID-19 vaccines, therapeutics, and rapid POC diagnostic tests were developed with cross-US government support, significantly changing the course of the pandemic. Next-generation nasal COVID-19 vaccines, combination influenza and COVID-19 vaccines, and pan-coronavirus vaccines are now in development with US support.
- Two licensed vaccines, two approved therapeutics, and a rapid POC test for Ebola Zaire were developed via various partnerships with NIH, DoD, and BARDA. Since their introduction, these tools have helped bring subsequent outbreaks under control more quickly, dramatically reducing their scale and toll.
- A promising vaccine for Marburg—a deadly cousin of the Ebola virus—which was developed by NIH, advanced with BARDA support, and trialed at a DoD-supported overseas lab, was deployed under clinical trial protocols to respond to the 2024 outbreak in Rwanda. A vaccine for Ebola Sudan that is built on the same vaccine platform is also undergoing a Phase 2 trial with US support.
- Thanks to investments from BARDA, the United States was prepared with an approved mpox vaccine when the global epidemic hit. Researchers are now advancing an adapted version of this vaccine for children.
- Vaccines for several other EIDs have recently entered or advanced in clinical trials, including the first human trial of a Nipah vaccine, the first Phase 2 study of a Lassa vaccine, and a Phase 2 trial of an mRNA-based Zika vaccine.
- Clinical trials are underway for several potential universal flu vaccine candidates, including an mRNA-based candidate developed at NIH’s Vaccine Research Center.
- Numerous diagnostic tools for EIDs beyond Ebola and COVID-19 have been advanced to market, including four tests for Zika that have full FDA approval, as well as 14 tests for Zika, 8 for mpox, and 2 for MERS that received Emergency Use Authorization.
US government investment in R&D for EIDs (in 2022) US$ millions
US Government R&D efforts
The US government is developing tools to improve health security through a whole-of-government approach:
- Biomedical Advanced Research and Development Authority (BARDA) supports the advanced development of vaccines, drugs, diagnostics, and other medical countermeasures against EIDs considered a threat to national security.
- National Institutes of Health (NIH) conducts basic and clinical research to advance new treatments, vaccines, diagnostics, and vector control products to combat EIDs.
- Department of Defense (DoD) supports R&D to create vaccines, drugs, and other tools for EIDs considered a threat to US service members or to national security.
- Centers for Disease Control and Prevention works to develop new and improved diagnostics and surveillance tools to improve global capacity to prevent, detect, and respond to outbreaks.
- US Agency for International Development has supported the development of select tools to combat EIDs designed for low-resource settings and contributes to the Coalition for Epidemic Preparedness Innovations (CEPI), a global vaccine development partnership.
- Food and Drug Administration (FDA) administers the Tropical Disease and Material Threat Medical Countermeasures Priority Review Programs to incentivize industry investment in products for select EIDs and grants Emergency Use Authorization to permit the use of not-yet-approved products during an emergency.
Introduction
$12.5 trillion cost: Reuters. IMF sees cost of COVID pandemic rising beyond $12.5 trillion estimate. Reuters. January 20, 2022. Accessed July 22, 2024. https://www.reuters.com/business/imf-sees-cost-covid-pandemic-rising-beyond-125-trillion-estimate-2022-01-20/
11,000+ lives lost Ebola: World Health Organization. Ebola: West Africa, March 2014-2016. Accessed July 22, 2024. https://www.who.int/emergencies/situations/ebola-outbreak-2014-2016-West-Africa
3x project increase in probability of epidemics: Joi P. New study suggests risk of extreme pandemics like COVID-19 could increase threefold in coming decades. Vaccines Work blog. September 5, 2022. Accessed July 22, 2024. https://www.gavi.org/vaccineswork/new-study-suggests-risk-extreme-pandemics-covid-19-could-increase-threefold-coming
Key missing tools
COVID-19: MedicalCountermeasures.gov. COVID-19 Portfolio. Accessed July 22, 2024. https://medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx
Crimean-Congo Haemorrhagic fever:
World Health Organization. Crimean-Congo haemorrhagic fever. Accessed July 22, 2024. https://www.who.int/news-room/fact-sheets/detail/crimean-congo-haemorrhagic-fever
