key: cord-0884533-ez2c0yoj authors: Cross, S.; Rho, Y.; Reddy, H.; Pepperrell, T.; Rodgers, F.; Osborne, R.; Eni-Olotu, A.; Banerjee, R.; Wimmer, S.; Keestra, S. M. title: Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine? - Approximating the funding to the University of Oxford for the research and development of the ChAdOx vaccine technology date: 2021-04-10 journal: nan DOI: 10.1101/2021.04.08.21255103 sha: cb95f2e72e82d67d5a2a5d3dbe77b51efe09359a doc_id: 884533 cord_uid: ez2c0yoj Objectives: The Oxford-AstraZeneca COVID-19 vaccine (ChAdOx1 nCoV-19 or Vaxzevira) builds on nearly two decades of research and development (R&D) into Chimpanzee adenovirus-vectored vaccine (ChAdOx) technology at the University of Oxford. This study aims to approximate the funding for the R&D of the ChAdOx technology and the Oxford-AstraZeneca vaccine, and assess the transparency of funding reporting mechanisms. Design: We conducted a scoping review and publication history analysis of the principal investigators to reconstruct the funding for the R&D of the ChAdOx technology. We matched award numbers with publicly-accessible grant databases. We filed Freedom Of Information (FOI) requests to the University of Oxford for the disclosure of all grants for ChAdOx R&D. Results: We identified 100 peer-reviewed articles relevant to ChAdOx technology published between 01/2002 and 10/2020, extracting 577 mentions of funding bodies from funding acknowledgement statements. Government funders from overseas were mentioned 158 (27.4%), the U.K. government 147 (25.5%) and charitable funders 138 (23.9%) times. Grant award numbers were identified for 215 (37.3%) mentions, amounts were available in the public realm for 121 (21.0%) mentions. Based on the FOIs, until 01/2020, the European Commision (34.0%), Wellcome Trust (20.4%) and CEPI (17.5%) were the biggest funders of ChAdOx R&D. From 01/2020, the U.K. Department of Health and Social Care was the single largest funder (89.3%). The identified R&D funding was GBP104,226,076 reported in the FOIs, and GBP228,466,771 reconstructed from the literature search. Conclusions: Our study identified that public funding accounted for 97.1-99.0% of the funding towards the R&D of ChAdOx and the Oxford-AstraZeneca vaccine. We furthermore encountered a severe lack of transparency in research funding reporting mechanisms. This is the first study that analysed the R&D funding and funders contributing to the Oxford-AstraZeneca vaccine and the underlying ChAdOx technology. ○ We used multiple sources and methods to approximate the R&D funding of the Oxford-AstraZeneca Vaccine and ChAdOx technology. ○ We cross-matched award numbers with all publicly-accessible databases by major funders of R&D. ○ Freedom Of Information requests were a useful method to identify R&D funding, but face limitations in their scope of data collection. ○ Integration of the two data sets was not possible due to insufficient grant information and lack of award numbers in funding acknowledgement statements in peer-reviewed articles. The ChAdOx1 nCoV-19 vaccine, commonly known as the Oxford-AstraZeneca vaccine, Covishield, or Vaxzevira, is one of three vaccines that has received conditional approval for the prevention of COVID-19 in the U.K. (March 2021) [1] . The Oxford-AstraZeneca vaccine has received regulatory approval in over 100 countries as of late March 2021, and approximately 50 million doses have been administered across the U.K., the E.U., and India [2] . This vaccine makes use of a novel technology that relies on a Chimpanzee Adenovirus-vector (ChAdOx) to encode the production of the SARS-CoV-2 spike protein, which induces an immune response [3] . The Oxford-AstraZeneca vaccine is particularly important because it does not require the same cold chain management and is more affordable than the other early-approved COVID-19 vaccines from Pfizer/BioNTech and Moderna [4] . It is therefore more feasible to distribute the vaccine for use globally, particularly in resource-limited settings [5] . Although the Oxford-AstraZeneca vaccine itself was developed in response to the COVID-19 pandemic, the underlying ChAdOx platform relies on two decades of virus-vectored vaccine research at the Jenner Institute, University of Oxford, led by Professor Sarah Gilbert (S.G.) and Professor Adrian Hill (A.H.). The ChAdOx technology has previously been trialled for other infectious diseases in human participants including Hepatitis C virus and malaria, where it was shown to induce a powerful immune response during phase 1 clinical trials [6, 7] . Before the emergence of SARS-CoV-2, the vaccine was under development for Middle East Respiratory Syndrome coronavirus (MERS-CoV) [8] . When the pandemic emerged, the ChAdOx1 MERS-CoV vaccine had already undergone clinical trials in non-human primates and humans (phase I) and was rapidly adapted to induce an immune response to SARS-CoV-2 [9] . Previous studies have shown that public funding has played a significant role in the medical innovation system for many decades, particularly in vaccine research [10] [11] [12] . Between 2000 and 2019, the U.S. National Institute of Health (NIH) funded over $17.2 billion in published research on vaccine technologies, providing the foundation for the COVID-19 vaccines currently entering the market [13] . Despite a number of public statements involving funding pledges for the development of the Oxford-AstraZeneca vaccine [4] [16] . Funders were categorised into the following funding types: overseas . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 10, 2021. ; government (including the EU), U.K. government, charity, public-private partnership (PPP), research institution, and industry. To gain access to the internal records held by the University of Oxford on grants received for ChAdOx R&D, we filed several requests under the Freedom Of Information Act (2000) to ask for the disclosure of all funding (including all financial support, grants, donations, etc.) for both the ChAdOx technology and the ChAdOx1 nCoV-19 vaccine. The FOIs are listed in Supplementary File 4. On the 25th of October 2020, we filed a request under the Freedom Of Information Act (2000) to the University of Oxford for the disclosure of all funding (including all financial support, grants, donations, etc.) that had been received by the University of Oxford and the Jenner institute relating to the ChAdOx vaccine platform, from the earliest date for which information is available to the present day [17] . This request was rejected as, according to the Information Compliance Team at the University of Oxford, it exceeded the maximum amount of time (18 hours) a public authority is legally required to spend on responding to a single FOI request (19/11/2020). To limit the scope of the first part of the request, we instead requested the disclosure of all funding (including all financial support, grants, donations, etc.) to the principal investigators, Sarah Gilbert and Adrian Hill, since 2000 to the most recent date available. We received a list of relevant grants received on the 27th of January 2021. FOI on the funding for the ChAdOx1 nCoV-19 vaccine The original FOI filed on 25/10/2020 also requested disclosure of all grants received from public entities and AstraZeneca for the development of the ChAdOx1 nCoV-19 vaccine specifically since January 1, 2020 to the date of the request. We received a response from the University of Oxford disclosing all pandemic funding for ChAdOx research at the university on the 19th of November 2020. On the 5th of February 2021, we filed a further FOI request to the University of Oxford to disclose all funding, monetary or in-kind contributions, received from AstraZeneca until February 2020 for the development of the ChAdOx1 nCoV-19 vaccine. We received a response to this request on the 2nd of March 2021 [18] . Two authors independently classified the grants into the following categories based on the project names pertaining to each grant, provided by the University of Oxford: (i.) funding towards the COVID-19 vaccine specifically, (ii.) funding towards the research & development (R&D) of the ChAdOx technology, (iii.) funding for the fellowships/salary/research equipment/infrastructure (later coded as "other vaccine research") that may have contributed to the development of the ChAdOx technology but is not directly identifiable (not displayed) (iv.) other funding not relevant to the ChAdOx technology (not displayed). Funders were additionally . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; categorised into the following funding types: overseas government (including the EU), U.K. government, charity, PPP, research institution, industry, and other, which included anonymous funders that could not be classified. From the first dataset, which included all grants to S.G. and A.H. from 2000 to October 2020, we analysed all grants up to January 2020 which were relevant to the R&D of the ChAdOx technology, excluding grants that mentioned COVID-19. From the second dataset, which included all grants relevant to ChAdOx1 nCoV-19 from January 2020 to October 2020, we analysed all grants that were relevant to the R&D of the Oxford-Astrazeneca vaccine specifically. Funding based on disclosure statements in academic publications on the ChAdOx technology We identified 100 published peer-reviewed articles relevant to the Oxford-AstraZeneca vaccine or the ChAdOx technology (Supplementary File 1 & 2). Publication dates ranged from January 2002 to November 2020. The concordance between the two independent reviewers was 93.61%. Funding acknowledgement statements differed in completeness between articles, with some only noting funding bodies and others detailing specific grants using grant titles or award numbers. In total, we extracted 577 mentions of funding bodies, with or without reference to specific grants. Of these, we were able to identify award numbers for 215 mentions (37.3%). Grant amounts were available in the public realm for 121 mentions (21.0%). Of the 215 mentions for which we ascertained award numbers, 73 mentions (12.7% of total mentions) corresponded to a previously identified award number. These mentions were not excluded from the total number due to the low proportion of mentions for which we were able to identify award numbers. However, grants identified as being duplicates based on having the same award numbers were excluded when calculating the amount of funding provided by that funding body. The total amount of funding we were able to reconstruct was £228,466,771. Overseas government bodies were mentioned in funding acknowledgement statements of peer-reviewed articles on ChAdOx 158 times (27.4%), followed by the U.K. government (147 mentions (25.5%)), and charities (138 mentions (23.9%)) ( Table 1) . Funders from industry were mentioned 6 times (1.0%), and public-private partnership (PPP) funders (including CEPI, PATH malaria vaccine initiative and CGIAR) 15 times (2.6%). Grant amounts could be matched with 27.9% of U.K. government mentions, 19.0% of overseas government (including EU) mentions, and 36% of charity mentions. Overseas government funders contributed the most funding for which grant amounts could be identified, namely £105,715,805 (46.3%). This was followed by the U.K. government who contributed £69,773,203 (30.5%) and charitable organisations who contributed £52,977,763 (23.2%) based on traceable grants that could be linked to amounts in publicly available grant databases. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. Table 2 provides an overview of individual funders for whom grant amounts were identified from publicly available databases, ranked based on the total number of mentions. Here, we have only displayed funders mentioned across more than 7 articles. The most frequently named funding body was the Wellcome Trust (107 (18.5%)), followed by the Jenner Institute (73 (12.7%)), the Medical Research Council (MRC) (66 (11.4%)) and the U.S. NIH (64 (11.4%)). The top three funders for which we could retrieve most grant amounts from publicly available databases to match them with funder mentions in the acknowledgement section were UKRI (72.2%), the European Commision (58.6%) and the Wellcome Trust (44.9%). . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; Funding based on Freedom of Information requests to the University of Oxford There were two datasets that the University of Oxford disclosed in response to our FOI requests, which related to pre-pandemic and pandemic grants towards ChAdOx R&D respectively. The first dataset includes all the grants that were received by S.G. and A.H since the year 2000, from which we extracted the grants relevant to the R&D of the ChAdOx technology based on the project numbers and grant names with a cut-off of January 2020. The second dataset is of grants received by the University of Oxford between January 2020 and October 2020 for the development of the Oxford-AstraZeneca vaccine. In total, the University of Oxford reported 189 grants, donations and payments to the university, 133 of which contributed to the development of the Oxford-AstraZeneca vaccine and the underlying ChAdOx technology ( . