The Coalition for Epidemic Preparedness Innovations (CEPI)
ASSOCIATIONS - People
Dr. Rick Arthur Bright (born 1966) - CEPI, since its inception, was said to play a key role in complementing the role of BARDA. As Rick Bright was the director of BARDA, Bright has always had a prominent role in commenting on the benefits offered by CEPI since its incepotion.
Abbreviation : CEPI
Formation : January 2017; 4 years ago
Founders :
Purpose : Fund vaccine development[3]
Headquarters : Oslo, Norway
Locations :
Chief executive - [Dr. Richard Jones Hatchett IV (born 1968)]
Key people : Jane Halton (Chair)
Staff (2020) : 68[4]
Website : CEPI.net
The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases (EID).[4][5]
CEPI is focused on the World Health Organization's (WHO) "blueprint priority diseases", which include: the Middle East respiratory syndrome-related coronavirus (MERS-CoV), the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the Nipah virus, the Lassa fever virus, and the Rift Valley fever virus, as well as the Chikungunya virus and the hypothetical, unknown pathogen "Disease X".[6][5] CEPI investment also requires "equitable access" to the vaccines during outbreaks,[7] although subsequent CEPI policy changes may have compromised this criteria.[8]
CEPI was conceived in 2015 and formally launched in 2017 at the World Economic Forum (WEF) in Davos, Switzerland. It was co-founded and co-funded with US$460 million from the Bill and Melinda Gates Foundation, The Wellcome Trust, and a consortium of nations, being Norway, Japan, Germany; to which the European Union (2019) and Britain (2020) subsequently joined.[3][5] CEPI is headquartered in Oslo, Norway.[3][4][5] In 2017, Nature said, "It is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats".[9] In 2020, CEPI was identified by several media outlets as a "key player in the race to develop a vaccine" for coronavirus disease 2019.[4][10][11]
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History
Founding
The concept for CEPI was outlined in a July 2015 paper in The New England Journal of Medicine, titled "Establishing a Global Vaccine-Development Fund", co-authored by British medical researcher [Jeremy James Farrar (born 1961)] (a director of Wellcome Trust), American physician [Dr. Stanley Alan Plotkin (born 1932)] (co-discoverer of the Rubellavaccine), and American expert in infectious diseases Adel Mahmoud (developer of the HPV vaccine and rotavirus vaccine). [see https://www.nejm.org/doi/pdf/10.1056/NEJMp1506820?articleTools=true ]
Their concept was further expanded at the 2016 WEF in Davos, where it was discussed as a solution to the problems encountered in developing and distributing a vaccine for the Western African Ebola virus epidemic.[3] Co-founder and funder, Bill Gates said: "The market is not going to solve this problem because epidemics do not come along very often — and when they do you are not allowed to charge some huge premium price for the tools involved".[3] CEPI's creation was also supported and co-funded by the pharmaceutical industry including GlaxoSmithKline (GSK), with CEO Sir Andrew Witty explaining at the WEF, "It is super-disruptive when the red phone rings in our vaccine division because of a health emergency. People do not realise that there's no spare capacity in the world's vaccine production system today".[3]
CEPI was formally launched at the 2017 WEF in Davos, with an initial investment of US$460 million by a consortium that included the governments of Norway, Japan, and Germany, The Wellcome Trust, and the Gates Foundation;[13][3] India joined a short time afterwards.[14][15] In a launch interview with the Financial Times (FT), Gates said that a key goal was to reduce the time to develop vaccines from 10 years to less than 12 months.[3]
The initial targets were the six EID viruses with known potential to cause major epidemics, being: MERS, Lassa fever, Nipah virus, Ebola, Marburg fever and Zika.[3][5] The FT reported CEPI would "build the scientific and technological infrastructure for developing vaccines quickly against pathogens that emerge from nowhere to cause a global health crisis, such as Sars in 2002/03 and Zika in 2015/16", and fund research papers on the costs and process of vaccine development.[3] Town & Country listed it as one of the top-10 newsworthy moments from the 2017 Davos.[16] At launch, Norwegian physician John-Arne Røttingen, who led the steering committee for Ebola vaccine trials, served as interim CEO, and CEPI was based at the Norwegian Institute of Public Health in Oslo.[7]
In April 2017, [Dr. Richard Jones Hatchett IV (born 1968)], former director of the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), became the full-time CEO.[17] Hatchett was also a member of the United States Homeland Security Council under George W. Bush, and the United States National Security Council, under Barack Obama.[11][18] Also in April 2017, CEPI opened an additional office in London, and in October 2017, a further office was opened in Washington, D.C.[19]
Funding
At its launch in 2017, CEPI announced five-year financial pledges from its founders that amounted to US$460 million and came from the sovereign governments of Japan (US$125 million), Norway (US$120 million), and Germany (US$10.6 million in 2017 alone, and which later became US$90 million), and from global foundations of the Gates Foundation (US$100 million), and the Wellcome Trust (US$100 million); India was finalising their financial commitment, which was made shortly afterward.[20] A funding target of US$1 billion was set for the first 5 years of operation (i.e. by January 2022).[20] The journal Nature said of the amount raised that: "It is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats".[9]
As part of its funding structure, CEPI has used "vaccine bonds" to "frontload" multi-year sovereign funding pledges. In 2019, the International Finance Facility for Immunisation (IFFIm) issued NOK 600 million in vaccine bonds to front-load the commitment by Norway, through Gavi, the Vaccine Alliance, to CEPI.[21][22]
