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Ebola, SARS, MERS, Nipah, Zika virus and beyond
CHALLENGES AND OPPORTUNITIES FOR VACCINE DEVELOPMENT
Sunday 15 May & Monday 16 May 2016
National Academy of Sciences Building
2101 Constitution Avenue NW
Professor Victor J Dzau
Professor Adel AF Mahmoud
Professor Christian Bréchot
Professor K. VijayRaghavan
Read more and download final program
About the event
This international forum is being held under the Chatham House Rule. The purpose is to build on the momentum generated by Ebola and Zika to focus attention on the need for comprehensive reform of the vaccine development process and how to accelerate the availability of new vaccines in advance of epidemics.
Topics for discussion include advances in science and technology, global research priorities, resource needs, financial gaps, resource allocation, mobilization of new assets, the merits and feasibility of different financing mechanisms that have been proposed to bridge these gaps, and the exploration of opportunities for greater collaboration and partnerships globally to maximize synergies and achieve mutual goals.
The Foundation for Vaccine Research
The National Academy of Medicine
Event chairs and co-chairs
Victor J. Dzau
Adel A.F. Mahmoud
Salim Abdool Karim
Speakers (in order of presentation)
Event format and target audience
This event is designed for decision makers, policy makers and other leaders, bringing together 125 scientists, industry leaders, funders, public health officials and other experts from the United States and globally, with knowledge of the challenges facing vaccine developers.
A set of recommendations will emerge from the meeting that will advance the global discussion currently underway on how to accelerate the development and availability of new vaccines. The meeting should generate increased support for exploring new mechanisms to leverage financing and mobilize new assets to speed vaccine development.
Date and venue
Sunday 15 May evening: Please note that the opening session and welcome reception at the NAS building have been cancelled.
The private dinner for speakers and invited guests on Sunday evening will still take place (venue to be announced) but will start at 6:00 pm instead of 8:00 pm.
Monday 16 May: Main event - all-day meeting from 8:00 am to 6:00 pm in the Lecture Room at the National Academy of Sciences building at 2101 Constitution Avenue NW, in Washington, DC.
Mix of topics
50% science, 50% policy. The agenda will allow ample time for discussion at the end of each session, and a full hour for discussion in the last session of the day.
Event sponsors and strategic partners
The Bill & Melinda Gates Foundation
The Wellcome Trust
23 July 2015
Call for establishing a global vaccine development fund published in the New England Journal of Medicine.
Plotkin SA, Mahmoud AAF, Farrar J. Establishing a global vaccine development fund. N Engl J Med. 2015 Jul 23;373(4):297-300
Vaccine-Preventable Diseases and Infections and Targets Currently Uncontrolled by Vaccination. Updated August 21, 2015.*
Diseases and infections with commonly used vaccines
- Haemophilus influenzae type b
- Hepatitis type A
- Hepatitis type B
- Human papillomavirus (HPV)
- Influenza types A and B (seasonal)
- Japanese encephalitis
- Pertussis (whooping cough)
- Tickborne encephalitis
- Varicella (chickenpox)
- Yellow fever
Diseases and infections with limited-use vaccines
- Adenovirus types 4 and 7
Diseases and infections with no vaccines or only partially effective vaccines
- Chlamydia Moraxella
- Clostridium difficile
- Ebola and viral hemorrhagic fevers
- Enterovirus including EV71, EV68, CA16
- Epstein-Barr virus
- Escherichia coli
- Haemophilus influenzae, nontypable
- Helminths (numerous)
- Hendra virus
- Hepatitis type C
- Hepatitis type E
- Herpesvirus type 6
- Herpes simplex
- Influenza, universal
- Influenza, avian types H5 and H7
- Lyme disease
- Moraxella (for otitis)
- Neisseria gonorrhoeae
- Nipah virus
- Nosocomial bacteria
- Salmonella paratyphi
- Strep Group A
- Strep Group B
- West Nile virus
* Updated information is from the Foundation for Vaccine Research. Nipah and Hendra viruses were unintentionally omitted in the list published in NEJM. MERS denotes Middle East Respiratory Syndrome, RSV Respiratory Syncytial Virus, and SARS Severe Acute Respiratory Syndrome. Vaccines for some of the targets indicated above are in advanced development, but most are not.
28 January 2016
Zika virus added to list of priority targets for proposed fund
The spread of Zika virus in the Americas has become a major source of concern since its pathogenicity has become more clear. Particularly worrisome is the alarming jump in the reported number of cases of infant microcephaly in Brazil. Adding Zika virus and Paratyphoid A (Salmonella enterica) brings the list of priority targets to 17, in close alignment with WHO's list of dangerous pathogens put out on 12 December 2015.
