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Policy Brief 002 Update 07.2021

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Policy Brief 002 Update 07.2021 Content ................................................................................................................................................................ 3 1 Background: policy question and methods ................................................................................................. 7 1.1 Policy Question ............................................................................................................................................. 7 1.2 Methodology ................................................................................................................................................. 7 1.3 Selection of Products for “Vignettes” ........................................................................................................ 10 2 Results: Vaccines ......................................................................................................................................... 13 2.1 Moderna Therapeutics—US National Institute of Allergy ..................................................................... 25 2.2 University of Oxford/ Astra Zeneca .......................................................................................................... 26 2.3 BioNTech/Fosun Pharma/Pfizer .............................................................................................................. 27 2.4 Janssen Pharmaceutical/ Johnson & Johnson .......................................................................................... 29 2.5 Novavax ....................................................................................................................................................... 30 2.6 CureVac ....................................................................................................................................................... 32 2.7 Sanofi and GSK .......................................................................................................................................... 34 2.8 Valneva ........................................................................................................................................................ 35 2.9 Sinovac Life Science Co., Ltd .................................................................................................................... 36 3 Results: Therapeutics ................................................................................................................................. 39 3.1 Remdesivir (Veklury®) .............................................................................................................................. 46 3.2 Lopinavir + Ritonavir (Kaletra®) ............................................................................................................ 46 3.3 Favipiravir (Avigan®) ................................................................................................................................ 46 3.4 Darunavir .................................................................................................................................................... 46 3.5 Chloroquine (Resochin®) and .................................................................................................................. 47 3.6 Hydroxychloroquine (Plaquenil®) ........................................................................................................... 47 3.7 Camostat Mesilate (Foipan®) ................................................................................................................... 47 3.8 APN01/ Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) ...................................... 48 3.9 Tocilizumab (Roactemra®) ....................................................................................................................... 49 3.10 Sarilumab (Kevzara®) ............................................................................................................................... 49 3.11 Interferon beta 1a (SNG001) (Rebif®, Avonex®) and Interferon beta 1b (Betaferon®, Extavia®) .................................................................................................................................................... 55 3.12 Convalescent plasma transfusion .............................................................................................................. 59 3.13 Plasma derived medicinal products .......................................................................................................... 63 3.13.1 REGN-COV2 - combination of two monoclonal antibodies (REGN10933 and REGN10987) ........................................................................................................................................... 63 3.13.2 LY-CoV555 - neutralizing IgG1 monoclonal antibody (bamlanivimab) and LY-CoV016 - recombinant fully human monoclonal neutralizing antibody (etesevimab) ................................... 69 3.13.3 AZD7442 - combination of two monoclonal antibodies (AZD8895 + AZD1061) .......................... 81 3.13.4 Sotrovimab (VIR-7831 monoclonal antibody) ..................................................................................... 81 3.13.5 Regdanvimab (CT-P59) .......................................................................................................................... 83 3.14 Combination therapy – triple combination of interferon beta-1b, lopinavir–ritonavir and ribavirin vs. lopinavir–ritonavir or other triple combination of interferons ......................................... 84 3.15 Solnatide ...................................................................................................................................................... 85 3.16 Umifenovir (Arbidol®) .............................................................................................................................. 86 3.17 Dexamethasone and other corticosteroids ................................................................................................ 90 3.17.1 Inhaled corticosteroids: Budesonide ..................................................................................................... 90 3.18 Anakinra (Kineret®) .................................................................................................................................. 93 3.19 Colchicine ................................................................................................................................................... 97 3.20 Nafamostat (Futhan©) ............................................................................................................................... 97 3.21 Gimsilumab ................................................................................................................................................. 98 3.22 Canakinumab .............................................................................................................................................. 98 3.23 Lenzilumab ................................................................................................................................................. 99 3.24 Vitamin D .................................................................................................................................................. 100 3.25 Olumiant (Baricitinib) ............................................................................................................................. 104 3.26 Molnupiravir ............................................................................................................................................. 108 3.27 Ivermectin ................................................................................................................................................. 109 3.28 Aspirin (acetylsalicylic acid).................................................................................................................... 114 3.29 ZYESAMI™ (Aviptadil, RLF-100) .......................................................................................................... 118 3.30 Dimethyl fumarate ................................................................................................................................... 119 3.31 Artesunate ................................................................................................................................................. 119 3.32 Tofacitinib (Xeljanz) ............................................................................................................................... 120 References ........................................................................................................................................................ 123 Figure 1.2-1: A living mapping of ongoing randomized trials, living systematic reviews with pairwise meta-analyses and network meta-analyses .................................................................... 9 Figure 1.2-2: Global Coronavirus COVID-19 Clinical Trial Tracker - a real-time dashboard of clinical trials for COVID-19 ........................................................................................................ 10 Table 1.2-1: International Sources .............................................................................................................................. 8 Table 2-1: Vaccines contracted or exploratory talks have concluded for EU, in the R&D pipeline (Phase 1 - Phase 4 clinical trials, not preclinical stages), April 9, 2021 .................................................
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