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FACTBOX-How AstraZeneca-Oxford developed Britain's homegrown COVID-19 vaccine

    Jan 3 (Reuters) - India's drugs regulator gave final approval on Sunday for the
emergency-use of a COVID-19 vaccine developed by AstraZeneca and Oxford University. Britain, El
Salvador and Argentina have also approved the vaccine.
    Once front-runners in a global race to develop a vaccine, the AstraZeneca and University of
Oxford partnership has been overtaken by Pfizer and German partner BioNTech,
whose vaccine is already being used in Britain and the United States.    
    The following are details of the Oxford-AstraZeneca vaccine effort:
        
    TYPE OF VACCINE
    * Called AZD1222 or ChAdOx1 nCoV-19, the vaccine is a recombinant viral vector vaccine,
meaning a
virus is used as a means of delivering the vaccine. 
    * It will be branded COVISHIELD in India and is being manufactured there by partner Serum
Institute of India.
    * 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, PROTECTION DURATION AND STORAGE
    * India has authorised a two full-dose regime.
    * UK authorisation recommends two-dose regime given between four and 12 weeks apart.

    * Two regimens are being tested: one in which recipients get two full doses, and another
with half
a dose followed by a full dose. 
    * The half-dose first regimen was found to be 90% effective in a subset of trial subjects.
The
success rate was 62% with the originally planned two full doses, based on interim data.

    * In December, Oxford said the vaccine has a better immune response when a two full-dose
regime is
used, citing data from early trials.
    * Immune response could last at least a year.
    * The vaccine should be effective against the new coronavirus variant, and studies are under
way
to fully probe the impact of the mutation.
    * The vaccine can be stored, transported and handled at normal refrigerated conditions for
at
least six months, making it logistically easier to transport than Pfizer's vaccine.
    * AstraZeneca aims to supply millions of doses in the first quarter to Britain and is
working with
the UK government for first vaccinations to begin early in the new year.


    EXPECTED DOSAGE PRICE
    * Serum Institute of India has said it would price the vaccine at 250 rupees (about $3) per
dose
for India's government and many other countries and at 1,000 rupees for the private
market.
    * Pricing in Britain is unknown so far.
    * Italy's health ministry said in June the vaccine would cost about 2.5 euros ($2.80) per
dose in
Europe.
    * AstraZeneca has said it will be able to manufacture the vaccine at a few dollars per dose.

    * Pricing in Latin America is not expected to exceed $4 per dose.
    * Sources told Reuters it could cost $4 to $5 per dose in Bangladesh.
    * Costs in other regions have not yet been disclosed.
    * 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.
    * AstraZeneca will look to profit from wealthier countries at the "appropriate time".


    
    TESTING AND DATA
    * Trials combining the vaccine with Russia's Sputnik V will start by the end of the year,
and
Russia wants to jointly produce the new vaccine if it is proven to be effective.

    * Vastly divergent performance with different dose regimens has called for more clarity on
the
vaccine's efficacy which averaged 70.4%, well below vaccines from Pfizer and Moderna, but above
the 50% threshold set by many regulators.   
    * Serum Institute of India will continue to test a two full dose regimen of the vaccine.

    * AstraZeneca had to pause global trials on Sept. 6 after an unexplained illness in a
participant.

    * Trial of the vaccine in the United States resumed in October after other countries had
ended
their pause.
    * AZD1222 produces an immune response in both old and young adults, and also led to lower
adverse
responses among the elderly, AstraZeneca said in October.
    * The vaccine also accurately follows genetic instructions programmed into it by its
developers,
according to an analysis by independent scientists.
    * Brazil said in October that a trial volunteer had died. 
    * A source told Reuters the Brazilian trial would have been suspended if the volunteer who
died
had received the COVID-19 vaccine, although the death was reported to be a suicide.
    * In July, data from early-stage trials published in The Lancet showed the vaccine was safe
and
produced an immune response. 

