Policy Brief 002 Update 04.2021.Pdf

Policy Brief 002 Update 04.2021.Pdf

.................................................................................................................................................................. 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 ..................................................................... 22 2.2 University of Oxford/ Astra Zeneca .......................................................................................................... 23 2.3 BioNTech/Fosun Pharma/Pfizer .............................................................................................................. 25 2.4 Janssen Pharmaceutical/ Johnson & Johnson .......................................................................................... 27 2.5 Novavax ....................................................................................................................................................... 27 2.6 CureVac ....................................................................................................................................................... 29 2.7 Sanofi and GSK .......................................................................................................................................... 30 2.8 Valneva ........................................................................................................................................................ 31 3 Results: Therapeutics ................................................................................................................................. 33 3.1 Remdesivir (Veklury®) .............................................................................................................................. 40 3.2 Lopinavir + Ritonavir (Kaletra®) ............................................................................................................ 49 3.3 Favipiravir (Avigan®) ................................................................................................................................ 49 3.4 Darunavir .................................................................................................................................................... 58 3.5 Chloroquine (Resochin®) and .................................................................................................................. 60 3.6 Hydroxychloroquine (Plaquenil®) ........................................................................................................... 60 3.7 Camostat Mesilate (Foipan®) ................................................................................................................... 60 3.8 APN01/ Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) ...................................... 61 3.9 Tocilizumab (Roactemra®) ....................................................................................................................... 61 3.10 Sarilumab (Kevzara®) ............................................................................................................................... 68 3.11 Interferon beta 1a (SNG001) (Rebif®, Avonex®) and Interferon beta 1b (Betaferon®, Extavia®) .................................................................................................................................................... 71 3.12 Convalescent plasma transfusion .............................................................................................................. 75 3.13 Plasma derived medicinal products .......................................................................................................... 81 3.13.1 REGN-COV2 - combination of two monoclonal antibodies (REGN10933 and REGN10987) ........................................................................................................................................... 81 3.13.2 LY-CoV555 - neutralizing IgG1 monoclonal antibody (bamlanivimab) and LY-CoV016 - recombinant fully human monoclonal neutralizing antibody (etesevimab) ................................... 85 3.13.3 AZD7442 - combination of two monoclonal antibodies (AZD8895 + AZD1061) .......................... 96 3.13.4 VIR-7831 monoclonal antibody ............................................................................................................. 96 3.13.5 Regdanvimab (CT-P59) .......................................................................................................................... 98 3.14 Combination therapy – triple combination of interferon beta-1b, lopinavir–ritonavir and ribavirin vs. lopinavir–ritonavir or other triple combination of interferons ......................................... 98 3.15 Solnatide .................................................................................................................................................... 104 3.16 Umifenovir (Arbidol®) ............................................................................................................................ 105 3.17 Dexamethasone and other corticosteroids .............................................................................................. 109 3.17.1 Inhaled corticosteroids: Budesonide ................................................................................................... 115 3.18 Anakinra (Kineret®) ................................................................................................................................ 116 3.19 Colchicine ................................................................................................................................................. 119 3.20 Nafamostat (Futhan©) ............................................................................................................................. 122 3.21 Gimsilumab ............................................................................................................................................... 122 3.22 Canakinumab ............................................................................................................................................ 123 3.23 Lenzilumab ............................................................................................................................................... 123 3.24 Vitamin D .................................................................................................................................................. 124 3.25 Baricitinib ................................................................................................................................................. 128 3.26 Molnupiravir ............................................................................................................................................. 131 3.27 Ivermectin ................................................................................................................................................. 132 3.28 Aspirin (acetylsalicylic acid).................................................................................................................... 137 3.29 Aviptadil (RLF-100) ................................................................................................................................. 138 References ........................................................................................................................................................ 140 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 in the R&D pipeline (Phase 1 - Phase 3 clinical trials, not preclinical stages), April 9, 2021 ............................................................................................................................ 18 Table 2-2: SARS-CoV-2 variants and vaccines contracted or exploratory talks have concluded for EU, and some vaccines not contracted nor exploratory talks have concluded for EU: clinical effectiveness and in-vitro neutralisation ...................................................................................................... 19 Table 2-3: COVID-19 Vaccines in development in children .................................................................................. 20 Table 2-4: Intranasal vaccine in development ........................................................................................................

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