challenges in ensuring global access to covid 19 vaccines production affordability CORD-Papers-2022-06-02 (Version 1)

Title: Challenges in ensuring global access to COVID-19 vaccines: production affordability allocation and deployment
Abstract: The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale priced affordably allocated globally so that they are available where needed and widely deployed in local communities. In this Health Policy paper we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates including efficacy levels dosing regimens storage requirements prices production capacities in 2021 and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26 758) on potential acceptance of COVID-19 vaccines conducted from October to December 2020. Vaccine acceptance was highest in Vietnam (98%) India (91%) China (91%) Denmark (87%) and South Korea (87%) and lowest in Serbia (38%) Croatia (41%) France (44%) Lebanon (44%) and Paraguay (51%).
Published: 2021-02-12
Journal: Lancet
DOI: 10.1016/s0140-6736(21)00306-8
DOI_URL: http://doi.org/10.1016/s0140-6736(21)00306-8
Author Name: Wouters Olivier J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wouters_olivier_j
Author Name: Shadlen Kenneth C
Author link: https://covid19-data.nist.gov/pid/rest/local/author/shadlen_kenneth_c
Author Name: Salcher Konrad Maximilian
Author link: https://covid19-data.nist.gov/pid/rest/local/author/salcher_konrad_maximilian
Author Name: Pollard Andrew J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/pollard_andrew_j
Author Name: Larson Heidi J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/larson_heidi_j
Author Name: Teerawattananon Yot
Author link: https://covid19-data.nist.gov/pid/rest/local/author/teerawattananon_yot
Author Name: Jit Mark
Author link: https://covid19-data.nist.gov/pid/rest/local/author/jit_mark
sha: 17e27e2c74f66bc579cbd6b31dac8fd889501850
license: no-cc
license_url: [no creative commons license associated]
source_x: Elsevier; Medline; PMC
source_x_url: https://www.elsevier.com/https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 33587887
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/33587887
pmcid: PMC7906643
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906643
url: https://www.sciencedirect.com/science/article/pii/S0140673621003068 https://www.ncbi.nlm.nih.gov/pubmed/33587887/ https://api.elsevier.com/content/article/pii/S0140673621003068 https://doi.org/10.1016/s0140-6736(21)00306-8
has_full_text: TRUE
Keywords Extracted from Text Content: Fosun € CureVac's COVID-19 CureVac ... AstraZeneca Coronavirus CureVac's vaccine-candidate COVID-19 vaccine CEPI Deal 1 Serum Xi'an Jiaotong German Novavax vaccine Xi'an COVID-19 vaccines B-2 Labour 354,500 virus-like-particle OJW CureVac NVX-CoV2373 £ Dynavax COVID-19 UK US$ 34M coronavirus nCOV-2019 CDMO CQDM Wave 2 §351(a Bill Novavax's vaccine City-based German Federal low-interest CAN$500,000 Tracker Wuhan funds CDMOs Food purchased Novavax
Extracted Text Content in Record: First 5000 Characters:The data presented in this Appendix are up to date as of February 3, 2021. The websites of the lead companies of all COVID-19 vaccines included in our dashboard (see Appendix 1 for inclusion criteria) were searched for press releases about public or non-profit funding commitments for their investigational vaccines; the websites of any identified external funders were also searched. Two investigators (OJW and MS-K) independently extracted information on the amount and nature of funding obtained from public and non-profit bodies. We also reviewed financial reports filed by these companies with the United States Securities and Exchange Commission (10-Q, 8-K, and other relevant forms) 1 or the China Securities Regulatory Commission for further details. Wunan Shi (Xi'an Jiaotong University, Xi'an, China) collected data from Chineselanguage sources on the costs of development and production for experimental COVID-19 vaccines being developed by Chinese firms; these data were not independently extracted by a second investigator. We also searched the online COVID-19 R&D Tracker (Policy Cures Research, Australia) 2 and a database maintained by the science data analytics company Airfinity (2021) 3 for additional data on the costs of research and development. We preferred press releases or other communications directly attributable to vaccine developers and organisations running trials, but also considered media reports from reputable sources when direct communications were not available. Only information published in Chinese, English, French, or German were included, since most candidates in clinical testing are being developed by firms headquartered in Australia, Canada, China, France, Germany, the United Kingdom, or the United States. We did not investigate the scale of private investment in these vaccine development and production projects (e.g., venture capital) since we could not reliably track such investments. We We did not count funds provided directly to licensees that produce and distribute vaccines on behalf of lead developers (e.g., Serum Institute of India), or to contract development and manufacturing organisations (CDMO) that contribute to lead developers' vaccine production (e.g., Emergent BioSolutions). Several of the licensees and CDMOs are collaborating with multiple vaccine makers, so it was not always possible to provide a breakdown by firm. And investments in licensees and CDMOs were often not publicly disclosed. We also excluded loans (i.e., debt financing) from the European Investment bank into companies like BioNTech and CureVac. We also excluded direct equity financing by governments; for example, the German federal government bought a stake in CureVac in June 2020. We included pre-purchase agreements between governments and companies where it appeared as though a significant portion of the funding was paid up front, or via milestone payments, for the late-stage development of an experimental vaccine (i.e., phase 1-3 trials) or the scaling up production at risk prior to the completion of clinical testing (e.g., US Government deals with Novavax, Sanofi/GSK, and AstraZeneca). We excluded such pre-purchase agreements when it appeared as though the purchase was only going towards paying for doses (e.g., US Government deal with BioNTech/Pfizer; deals between the European Union and several companies; deals between the government of Japan and companies; deal between the Brazilian government's Fiocruz and AstraZeneca). 