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; Since January 1, 2020, the largest funding source for pandemic R&D into ChAdOx for pandemic R&D into ChAdOx was the U.K. government which contributed £33,354,469 (95.5%). On or after this date, charitable funders (Wellcome Trust) accounted for £1,217,835 (3.5%), PPP, specifically CEPI, accounted for £272,286 (0.8%) and research institutions accounted for £68,106 (0.2%) of R&D funding for the Oxford-AstraZeneca vaccine. Taking pre-pandemic and pandemic R&D funding together, the U.K. government provided £38,865,785 (37.3%) of the R&D funding for the Oxford-AstraZeneca vaccine and ChAdOx technology, making it the largest funder type identified. Overseas government ranked the second highest funder type, providing £26,252,085 (25.2%%) of R&D funding for the Oxford-AstraZeneca vaccine and ChAdOx technology, while charitable funders contributed £22,686,739 (21.8%). Industry funders contributed £1,970,370 (1.9%). Overall, public funding sources accounted for 97.1% of the R&D funding towards the ChAdOx technology and its application to SARS-CoV-2, as disclosed by the University of Oxford per FOI. Direct government funding accounted for 62.5%, equalling a total of £65,117,870, whilst charitable sources accounted for £22,686,739 (21.8%). The PPPs CEPI and PATH malaria vaccine initiative accounted for 12.7% of R&D funding. Private industry contributed 1.9% of R&D funding, 1.2% was from other sources. The total amount of funding received for the Oxford-AstraZeneca vaccine and adenovirus technology, for each funder type, is given in the Total column. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; https://doi.org/10.1101/2021.04.08.21255103 doi: medRxiv preprint Together, the top 9 funders were responsible for 95.6% of the disclosed funding for the ChAdOx technology and the Oxford-AstraZeneca vaccine ( Table 4 ). The remaining ten funders contributed £4,574,803 (4.4%). Of the top funders identified, three were U.K. government funders, two E.U. funders, and three charities. Before January 1, 2020, the biggest funders of the R&D into the ChAdOx technology were the European Commission (22.6%), Wellcome Trust (14.7%) and CEPI (11.9%). Since January 1, 2020, the Department of Health and Social Care was the largest funder as declared by the University of Oxford contributing 89.3% of R&D funding. The University of Oxford disclosed that they had not received any funding for the Oxford-AstraZeneca vaccine in the period from January 1st 2020 to the 5th of February 2021 (Supplementary File 3) . . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. Due to insufficient identifiable information that could link the two datasets, we were not able to cross-match the funding reported in academic articles and the FOIs, which is a major limitation of our study. Furthermore, exact grant amounts were retrievable from publicly available information for only 21.0% of grants mentioned in academic publications on ChAdOx. Receiving funding information through FOIs was largely successful, making it a useful method for reconstructing funders of R&D at public research institutions. The restriction we faced was the maximum amount of 18 hours a public institution in the U.K. is legally required to spend collecting the data, limiting the scope of these requests. It is therefore likely that we missed further public funding received by other departments of the University of Oxford working on the clinical trials and manufacturing of the vaccine. For example, grants to research groups working on the manufacturing of ChAdOx, such as the one led by Dr. Alexander Douglas at the Nuffield Department of Medicine[19], were not included in the FOI. However, some of these grants are captured within the funding acknowledgement statements in peer-reviewed articles, which did cover other research groups at the University of Oxford as well. By applying a methodology that included data collection through two different mechanisms, this should have captured most of the R&D costs of the fundamental research into the ChAdOx technology conducted at the Jenner Institute. Finally, it was not possible to measure relevant non-monetary contributions to the ChAdOx R&D, such as the participation in clinical trials, most recently in South Africa and Brazil for the Oxford-AstraZeneca vaccine [20] . There is also circa £18m worth of funding in the . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; FOI regarding S.G and A.H that may be linked to the development of the vaccine, consisting of fellowship grants and general vaccine grants with descriptions too vague to attribute them to the development of ChAdOx specifically (listed in full in Supplementary File 4) . Beyond the funding captured in our study, the University of Oxford received at least £65.5 million from the U.K. Department of Business, Energy and Industrial Strategy for the development of the COVID-19 vaccine and the relevant clinical trials [21] . The UKRI database further listed two UKRI grants to the University of Oxford, worth £657,388 [22] . These were not identified in the scoping review or FOI as they were awarded for the scale-up of manufacturing process of the Oxford-AstraZeneca vaccine. Additionally, the U.S. government awarded US$125.6 million and over US$1.2 billion in funding to AstraZeneca for vaccine trials, manufacturing and distribution of vaccine doses to the U.S. government [23, 24] . A further 9 donations totalling £1.8-2.9 million (included in Supplementary File 4) were reported by the University of Oxford in their response to our FOI, 2 of which came from charitable sources, totalling £50,000-100,000. The remaining 7 donations were private or anonymous funders. All 9 donations were not integrated into the FOI dataset as exact amounts were not provided and donor names or amounts were missing for 44.4% of donations. The lack of transparency around the costs of R&D of novel health technologies is a prevailing issue, with large disparities in estimates reported [25] . Although there have been improvements in funding reporting in the past years, there are still major obstacles to investigating the funding of biomedical innovation based on disclosures made in the published scientific literature [26, 27] . Furthermore, the cumulative nature of scientific research makes it difficult to ascertain the R&D costs of previous innovation which may have enabled the development of the ChAdOx technology and the Oxford-AstraZeneca vaccine [28] . Of the grant mentions relevant to the R&D of ChAdOx identified through the scoping review, 79.0% could not be matched to an amount using searchable online grant databases. Attempting to match grants without award numbers was unreliable and inconsistent. Another issue was a lack of publicly available grant information, especially from the two main research institution funding bodies that contributed to the ChAdOx technology based on the funding acknowledgement statements, the Jenner Institute and The Oxford Martin School. Funding amounts from the private sector and PPPs were especially difficult to identify in this study as they often do not disclose their grants in publicly accessible databases. Initiatives to address the lack of transparency in R&D funding have been initiated, such as a World Health Assembly resolution [29] . However, the voluntary nature of such initiatives and opposition from the private sector and high-income governments limit efforts to increase R&D transparency [30] . Despite a lack of research funding transparency, our findings show the dominance of government and charity funding throughout the R&D process of the ChAdOx technology, which accelerated during the pandemic. Public funding has been especially critical for vaccine research, where the failure rate is as high as 94%, and has enabled the rapid development of many COVID-19 vaccines [13, 31] . Prior to the pandemic, the WHO identified emerging infectious diseases requiring urgent R&D efforts [32] . Their Blueprint for Action to Prevent Epidemics listed diseases on which the ChAdOx technology has been studied, including Nipah, . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 10, 2021. ; MERS, and Ebola [8, 33, 34] . In addition to government and charitable funders, PPPs are growing global health actors prominent in R&D efforts for diseases endemic to lower-income populations, for which a funding gap prevails [35, 36] . Launched in 2017 as an innovative partnership between public, private, philanthropic, and civil organisations, CEPI's mission is accelerating vaccine development to address pathogens of pandemic potential, whereas the PATH malaria vaccine initiative was created to develop malaria vaccines [37] . Since the PPPs that contributed to ChAdOx were largely supported by public funding, we categorised them as public in our study [38] [39] [40] . To recognise the public contributions and risk-taking in the R&D of the ChAdOx technology on which the Oxford-AstraZeneca vaccine relies, the benefits of this research should be shared fairly and equitably with the global population [41] . In response to the pandemic, Oxford University Innovation, a subsidiary of the University of Oxford managing the university's technology transfer, published a statement outlining the university's default approach for the licensing of COVID-19 related intellectual property to third parties [42] . In this statement, the university committed to non-exclusive, royalty-free licensing and price-setting at-cost or cost plus small a profit margin for the duration of the pandemic. Despite these commitments, the