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FACTBOX-Development of AstraZeneca's potential coronavirus vaccine

    * For a separate FACTBOX on other vaccines, click

 (Adds Switzerland supply deal in table 4)
    Oct 16(Reuters) - AstraZeneca's experimental COVID-19 vaccine is one of
the most advanced candidates in the race against the novel coronavirus. 
    The British drugmaker has signed several supply and manufacturing deals with
companies and governments around the world as it gets closer to reporting early
results of a late-stage clinical trial.
    Developed by the University of Oxford and licensed to AstraZeneca in April, the
vaccine is expected to be one of the first from big pharma to secure regulatory
approval, along with Pfizer and BioNTech's candidate.
    Although drugmakers and researchers are also working on various treatments,
vaccines are at the heart of the long-term fight to stop the virus, which has killed
more than a million people, infected more than 38 million and crippled the global
economy. 
    Below are the main details of the British vaccine.
    
    TYPE
    * Called AZD1222 or ChAdOx1 nCoV-19, the vaccine is a recombinant viral vector
vaccine.
    * It uses a weakened version of a chimpanzee common cold virus that encodes
instructions for making proteins from the novel coronavirus to generate an immune
response and prevent infection. 

    DOSAGE AND PROTECTION DURATION
    * AstraZeneca and Oxford University have said a two-dose regimen showed greater
promise, while a single-dose injection is also being tested in trials.
    * The vaccine is likely to provide protection for about a year, CEO Pascal Soriot
said
in June.

    EXPECTED COST/PRICING

    * In the first indication of pricing, Italy's health ministry said in June an
AZD1222
vaccine would cost about 2.5 euros ($2.8) per dose in Europe.
    * AstraZeneca said in July it will be able to manufacture the vaccine at a few
dollars
per dose.
    * Pricing in Latin America, while still not final, is not expected to exceed $4
per
dose, AstraZeneca's Mexico head said in August.
    * The Serum Institute of India said in August it would price the vaccine at $3
per dose
for India and other emerging economies.
    * Costs in other regions have not been disclosed so far.
    * AstraZeneca has said it would not profit from the vaccine during the pandemic,
but a
report from the Financial Times in October showed the company can declare when it
considers the pandemic to have ended in its deals for the vaccine.    

    
    TESTING
    * AstraZeneca had to pause global trials on Sept. 6 after an unexplained illness
in a
participant.
    * Most trials have since resumed, although the United States has widened its
investigation. President Donald Trump is pushing for a vaccine to be fast-tracked
before November's presidential elections.
    * AstraZeneca's CEO said in July that good data had come in on the vaccine, after
early-stage trials showed it was safe and produced an immune response.
 

    
    GLOBAL TRIALS
    
    (In alphabetical order of geographies)    
       
 REGION        STAGE OF      STATUS       VOLUNTEERS           EXPECTED COMPLETION
               DEVELOPMENT                                     
 Brazil        Phase III     Ongoing,     5,000 estimated,     Sept. 2021 (bit.ly/2GAeB4K)
                             restarted    with participants    
                             after pause  aged 18 years and    
                             in           older                
                             September                         
 India         Phase II/III  Ongoing,     1,600 estimated,     In seven months
                             restarted    with participants    from August (bit.ly/3nAwXTC)
                             after pause  aged 18 years and    
                             in           older                
                             September                         
 Japan         Phase I/II    Ongoing,     12 estimated, with   Sept. 2021 (bit.ly/3nAnImj)
                             restarted    participants aged    
                             after pause  18 years and older   
                             in                                
                             September                         
 Russia        Phase III     On hold,     100 estimated, with  March 2021 (bit.ly/36NKpxr)
                             paused in    participants aged    
                             September    18 years and older   
 South Africa  Phase I/II    Ongoing,     2000 estimated,      Dec. 2021 (bit.ly/2Gy8mhS)
                             restarted    with 1,950           
                             after pause  HIV-uninfected       
                             in           adults and 50        
                             September    people living with   
                                          HIV                  
 UK            Phase II/III  Ongoing,     12,330 estimated,    Aug. 2021 (bit.ly/34EOHVj)
                             restarted    with participants    
                             after pause  aged 5 years and     
                             in           older                
                             September                         
 U.S.          Phase III     On hold,     30,000 estimated,    Oct. 2022 (bit.ly/30O4XCl)
                             paused in    with participants    
                             September    aged 18 years and    
                                          older                
 