In March 2019, the European Commission granted access to CEPI into the EU's Horizon 2020 programme, and a longer-term financial funding programme.[23] CEPI note presentations that the EU's financial commitment amounts to US$200 million, which when added to the seed amount (including the full German commitment), came to US$740 million.[24]
By February 2020, Bloomberg News reported that CEPI had raised a total of US$760 million with additional donations from the governments of Australia, Belgium, Canada, and the U.K.[4] Bloomberg said that "CEPI solves what economists call a 'coordination problem'. It can help pair boutique research and development companies with big vaccine manufacturers, work with regulators to streamline approval processes and resolve patent disputes on the spot. Its scientific advisory committee has executives from Pfizer, Johnson & Johnson, and Japan's Takeda Pharmaceutical, among others".[4]
In March 2020, the British government pledged £210 million in funding to CEPI to specifically focus on a vaccine for the coronavirus; making Britain CEPI's largest individual donor.[25][26]
Contributor : Category / Value (million USD) (TOTAL: 211.0)
Norway : Common Pool / 81.7
Germany : Common Pool / 39.3
Japan : Common Pool / 25.0
Bill & Melinda Gates Foundation : Common Pool / 20.0
UK : Common Pool / 13.0
Canada : Common Pool / 7.5
EU : Ebola / 3.7
Vulcan Inc. : Ebola / 2.5
Australia : Common Pool / 0.7
Wellcome Trust : Common Pool / 0.1
Mission
Main article: Economics of vaccines
The founding mission of CEPI was "equitable access" in pandemics: selling vaccines to developing nations at affordable prices.[8]Affordable access to existing patented vaccines had long been a concern for the medical community, and concern mounted in the wake of the struggle to get access to vaccine in the 2013–2016 Ebola epidemic.[28][8] Averting a repetition of this crisis was the motivating factor behind founding CEPI.[12]
The struggle to get access to vaccine in the 2013–2016 Ebola epidemic was one of the factors motivating the creation of the CEPI
Policy changes
CEPI's original policy[29] contained specific measures to prevent some of these market problems. All vaccine-manufacturing contracts would need initial approval by a public review board. The policy also stated that vaccine prices would be set at levels affordable to those needing vaccines and sustainable to the manufacturer.[30] Trade secrets would not be funded by the CEPI. Companies had to share all research data developed with CEPI funds. While CEPI would, controversially, not retain and license the intellectual property developed with CEPI funds (allowing the groups awarded funding to own it),[31] the CEPI retained "step-in" rights: the right to license and use intellectual property developed with CEPI funds for vaccine production, even if the company that had received the funding and taken ownership of the IP later withdrew from the agreement with CEPI.[8] The original policy also required that funded parties pre-register any trials in a clinical trials registry, publish results within a year of study completion (except with compelling reason and permission of CEPI), publish results in open-access articles, and have mechanisms for securely sharing underlying data and results, including negative results, in a way that preserves trial volunteer privacy (see AllTrials for further information).[31]
Pharmaceutical corporations, including Johnson & Johnson, Pfizer, and Takeda, objected to the original policy, and these provisions were removed in December 2018,[32][8] after the CEPI had obtained significant funding.[33] The policy changes met with strong criticism, led by Médecins Sans Frontières.[34][35] CEPI was also criticized for not following its own policies on transparency, and for removing the requirement that CEPI's board review CEPI's contracts.[31][36][35]
The CEPI stated that its vaccines would continue to be affordable and available,[4] and published an article discussing the changes, saying that the old policy "while reflective of the idealism that inspired the creation of CEPI, was felt by others not to be pragmatic or reflect the business realities confronted by vaccine developers".[30] It said that several unnamed vaccine manufacturers had declared that they could not work with the CEPI under the original policy. It said that the policy change did not reflect a change in commitment to access, and CEPI would still retain the right to do research and development using intellectual property it had funded, if the old partner was unable to continue. It also said that the CEPI would retain the right to find a new manufacturer if the old manufacturer could not continue, provided the old manufacturer agrees to the transfer of the information and intellectual property to the new one.[30]
The New York Times said that CEPI had made a "failed effort to get large pharmaceutical firms to agree to be partners without insisting on substantial profits or proprietary rights to research that CEPI helped to finance and produce," and had replaced specific implementation measures with lip service to its funding mission.[8]
Reception
The coalition was nominated for the 2021 Nobel Peace Prize by Norwegian MP Carl-Erik Grimstad.[37][38]
Structure
[Dr. Richard Jones Hatchett IV (born 1968) was CEO of CEPI from 2017.]
CEPI is incorporated under Norwegian law. As of March 2020,[39][5] a full-time staff of 68[4] that runs the organisation under the direction of a chief executive officer, [Dr. Richard Jones Hatchett IV (born 1968).[39]
The board consists of members, four from the Investors Council, and eight "independent members representing competencies including industry, global health, science, resource mobilization, finance."[39] T
Scientific Advisory Committee (SAC consists of 24 voting members that provide "scientific support, advice, and guidance to the CEPI Board and Secretariat."