    
    GLOBAL TRIALS
    
    Below are other regions where testing of the vaccine is being carried out or planned: (In
alphabetical order of regions)    
       
 REGION        STAGE OF      STATUS       VOLUNTEERS   DATA          EXPECTED
               DEVELOPMENT                                           COMPLETION
 Brazil        Phase III     Recruiting,  10,300       First data    Sept. 2021 (bit.ly/2GAeB4K)
                             restarted    anticipated  published in      (bit.ly/2I4BNIz)
                             after pause  , with       late          
                             in early     participant  November      
                             September    s aged 18                  
                                          years and                  
                                          older                      
 Chile         Unknown       Wrapped up   2,000        Unknown       Unknown
                             recruitment  enrolled China         Unknown       To begin     Unknown      Unknown       Unknown
                                                                                 
 India         Phase II/III  Ongoing,     1,600        Not           In seven months
                             restarted    anticipated  available     from August (bit.ly/3nAwXTC)
                             after pause  , with                     
                             in early     participant                
                             September    s aged 18                  
                                          years and                  
                                          older                      
 Japan         Phase I/II    Active, not  256          Not           Nov. 2021 (bit.ly/3nAnImj)
                             recruiting.  anticipated  available     
                             Restarted    , with                     
                             after pause  participant                
                             in early     s aged 18                  
                             September    years and                  
                                          older                      
 Kenya         Phase Ib/II   Ongoing      400          Not           In approximately
                                          anticipated  available     two years (bit.ly/362fsUy)
                                          , with                     
                                          participant                
                                          s aged 18                  
                                          years and                  
                                          older, and                 
                                          will only                  
                                          enrol                      
                                          healthcare                 
                                          workers                    
 Peru          Unknown       To begin     Unknown      Unknown       Unknown
                                                                                 
 Russia        Phase III     Suspended,   100          Not           March 2021 (bit.ly/36NKpxr)
                             on hold      anticipated  applicable    
                             till         , with                     
                             Russian      participant                
                             approval     s aged 18                  
                             following    years and                  
                             pause in     older                      
                             September                               
 Russia, in    Unknown       To begin     Unknown      Unknown       Unknown (bit.ly/2KljQ9F)
 combination                              number of                  
 with Sputnik                             adults aged                
 V                                        18 and                     
                                          older                      
 South Africa  Phase I/II    Active, not  2,130        First data    Dec. 2021 (bit.ly/2Gy8mhS)
                             recruiting.  enrolled,    was           
                             Restarted    with both    anticipated   
                             after pause  HIV-uninfec  in Q4 2020,   
                             in early     ted adults   but the       
                             September    and people   principal     
                                          living with  investigator  
                                          HIV          told Reuters  
                                                       that          
                                                       efficacy      
                                                       results may   
                                                       not be ready  
                                                       for months    
                                                                     
 UK            Phase I/II    Active, not  1,090        Initial data  Oct. 2021 (bit.ly/3n81UxJ)
                             recruiting   enrolled,    readout in        (bit.ly/2HY2pe5)
                                          with         July 2020     
                                          participant                
                                          s aged                     
                                          between 18                 
                                          and 55                     
 UK            Phase II/III  Recruiting,  12,390       First data    Sept. 2021 (bit.ly/34EOHVj)
                             restarted    anticipated  published in      (bit.ly/2HSU37G)
                             after pause  , with       late          
                             in early     participant  November      
                             September    s aged 18                  
                                          years and                  
                                          older. Also                
                                          includes                   
                                          HIV                        
                                          infected                   
                                          adults in                  
                                          one group.                 
                                          Previously                 
                                          included                   
                                          children                   
                                          above 5                    
                                          years of                   
                                          age.                       
 U.S. with     Phase III     Recruiting,  40,000       First data    Feb. 2023 (bit.ly/30O4XCl)
 global sites                restarted    anticipated  anticipated   
                             in late      , with       in H1 2021    
                             October      participant                
                             after pause  s aged 18                  
                             in early     years and                  
                             September    older                      
 
    DATA AND REGULATORY TIMELINE    

    * The lead developer had said in July the vaccine could be rolled out by year-end, but the
delivery and testing timeline has since been pushed back.
    * Data read-out submitted to regulators across the world to seek approval.