4 The company received $60 million in funding from the Department of Defense "to support Novavax in its production of several components of the vaccine that will be manufactured in the U.S. The agreement includes a 2020 delivery of 10 "In the event that, prior to the delivery of 100 million doses of the vaccine candidate, the Company has submitted an Emergency Use Authorization under §564 of the Food, Drug and Cosmetic Act or a biologics license application under §351(a) of the Public Health Service Act and the Company (a) terminates manufacturing of NVX-CoV2373, (b) discontinues sale of NVX-CoV2373 to the U.S. Government or (c) makes any filing that anticipates federal bankruptcy protection, then upon the request of the U.S. Government, the Company will provide certain items necessary for the U.S. Government to pursue manufacturing of NVX-CoV2373 with a third party for exclusive sale to the U.S. Government. Such items include the (1) Notes: Takeda will manufacture and sell Novavax's vaccine in Japan; Takeda has received funding from Japan's Health, Labour, and Welfare Ministry to scale up production of the vaccine. 19, 20 The Serum Institute of India, which is expected to produce up to 1 billion doses of the Novavax vaccine for low-and middle-income countries, 21, 22 is receiving funding from the Gates Foundation to scale up production of COVID-19 vaccines at risk. 23 University of Oxford / AstraZeneca $1.7 billion Deal 1 ($2.9m): The UK government provided £2.2 million in funding to
Keywords Extracted from PMC Text: COVID-19 vaccine candidates H1N1 influenza pandemic.77 systems.88 community91 years.108 Serum human COVID-19 Vaccine Global Access (COVAX) Facility need.37 H1N1 pre-orders Vaccines Bangladesh, manufacturers.52 Pharmacare Argentina bodies relaxed,76 success.106, 107 Funders CEPI appendix 2 deployment.47 AstraZeneca review.10 COVID-19 Gamaleya Novavax 2021.3 come.3 COVAX Russia— them.27 population.37 elsewhere,35 capacity,16 CureVac Croatia (41% recovery,104 Kazakhstan manufacturers.53 donors Lebanon Pan American Health Organization people manufacturers.17 France COVID-19 Technology Access Pool stock −80°C.57 left −60 affected.33 red light distribution.38 Gavi Siam Bioscience roots vaccines.54 G20 funds herd patients green levels.26 Vaccine UNICEF Hesitancy WHO.4 Vaccine respondents health-care COVID-19 vaccine COVID-19 vaccines Oct 21 C-TAP population.93
Extracted PMC Text Content in Record: First 5000 Characters:The COVID-19 pandemic has caused substantial excess mortality and plunged national economies into deep recessions.1 Although the spread of the virus can be mitigated through physical distancing, face coverings, and testing and tracing—and potentially with therapeutics—the risk of outbreaks and disruption to economic and social life will probably remain until effective vaccines are administered to large portions of the global population to prevent hospitalisation and severe disease, and preferably achieve herd immunity to halt transmission of the virus. Several COVID-19 vaccines have now been authorised or approved for human use, with many more in the late stages of clinical development. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities (figure 1 ). These four dimensions of the global vaccination challenge are closely related, and the development and production steps have important implications for pricing, allocation, and public confidence. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard (figure 2 ) to highlight the key characteristics of 26 leading vaccine candidates, based on the target product profiles for COVID-19 vaccines set by WHO.4 We focused on characteristics that distinguish individual vaccine candidates from one another. We used a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, with the colour red indicating high risks to achieving widespread immunity, amber indicating medium risk, and green indicating little or no risk. Appendix 1 outlines the methodology for constructing the dashboard, including the criteria for assigning a green, amber, or red light for each characteristic. Although specific datapoints and their corresponding traffic-light categorisations are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. Several manufacturers have successfully developed COVID-19 vaccines in less than 12 months—an extraordinary achievement, given it typically takes a decade or longer to develop new vaccines.5, 6, 7, 8 The world now needs more doses of COVID-19 vaccines than it has done for any other vaccine in history to inoculate enough people for global vaccine immunity. Vaccines often suffer from underinvestment,9 but that has not been the case in this pandemic. As of Feb 3, 2021, there were 289 experimental COVID-19 vaccines in development, 66 of which were in different phases of clinical testing, including 20 in phase 3. Only five of these 66 vaccines—those developed by AstraZeneca in partnership with Oxford University, BioNTech in partnership with Pfizer, Gamaleya, Moderna, and Sinopharm in partnership with the Beijing Institute—have been authorised by stringent regulatory authorities (as per WHO criteria of such authorities2) or WHO (figure 2). Another five—from China, India, Kazakhstan, and Russia—have received approval or been authorised for emergency use by other regulatory agencies; some of the organisations developing these vaccines have submitted documentation to WHO for emergency use listing or prequalification, but these submissions are still under review.10 Additional vaccines from Novavax and Johnson & Johnson are expected to be authorised on the basis of positive interim phase 3 results. Several vaccines have shown high levels of efficacy (ie, more than 70%) in clinical trials, although not all developers have published their results; most of the authorised vaccines have been shown to provide strong protection against hospitalisations and deaths due to COVID-19. Whereas public support for basic research and early-stage drug development is widespread,11 the urgent need to develop COVID-19 vaccines and scale up supply has inspired new ways of aiding research, development, and production activities and enlisting broad participation among private companies.12 Governments and non-profit organisations have financed clinical trials, invested in the building and expansion of production facilities, and established contract manufacturing and distribution networks to enable the rapid roll-out of successful vaccines.13 The table summarises publicly available data on investments by governments and non-profit organisations into the research, development, and production of advanced COVID-19 vaccine candidates (appendix 2). In total, developers have received approximately $10 billion in public and non-profit funding for their vaccine candidates, although this number is probably an underestimate, given the scarcity of data on some of these projects. The top five companies have each recei
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