World Health Organization. Crimean-Congo haemorrhagic fever Research and Development (R&D) Roadmap. World Health Organization; 2019. https://www.who.int/publications/m/item/crimean-congo-haemorrhagic-fever-(cchf)-research-and-development-(r-d)-roadmap
Ebola Sudan: Ibrahim S, Ndwandwe D, Thomas K, et al. Sudan virus disease outbreak in Uganda: urgent research gaps. BMJ Global Health. 2022;7:e010982. https://doi.org/10.1136/bmjgh-2022-010982
Ebola Zaire:
MedicalCountermeasures.gov. FDA Approvals, Licensures & Clearances, BARDA Supported Products: Accessed July 22, 2024. https://medicalcountermeasures.gov/barda/fdaapprovals
MedicalCountermeasures.gov. Global collaboration with BARDA scientists successfully develop Ebola countermeasures. Medicalcountermeasures.gov. June 21, 2021. Accessed July 25, 2024. https://medicalcountermeasures.gov/stories/ebola-story/
US Food and Drug Administration. Emergency Use Authorization. Accessed July 22, 2024. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#ebola
Lassa fever: World Health Organization. Lassa fever. Accessed July 25, 2024. https://www.who.int/news-room/fact-sheets/detail/lassa-fever
Marburg: World Health Organization. Marburg virus disease. Accessed July 25, 2024. https://www.who.int/news-room/fact-sheets/detail/marburg-virus-disease
Middle East respiratory syndrome:
World Health Organization. Middle East respiratory syndrome coronavirus (MERS-CoV). Accessed July 25, 2024. https://www.who.int/health-topics/middle-east-respiratory-syndrome-coronavirus-mers
US Food and Drug Administration. Emergency Use Authorization. Accessed July 22, 2024. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Mpox:
Administration for Strategic Preparedness & Response. SNS Products: Vaccines and Treatment Available for Use in the Mpox Response. Accessed July 22, 2024. https://aspr.hhs.gov/SNS/Pages/Mpox.aspx
National Institutes of Health National Institute of Allergy and Infectious Diseases. Mpox (Formerly Monkeypox) Vaccines. Accessed July 25, 2024. https://www.niaid.nih.gov/diseases-conditions/mpox-vaccines
World Health Organization. Mpox Questions and Answers. Accessed September 13, 2024. https://www.who.int/news-room/questions-and-answers/item/mpox
Mast J. Antiviral used for mpox no better than placebo, NIH says. STAT. August 15, 2024. Accessed September 13, 2024. https://www.statnews.com/2024/08/15/mpox-antiviral-tecovirimat-no-better-than-placebo-nih/
US Food and Drug Administration. Monkeypox (mpox) Emergency Use Authorizations for Medical Devices. Accessed July 22, 2024. https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-mpox-emergency-use-authorizations-medical-devices
Nipah:
World Health Organization. Nipah virus. Accessed July 25, 2024. https://www.who.int/news-room/fact-sheets/detail/nipah-virus
World Health Organization. Nipah Research and Development (R&D) Roadmap. World Health Organization; 2019. https://cdn.who.int/media/docs/default-source/blue-print/nipah_rdblueprint_roadmap_advanceddraftoct2019.pdf?sfvrsn=4f0dc9ad_3&download=true
Rift Valley fever:
World Health Organization. Rift Valley Fever. Accessed July 25, 2024. https://www.who.int/news-room/fact-sheets/detail/rift-valley-fever
Petrova V, Kristiansen P, Northeim G, Yimer A. Rift valley fever: diagnostic challenges and investment needs for vaccine development. BMJ Global Health. 2020:5:e002694 https://doi.org/10.1136/bmjgh-2020-002694
Severe Acute Respiratory Syndrome: World Health Organization. Severe Acute Respiratory Syndrome (SARS). Accessed July 25, 2024. https://www.who.int/health-topics/severe-acute-respiratory-syndrome
Zika:
World Health Organization. Zika virus. Accessed July 25, 2024. https://www.who.int/news-room/fact-sheets/detail/zika-virus
US Food and Drug Administration. Emergency Use Authorization. Accessed July 22, 2024. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#zika
Pandemic influenza:
Fuller D. How do you make a universal flu vaccine? A microbiologist explains the challenges, and how mRNA could offer a promising solution. The Conversation. February 7, 2023. Accessed July 25, 2024. https://theconversation.com/how-do-you-make-a-universal-flu-vaccine-a-microbiologist-explains-the-challenges-and-how-mrna-could-offer-a-promising-solution-195807
Jones J, Yen H, Adams P, et al. Influenza Antivirals and Their Role in Pandemic Preparedness. Antiviral Research. 2023 Feb;210:105499. https://doi.org/10.1016/j.antiviral.2022.105499
Diagnostics, all: Consultation with topic area experts from FIND.