Learn more about Zika virus
The Zika virus is a flavivirus, part of the same family as yellow fever, West Nile, chikungunya and dengue viruses. Like them, it is transmitted to humans via the bite of an infected Aedes sp. mosquito. But unlike some of those viruses, there is no vaccine to prevent Zika or medicine to treat the infection. Zika is commanding worldwide attention because of an alarming, suspected but not proven connection between infection with the virus and microcephaly, a neurological complication that results in babies being born with abnormally small heads. This causes severe developmental issues and sometimes death. Since November 2015, Brazil has reported 4,180 cases of microcephaly in babies born to women who were infected with Zika during their pregnancies, compared to only 146 cases in 2014. Authorities have not been able to confirm that all 4,180 cases are attributable to infection with the virus. So far, 51 babies have died. Until recently, the virus was considered relatively harmless. In 80% of cases, it causes no symptoms and people are unaware they have been infected. In 20% of cases, it causes Zika fever, a mild disease with symptoms including rash, joint pain and conjunctivitis. The Zika virus was first identified in Uganda in 1947. It was not until 2015 that a previously unknown connection between Zika infection in pregnant women and microcephaly in newborns was reported.
17 priority targets (updated January 28)
Same criteria as before (see note below). List modified to provide more detail on prioritization based on the latest information.
- Ebola hemorrhagic fever virus
- Lassa hemorrhagic fever virus
- Marburg hemorrhagic fever virus
- MERS coronavirus
- SARS coronavirus
- Crimean-Congo hemorrhagic fever virus
- Chikungunya virus
- Nipah virus
- Hepatitis E virus
- Zika virus
- Enterovirus 71
- Enterovirus 68
- Coxsackievirus 16
- Paratyphoid A (Salmonella enterica)
- West Nile virus
- Rift Valley fever virus
- Plague (Yersinia pestis)
The criteria used for developing this updated list are unchanged. They include: case fatality rate; transmissibility and capacity for human-to-human transmission; frequency of outbreaks; geographical spread; existence of other interventions, investment, and development stage globally; and scientific feasibility of candidates.
Source: Working group
20 January 2016
Vaccine development fund to be discussed at the World Economic Forum in Davos.
The proposed global vaccine development fund called for in The New England Journal of Medicine will be discussed at a high-level, 90-minute closed session at the Davos summit on 21 January. Moderated by Dr. Peter Piot, the session will be attended by 30 senior decision makers from governments, industry, foundations, WHO, MSF, and other stakeholders. The purpose of the meeting is to forge a broad consensus on the way forward in the development of the fund.
12 January 2016
Leading vaccinologist endorses proposed fund
“In 1955, twenty-seven companies made vaccines. By 1980, due to drop out and merger, 18 vaccine makers remained. Today, only 4 major pharmaceutical companies focus on vaccines. This dramatic decline isn't because infectious diseases are now a thing of the past. Quite the opposite. Recent outbreaks of viral diseases like MERS-CoV, SARS, Ebola, West Nile, and chikungunya show that vaccines are needed now more than ever before. The problem is that the business model is geared to products with only a large market potential. Something needs to be done. Perhaps the single best solution would be the creation of a global vaccine development fund that would promote the development of vaccines that currently have fallen through the cracks. Without such a program, the continued erosion in vaccine research and development is inevitable.”
Paul Offit MD
Maurice R Hilleman Professor of Vaccinology
Co-inventor of the rotavirus vaccine
and Professor of Pediatrics
The Children's Hospital of Philadelphia
1 January 2016
Scientifically feasible vaccines against major diseases are stalled for lack of funds, says Science.
In a feature article entitled “Unfilled Vials,” the journal Science names 10 top candidate vaccines that need a boost. “Vaccines that appear scientifically feasible often move through development slowly because they have little commercial potential and thus have trouble attracting serious investments,” writes Jon Cohen, senior Science reporter who covers vaccines. “Just such a situation held back R&D on Ebola vaccines, one of which quickly proved its worth in a real-world trial held in Guinea last year. In the wake of that success, a growing number of researchers and public health advocates are lobbying to find new money and strategies to develop vaccines that could thwart both outbreak diseases like chikungunya and Marburg to endemic afflictions like paratyphoid fever and schistosomiasis. In the past few weeks, the WHO and the nonprofit Foundation for Vaccine Research have taken a stab at identifying what those vaccines are, and they’ve zeroed in on the exact same targets.”
Cohen went on to describe in some detail the proposed $2 billion global vaccine development fund called for in The New England Journal of Medicine last July, noting that it is on the agenda to be discussed at the World Economic Forum in Davos, Switzerland, on 21 January.
9 December 2015
Priority targets provisionally identified for proposed fund
Fifteen infections have been provisionally identified as priority targets for the fund. Criteria used include: case fatality rate; transmissibility and capacity for human-to-human transmission; frequency of outbreaks; geographical spread; existence of other interventions, investment, and development stage globally; and scientific feasibility of candidates.