Joint coordination group (JAG). The JAG is a "roundtable of independent institutions with an interest in seeing CEPI's vaccines successfully developed and deployed in an outbreak." Members of the JAG included the WHO, GAVI, European Medicines Agency, Food and Drug Administration, Médecins Sans Frontières, UNICEF, International Federation of Red Cross and Red Crescent Societies, African Vaccine Regulatory Forum, National Institute for Biological Standards and Control, and The Wellcome Trust.[39]
Investors Council (IC). The IC nominates four investor representatives to the board, and its approval is required for single investments over US$100 million. It included representatives from the governments of Norway, UK, Germany, Japan, Canada, Ethiopia, Australia, Belgium, the EU, and the Gates Foundation and the Wellcome Trust.[39]
Publications
In October 2018, CEPI scientists estimated that the costs of developing at least one vaccine for each of the diseases that could escalate into global humanitarian crises was between US$2.8 billion and US$3.7 billion.[40] In November 2019, CEPI discussed its target portfolio was on the WHO's "blueprint priority diseases", that included: MERS-CoV, Nipah virus, Lassa fever virus, and Rift Valley fever virus, as well as Chikungunya virus, and the WHO's Disease X.[6] CEPI outlined its projects to update CEPI priorities for establishment of technical and regulatory pathways for vaccine development, develop sustainable manufacturing solutions for vaccine candidates nearing completion, and create investigatory stockpiles of its vaccine candidates for use in emergency situations.[5]
Investments
See also: COVID-19 vaccine
General development
In December 2018, US$8.4 million to Imperial College in London, to fund the development of a "self-amplifying RNA vaccineplatform" that CEPI said: "would enable a tailored vaccine production against multiple viral pathogens (including H1N1 influenza, rabies virus, and Marburg virus)".[5]
In December 2018, US$10.6 million was given to the University of Queensland to fund the development of a "molecular clamp" vaccine platform, that CEPI described as a "transformative technology that enables targeted and rapid vaccine production against multiple viral pathogens (including influenza virus, MERS-CoV, and respiratory syncytial virus)".[5]
In February 2019, US$34 million was given to the German-based CureVac biopharmaceutical company, to fund the development of an "RNA Printer prototype", which CEPI described as being a "transportable, down-scaled, automated mRNA printing facility, that can produce rapidly, a supply of lipid-nanoparticle–formulated mRNA vaccine candidate that can target known pathogens (including Lassa fever, yellow fever, and rabies); and prepare for rapid response to unknown pathogens (i.e., Disease X)".[5]
Specific vaccines
Lassa fever/MERS-CoV
In March 2018, US$37.5 million was given to Austrian-based Themis Bioscience to fund a vaccine against Lassa virus and MERS-CoV, using a measles vector technology.[41][5]
In April 2018, US$56 million was given to U.S.-based Inovio Pharmaceuticals to fund a DNA-vaccine against Lassa virus and MERS-CoV.[42][5]
In May 2018, US$54.9 million was given to the International AIDS Vaccine Initiative (IAVI), to fund a vaccine against Lassa virus via replication-competent vesicular stomatitis viral vector technology.[5]
In June 2018, US$35 million was given to U.S.-based Profectus Biosciences, to fund an attenuated "VesiculoVax" vaccine against Lassa virus.[5]
In August 2018, US$36 million was given to German-based IDT Biologika, to fund a vaccine against MERS-CoV (only) using a recombinant modified vaccinia Ankara viral vector technology.[5]
In September 2018, US$19 million to Janssen Pharmaceutica and the University of Oxford, to fund a vaccine against Lassa and MERS-Cov using a simian adenoviral vaccine viral vector technology.[5]
Nipah virus
In May 2018, US$25 million was given to U.S.-based Profectus Biosciences, to make a recombinant protein subunit vaccine against Nipah virus.[5]
In February 2019, US$31 million was given to the University of Tokyo, to develop a vaccine by inserting the Nipah-virus G gene ("Malaysia strain"), into a measles vector ("Edmonston B strain").[5]
In August 2019, US$43.6 million was given to Public Health Vaccines LLC, to fund the development and manufacture of a vaccine using a recombinant vesicular stomatitis virus technology.[43][5]
SARS-CoV-2
In January 2020, CEPI funded three teams working on a vaccine for SARS-CoV-2, being: Moderna, Inovio Pharmaceuticals, and the University of Queensland (UQ).[44][45] By February 2020, Inovio announced that it had produced a pre-clinical DNA-based vaccination to fight COVID-19 at its lab in San Diego.[46] Inovio collaborated with a Chinese firm to speed its acceptance by regulatory authorities in China for human trialing.[47] The strategy of the UQ team is to develop a molecular clamp vaccine that genetically modifies viral proteins to make them mimic the coronavirus and stimulate an immune reaction.[45][44]
In January 2020, CEPI announced a fourth SARS-CoV-2 project in a collaboration with their existing partner CureVac, to develop and manufacture a vaccine.[48] CEPI's CEO, Richard J. Hachett said in an interview with the FT that CEPI expected to have human trials within 16 weeks, but cautioned "All these timelines are aggressive and aspirational. As circumstances unfold there may be opportunities to reduce the timing but it is critically important that any new vaccine is safe and effective".[11]
In February 2020, Bloomberg News, citing virologists, identified CEPI as a "key player in the race to develop a vaccine";[4] a status other media outlets have attributed.[49][11] In reviewing vaccine development on the virus Vox said: "CEPI is a large part of why there are already dozens of Covid-19 vaccine candidates making their way through animal and human trials, as well as platforms to develop more",[50] while The Guardian said CEPI was "leading efforts to finance and coordinate Covid-19 vaccine development".[10]
In March 2020, Hatchett gave an interview to Channel 4 News saying that "war is an appropriate analogy", for the steps needed to counter the virus, and that "this is the most frightening disease that I have ever encountered in my career, and that includes Ebola, it includes MERS, it includes SARS. And it's frightening because of the combination of infectiousness and a lethality that appears to be many-fold higher than flu".[51] Hatchett told The Daily Telegraph that coronaviruses are the most serious threat to public health since the Spanish flu, and that a vaccine will take up to 18 months to deliver at a cost of £1.5 billion.[52] CEPI said that its funds for fighting the virus would be fully allocated by the end of March and that it was launching a new funding call for US$2 billion to support fighting the virus.[53][54][55]
In March 2020, CEPI invested US$4.4 million in two more projects with Swedish vaccine laboratory Novavax, and with Oxford University, bringing its total investment in SARS-CoV-2 vaccine work to US$23.7 million, and announcing that it would invest up to US$100 million in further COVID-19 projects.[56]
Chikungunya virus
In June 2019, US$21 million was given to Themis Bioscience to fund phase 3 clinical trials and regulatory approval of a vaccine using measles viral vector technology.[5]
In July 2019, US$23.4 million was given to Austrian-based biotech Valneva SE to fund manufacturing and late-stage clinical development of a single-dose, live-attenuated vaccine.[5]
Rift Valley fever
In July 2019, US$12.5 million was given to Dutch-based Wageningen University and Research for a single-dose vaccine candidate for Rift Valley fever that uses an attenuated virus technology, which included: vaccine manufacturing, preclinical research, and a phase 1 study.[5]
In July 2019, US$9.5 million was given to Colorado State University for manufacturing and preclinical studies to assess another single-dose vaccine candidate against Rift Valley fever (also using an attenuated virus technology).[5]
References
- a b c d e "A global coalition to create new vaccines for emerging infectious diseases". cepi.net. January 18, 2017. Archived from the original on March 22, 2021. Retrieved March 9, 2021. CEPI is a direct response to calls from four independent expert reports into the Ebola epidemic for a new system for stimulating the development of vaccines against epidemic threats. It was founded by the governments of India and Norway, the Bill & Melinda Gates Foundation, Wellcome and the World Economic Forum, which has played a key convening role, bringing together stakeholders at the 2016 Davos meeting and other events.