    * Experts have predicted a safe and effective vaccine could take 12-18 months to develop,
even at
the record speeds.

    
    REGULATORY REVIEWS AND APPROVALS   
    (Most recent first)    
    
 REGION/REGULATOR   REVIEW STATUS  TYPE OF               FORMAL         FURTHER
                                   APPROVAL/APPLICATION  APPLICATION    
 India/Central      Approved       Review launched in    Submitted by               
 Drugs Standard     after          December and          Serum          
 Control            accelerated    approval for          Institute and              
 Organisation       review         two-dose regime       approved Argentina/Nationa  Approved for   Approval for the      Approved                   
 l Administrator    emergency use  vaccine to be                        
 for Food and                      administered to                      
 Medical                           people over the age                  
 Technology                        of 18 in two doses                   
                                   between four and 12                  
                                   weeks apart, as per                  
                                   UK greenlight.                       
 El                 Approved       Approval based on     Approved                   
 Salvador/National                 evidence provided by                 
 Directorate of                    the developer,                       
 Medicines                         emergency use                        
                                   permissions                          
                                   authorised by other                  
                                   countries.                           
 Britain/Medicines  Approved for   Approved in late      Submitted and              
 and Healthcare     emergency use  December after        Approved       
 Products                          rolling review was                               
 Regulatory Agency                 launched in Oct Chile/Public       Under review   Application for       Submitted                  
 Health Institute                  emergency use                        
 Brazil/Anvisa      Under review   Application will be   Expected to                
                                   for two-dose regimen  be submitted   
                                                         by Fiocruz on  
                                                         Jan. 15        
 Mexico/COFEPRIS    Under review   Expected to request   Not submitted              
                                   emergency                            
                                   authorization in                     
                                   January                              
 United States/     Under review   Likely be authorised  Not submitted              
 Food and Drug                     for emergency use in                 
 Administration                    April                                
 Canada/Health      Rolling        Review launched in    Not submitted              
 Canada             submission     Oct, there is still                  
                                   information and data                 
                                   to be provided for                               
                                   review                               
 Europe/European    Rolling        Review launched in    Not submitted              
 Medicines Agency   review for     Oct, is seeking more                 
                    conditional    data and it could be                             
                    approval       months before an                     
                                   approval is given                    
 
    * The World Health Organization expects to make decisions on whether to give emergency use
approval to COVID-19 vaccines, including AstraZeneca's, its chief scientist said in December.


        
    
    TARGET DOSES/GLOBAL CAPACITY OF SUPPLY
    * More than 3 billion doses are planned.   
    * The company will have as many as 200 million doses by the end of 2020, and 700 million
doses
could be ready globally as soon as the end of the first quarter of 2021.
    * AstraZeneca is keeping the vaccine frozen in large containers and will only add a final
ingredient, put it into vials and refrigerate it when the vaccine gets closer to approvals.



    TIE-UPS 
    * Even before studies showed any signs of efficacy, AstraZeneca had signed several supply
and
manufacturing deals around the world.
    * It also joined forces 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.

    

    SUPPLY DEALS
    
    (Most recent first)
    
