The Foundation for Vaccine Research - Working to Secure Our Children's Future
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2 September 2016

CEPI formally established

The Coalition for Epidemic Preparedness Innovations (CEPI) was formally established following a meeting of CEPI stakeholders at the Wellcome Trust in London on August 30. This announcement comes seven months after the World Economic Forum in Davos in January 2016 where the idea of a multinational partnership was born in a session devoted to vaccines and preparing for the next epidemic.

K. Vijay RagHavan, Secretary of the Indian Ministry of Science and Technology in Delhi, was elected CEPI chair, and Peter Piot, Director of the London School of Hygiene and Tropical Medicine, was elected CEPI vice-chair.

With this announcement, CEPI, which is as yet unfunded, is getting one step closer to the stage of preparing for a successful launch at the World Economic Forum in January 2017.

Congratulations to the FVR’s Stanley Plotkin, who co-chaired the science task force advising CEPI, and to the FVR’s Simon Wain-Hobson, who participated as a member of the science team.

See article in The Economist.

See article in Science.

Visit CEPI website.

Putting shots in the locker

"The formation of CEPI is the latest in a series of commendable initiatives post-Ebola to increase our preparedness ahead of the next pandemic. It is complementary to the proposed global vaccine development fund that is required to bridge the funding chasm that is impeding the development of vaccines for global diseases and infections that have been neglected for lack of a commercial market but which could save millions of lives.

We must not lose sight of the fact that we have a funding gap, and that resources will be needed on a massive scale to bridge this gap - both for pandemic preparedness and the endemic infections that continue unabated."

Prof. Simon Wain-Hobson, FVR Board Chair
Chief, Molecular Retrovirology
Institut Pasteur, Paris

16 May 2016

Industry leaders and policymakers express support for proposed fund in international forum organized by the Foundation and the National Academy of Medicine

"The stars are unusually aligned," said one senior vaccine industry expert. "We must seize this opportunity and not miss the occasion to act."

Industry leaders, government scientists and health officials, academicians and policymakers express support for the proposed global vaccine development fund and reform of the vaccine development process at a high-level, invitation-only international forum held May 16 at the National Academy of Sciences building in Washington DC.

Co-hosted and organized by the Foundation for Vaccine Research in partnership with the National Academy of Medicine, the forum drew 125 participants from the U.S. and around the world.

Key accomplishments

  • Broad consensus that the status quo is unacceptable and that reform of the vaccine development process is needed
  • Recognition that a persistent, identifiable, quantifiable financial gap is impeding the development of new vaccines
  • Agreement that substantial resources are needed to bridge this gap, and that industry alone cannot be expected to assume the investment risk
  • Acknowledgment that only governments have the resources on the scale required to bridge this gap and make this happen
  • Increased support for exploring financial mechanisms to leverage funding and mobilize new assets, including the establishment of a pooled funding mechanism
  • Recognition that the window of opportunity is fast closing

Next steps

  • Continue high-level consultations with stakeholders in the U.S. and globally
  • Coordinate with other bilateral and multilateral initiatives
  • Build political support to spur leadership, with special emphasis on U.S. government
  • Conduct a series of high-level private briefings for members of U.S. Congress and other decision makers
  • Prepare the groundwork for a major push by the next U.S. Administration
  • G7 summit in Italy 2017

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About the event

This international forum was held under the Chatham House Rule. The purpose was 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 included 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.

Event organizers

The Foundation for Vaccine Research
The National Academy of Medicine

Event chairs and co-chairs

Victor J. Dzau
Adel A.F. Mahmoud
Christian Bréchot
K. VijayRaghavan

Session co-chairs

Marie-Paule Kieny
Nicole Lurie
Julie Gerberding
Salim Abdool Karim
Simon Wain-Hobson

Speakers (in order of presentation)

Anthony Fauci
Stanley Plotkin
Anne Schuchat
Richard Hatchett
Ron Klain
Kenneth Frazier
Gary Nabel
David Weiner
Paul Stoffels
Tachi Yamada
Rino Rappuoli
Peter Piot
Mark Feinberg
Christopher Egerton-Warburton
Heather Deehan
Peter Hale

Event format and target audience

This event was designed for decision makers, policy makers and other leaders, bringing together 125 scientists, industry leaders, funders, public health officials and other experts from the U.S. and globally, with knowledge of the challenges facing vaccine developers.

