Coalition for Epidemic Preparedness Innovations

Founding , 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). 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. India joined a short time afterwards. 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. 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. 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. 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. 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. Also in April 2017, CEPI opened an additional office in London, and in October 2017, a further office was opened in Washington, D.C. Nature later stated, "It is by far the largest vaccine development initiative ever against viruses that are potential epidemic threats". In 2020, CEPI was identified by several media outlets as a "key player in the race to develop a vaccine" for coronavirus disease 2019. A funding target of US$1 billion was set for the first 5 years of operation (i.e. by January 2022). 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. In March 2019, the European Commission granted access to CEPI into the EU's Horizon 2020 programme, and a longer-term financial funding programme. 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. 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. In January 2022, The Wellcome Trust and the Bill & Melinda Gates Foundation pledged $300 million to CEPI. This is part of CEPI's effort to enable the world to reduce vaccine development timelines to 100 days. Mission The founding mission of CEPI was "equitable access" in pandemics: selling vaccines to developing nations at affordable prices. 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. 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. The policy changes met with strong criticism, led by Médecins Sans Frontières. 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. 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. Reception The coalition was nominated for the 2021 Nobel Peace Prize by Norwegian MP Carl-Erik Grimstad. ==Structure==

CEPI is incorporated under Norwegian law. As of March 2020, • 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. ==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. 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. 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. ==Investments==

General development • In December 2018, US$8.4 million was given 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)". Specific vaccines Lassa fever/MERS-CoV of Lassa virions • 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. Inovio collaborated with a Chinese firm to speed its acceptance by regulatory authorities in China for human trialing. 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. 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". • In February 2020, Bloomberg News, citing virologists, identified CEPI as a "key player in the race to develop a vaccine"; while The Guardian said CEPI was "leading efforts to finance and coordinate COVID-19 vaccine development". • 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". 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. 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. • 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. • In February 2021, CEPI launched the CIHR-CEPI Leadership Award for Excellence in Vaccine Research for Infectious Diseases of Epidemic Potential, co-administered with the Canadian Institutes of Health Research (CIHR). • CEPI invested approximately US$65 million for the early development of the pancoronavirus vaccine candidate GBP511 to help prevent and prepare for future coronavirus-related pandemics. 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. Monkeypox • In September 2023, CEPI committed funding of up to $90 million to BioNTech SE in order to help expedite the development of new mRNA-based vaccine candidates against mpox. 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. • 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). ==See also==