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FACTBOX-U.S. pours billions into development of coronavirus vaccines, tests

 (Updates with BARDA investment in Novavax vaccine, new grants to Regeneron's and AstraZeneca's therapies, updates development stage for AstraZeneca vaccine and
diagnostics table)
    July 7 (Reuters) - As drugmakers race to develop vaccines, tests and therapies for the novel coronavirus, the United States is rushing to secure access to
them by providing funding.
    The Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology, awarded Novavax Inc
$1.6 billion to cover testing, commercialization and manufacturing of a potential coronavirus vaccine in the United States - the biggest yet grant from "Operation
Warp Speed," the White House program aimed at accelerating access to vaccines and treatments for the new coronavirus.
    BARDA has invested more than $3 billion in vaccines and funded more than 30 projects, including for diagnostics and treatments. The agency has awarded grants
to Moderna, the first in the United States to begin human trials of a coronavirus vaccine, Sanofi, the world's largest vaccine maker, and Johnson & Johnson
.  
    The following tables list publicly disclosed BARDA funding over $1 mln to date:
    
 VACCINES           
 Company                       BARDA Funding         Vaccine type                            Stage of development
 AstraZeneca Plc               up to $1.2 bln        AZD1222 was developed by the            Mid-stage trials underway
                                                     University of Oxford and licensed to    
                                                     AstraZeneca                             
 Moderna Plc                   $486 mln              mRNA-1273 - uses synthetic messenger    Vaccine produced positive results in 45-subject
                                                     RNA (mRNA) to inoculate against the     safety trial; late-stage trial to start in July 
                                                     coronavirus                             
 Johnson & Johnson             $456.2 mln            Viral Vector Vaccine for COVID-19 -     Will begin human testing in September, with an eye
                                                     uses pharma unit Janssen Research's     toward having a vaccine ready under an emergency use
                                                     established Adenovirus 26 platform      authorization in early 2021
 Sanofi SA                     $30.7 mln             Recombinant SARS-CoV-2 Protein Vaccine  Plans to enroll 1000s of subjects globally for
                                                     -  Based on co's FDA-licensed seasonal  early-stage trials for the vaccine it is developing
                                                     influenza vaccine Flublok               with GlaxoSmithKline Plc        
 Merck & Co Inc                $38 mln               Recombinant COVID-19 vaccine - Based    Human trials for vaccine, being developed jointly
                                                     on same technology used in co's Ebola   with research nonprofit IAVI, expected sometime this
                                                     vaccine ERVEBO                          year
 Novavax Inc                   $1.6 bln              Works with an adjuvant - a substance    Mid-stage trials to begin in August or September,
                                                     that boosts immune response to help     late-stage in October. Grant covers testing,
                                                     body build a robust defense against     commercialization and manufacturing of vaccine in
                                                     the virus                               U.S., with aim of delivering 100 mln doses by January
 *Sanofi is also working with U.S.-based Translate Bio Inc on another vaccine candidate based on messenger RNA technology (mRNA). This vaccine has not
received funding from BARDA.
    
THERAPIES
 Company                        BARDA Funding          Therapy type                                           Stage of development
 Grifols Shared Services North  $12.5 mln              Treatment based on plasma donated by patients who      Company collecting plasma samples. Human studies yet
 America                                               have recovered from COVID-19; plasma contains          to begin
                                                       antibodies that can target the virus                   
 Emergent Biosolutions          $14.5 mln              Treatment based on plasma from recovered COVID-19      Planning clinical trials 
                                                       patients                                               
 SAb Biotherapeutics            $7.2 mln               Immunotherapy that uses SAb's technology to produce    Human trials have not started. Company says it has
                                                       COVID-19 antibodies without blood donations from       finished preclinical studies 
                                                       recovered people                                       
 Genentech USA                  $25.1 mln              Repurposing its rheumatoid arthritis therapy,          Regulatory nod for late-stage clinical trial to
                                                       Actemra(tocilizumab), to help control                  study efficacy along with standard of care in
                                                       COVID-19-associated inflammation that could cause      hospitalized adult patients with severe COVID-19
                                                       respiratory failure                                    pneumonia
 Regeneron Pharmaceuticals      $16.3 mln, $82 mln     Testing Kevzara, developed with Sanofi           and   U.S.-based trial stopped as Kevzara did not show
                                                       approved for rheumatoid arthritis, to see if it can    results in patients with severe COVID-19, expects to
                                                       reduce symptoms of inflammation in hospitalized        report results of Kevzara trial outside U.S. in Q3
                                                       people with COVID-19                                   2020 SARS-CoV-2 specific monoclonal antibodies - A          Antibody being tested for preventing and treating
                                $450 mln               therapeutic antibody cocktail using Regeneron's        COVID-19, late-stage prevention trial run jointly
                                                       discovery platform VelocImmune                         with National Institutes of Health $450 mln contract to cover manufacture and supply of a fixed number of bulk lots of the antibody cocktail, to be completed in fall of 2020
 Johnson & Johnson              $152 mln               Janssen Research & Development and Rega Institute of   No development details available
                                                       Medical Research to screen libraries to identify       
                                                       therapeutic compounds with antiviral activity against  
                                                       COVID-19.                                              
 AstraZeneca                    $23.6 mln              Novel monoclonal antibody combination that recognizes  Grant supports company’s efforts to develop the
                                                       and neutralizes SARS-CoV-2                             treatment, including early clinical trial and manufacturing of investigational product for testing
 
    DIAGNOSTICS
    
 Company                         BARDA funding        Type of test                               Stage of development
 Hologic Inc                     $13 mln              Aptima SARS-CoV-2 assay and Panther        Emergency Use Authorization issued
                                                      Fusion SARS-CoV-2 assay - use respiratory  
                                                      specimens to detect SARS-CoV-2; both can   
                                                      process 1,000 tests in 24 hours and        
                                                      deliver test results in 3 hours            
 Cue Inc                         $13.6 mln            A portable test that can detect            Emergency Use Authorization issued
                                                      SARS-CoV-2 in less than 25 minutes using   
                                                      a simple nasal swab                        
 Cepheid, a unit of Danaher      $3.7 mln;            A rapid, point-of-care test that detects   Emergency Use Authorization issued
 Corp                            Additional funding   virus in nasal swab samples within 45      
                                 planned as the       minutes and is designed for use in         
                                 program progresses   clinical and hospital laboratories         
 There are 24 other diagnostics-makers, including GenMark Diagnostics and Luminex Corporation, who have received grants under $1 million from
BARDA.
    
Source: BARDA website (bit.ly/2z9CMDr), U.S. FDA as well as company press releases

 (Reporting By Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Ankur Banerjee, Sriraj Kalluvila and Aditya Soni)
  
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