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Coalition for Epidemic Preparedness Innovations

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Coalition for Epidemic Preparedness Innovations
CEPI.svg
AbbreviationCEPI
MottoNew vaccines for a safer world
FormationJanuary 2017; 3 years ago (2017-01)
Founders
Founded atDavos, Switzerland.[1]
PurposeFund vaccine development[1]
HeadquartersOslo, Norway
Locations
Chief executive
Richard J. Hatchett
Key people
Jane Halton (Chair)
Staff (2020)
68[2]
WebsiteCEPI.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 disease (EID).[2][3] CEPI is focused on the World Health Organisation's (WHO) "blueprint priority diseases", which includes: 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".[4][3] CEPI investment also requires "equitable access" to the vaccines during outbreaks.[5]

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.[1][3] CEPI is headquartered in Oslo, Norway.[1][2][3] In 2017, Nature said, "It is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats".[6] In 2020, CEPI was identified as a "key player in the race to develop a vaccine" for the Coronavirus disease 2019.[2][7][8]

History

Founding

Jeremy Farrar, co-author of the concept of CEPI, and board member

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 Farrar (a director of Wellcome Trust), American physician Stanley A. Plotkin (co-discoverer of the Rubella vaccine), and American expert in infectious diseases Adel Mahmoud (developer of the HPV vaccine and rotavirus vaccine).[5][9]

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.[1] 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".[1] 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".[1]

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;[10][1] India joined a short time afterwards.[11][12] 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.[1] 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.[1][3] 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.[1] Town & Country listed it as a "Top 10 moment from Davos".[13]

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 Olso.[5]

In April 2017, Richard J. Hatchett, former director of the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), became the full-time CEO.[14] 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.[8][15]

In April 2017, CEPI opened an additional office in London, and in October 2017, a further office was opened in Washington D.C.[16]

Funding

Launch during the 2017 WEF at Davos

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.[17] A funding target of US$1 billion was set for the first 5 years of operation (i.e. by January 2022).[17] 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".[6]

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.[18][19]

In March 2019, the European Commission granted access to CEPI into the EU's Horizon 2020 programme, and a longer-term financial funding programme.[20] 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.[21]

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.[2] 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".[2]

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.[22][23]

Equitable access

One of the founding principles of CEPI is around what it calls "equitable access" by charging vaccines at affordable prices to developing nations.[2] CEPI's original 18-page policy document gave CEPI "step-in" rights to use the intellectual property of its partner companies in which it had invested, for vaccine production even if they withdrew from the CEPI agreement.[2] However, part of this policy had to be later scaled back into a shorter, two-page, document in order to encourage more private sector partner companies to engage in vaccine research.[2] CEPI came under criticism for this by Médecins Sans Frontières, however, commentators expressed an opinion that this may have been an inevitable consequence to get higher engagement by the pharmaceutical industry in supporting vaccine development.[24]

Structure

Richard J. Hatchett, CEO of CEPI from 2017

CEPI is a Norwegian Association, and had the following governance structure as at March 2020:[25][3]

Publications

In October 2018, CEPI published a study in British healthcare journal The Lancet, that estimated the costs of developing vaccines for diseases that could escalate into global humanitarian crises. The study focused on 11 diseases which cause relatively few deaths at present and primarily strike the poor. The authors estimated that it would cost between US$2.8 billion and US$3.7 billion to develop at least one vaccine for each of the diseases. This should be set against the potential cost of an outbreak. The 2003 SARS outbreak in East Asia cost US$54 billion.[26][27]

In November 2019, CEPI published a paper in the German healthcare journal Bundesgesundheitsblatt [de], discussing the structure and operation of CEPI and that 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.[4]

In November 2019, CEPI also published a paper in the healthcare journal Epidemiologic Reviews, outlining all of the projects they had invested in and their scientific and medical rationale. The paper also updated CEPI's priorities saying that in addition to investing in vaccines for its target portfolio, it also wanted to fund the establishment of technical and regulatory pathways for vaccine development, develop sustainable manufacturing solutions for vaccine candidates nearing completion, and create investigational stockpiles of its vaccine candidates for use in emergency situations.[3]

Investments

Most of CEPI's work is performed by allocating funds to independent third-party laboratories and vaccine research organizations through investments, the most material ones being:[2][3]

General development

In December 2018, US$8.4 million to Imperial College in London, to fund the development of a "self-amplifying RNA vaccine platform" that CEPI said: "would enable a tailored vaccine production against multiple viral pathogens (including H1N1 influenza, rabies virus, and Marburg virus)".[3]