- ^ "Who we are". cepi.net. Archived from the original on June 11, 2020.
- a b c d e f g h i j k Clive Cookson (January 18, 2017). "Davos launch for coalition to prevent epidemics of emerging viruses". Financial Times. Archived from the original on April 2, 2020. Retrieved March 6, 2020. Billion-dollar programme aims to cut vaccine-development time from 12 years to one
- a b c d e f g h i Peter Coy (February 13, 2020). "The Road to a Coronavirus Vaccine Runs Through Oslo". Bloomberg News. Archived from the original on March 20, 2020. Retrieved March 7,2020.
- a b c d e f g h i j k l m n o p q r s t u v w Dimitrios Gouglas; Mario Christodoulou; Stanley A Plotkin; Richard Hatchett (November 2019). "CEPI: Driving Progress Towards Epidemic Preparedness And Response". Epidemiologic Reviews. 41 (1): 28–33. doi:10.1093/epirev/mxz012. PMC 7108492. PMID 31673694.
- a b Bernasconi, Valentina; Kristiansen, Paul A.; Whelan, Mike; Román, Raúl Gómez; Bettis, Alison; Yimer, Solomon Abebe; Gurry, Céline; Andersen, Svein R.; Yeskey, Debra; Mandi, Henshaw; Kumar, Arun; Holst, Johan; Clark, Carolyn; Cramer, Jakob P.; Røttingen, John-Arne; Hatchett, Richard; Saville, Melanie; Norheim, Gunnstein (2020). "Developing vaccines against epidemic-prone emerging infectious diseases". Bundesgesundheitsblatt. 63 (1): 65–73. doi:10.1007/s00103-019-03061-2. PMC 6925075. PMID 31776599.
- a b c John Cohen (September 2, 2016). "New vaccine coalition aims to ward off epidemics". Science. 353 (6303). Archivedfrom the original on September 6, 2016. Retrieved September 5,2016.
- a b c d e f Gerald Posner (March 2, 2020). "Big Pharma May Pose an Obstacle to Vaccine Development". The New York Times. Archived from the original on March 7, 2020. Retrieved March 8,2020. Drug companies on CEPI's scientific advisory panel, including Johnson & Johnson, Pfizer, and Japan's Takeda, pushed back. CEPI mostly capitulated in a December 2018 two-page declaration in which it jettisoned specifics but gave lip service to its founding mission of "equitable access to these vaccines for affected populations during outbreaks."
- a b Butler, Declan (January 18, 2017). "Billion-dollar project aims to prep vaccines before epidemics hit". Nature. 541 (7638): 444–445. Bibcode:2017Natur.541..444B. doi:10.1038/nature.2017.21329. PMID 28128262.
- a b Laura Spinney (March 15, 2020). "When will a coronavirus vaccine be ready?". The Guardian. Archived from the original on March 16, 2020. Retrieved March 15, 2020. "The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses", says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations (Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.
- a b c d Hannah Kuchler (January 30, 2020). "The scientist leading the coronavirus vaccine race". Financial Times. Archived from the original on April 2, 2020. Retrieved March 8, 2020.
- a b Stanley A. Plotkin; Adel A.F. Mahmoud; Jeremy Farrar (July 23, 2015). "Establishing a Global Vaccine-Development Fund"(PDF). The New England Journal of Medicine. 373 (4): 297–300. doi:10.1056/NEJMp1506820. PMID 26200974. Archived(PDF) from the original on May 5, 2017. Retrieved April 10, 2020.
- ^ Alexandra Sifferlin (January 19, 2017). "This New Group Wants to Stop Pandemics Before They Start". Time. Archived from the original on March 3, 2020. Retrieved March 8, 2020.
- ^ Paton, James (January 18, 2017). "Ebola, Zika Push Drugmakers into Effort to Avert Pandemics". Bloomberg. Archived from the original on February 8, 2017. Retrieved February 7, 2017.
- ^ "Putting shots in the locker". The Economist. 420 (9003): 67–68. September 3, 2016. Archived from the original on August 1, 2017. Retrieved August 25, 2017.