Research progress
COVID-19 vaccines, therapeutics, rapid POC tests: MedicalCountermeasures.gov. COVID-19 Portfolio. Accessed July 22, 2024. https://medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx
Next-generation COVID-19 vaccines:
MedicalCountermeasures.gov. Project NextGen: Next Generation Medical Countermeasures. Accessed July 22, 2024. https://medicalcountermeasures.gov/nextgen
Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19. Press release. Moderna; October 24, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-First-Participant-Dosed-in-Phase-3-Study-of-mRNA-1083-a-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx
Ebola Sudan vaccine:
Sabin Vaccine Institute Begins Phase 2 Clinical Trial for Sudan Ebolavirus Vaccine. Press release. Sabin Vaccine Institute; July 15, 2024: https://www.sabin.org/resources/sabin-vaccine-institute-begins-phase-2-clinical-trial-for-sudan-ebolavirus-vaccine/
Sabin Vaccine Institute Delivers Marburg Vaccines to Combat Outbreak in Rwanda. Press release. Sabin Vaccine Institute; October 5, 2024. https://www.sabin.org/resources/sabin-vaccine-institute-delivers-marburg-vaccines-to-combat-outbreak-in-rwanda/
Marburg vaccine: Sabin Vaccine Institute Begins Phase 2 Clinical Trial for Marburg Vaccine in Uganda. Press release. Sabin Vaccine Institute; October 19, 2024. https://www.sabin.org/resources/sabin-vaccine-institute-begins-phase-2-clinical-trial-for-marburg-vaccine-in-uganda/
Mpox vaccine: Administration for Strategic Preparedness & Response. SNS Products: Vaccines and Treatment Available for Use in the Mpox Response. Accessed July 22, 2024. https://aspr.hhs.gov/SNS/Pages/Mpox.aspx
Mpox vaccine adapted for children: Schnirring L. Bavarian Nordic, CEPI announce plan to advance mpox vaccine for African children. CIDRAP. May 30, 2024. Accessed July 22, 2024. https://www.cidrap.umn.edu/mpox/bavarian-nordic-cepi-announce-plan-advance-mpox-vaccine-african-children
Nipah vaccine: Pickover E. Scientists test world-first Nipah virus vaccine. The Independent. January 11, 2024. Accessed July 22, 2024. https://www.independent.co.uk/news/health/sarah-gilbert-nipah-scientists-nipah-virus-covid-b2476686.html
Lassa vaccine: Participants in Nigeria vaccinated in first-ever Phase 2 Lassa fever vaccine clinical trial, sponsored by IAVI. Press release. IAVI; April 24, 2024. https://www.iavi.org/press-release/iavi-c105-lassa-fever-vaccine-clinical-trial/
mRNA-based Zika vaccine: Bayer M. Moderna won't advance US-backed Zika vaccine without more outside funding. Fierce Biotech. May 25, 2024. Accessed July 22, 2024. https://www.fiercebiotech.com/biotech/moderna-says-it-wont-advance-us-backed-zika-vaccine-without-more-outside-funding
Universal flu vaccine: Universal Influenza Vaccine Technology Landscape. University of Minnesota; 2024. Accessed July 22, 2024. https://ivr.cidrap.umn.edu/universal-influenza-vaccine-technology-landscape
Universal flu vaccine, mRNA-based candidate: Clinical trial of mRNA universal influenza vaccine candidate begins. Press Release. National Institutes of Health; May 15, 2023. https://www.nih.gov/news-events/news-releases/clinical-trial-mrna-universal-influenza-vaccine-candidate-begins
Diagnostic tools for EIDs, Zika: US Food and Drug Administration. Emergency Use Authorization. Accessed July 22, 2024. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#zika
Diagnostic tools for EIDs, mpox: US Food and Drug Administration. Monkeypox (mpox) Emergency Use Authorizations for Medical Devices. Accessed July 22, 2024. https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-mpox-emergency-use-authorizations-medical-devices
Diagnostic tools for EIDs, MERS: US Food and Drug Administration. Emergency Use Authorization. Accessed July 22, 2024. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#MERS
US government investment in HIV R&D for emerging infectious diseases
G-FINDER data portal. Policy Cures Research; 2023. Accessed May 14, 2024. https://gfinderdata.policycuresresearch.org/
US Government R&D efforts
The White House. U.S. Government Global Health Security Strategy 2024. The White House; 2024. https://www.whitehouse.gov/wp-content/uploads/2024/04/Global-Health-Security-Strategy-2024-1.pdf
US Agency for International Development. Global Health Security Areas of Investment. Accessed July 22, 2024. https://www.usaid.gov/global-health/health-areas/global-health-security/global-health-security-areas-investment