15 priority targets
- Hemorrhagic fever viruses (Ebola,* Marburg, Lassa)
- SARS and MERS coronaviruses
- Chikungunya virus
- West Nile virus
- Nipah virus
- Hepatitis E virus
- Enteroviruses (EV68, EV71 and CA16)
- Crimean-Congo hemorrhagic fever
- Rift Valley fever
- Plague (Yersinia pestis)
*To support licensure of existing candidates against Ebola Zaire species and the development of less advanced, multivalent, next-generation vaccines protective against Zaire, Bundibugyo and Sudan Ebola viruses.
Note: The fund’s purpose is to accelerate vaccine development globally for new and emerging infections, as well as neglected diseases and infections endemic in developing countries for which there is low market potential. Considerable resources are already being employed developing vaccines for pandemic influenza, Respiratory Syncytial Virus (RSV), HIV, Tuberculosis, malaria and Dengue, all of which are top priorities but outside the scope of the proposed fund.
Source: Working group
24 November 2015
World needs to create a fund to help pay for vaccine development, say experts in The Guardian.
“There are many diseases, like Ebola, for which no vaccine has yet been developed and this is largely because there is very little incentive for companies or public institutions to undertake research and development. To overcome this challenge, the world needs to create a fund to help pay for the development and distribution of vaccines for this and many other emerging epidemics and infectious diseases.”
Director, London School of Hygiene & Tropical Medicine
Co-discoverer of the Ebola virus in 1976 in Zaire (now Democratic Republic of the Congo)
Chief scientific officer and worldwide chairman of Johnson & Johnson Pharmaceuticals group
22 November 2015
Harvard-LSHTM panel recommends a global facility to finance, accelerate, and prioritise R&D.
An independent panel of 19 experts convened by the Harvard Global Health Institute and the London School of Hygiene & Tropical Medicine has issued a hard-hitting analysis of the global response to the 2014 Ebola outbreak in West Africa, published in The Lancet.
Among ten essential reforms, the panel recommends establishing a global facility to finance, accelerate, and prioritize research and development, citing the New England Journal of Medicine paper calling for establishing a global vaccine development fund.
Members of the Panel
Dr Suerie Moon, Harvard Global Health Institute/Harvard School of Public Health/Harvard Kennedy School (Study Director)
- Professor Peter Piot, London School of Hygiene & Tropical Medicine (Chair)
- Dr Ashish Jha, Harvard Global Health Institute/Harvard School of Public Health (Co-chair)
- Dr Muhammad Pate,
Duke University (Co-chair)
- Dr Devi Sridhar,
Edinburgh Medical School (Co-chair)
- Dr Chelsea Clinton,
Bill, Hillary & Chelsea Clinton Foundation
- Ms Sophie Delaunay,
Médecins Sans Frontières
- Ms Valnora Edwin,
Campaign for Good Governance
- Dr Mosoka Fallah,
Action Contre La Faim International (ACF)
- Mr David Fidler,
Indiana University Maurer School of Law
- Dr Eric Goosby,
University of California, San Francisco
- Ms Laurie Garrett,
Council on Foreign Relations
- Dr Larry Gostin,
- Dr David Heymann,
- Dr Kelley Lee,
Simon Fraser University
- Dr Gabriel Leung,
The University of Hong Kong
- Dr Steve Morrison,
Center for Strategic and International Studies
- Dr Jorge Saavedra,
AIDS Healthcare Foundation
- Dr Marcel Tanner,
Swiss Tropical & Public Health Institute
Recommendation 7: Establish a global facility to finance, accelerate, and prioritise research and development
The UN Secretary General and WHO Director-General should convene in 2016 a high-level summit of public, private and not-for-profit research funders to establish a global financing facility for research and development for health technologies relevant for major disease outbreaks. The facility would support manufacturing, research and development for drugs, vaccines, diagnostics and other non-pharmaceutical supplies (such as personal protective equipment) where the commercial market does not offer appropriate incentives. For known pathogens, the facility could invest in bringing candidate drugs, vaccines, technology platforms, and other relevant products through proof of concept, phase 1 and phase 2 testing in humans, so that they are ready for wider testing, manufacturing, and distribution when an outbreak strikes. During an outbreak the fund would rapidly mobilise financing for priority research and development projects, such as diagnostics for novel pathogens.
The establishment of a similar fund for diseases affecting developing countries was a central recommendation of the 2012 report of the WHO Consultative Expert Working Group on research and development.1 As a result, a pooled international fund was created to support “demonstration projects” that test new research and development business models, such as open knowledge innovation and de-linkage of research and development financing from end product prices. With a management structure already established, the demonstration projects offer an important option for pursuing research and development for Ebola or other diseases.