Desired outcomes

It was hoped that a set of recommendations would emerge from the meeting that will help advance the global discussions currently underway on how to accelerate the development and availability of new vaccines. In addition, it was hoped that the meeting would generate increased support for exploring new mechanisms to leverage financing and mobilize new assets to speed vaccine development.  

Date and venue

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 was designed to 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

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Feature Story

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

See updated list of diseases and infections uncontrolled by vaccination.
 

Supplement to the N Engl J Med article

Audio interview with Dr. Stanley Plotkin, Emeritus Professor, University of Pennsylvania, and a Director, Foundation for Vaccine Research, on a strategy for stimulating and supporting global vaccine research. (9:21)

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Vaccine-Preventable Diseases and Infections and Targets Currently Uncontrolled by Vaccination. Updated August 21, 2015.*

Diseases and infections with commonly used vaccines

  • Diphtheria
  • Haemophilus influenzae type b
  • Hepatitis type A
  • Hepatitis type B
  • Human papillomavirus (HPV)
  • Influenza types A and B (seasonal)
  • Japanese encephalitis
  • Measles
  • Meningococcus
  • Mumps
  • Pertussis (whooping cough)
  • Polio
  • Pneumoccocus
  • Rabies
  • Rotavirus
  • Rubella
  • Smallpox
  • Tetanus
  • Tickborne encephalitis
  • Typhoid
  • Varicella (chickenpox)
  • Yellow fever

Diseases and infections with limited-use vaccines

  • Adenovirus types 4 and 7
  • Anthrax

Diseases and infections with no vaccines or only partially effective vaccines

  • Campylobacter
  • Cancer
  • Candida
  • Chikungunya
  • Chlamydia Moraxella
  • Clostridium difficile
  • Cryptosporidium
  • Cytomegalovirus
  • Dengue
  • Ebola and viral hemorrhagic fevers
  • Enterovirus including EV71, EV68, CA16
  • Epstein-Barr virus
  • Escherichia coli
  • Haemophilus influenzae, nontypable
  • Helicobacter
  • Helminths (numerous)
  • Hendra virus
  • Hepatitis type C
  • Hepatitis type E
  • Herpesvirus type 6
  • Herpes simplex
  • HIV/AIDS
  • Influenza, universal
  • Influenza, avian types H5 and H7
  • Leishmaniasis
  • Lyme disease
  • Malaria
  • MERS
  • Metapneumovirus
  • Moraxella (for otitis)
  • Neisseria gonorrhoeae
  • Nipah virus
  • Norovirus
  • Nosocomial bacteria
  • Parainfluenza
  • Plague
  • Rhinovirus
  • RSV
  • Salmonella paratyphi
  • SARS
  • Schistosomiasis
  • Shigella
  • Staphylococcus
  • Strep Group A
  • Strep Group B
  • Toxoplasmosis
  • Trypanosomiasis
  • Tuberculosis
  • 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.

See WHO list of priority pathogens.

 

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

The Zika virus

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.

Davos prepares to discuss proposed 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

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.

Read the full article

See results of survey

Feature article in Science magazine

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

Cluster of coronaviruses

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.”

Peter Piot
Director, London School of Hygiene & Tropical Medicine
Co-discoverer of the Ebola virus in 1976 in Zaire (now Democratic Republic of the Congo)

Paul Stoffels
Chief scientific officer and worldwide chairman of Johnson & Johnson Pharmaceuticals group

Vaccine development is a lengthy, labor-intensive, multistep process

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.

See Recommendation 7 calling for establishing a global facility to finance and accelerate R&D.

See members of the panel.

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,
    Georgetown University
  • Dr David Heymann,
    Chatham House
  • 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

See video recording of the event on 23 November 2015 when the findings were presented at the Royal Society, London.

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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

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

The Institut Pasteur, Paris

15 November 2015

We're moving!

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.

Entrance to the Paramount Building at 1775 Eye Street, Washington, DC

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.

See members of core group.

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
peter.hale@vaccinefoundation.org

The Westin Dublin Hotel

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.

See agenda
See slide presentation

Oslo City Hall and waterfront

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.

World Bank Group Headquarters, Washington, DC

21 August 2015

Support builds for reform of vaccine development through proposed fund.

See editorial in The New York Times; see articles in The New York Times, The Wall Street Journal, The Guardian, Reuters, Business Insider, CIDRAP News, and Fierce Vaccines.

 

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)

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