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)".[3]

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)".[3]

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.[28][3]

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.[29][3]

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.[3]

In June 2018, US$35 million was given to U.S.-based Profectus Biosciences, to fund an attenuated "VesiculoVax" vaccine against Lassa virus.[3]

In August 2018, US$36 million was given to German-based IDT Biologika [de], to fund a vaccine against MERS-CoV (only) using a recombinant modified vaccinia Ankara viral vector technology.[3]

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.[3]

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.[3]

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").[3]

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.[30][3]

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).[31][32] 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.[33] Inovio collaborated with a Chinese firm to speed its acceptance by regulatory authorities in China for human trialing.[34] 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.[32][31]

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.[35] 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".[8]

In February 2020, Bloomberg News, citing virologists, identified CEPI as a "key player in the race to develop a vaccine";[2] a status other media outlets have attributed.[36][8] 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",[37] while The Guardian said CEPI was "leading efforts to finance and coordinate Covid-19 vaccine development".[7]

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 manyfold higher than flu".[38] 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.[39] 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.[40][41][42]

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.[43]

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.[3]

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.[3]

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.[3]

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).[3]

See also

References

  1. ^ a b c d e f g h i j k l Clive Cookson (18 January 2017). "Davos launch for coalition to prevent epidemics of emerging viruses". Financial Times. Retrieved 6 March 2020. Billion-dollar programme aims to cut vaccine-development time from 12 years to one
  2. ^ a b c d e f g h i j k l Peter Coy (13 February 2020). "The Road to a Coronavirus Vaccine Runs Through Oslo". Bloomberg News. Retrieved 7 March 2020.
  3. ^ a b c d e f g h i j k l m n o p q r s t u v w x Dimitrios Gouglas; Mario Christodoulou; Stanley A Plotkin; Richard Hatchett (November 2019). "CEPI: Driving Progress Towards Epidemic Preparedness And Response". Epidemiologic Reviews. doi:10.1093/epirev/mxz012. PMID 31673694.
  4. ^ 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.
  5. ^ a b c John Cohen (2 September 2016). "New vaccine coalition aims to ward off epidemics". Science. 353 (6303).
  6. ^ a b Butler, Declan (18 January 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.
  7. ^ a b Laura Spinney (15 March 2020). "When will a coronavirus vaccine be ready?". The Guardian. Retrieved 15 March 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.
  8. ^ a b c d Hannah Kuchler (30 January 2020). "The scientist leading the coronavirus vaccine race". Financial Times. Retrieved 8 March 2020.
  9. ^ Stanley A. Plotkin; Adel A.F. Mahmoud; Jeremy Farrar (23 July 2015). "Establishing a Global Vaccine-Development Fund". The New England Journal of Medicine. 373 (4): 297–300. doi:10.1056/NEJMp1506820. PMID 26200974.
  10. ^ Alexandra Sifferlin (19 January 2017). "This New Group Wants to Stop Pandemics Before They Start". Time.
  11. ^ Paton, James (January 18, 2017). "Ebola, Zika Push Drugmakers Into Effort to Avert Pandemics". Bloomberg.
  12. ^ "Putting shots in the locker". The Economist. 420 (9003): 67–68. 3 September 2016.
  13. ^ Natalina Lopez (27 January 2017). "The Top 10 Moments at the 2017 Davos World Economic Forum". Town & Country. Retrieved 13 March 2020.
  14. ^ Michael Dumiak (2017). "AN INTERVIEW WITH RICHARD HATCHETT". IAVIReport. 21 (1).
  15. ^ "Richard Hatchett at LSHTM". London School of Hygiene & Tropical Medicine. Retrieved 8 March 2020.
  16. ^ "Coalition for Epidemic Preparedness Innovations". CEPI. Retrieved 11 March 2020.
  17. ^ a b Lena H. Sun (18 January 2017). "New global coalition launched to create vaccines, prevent epidemics". Washington Post. Retrieved 12 March 2020.