The global financing facility should be a lean, efficient entity that mobilises and strategically deploys resources. It would not be a monolithic entity nor the sole funder for epidemic-related research and development because some pluralism and competition among funders is desirable. Nevertheless, a global facility would offer the advantage of facilitating coordination among different research funders through a common framework, strengthening networks between researchers, establishing processes for priority setting, and reducing transaction costs for both grantees and smaller donors.2,3 It could also require information sharing among researchers as a condition of funding, thereby giving teeth to the data-sharing framework (recommendation 6). Intellectual property or any other asset resulting from these investments should be managed as a public good to facilitate follow-on innovation, open knowledge sharing, access to technology and a fair public return on investment. Support for a global research and development financing mechanism now seems to be growing, as shown in calls for a $2 billion global fund for vaccine development for pandemics,2 a $2 billion global fund for antimicrobial resistance,4 and a $2-3 billion global fund that would cover emerging infectious diseases, neglected diseases and antimicrobial resistance.5
- 1 WHO Consultative Expert Working Group on research and development: Research and development to meet health needs in developing countries: Strengthening global financing and coordination. 2012. http://www.who.int/phi/CEWG_Report_5_April_2012.pdf (accessed May 29, 2015).
- 2 Plotkin SA, Mahmoud AA, Farrar J. Establishing a Global Vaccine-Development Fund. N Engl J Med. 2015; 373:297-300.
- 3 Moon S. Demonstration financing: considerations for the new international fund for R&D. 2014. http://www.dndi.org/images/stories/advocacy/pilot-pooled-international-fund_web.pdf (accessed July 25, 2015).
- 4 O’Neill J. Securing new drugs for future generations: the pipeline of antibiotics. 2015. http://amr-review.org/sites/default/files/SECURING NEW DRUGS FOR FUTURE GENERATIONS FINAL WEB_0.pdf (accessed May 29, 2015).
19 November 2015
World-renowned Institut Pasteur is first to endorse the proposed fund
“The Institut Pasteur has been at the forefront of the fight against many epidemics over the past century, most recently against Ebola. Research in vaccinology is at the heart of our legacy and we are significantly reinforcing our efforts in this area. The Institut Pasteur is pleased to support your most valuable efforts to set up a global vaccine development fund. The initiative you have launched is a most important progress for the control of infectious diseases; clearly, this is what should be implemented to meet with the next epidemics, worldwide.”
Professor Christian Bréchot
President, Institut Pasteur
15 November 2015
The Foundation will be moving over the Thanksgiving weekend from 1425 K Street NW into sparkling new offices in the Paramount Building at 1775 Eye Street NW in Washington, DC. Please note our new address. Our phone and fax numbers stay the same.
1 November 2015
Foundation hosts second planning meeting of the core group in Dublin
The FVR’s Board Chair Simon Wain-Hobson, Institut Pasteur, and FVR Director Adel Mahmoud, Princeton University, host a planning meeting of the core group driving the proposed vaccine development fund at the Westin Dublin Hotel. Held on the eve of the Princeton-Fung Global Forum 2015 on lessons learned from the Ebola crisis, this highly-productive meeting marked another milestone in the fund’s development with agreement on the need to set up an interim secretariat.
The Dublin meeting follows an inaugural meeting of the core group in a retreat-like setting hosted by Dr. Mahmoud at his home in Princeton on September 12-13. The group has since expanded from five to seven members.
Global Vaccine Development Fund Working Group
- Jeremy Farrar MD PhD
- Tore Godal MD
- Peter Hale
- Adel AF Mahmoud MD PhD
- Peter Piot MD PhD
- Stanley A Plotkin MD
- Simon Wain-Hobson DPhil
Contact: Peter Hale
c/o The Foundation for Vaccine Research
Office +1 202 587 2754
Mobile +1 202 297 7458
29-30 October 2015
Support for proposed fund grows in Oslo consultation
The FVR’s founder and executive director Peter Hale gives a talk on the proposed vaccine development fund in Oslo at a high-level consultation organized by the WHO and the Norwegian Institute of Public Health on financing for R&D preparedness. The outcome of the consultation will inform the development of a blueprint for accelerating R&D in future epidemics or public health emergencies.
21-22 September 2015
Proposed fund makes its debut at World Bank-WHO meeting in Washington
The FVR’s Stanley Plotkin makes the case for the proposed global vaccine development fund in a special session of the World Bank Group-WHO stakeholders meeting on pandemic financing at the World Bank in Washington.
21 August 2015
Support builds for reform of vaccine development through proposed fund.
Global Dispatches Podcast
Interview with Dr. Jeremy Farrar, Professor of Tropical Medicine and Director of the Wellcome Trust, in which he discusses the implications of the recent Ebola vaccine trial and how the creation of a global vaccine development fund will spur the development and deployment of vaccines to counter fast emerging epidemics. (12:00)