university chose to enter an exclusive licensing agreement with the British-Swedish pharmaceutical company AstraZeneca for the COVID-19 vaccine [43] . As of March 2021, the University of Oxford has not made the licensing agreement publicly available, however, the university has expressed the intention to publish a redacted version [44] . While AstraZeneca pledged to sell the vaccine globally at no profit during the pandemic, the price of the vaccine reportedly includes a profit margin of 20% on top of the production cost [45, 46] . The Oxford-AstraZeneca vaccine is offered at the lowest price of $5 per course, making it one of the most affordable vaccines available for COVID-19 [4] . Vaccine prices paid by countries are kept confidential, yet discrepancies in pricing have been reported with lower income countries seemingly paying more than higher income countries [47] . AstraZeneca has, in collaboration with the Serum Institute of India, committed a large number of vaccine doses to the COVAX facility [48] . However, the Oxford-AstraZeneca vaccine is facing global supply issues following manufacturing delays and export disputes [49, 50] . Global equitable access is further hindered by bilateral purchasing agreements made between AstraZeneca and countries outside of COVAX [51] . Given that the Oxford-AstraZeneca vaccine price is determined by the pandemic status and SARS-CoV-2 will likely become an endemic virus requiring repeated vaccinations, affordability of the vaccine post-pandemic remains a concern[52]. While the Oxford-AstraZeneca vaccine has been licensed exclusively to AstraZeneca, the type and any conditions included in the licenses of the ChAdOx vaccine platform patents to the University of Oxford's spin out company, Vaccitech, remain unknown [53] . As the ChAdOx vaccine platform is potentially applicable to many more global health challenges, including emerging infectious diseases and pathogens of pandemic potential other than SARS-CoV-2, its mode of technology transfer is of global public health relevance with potential impact for global equitable access and affordability. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 10, 2021. ; https://doi.org/10.1101/2021.04.08.21255103 doi: medRxiv preprint Approximating the funding of ChAdOx offers a relevant and timely case study to understand wider trends in R&D taking place at universities and the importance of transparency in funding reporting. We found that government and charitable funders provided the majority of funding to the University of Oxford towards the R&D of the Oxford-AstraZeneca vaccine and the underlying ChAdOx technology, which may have significant implications for the global discourse around vaccine nationalism and COVID-19 health technology access. Understanding who contributed to the development of ChAdOx is of importance to other global health challenges as well, considering that the vaccine platform may be used for multiple applications beyond SARS-CoV-2, offering an opportunity to rapidly and equitably develop affordable solutions to other existing and emerging infectious disease threats. However, a lack of transparency of funding reporting mechanisms hinders the discourse surrounding public and private contributions towards R&D and the cost of R&D. We therefore urge medical journal editors and research funders to further improve their funding reporting mechanisms by publishing funding and grant information more widely in a publicly accessible manner. Medicines & Healthcare products Regulatory Agency. 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BBC 2021 EU moves toward six-week vaccine export cut The unequal scramble for coronavirus vaccines -by the numbers The authors wish to thank Molly Pugh-Jones for filing one of the FOI requests to the University of Oxford and Manuel Martin for his comments on an earlier version of the manuscript. S.K. and S.W. conceived of the study. F.R. and S.K. devised the methodology. F.R. made the search strategy. S.K. filed the FOI requests and managed communication with the University of Oxford. F.R. and S.K. screened all articles. S.C. and H.R. extracted the data from the articles. Y.R. searched grant databases using award numbers. S.C. and Y.R. classified all the grants from the FOI. T.P. contributed to the data management. S.C. and S.K. wrote up the methods and results. S.W., S.C., S.K., R.O., A.E. and R.B. wrote the first draft of the manuscript. All authors contributed to and edited the final manuscript. Funding statement: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.