 REGION/GROUP  DOSES               FUNDING          EXPECTED            FURTHER
                                                    DELIVERIES          
 Indonesia     50 million          Undisclosed      First batch                     
                                                    expected to be      
                                                    available by first              
                                                    half of 2021        
 Malaysia      6.4 million         Undisclosed      Unknown                         
 Colombia      10 million          Undisclosed      Unknown                         
 Philippines   2.6 million         Undisclosed      Shipment expected               
                                                    in May              
 Thailand      Addition under      Previously       First batch                     
               further agreement   approved budget  expected to be      
               unknown,            of 6 billion     available in        {nL4N2IC2R6]
               previously 26       baht ($199       mid-2021            
               million doses       million)                             
 Bangladesh    30 million from     Undisclosed      "Whenever the                   
               Serum Institute of                   vaccine is ready"   
               India                                                    
 Argentina     22 million          Undisclosed      Depends on trials               
                                                    being successful    
                                                    and obtaining       
                                                    necessary           
                                                    approvals           
 Chile         14.4 million        Undisclosed      Unknown                         
 Spain         31.6 million as     Undisclosed      Between Dec. 2020               
               part of a European                   and June 2021       
               Union scheme                                             
 Switzerland   5.3 million         Undisclosed      Unknown                         
 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   20 million          Undisclosed      Shipments would                 
                                                    begin no later      
                                                    than March, and     
                                                    vaccinations may    
                                                    start in the first  
                                                    half of next year   
 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 were       
 India         of doses will go                     expected            
               to India                             previously          
 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     Was earlier                     
 States                                             expected by Oct.    
                                                    2020                
 United        100 million         84 million       4 million in 2020.              
 Kingdom                           pounds           Earlier about 30    
                                                    million doses were              
                                                    expected with       
                                                    initial deliveries  [nL8N2IO2YJ
                                                    by Sept/Oct. 2020.  
                                                    Initial supply to   
                                                    come from Europe.   
 
    

    MANUFACTURING DEALS  
    
    (Most recent first)    

 FIRM           BASED IN        DEAL VALUE    FOR                      FURTHER
 CSL Ltd        Australia       Undisclosed   Additional 20 million                
                                              requested by Australian  
                                              government,              
                                              approximately 30         
                                              million doses already    
                                              being manufactured       
 Halix B.V.     Netherlands     Undisclosed   Commercial  manufacture              
                                              of the vaccine           
 Siam           Thailand        Undisclosed   Manufacture and supply               
 Bioscience,                                  the vaccine in Thailand  
 SCG                                          and other nations in     
                                              Southeast Asia           
 Albany         U.S.            Undisclosed   Produce millions of                  
 Molecular                                    doses through sterile    
 Research                                     finishing services at    
                                              its manufacturing plant  
                                              in Albuquerque, New      
                                              Mexico                   
 Oxford         UK              15 million    Unknown doses for                    
 Biomedica                      pounds to     large-scale commercial   
                                reserve       manufacture under        
                                manufacturin  expanded deal            
                                g 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 of  Mexico          Undisclosed   Latin American supply                
 Mexican                                      with Argentina,          
 billionaire                                  excluding Brazil, could  
 Carlos Slim                                  reach 250 million        
 mAbxience of   Argentina       Undisclosed   Initially producing 150              
 the INSUD                                    million doses for Latin  
 Group                                        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 million  Undisclosed doses in                 
 BioSolutions                                 second deal with AZ      
                                                                       
 SK Bioscience  South Korea     Undisclosed   Undiluted solutions of               
                                              the vaccine until early  
                                              2021                     
 R-Pharm        Russia          Undisclosed   Unknown doses                        
 Daiichi        Japan           Undisclosed   Unknown doses                        
 Sankyo Fundação       Brazil          $127 million  About 30 million doses               
 Osvaldo Cruz                                                          
 (Fiocruz)                                                             
 Symbiosis      Scotland        Undisclosed   Clinical trial supply                
 Pharmaceutica                                                         
 l                                                                     
 Cobra          U.S.            Undisclosed   One million doses per                
 Biosciences                                  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 for                
 Institute of                                 low and middle-income    
 India                                        countries.  400 million  
                                              before end-2020 were     
                                              expected previously      
 Oxford         UK              Undisclosed   Manufacturing unknown                
 Biomedica                                    number of doses          
                                                                       
 
    
    
    (Sources: Reuters reporting, media releases, clinical trial registers, regulatory bodies,
medical journals, World Health Organization)
    

    
 (Reporting by Pushkala Aripaka, Tanishaa Nadkar and Aakash Jagadeesh Babu in Bengaluru; Editing
by William Maclean, Patrick Graham and Carmel Crimmins)
  
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