- ^ Natalina Lopez (January 27, 2017). "The Top 10 Moments at the 2017 Davos World Economic Forum". Town & Country. Archived from the original on February 6, 2017. Retrieved March 13, 2020.
- ^ Michael Dumiak (2017). "AN INTERVIEW WITH RICHARD HATCHETT". IAVIReport. 21 (1). Archived from the original on April 14, 2020. Retrieved March 7, 2020.
- ^ "Richard Hatchett at LSHTM". London School of Hygiene & Tropical Medicine. Archived from the original on March 29, 2020. Retrieved March 8, 2020.
- ^ "Coalition for Epidemic Preparedness Innovations". CEPI. Archived from the original on March 8, 2020. Retrieved March 11,2020.
- a b Lena H. Sun (January 18, 2017). "New global coalition launched to create vaccines, prevent epidemics". The Washington Post. Archived from the original on April 10, 2020. Retrieved March 12, 2020.
- ^ "Coalition for Epidemic Preparedness Innovation turns to IFFIm to accelerate funding for new vaccine development". GAVI. December 12, 2018. Archived from the original on April 10, 2020. Retrieved March 8, 2020. Under the just-approved arrangement, IFFIm will, on CEPI's behalf, issue bonds on international capital markets supported by new pledges from the Kingdom of Norway, which hosts CEPI. Norway and CEPI have turned to IFFIm because of its simplicity, speed of execution, cost, compliance and strong reputation among investors.
- ^ "IFFIm issues NOK600 million Vaccine Bonds". International Finance Facility for Immunisation. July 18, 2019. Archived from the original on May 27, 2020. Retrieved March 8, 2020.
- ^ "FPA-SC1-CEPI-2019 – Grant to the Coalition for Epidemic Preparedness Innovations (CEPI)". European Commission. March 19, 2019. Retrieved March 9, 2020.
- ^ Dimitrios Gouglas (April 13, 2019). "[PRESENTATION] Coalition for Epidemic Preparedness Innovations" (PDF). Unite For Sight. Retrieved March 12, 2020.
- ^ Rhys Blakely (March 27, 2020). "UK promises £210m to find coronavirus vaccine". The Times. Archived from the original on March 28, 2020. Retrieved March 28, 2020.
- ^ Andrew Woodcock (March 27, 2020). "Coronavirus: Britain now the largest contributor to international effort to find vaccine after £210m commitment". The Independent. Archived from the original on March 27, 2020. Retrieved March 28, 2020.
- ^ "Annual Progress Report" (PDF). CEPI. March 31, 2020.
- ^ "The Right Shot: Bringing down barriers to affordable and adapted vaccines – 2nd Ed., 2015". Médecins Sans Frontières Access Campaign. Archived from the original on March 22, 2020. Retrieved April 10, 2020.
- ^ "Original CEPI Policy Documentation" (PDF). Médecins Sans Frontières. Archived (PDF) from the original on March 31, 2020. Retrieved April 10, 2020.
- a b c Huneycutt, Brenda; Lurie, Nicole; Rotenberg, Sara; Wilder, Richard; Hatchett, Richard (February 2020). "Finding equipoise: CEPI revises its equitable access policy". Vaccine. 38 (9): 2144–2148. doi:10.1016/j.vaccine.2019.12.055. PMC 7130943. PMID 32005536.
- a b c "MSF's response to CEPI's policy regarding equitable access". Médecins Sans Frontières Access Campaign. Archived from the original on April 10, 2020. Retrieved April 10,2020.
- ^ "Open letter to CEPI Board Members: Revise CEPI's access policy". Médecins Sans Frontières Access Campaign. Archivedfrom the original on April 10, 2020. Retrieved April 10, 2020.
- ^ "Norway has invested 200 million euros in epidemic preparedness, but are they getting what they're paying for?". Médecins Sans Frontières Access Campaign. Archived from the original on April 10, 2020. Retrieved April 10, 2020.
- ^ Lei Ravelo, Jenny (March 11, 2019). "Battle over CEPI's access to vaccines policy deepens". Devex. Archived from the original on April 10, 2020. Retrieved April 30, 2020.
- a b Gulland, Anne (June 25, 2019). "Warning over lack of transparency in the development of vaccines". The Daily Telegraph. Archived from the original on May 17, 2020. Retrieved April 30, 2020.
- ^ "The wrong prescription for vaccine access". Médecins Sans Frontières Access Campaign. Archived from the original on April 10, 2020. Retrieved April 10, 2020.
- ^ "Flere fredsprisforslag før fristen gikk ut". Aftenposten. Norwegian News Agency. January 31, 2021.
- ^ "Hektisk nomineringsaktivitet før fredsprisfrist". Dagsavisen. January 31, 2021.
- a b c d e "Who we are". Coalition for Epidemic Preparedness Innovations. Archived from the original on March 8, 2020. Retrieved March 9, 2020.
- ^ Gouglas, D.; Thanh Le, T.; Henderson, K.; Kaloudis, A.; Danielsen, T.; Hammersland, N. C.; Robinson, J. M.; Heaton, P. M.; Røttingen, J. A. (2018). "Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study". The Lancet. 6 (12): e1386–e1396. doi:10.1016/S2214-109X(18)30346-2. PMC 7164811. PMID 30342925. Archived from the original on May 10, 2020.
- ^ "CEPI Partners with Themis Bioscience to Advance Vaccines Against Lassa Fever and MERS – Press Release". Archivedfrom the original on April 16, 2018. Retrieved April 15, 2018.