    
    
    DATA AND REGULATORY TIMELINE    
    * The lead developer said in July the vaccine could be rolled out by year-end,
but
there has been some uncertainty over the timeline since trials were
paused.
    * Experts have predicted a safe and effective vaccine could take 12-18 months to
develop.
    * A scientist leading the studies in August said data could be given to
regulators this
year.
    * Data from early-stage trials was published in The Lancet medical journal in
July.

    * Data from late-stage studies was expected around September, but is now
anticipated to
come in the next few weeks.
    * Delivery of the first doses was expected between September and October to
Americans
and Britons, as per the deals signed by AstraZeneca.

    
    
    REGULATORY REVIEWS    
    (Most recent first)    
    
 REGION/REGULATOR  SUBMISSION/R  STATUS               FORMAL         FURTHER
                   EVIEW                              APPLICATION    
 Canada/Health     Rolling       Launched in Oct      Not submitted              
 Canada            submission                                        
 Europe/European   Rolling       Launched in Oct      Not submitted              
 Medicines Agency  review                                            
        
    
    TARGET DOSES/GLOBAL CAPACITY
    * More than 3 billion doses.   

    
    
    TIE-UPS 
    * AstraZeneca has already signed more than a dozen deals to supply the vaccine
and a
similar number of manufacturing agreements. It has also joined with IQVIA to
speed up testing.
    * AstraZeneca has been granted protection from future liability claims related to
the
vaccine by most of the countries with which it has struck supply agreements, a senior
executive told Reuters in July.

    
    
    MANUFACTURING DEALS  
    
    (Most recent first)    

 FIRM          BASED IN      DEAL VALUE   FOR                   FURTHER
 Siam          Thailand      Undisclosed  Manufacture and                   
 Bioscience,                              supply the vaccine    
 SCG                                      in Thailand and       
                                          other nations in      
                                          southeast Asia        
 Albany        U.S.          Undisclosed  Produce millions of               
 Molecular                                doses through         
 Research                                 sterile finishing     
                                          services at its       
                                          manufacturing plant   
                                          in Albuquerque, New   
                                          Mexico                
 Oxford        UK            15 million   Unknown doses for                 
 Biomedica                   pounds to    large-scale           
                             reserve      commercial            
                             manufacturi  manufacture under     
                             ng           expanded deal         
                             capacity,                          
                             further 35                         
                             million                            
                             pounds plus                        
                             costs                              
                             payable in                         
                             certain                            
                             situations                         
 Catalent      U.S.          Undisclosed  Making the drug                   
                                          substance used in     
                                          the vaccine at its    
                                          Maryland facility.    
                                          AZ's second deal      
                                          with firm             
 Foundation    Mexico        Undisclosed  Latin American                    
 of Mexican                               supply with           
 billionaire                              Argentina, excluding  
 Carlos Slim                              Brazil, could reach   
                                          250 million           
 mAbxience of  Argentina     Undisclosed  Initially producing               
 the INSUD                                150 million doses     
 Group                                    for Latin America,    
                                          excluding Brazil      
 Kangtai Bio   China         Undisclosed  Annual production                 
                                          capacity of at least  
                                          100 million doses     
                                          this year, and  at    
                                          least 200 million     
                                          doses by end-2021     
 Emergent      U.S.          $174         Undisclosed doses in              
 BioSolutions                million      second deal with AZ   
                                                                