  18. ^ "Coalition for Epidemic Preparedness Innovation turns to IFFIm to accelerate funding for new vaccine development". GAVI. 12 December 2018. Retrieved 8 March 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.
  19. ^ "IFFIm issues NOK600 million Vaccine Bonds". International Finance Facility for Immunisation. 18 July 2019. Retrieved 8 March 2020.
  20. ^ "FPA-SC1-CEPI-2019 - Grant to the Coalition for Epidemic Preparedness Innovations (CEPI)". European Commission. 19 March 2019. Retrieved 9 March 2020.
  21. ^ Dimitrios Gouglas (13 April 2019). "[PRESENTATION] Coalition for Epidemic Preparedness Innovations" (PDF). Unite For Sight. Retrieved 12 March 2020.
  22. ^ Rhys Blakely (27 March 2020). "UK promises £210m to find coronavirus vaccine". The Times. Retrieved 28 March 2020.
  23. ^ Andrew Woodcock (27 March 2020). "Coronavirus: Britain now the largest contributor to international effort to find vaccine after £210m commitment". The Independent. Retrieved 28 March 2020.
  24. ^ Gerald Posner (2 March 2020). "Big Pharma May Pose an Obstacle to Vaccine Development". New York Times. Retrieved 8 March 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."
  25. ^ a b c d e f g "Who we are". Coalition for Epidemic Preparedness Innovations. Retrieved 9 March 2020.
  26. ^ "Scientists have estimated the cost of stopping 11 diseases that could kill millions in a pandemic". Vox. 22 October 2018. Retrieved 2 December 2018.
  27. ^ 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. PMID 30342925.
  28. ^ "CEPI Partners with Themis Bioscience to Advance Vaccines Against Lassa Fever and MERS – Press Release". Retrieved 2018-04-15.
  29. ^ "Inovio Awarded up to $56 Million from CEPI to Advance DNA Vaccines Against Lassa Fever and MERS – Press Release". GlobeNewswire News Room. Retrieved 2018-04-15.
  30. ^ "CEPI awards up to US$43.6 million to Public Health Vaccines, LLC. for development of a single-dose Nipah virus vaccine candidate". CEPI. 19 August 2019. Retrieved 9 March 2020.
  31. ^ a b Steenhuysen, Julie; Kelland, Kate (2020-01-24). "With Wuhan virus genetic code in hand, scientists begin work on a vaccine". Thomson Reuters. Archived from the original on 2020-01-25. Retrieved 2020-01-25.
  32. ^ a b Devlin, Hannah (2020-01-24). "Lessons from Sars outbreak help in race for coronavirus vaccine". The Guardian. Archived from the original on 2020-01-25. Retrieved 2020-01-25.
  33. ^ "Is a vaccine for the coronavirus coming? Inovio says it has designed one in San Diego". Los Angeles Times. 15 February 2020. Retrieved 17 February 2020.
  34. ^ Mazumdar T (30 January 2020). "Coronavirus: Scientists race to develop a vaccine". BBC News Online. Archived from the original on 30 January 2020. Retrieved 3 February 2020.
  35. ^ "CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019". CureVac AG. 31 January 2020. Retrieved 25 February 2020.
  36. ^ Andrew Dunne (23 January 2020). "A coalition backed by Bill Gates is funding biotechs that are scrambling to develop vaccines for the deadly Wuhan coronavirus". Business Insider. Retrieved 8 March 2020.
  37. ^ Julia Belluz; Umair Irfan; Brian Resnick (6 March 2020). "A simple guide to the vaccines and drugs that could fight coronavirus". Vox. Retrieved 8 March 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.
  38. ^ Matt Frei (6 March 2020). "'This is the most frightening disease I've ever encountered' – virus expert Dr. Richard Hatchett". Channel 4 News. Interview on C4 News [VIDEO]. Retrieved 8 March 2020. Dr. Richard Hatchett advised the Bush and Obama White Houses and worked for the agency that protects Americans against pandemics and bioweapons.
  39. ^ Robert Mendick (6 March 2020). "Coronavirus poses most serious threat to public health since Spanish flu pandemic, says expert". Daily Telegraph. Retrieved 7 March 2020.
  40. ^ Kate Kelland (6 March 2020). "$2 billion needed to develop COVID-19 shot, says epidemic response group". Reuters News. Retrieved 7 March 2020.
  41. ^ Hannah Kultcher (5 March 2020). "Coronavirus and the $2bn race to find a vaccine". Financial Times. Retrieved 7 March 2020.
  42. ^ James Paton (6 March 2020). "Coronavirus Vaccine Work Faces Funding Gap of Almost $2 Billion". Bloomberg News. Retrieved 8 March 2020.
  43. ^ Kate Kelland (9 March 2020). "Epidemic response group ups coronavirus vaccine funding to $23.7 million". Reuters News. Retrieved 9 March 2020.

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