- ^ "Inovio Awarded up to $56 Million from CEPI to Advance DNA Vaccines Against Lassa Fever and MERS – Press Release". GlobeNewswire News Room. Archived from the original on April 14, 2018. Retrieved April 15, 2018.
- ^ "CEPI awards up to US$43.6 million to Public Health Vaccines, LLC. for development of a single-dose Nipah virus vaccine candidate". CEPI. August 19, 2019. Retrieved March 9, 2020.
- a b Steenhuysen, Julie; Kelland, Kate (January 24, 2020). "With Wuhan virus genetic code in hand, scientists begin work on a vaccine". Thomson Reuters. Archived from the original on January 25, 2020. Retrieved January 25, 2020.
- a b Devlin, Hannah (January 24, 2020). "Lessons from Sars outbreak help in race for coronavirus vaccine". The Guardian. Archived from the original on January 25, 2020. Retrieved January 25, 2020.
- ^ "Is a vaccine for the coronavirus coming? Inovio says it has designed one in San Diego". Los Angeles Times. February 15, 2020. Archived from the original on February 16, 2020. Retrieved February 17, 2020.
- ^ Mazumdar T (January 30, 2020). "Coronavirus: Scientists race to develop a vaccine". BBC News Online. Archived from the original on January 30, 2020. Retrieved February 3, 2020.
- ^ "CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019". CureVac AG. January 31, 2020. Archived from the original on February 25, 2020. Retrieved February 25, 2020.
- ^ Andrew Dunne (January 23, 2020). "A coalition backed by Bill Gates is funding biotechs that are scrambling to develop vaccines for the deadly Wuhan coronavirus". Business Insider. Archivedfrom the original on March 6, 2020. Retrieved March 8, 2020.
- ^ Julia Belluz; Umair Irfan; Brian Resnick (March 6, 2020). "A simple guide to the vaccines and drugs that could fight coronavirus". Vox. Archived from the original on March 6, 2020. Retrieved March 8, 2020. Knowing there will be more Ebola-like emergencies in need of ready vaccines was the starting point for the Coalition for Epidemic Preparedness Innovations, or CEPI, a public-private partnership that launched in 2017. Their raison d'être: to award grants for swift vaccine development targeting emerging threats that the pharmaceutical industry might otherwise ignore.
- ^ Matt Frei (March 6, 2020). "'This is the most frightening disease I've ever encountered' – virus expert Dr. Richard Hatchett". Channel 4 News. Interview on C4 News [VIDEO]. Archived from the original on March 7, 2020. Retrieved March 8, 2020. Dr. Richard Hatchett advised the Bush and Obama White Houses and worked for the agency that protects Americans against pandemics and bioweapons.
- ^ Robert Mendick (March 6, 2020). "Coronavirus poses most serious threat to public health since Spanish flu pandemic, says expert". The Daily Telegraph. Archived from the original on March 7, 2020. Retrieved March 7, 2020.
- ^ Kate Kelland (March 6, 2020). "$2 billion needed to develop COVID-19 shot, says epidemic response group". Reuters News. Archived from the original on March 7, 2020. Retrieved March 7,2020.
- ^ Hannah Kultcher (March 5, 2020). "Coronavirus and the $2bn race to find a vaccine". Financial Times. Archived from the original on March 6, 2020. Retrieved March 7, 2020.
- ^ James Paton (March 6, 2020). "Coronavirus Vaccine Work Faces Funding Gap of Almost $2 Billion". Bloomberg News. Archivedfrom the original on March 7, 2020. Retrieved March 8, 2020.
- ^ Kate Kelland (March 9, 2020). "Epidemic response group ups coronavirus vaccine funding to $23.7 million". Reuters News. Archived from the original on March 10, 2020. Retrieved March 9,2020.
External links
Wikimedia Commons has media related to Coalition for Epidemic Preparedness Innovations.
Dr Richard Hatchett Interview Channel 4 News (March 6, 2020)
CEPI: Presentation to SAGE Meeting, World Health Organization (April 4, 2020)
EVIDENCE TIMELINE
2016 (Oct) CEPI Website (on archive.org)
https://web.archive.org/web/20161006052211/http://cepi.net/governance
Interim Board
- K Vijay Raghavan, Secretary, Department of Biotechnology, Ministry of Science and Technology, India (Chair)
- Peter Piot, Director of the London School of Hygiene and Tropical Medicine (Vice Chair)
- Christopher Whitty, Chief Scientific Adviser, Department of Health, UK
- Jane Halton, Permanent Secretary, Department of Finance, Australia
- Tore Godal, Special Adviser on Global Health, Section for Global Initiatives, Ministry of Foreign Affairs, Norway
- Ruxandra Draghia-Akli, Deputy director-general of DG RTD, European Commission
- Yah Zolia, Deputy Minister of Health and Social Welfare, Liberia
- Kesetebirhan Admasu, Minister of Health, Ethiopia
- Jeremy Farrar, Director, Wellcome Trust
- Trevor Mundel, President, Global Health Division, The Bill & Melinda Gates Foundation
- Adar Poonawalla, CEO and Executive Director, Serum Institute of India
- Nima Farzan, President and CEO, PAXVAX INC
- Julie Gerberding, Executive Vice President, Strategic Communications, Global Public Policy, and Population Health, Merck
- Moncef Slaoui, Chairman of vaccines, GSK
- Joanne Liu, International President, Medecins sans Frontieres
- Victor Dzau, President of the Institute of Medicine, National Academy of Sciences
- Arnaud Bernaert, Head of Global Health and Healthcare Industries, World Economic Forum
Observers
- Marie-Paule Kieny, Assistant Director-General , World Health Organization
- Mark Feinberg , President and Chief Executive Officer, IAVI (Chair of CEPI Scientific Advisory Committee)
- Peggy Hamburg, Foreign Secretary of the Institute of Medicine, National Academy of Sciences (Chair of CEPI Joint Coordination Group)
- John-Arne Røttingen, Interim CEPI CEO
- Nicole Lurie, Assistant Secretary for Preparedness and Response, Department of Health and Human Services, USA (serving in a liaison position)
2016 (Nov) - First edition of "Business Plan" for CEPI (2017-2021 outlook)
https://cepi.net/wp-content/uploads/2019/02/CEPI-Preliminary-Business-Plan-061216_0.pdf
2024-download-cepi-preliminaty-business-plan-2017-2021-061216-0-2.podf
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2017 (Jan 18/19) - Washington Post News service : "Global coalition launched ot combat emerging diseases, prevent epidemics" / aka "CEPI"
See The Coalition for Epidemic Preparedness Innovations (CEPI)
By Lena H. Sun / Text (from Washington Post) - See [HN027F][GDrive]
Mentioned : Dr. Rebecca Lynn Katz (born 1973) / Dr. Rick Arthur Bright (born 1966) / Jeremy James Farrar (born 1961) /
A global coalition to create new vaccines for emerging infectious diseases launched Wednesday with the ambitious aim of protecting the world from future epidemics.
