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Policy Brief 002 Update 06.2021

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Policy Brief 002 Update 06.2021 Content ................................................................................................................................................................ 3 1 Background: policy questi on and met hods ................................................................................................. 7 1.1 Policy Question ............................................................................................................................................. 7 1.2 Methodology ................................................................................................................................................. 7 1.3 Selection of Products for “Vignettes” ........................................................................................................ 10 2 Results: Vacci nes ......................................................................................................................................... 13 2.1 Moderna Therapeutics—US National Institute of Allergy ..................................................................... 24 2.2 University of Oxford/ Astra Zeneca .......................................................................................................... 24 2.3 BioNTech/Fosun Pharma/Pfizer .............................................................................................................. 25 2.4 Janssen Pharmaceutical/ Johnson & Johnson .......................................................................................... 27 2.5 Novavax ....................................................................................................................................................... 28 2.6 CureVac ....................................................................................................................................................... 30 2.7 Sanofi and GSK .......................................................................................................................................... 31 2.8 Valneva ........................................................................................................................................................ 33 2.9 Sinovac Life Science Co., Ltd .................................................................................................................... 33 3 Results: Therapeutics ................................................................................................................................. 35 3.1 Remdesivir (Veklury®) .............................................................................................................................. 42 3.2 Lopinavir + Ritonavir (Kaletra®) ............................................................................................................ 42 3.3 Favipiravir (Avigan®) ................................................................................................................................ 42 3.4 Darunavir .................................................................................................................................................... 52 3.5 Chloroquine (Resochin®) and .................................................................................................................. 54 3.6 Hydroxychloroquine (Plaquenil®) ........................................................................................................... 54 3.7 Camostat Mesilate (Foipan®) ................................................................................................................... 54 3.8 APN01/ Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) ...................................... 55 3.9 Tocilizumab (Roactemra®) ....................................................................................................................... 56 3.10 Sarilumab (Kevzara®) ............................................................................................................................... 56 3.11 Interferon beta 1a (SNG001) (Rebif®, Avonex®) and Interferon beta 1b (Betaferon®, Extavia®) .................................................................................................................................................... 60 3.12 Convalescent plasma transfusion .............................................................................................................. 64 3.13 Plasma derived medicinal products .......................................................................................................... 72 3.13.1 REGN-COV2 - combination of two monoclonal antibodies (REGN10933 and REGN10987) ........................................................................................................................................... 72 3.13.2 LY-CoV555 - neutralizing IgG1 monoclonal antibody (bamlanivimab) and LY-CoV016 - recombinant fully human monoclonal neutralizing antibody (etesevimab) ................................... 76 3.13.3 AZD7442 - combination of two monoclonal antibodies (AZD8895 + AZD1061) .......................... 87 3.13.4 Sotrovimab (VIR-7831 monoclonal antibody) ..................................................................................... 87 3.13.5 Regdanvimab (CT-P59) .......................................................................................................................... 90 3.14 Combination therapy – triple combination of interferon beta-1b, lopinavir–ritonavir and ribavirin vs. lopinavir–ritonavir or other triple combination of interferons ......................................... 91 3.15 Solnatide ...................................................................................................................................................... 91 3.16 Umifenovir (Arbidol®) .............................................................................................................................. 92 3.17 Dexamethasone and other corticosteroids ................................................................................................ 96 3.17.1 Inhaled corticosteroids: Budesonide ..................................................................................................... 96 3.18 Anakinra (Kineret®) .................................................................................................................................. 98 3.19 Colchicine ................................................................................................................................................. 101 3.20 Nafamostat (Futhan©) ............................................................................................................................. 106 3.21 Gimsilumab ............................................................................................................................................... 106 3.22 Canakinumab ............................................................................................................................................ 106 3.23 Lenzilumab ............................................................................................................................................... 107 3.24 Vitamin D .................................................................................................................................................. 108 3.25 Olumiant (Baricitinib) ............................................................................................................................. 112 3.26 Molnupiravir ............................................................................................................................................. 116 3.27 Ivermectin ................................................................................................................................................. 117 3.28 Aspirin (acetylsalicylic acid).................................................................................................................... 122 3.29 ZYESAMI™ (Aviptadil, RLF-100) .......................................................................................................... 124 3.30 Dimethyl fumarate ................................................................................................................................... 126 3.31 Artesunate ................................................................................................................................................. 126 References ........................................................................................................................................................ 128 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 .................................................. 19 Table 2-2: SARS-CoV-2 variants of concern in EU and vaccines contracted or exploratory talks have concluded for EU, and some vaccines not contracted
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