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ObjectivesThe 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. DesignWe 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. ResultsWe 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 {pound}104,226,076 reported in the FOIs, and {pound}228,466,771 reconstructed from the literature search. ConclusionsOur 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. Strengths and limitations of this studyO_LIThis is the first study that analysed the R&D funding and funders contributing to the Oxford-AstraZeneca vaccine and the underlying ChAdOx technology. C_LIO_LIWe used multiple sources and methods to approximate the R&D funding of the Oxford-AstraZeneca Vaccine and ChAdOx technology. C_LIO_LIWe cross-matched award numbers with all publicly-accessible databases by major funders of R&D. C_LIO_LIFreedom Of Information requests were a useful method to identify R&D funding, but face limitations in their scope of data collection. C_LIO_LIIntegration 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. C_LI
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BackgroundSeveral drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in safety data by quantifying the number of missing clinical trial results for drugs potentially being repurposed for COVID-19 by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications. MethodsClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. ResultsOf 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. 1172 (31.2%) completed trials had tabular results on ClinicalTrials.gov. A further 1066 (28.4%) completed trials had results from the literature search, but did not report results on ClinicalTrials.gov. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). ConclusionsThere is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause a large burden of additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.
