July 22, 2020 / 5:16 PM / 15 days ago

FACTBOX-U.S. pours billions into securing access to coronavirus vaccine candidates

 (Adds GlaxoSmithKline)
    July 31 (Reuters) - As drugmakers race to develop vaccines and therapies for the novel coronavirus, the United States is rushing to secure access to them.
    The U.S. government has agreed to invest more than $7 billion in vaccines and has funded more than 30 projects, including for diagnostics and treatments. It is giving
$2.1 billion to Sanofi SA and GlaxoSmithKline Plc for COVID-19 vaccines to cover 50 million people.
    The award is the biggest from "Operation Warp Speed," the White House initiative aimed at accelerating access to vaccines and treatments to fight COVID-19. 
    The following tables list publicly disclosed funding of over $1 million from BARDA, a U.S. federal agency that funds disease-fighting technology:
    
 VACCINES           
 Company                    BARDA Funding     Vaccine type                                        Stage of development
 GlaxoSmithKline Plc        $2.1 billion      Combination of a vaccine based on Sanofi's flu      Plans to enroll 1.000s of subjects globally for early-stage trials for
         and Sanofi SA                        shots and a complementary technology from GSK       the vaccine. Aims to start clinical trials in September.
                                              called an adjuvant, designed to improve the         
                                              vaccine's potency                                   
 Pfizer Inc         and     $1.95 bln         Uses the so-called messenger RNA approach that      Large study has begun, companies expect some form of regulatory
 BioNTech SE                                  sets off an immune response to target the virus     approval as early as October and aim to make up to 100 million doses by
                                                                                                  end of 2020 and potentially more than 1.2 billion doses by end of 2021
 Novavax Inc                $1.6 bln          Works with an adjuvant - a substance that boosts    Mid-stage trials to begin in August or September, late-stage in
                                              immune response to help body build a robust         October. Grant covers testing, commercialization and manufacturing of
                                              defense against the virus                           vaccine in U.S., with aim of delivering 100 mln doses by January 
 AstraZeneca Plc            up to $1.2 bln    AZD1222 was developed by the University of Oxford   Large, late-stage trials underway
                                              and licensed to AstraZeneca                         
 Moderna Plc                about $955 mln    mRNA-1273 - uses synthetic messenger RNA (mRNA) to  Vaccine produced positive results in 45-subject safety trial;
                                              inoculate against the coronavirus                   late-stage trial to start in July 
 Johnson & Johnson          $456.2 mln        Viral Vector Vaccine for COVID-19 - uses pharma     Kicked off human study, late-stage study planned for September
                                              unit Janssen Research's established Adenovirus 26   
                                              platform                                            
 Merck & Co Inc             $38 mln           Recombinant COVID-19 vaccine - Based on same        Human trials for vaccine, being developed jointly with research
                                              technology used in co's Ebola vaccine ERVEBO        nonprofit IAVI, expected sometime this year
 *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
 Regeneron Pharmaceuticals  $85 mln and      SARS-CoV-2 specific monoclonal antibodies - A       Antibody being tested for preventing and treating COVID-19, late-stage
                            $450 mln         therapeutic antibody cocktail using Regeneron's     prevention trial run jointly with National Institutes of Health 
                                             discovery platform VelocImmune                      
                                                                                                 $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   No development details available
                                             of Medical Research to screen libraries to          
                                             identify therapeutic compounds with antiviral       
                                             activity against COVID-19.                          
 Genentech USA              $25.1 mln        Repurposing its rheumatoid arthritis therapy,       Regulatory nod for late-stage clinical trial to study efficacy along with
                                             Actemra(tocilizumab), to help control               standard of care in hospitalized adult patients with severe COVID-19
                                             COVID-19-associated inflammation that could cause   pneumonia
                                             respiratory failure                                 
 AstraZeneca                $23.6 mln        Novel monoclonal antibody combination that          Grant supports company’s efforts to develop the treatment, including
                                             recognizes and neutralizes SARS-CoV-2               early clinical trial and manufacturing of investigational product for
                                                                                                 testing 
 Emergent Biosolutions      $14.5 mln        Treatment based on plasma from recovered COVID-19   Planning clinical trials 
                                             patients                                            
 Grifols Shared Services    $12.5 mln        Treatment based on plasma donated by patients who   Company collecting plasma samples. Human studies yet to begin
 North America                               have recovered from COVID-19; plasma contains       
                                             antibodies that can target the virus                
 SAb Biotherapeutics        $7.2 mln         Immunotherapy that uses SAb's technology to         Human trials have not started. Company says it has finished preclinical
                                             produce COVID-19 antibodies without blood           studies 
                                             donations from recovered people                     
 
Source: BARDA website (bit.ly/2z9CMDr), U.S. FDA as well as company press releases

 (Reporting By Dania Nadeem Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Ankur Banerjee, Sriraj Kalluvila and Anil D'Silva)
  
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