for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up

FACTBOX-Pfizer-BioNTech vaccine days away from UK roll-out

    * For a separate FACTBOX on other vaccines, click
,
and click for the frontrunners

 (Adds UK approval, updates regulatory reviews section)
    Dec 2 (Reuters) - Britain on Wednesday became the first
country in the world to approve the Pfizer-BioNTech COVID-19
vaccine for use and said that it will be rolled out from early
next week.
    Drugmaker Pfizer said last month final results from
the late-stage trial of its COVID-19 vaccine showed it was 95%
effective.
    Pfizer said efficacy of the vaccine was consistent across
age and ethnic groups, and there were no major side effects, a
sign that the immunization could be employed broadly around the
world.
    Dozens of drugmakers and research groups have been racing to
develop vaccines against COVID-19, which has killed more than
1.3 million people, shuttered businesses and left millions out
of work around the globe.
    Below are the main details of the vaccine and progress on
supply deals and potential approvals:

    TYPE
    - The vaccine candidate, called BNT162b2, is based on
messenger RNA (mRNA) technology, which uses a chemical messenger
to instruct cells to make proteins that mimic the outer surface
of the new coronavirus, thereby creating immunity.
    
    - mRNA relies on synthetic genes that can be generated and
manufactured in weeks, and produced at scale more rapidly than
conventional vaccines.
    
    - The new technology has not been approved for any vaccines
so far; Pfizer and BioNTech have already collaborated to develop
influenza vaccines based on mRNA.

    DOSAGE AND EXPECTED COST
    - Based on the supply deal with the United States, the price
tag amounts to $39 for what is likely to be a two-dose course of
treatment.
    
    - Pfizer has said it will not charge other developed
countries a lower price for the vaccine than what the United
States will pay.
    
    PROTECTION DURATION    
    - BioNTech Chief Executive Officer Ugur Sahin said he was
optimistic the immunization effect of the vaccine would last for
a year. Scientists do not know how long the effect will last.
    

    DATA AND REGULATORY TIMELINE 
    -  The European Medicines Agency said on Tuesday that if its
experts have received enough data from Pfizer about the
candidate vaccine against the coronavirus, the agency would
complete its reviews by Dec. 29.  
    
    - Canada could approve Pfizer's vaccine "around December", a
senior official at Canada's drug regulator said on Thursday.

    
    - U.S. FDA granted the vaccine a 'fast track' status in
mid-July.
    
    - The European Medicines Agency said in November Pfizer and
BioNTech had submitted data from large-scale trial of their
potential COVID-19 vaccine for the agency's rolling review, but
had not yet applied for approval.

    - Pfizer signed a deal worth up to $750 million with
BioNTech in March to co-develop the potential vaccine, and it
ran clinical trials in April.


    - Testing of the vaccine began in the United States in May
after trials started in Germany the previous month.
    

   
    TRIALS    
    - Trials are continuing globally in 154 locations, including
in Germany, Japan, Brazil and in several locations within the
United States in participants aged 12 years and older. The
global Phase I/II/III trials enrolled about 44,000 volunteers.
(bit.ly/3lfaaeF)
    
    - Below are the different countries, in alphabetical order,
where trials are being conducted or are planned:

 REGION     STATUS         EXPECTED PRIMARY COMPLETION
 Argentina  Recruiting     June 2021
 Brazil     Recruiting,    June 2021 (reut.rs/3kdU2J1)
            Late stage     
 Germany    Recruiting/Ac  June 2021
            tive           
 Japan      Not yet        Nov. 2021 (reut.rs/32tz0Qr)
            recruiting     
 South      Recruiting     June 2021
 Africa                    
 Turkey     Recruiting     June 2021
 U.S.       Recruiting/Ac  June 2021 (bit.ly/35IlXfW)
            tive           
 
    REGULATORY REVIEWS
    (most recent first)
    
 REGION    SUBMISSI  STATUS         FORMAL       FURTHER
           ON/REVIE                 APPLICATION  
           W                                     
 Britain   Emergenc  Granted        Approved                 
           y Use     temporary                   
                     authorization               
 Europe    Emergenc  Launched in    Applied                  
           y Use     Dec                         
 United    Emergenc  Launched in    Applied                  
 States    y Use     Nov                         
 Canada    Rolling   Launched in    Not                      
           review    Oct            submitted    
    
     TARGETED DOSES
    - Currently the companies expect to produce globally up to
50 million doses of the coronavirus vaccine in 2020, enough to
protect 25 million people
    
    - The companies expect to manufacture up to 1.3 billion
doses in 2021.
    
    SUPPLY DEALS
    (most recent first)
    
 REGION    DOSES      FUNDING        EXPECTED       FURTHER
                                     DELIVERIES     
 Germany   Unknown    375 mln euros  Unknown                    
                      ($446 mln)                    
 Japan     120 mln    Undisclosed    First half of              
                                     2021           
 Europe    Up to 300  Undisclosed    To start by                
           mln                       end of 2020    
 Canada    Unknown    Undisclosed    Unknown                    
 U.S.      100 mln    $1.95 bln for  Unknown                    
           plus       100 mln doses                 
           option                                   
           for 500                                  
           mln more                                 
 UK        Increased  Undisclosed    10 mln by the              
           to 40 mln                 end of 2020    
           in Nov,                                  
           had                                      
           agreed 30                                
           mln in                                   
           July                                     
 
    (Sources: Reuters reporting, press releases, clinical trial
registries, World Health Organization)
    
 ($1 = 0.8405 euros)

    
 (Reporting by Pushkala Aripaka, Vishwadha Chander and Yadarisa
Shabong in Bengaluru; Editing by Aurora Ellis and Shounak
Dasgupta)
  
for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up