 SK            South Korea   Undisclosed  Undiluted solutions               
 Bioscience                               of the vaccine until  
                                          early 2021            
 R-Pharm       Russia        Undisclosed  Unknown doses                     
 Daiichi       Japan         Undisclosed  Unknown doses                     
 Sankyo Fundação      Brazil        $127         About 30 million                  
 Osvaldo Cruz                million      doses                 
 (Fiocruz)                                                      
 Symbiosis     Scotland      Undisclosed  Clinical trial                    
 Pharmaceutic                             supply                
 al                                                             
 Cobra         U.S.          Undisclosed  One million doses                 
 Biosciences                              per month             
 Catalent      U.S.          Undisclosed  Vial filling and                  
                                          packaging capacity    
                                          at its manufacturing  
                                          facility in Anagni,   
                                          Italy                 
 Emergent      U.S.          $87 million  300 million doses                 
 BioSolutions Serum         India         Undisclosed  One billion doses                 
 Institute of                             for low and           
 India                                    middle-income         
                                          countries, with 400   
                                          million before        
                                          end-2020              
 Oxford        UK            Undisclosed  Manufacturing                     
 Biomedica                                unknown number of     
                                          doses                 
 
    
               
    
    SUPPLY DEALS
    
    (Most recent first)
    
 REGION/GROUP  DOSES               FUNDING          DELIVERIES          FURTHER
 Switzerland   5.3 million         Undisclosed      Unknown                         
 Indonesia     100 million         Undisclosed      First batch                     
                                                    expected to be      
                                                    available by first  
                                                    half of 2021        
 Thailand      Unknown             Undisclosed      First batch                     
                                                    expected to be      
                                                    available in        
                                                    mid-2021            
 Canada        Up to 20 million    Undisclosed      Unknown                         
               doses                                                    
 Australia     "Enough" for        Undisclosed      Unknown                         
               population of 25                                         
               million, free of                                         
               cost                                                     
 European      300 million, with   750 million      By end-2020                     
 Union         option of           euros for 300                                    
               additional 100      million doses                        
               million                                                  
 Latin         Initially produce   Estimated at     First half 2021                 
 America,      150 million doses,  $600 million                         
 excluding     and eventually      for the first                        
 Brazil        make at least 400   150 million                          
               million             doses                                
 Japan         120 million doses   Undisclosed      30 million doses                
                                                    by March 2021       
 China         Aims for annual     Undisclosed      By end-2020                     
               production                                               
               capacity of at                                           
               least 100 million                                        
               doses this year,                                         
               and  at least 200                                        
               million doses by                                         
               the end of next                                          
               year                                                     
 South Korea   Unknown             Undisclosed      Unknown                         
 Russia        Unknown             Undisclosed      Unknown                         
 Israel        Unknown             Undisclosed      Unknown                         
 Brazil        Initially receive   $356 million     Unknown                         
               100 million doses                                        
 Serum         One billion,        Undisclosed      400 million before              
 Institute of  unspecified number                   end-2020            
 India         of doses will go                                         
               to India                                                 
 Epidemic      300 million         $750 million,    Some before end-                
 response                          with $383 from   2020                
 group CEPI                        CEPI                                 
 and Vaccine                                                            
 alliance                                                               
 GAVI                                                                   
 United        300 million         $1.2 billion     By Oct                          
 States                                                                 
 United        100 million         84 million       By Sept/Oct                     
 Kingdom                           pounds                               
 

    
    (Sources: Reuters reporting, press releases, clinical trial registers, World
Health Organisation)
    
    
    ($1 = 0.8850 euros)
    ($1 = 0.8156 pounds)
    ($1 = 5.6107 reais)
    

    
 (Reporting by Pushkala Aripaka and Aakash Jagadeesh Babu in Bengaluru; Editing by
Jan Harvey, Mark Potter, Louise Heavens, Alexander Smith and Kirsten Donovan)
  
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