Announced at the World Economic Forum in Davos, Switzerland, the initiative has an initial investment of nearly $500 million from the Bill and Melinda Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany.
The partnership will be called the Coalition for Epidemic Preparedness Innovations, or CEPI. It grew out of the lessons from the world’s woeful lack of preparedness for the 2014 Ebola epidemic in West Africa, which killed more than 11,000 people and caused at least $2.2 billion in economic losses in the three hardest-hit countries.
As a result of that and the current Zika epidemic in the Americas, a global consensus has steadily grown among an array of governments, public health leaders, scientists and vaccine industry executives that a new system is needed to guard against future health threats.
Global health experts welcomed the initiative, saying it would complement efforts already underway by the World Health Organization and the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services, which are working on Ebola and Zika vaccines.
The United States is not providing funding for CEPI, but it is offering subject expertise. Officials took part in the planning discussions, and “while we are not a formal partner to CEPI, we foresee synergies between our approaches,” BARDA Director [Dr. Rick Arthur -Bright (born 1966)] said in a statement. One such area is development of the most efficient technology for biodefense and infectious disease response, he said.
[Dr. Rebecca Lynn Katz (born 1973)], director of Georgetown University’s Center for Global Health Science and Security, expects the new coalition “will just add much needed resources to a hard problem” and not detract from other efforts' funding and resources.
CEPI initially plans to target three viruses that have known potential to cause serious epidemics and can be transmitted from animals to humans: MERS, a deadly respiratory virus first identified in Saudi Arabia in 2012 that can be spread by camels and now is in 27 countries, including the United States; Lassa fever, an acute viral illness mainly found in West Africa and spread by rats; and [Nipah Virus], a newly emerging infection initially identified in 1999 in Malaysia and Singapore. During a Nipah outbreak there among pig farmers and people with close contact with pigs, nearly 300 people were infected and more than 100 died.
Each virus is among WHO's priority pathogens. Few or no medical countermeasures exist to combat them. The current system for vaccine development is in crisis, health experts say, because it’s a costly, complicated and labor-intensive development process that prioritizes therapeutics with the biggest possible market.
CEPI hopes to develop two vaccine candidates against each of the target diseases. Officials said they did not choose Ebola and Zika vaccine work because considerable research is already underway.
“The last thing we would like to do is duplicate efforts,” Trevor Mundel, president of the Gates Foundation’s global health division, told reporters during a briefing.
Officials said they have raised $460 million, almost half of their $1 billion target for the first five years. They’re now seeking proposals from researchers and companies and expect to announce which will be funded by mid-year. They're also calling for other governments and organizations to help complete fundraising by the end of the year.
The Indian government, one of the coalition founders, is finalizing a financial commitment, according to CEPI.
Several major pharmaceutical companies are providing support in the form of vaccine technology, expertise and guidance. Industry representatives are on the coalition’s board and scientific advisory committee.
Bill Gates has said his biggest worry is a pathogen, more infectious than Ebola, for which the world is totally unprepared. In a statement Wednesday, Gates said, “The ability to rapidly develop and deliver vaccines when new ‘unknown’ diseases emerge offers our best hope to outpace outbreaks, save lives and avert disastrous economic consequences.”
Wellcome Director Jeremy James Farrar (born 1961) was among those who first proposed a global vaccine development fund in mid-2015. CEPI’s initial $1 billion investment goal, he said, pales in comparison to the tens of billions of dollars in costs from epidemics, starting with the 2003 SARS outbreak.
“Vaccines can protect us, but we’ve done too little to develop them as an insurance policy,” Farrar said.
CEPI's financial contributions so far for its first five years include:
Japan: $125 million
Norway: about $120 million
Germany: about $10.6 million in 2017 with more funding to come
Wellcome Trust: $100 million
Bill & Melinda Gates Foundation: $100 million
2020 (Jan 23) - FiercePharma.com : "Inovio, Moderna score CEPI funding for vaccine work against deadly coronavirus"
By Eric Sagonowsky / Jan 23, 2020 03:11pm / Saved PDF : [HW00A6][GDrive]
See Inovio Pharmaceuticals, Incorporated / The Coalition for Epidemic Preparedness Innovations (CEPI) / Moderna, Inc.
In a swift response to the spread of a new coronavirus in China, global outbreak preparedness group Coalition for Epidemic Preparedness Innovations (CEPI) unveiled funding for three early-stage vaccine programs.
Moderna this week disclosed that it’s working with federal researchers on a candidate, and now it'll have financial backing from CEPI. Pennsylvania-based Inovio Pharmaceuticals scored $9 million in funding for its own program, and CEPI is further expanding a partnership with the University of Queensland.
For Moderna, CEPI’s funding will cover manufacturing for an mRNA vaccine candidate against the new coronavirus strain. The work will be further supported by federal researchers at the National Institute of Allergy and Infectious Diseases (NIAID) who will conduct preclinical tests and a phase 1 study.
Separately, the CEPI grant will cover Inovio's development costs through phase 1 for the biotech's candidate, dubbed INO-4800. The vaccine is based on Inovio’s DNA medicine platform that the company says enables rapid development of a vaccine against emerging threats.
Inovio and CEPI already have some history. In 2018, CEPI awarded Inovio up to $56 million over five years for its work on Middle East respiratory syndrome (MERS) and Lassa fever vaccine candidates.
Inovio was involved in the Zika outbreak response as well and reached human testing with its vaccine candidate in just seven months, CEO Joseph Kim said in a statement [See [HW00A8][GDrive] ].
“We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging Chinese coronavirus 2019-nCoV,” he added.
The company has routinely jumped into emerging disease research, but has yet to take a product through to an approval. Moderna doesn't have any approved drugs or vaccines, either.
The coronavirus has already killed 26 people and infected at least 881 people in Wuhan, China state TV reported this week.
Aside from those vaccine efforts, Baylor College of Medicine has a program to develop new coronavirus vaccines for severe acute respiratory syndrome and MERS, Peter Hotez, dean for the National School of Tropical Medicine, told FiercePharma. In conjunction with NIAID, plus scientists in New York and Shanghai, the team is testing whether the vaccines could protect against the new coronavirus.
CEPI formed in 2017 as a partnership between governments, philanthropists, pharma companies and others to address a gap in vaccine development funding after Ebola and Zika caught the world off guard. The group set out to raise $1 billion to fund research against numerous threats, and, so far, it has granted $450 million.
PLYMOUTH MEETING, Pa., Jan. 23, 2020 /PRNewswire/ -- [Inovio Pharmaceuticals, Incorporated] today announced [The Coalition for Epidemic Preparedness Innovations (CEPI)] has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV) that has killed numerous people and infected hundreds more in China to date. This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.
Inovio's participation in this developing effort is based on the ideal suitability of its DNA medicine platform to rapidly develop a vaccine against an emerging virus with pandemic potential, proven vaccine development capabilities and a strong track record of rapidly generating promising countermeasures against previous pandemic threats. Inovio was the first to advance its vaccine (INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans. Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred.
In a recently published paper in Lancet Infectious Diseases, Inovio's Phase 1 study of its MERS-CoV vaccine demonstrated it was well tolerated and furthermore induced high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to INO-4700 were also maintained through 60 weeks following dosing.
[Dr. Richard Jones Hatchett IV (born 1968)], CEPI's CEO, said, "Given the rapid global spread of the 2019-nCoV virus the world needs to act quickly and in unity to tackle this disease. Our intention with this work is to leverage our work with Inovio on the MERS coronavirus and rapid response platform to speed up vaccine development."
[Dr. Jong Joseph Kim (born 1969)], Inovio's President & CEO said, "We're extremely honored to expand our partnership with CEPI to tackle this new threat to global public health. Our DNA medicine platform represents the best modern day approach to combatting emerging pandemics. We have already demonstrated positive clinical outcomes with our vaccine against MERS-CoV, another coronavirus. Importantly, following the Zika viral infection outbreak, Inovio and our partners developed a vaccine that went from bench to human testing in just seven months – the fastest vaccine development on record in recent decades. We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging Chinese coronavirus 2019-nCoV."
Inovio's collaborators in this coronavirus vaccine development include the Wistar Institute, [VGX International], a fully owned subsidiary of [GeneOne Life Science, Inc.] (KSE: 011000), and Twist Bioscience (NASDAQ: TWST).
- About CEPI : CEPI is an innovative partnership between public, private, philanthropic, and civil organisations launched in Davos in 2017 to develop vaccines to stop future epidemics. CEPI has received multi-year funding from Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and Wellcome. CEPI has also received single-year investments from the government of Belgium and the United Kingdom. The European Commission forsees substantial financial contributions to support relevant projects through EC mechanisms. CEPI has reached over US$ 750 million of its $1 billion funding target. Since its launch in January 2017, CEPI has announced three calls for proposals. The first call was for candidate vaccines against Lassa virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The second call was for the development of platforms that can be used for rapid vaccine development against unknown pathogens. The third call is for candidate vaccines against Rift Valley fever and Chikungunya viruses. To date, CEPI has committed to investing over $310 million in 12 vaccine candidates (five against Lassa virus, four against MERS-CoV, three against Nipah virus) and two vaccine platforms to develop vaccines against Disease X.
- About Inovio Pharmaceuticals, Inc. : Inovio is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure and/or protect people from diseases associated with HPV, cancer, and infectious diseases. Inovio is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to safely produce a robust immune response to destroy and clear high-risk HPV 16 and 18, which are responsible for 70% of cervical cancer, 90% of anal cancer and 69% of vulvar cancer. In addition to HPV, Inovio's optimized plasmid design and delivery technology has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio's most advanced clinical program, VGX-3100, is in Phase 3 development for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers and GBM, as well as externally funded platform development programs in Zika, MERS, Lassa, and HIV. Partners and collaborators include ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Regeneron, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.