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

FACTBOX-Development of Pfizer-BioNTech coronavirus vaccine

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

 (Updates with details of final results from trial)
    Nov 18 (Reuters) - Drugmaker Pfizer said on
Wednesday that final results from the late-stage trial of its
COVID-19 vaccine showed it was 95% effective, and that it would
apply for emergency U.S. authorization within days.
    Pfizer said efficacy of the vaccine was consistent across
age and ethnic groups, and that there were no major side
effects, a sign that the immunization could be employed broadly
around the world.
    The final analysis of the vaccine from U.S. company Pfizer
and German partner BioNTech comes one week after
initial results from the trial showed the vaccine was more than
90% effective.    
    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 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    
    
    - U.S. FDA granted the vaccine a 'fast track' status in
mid-July. 
    
    - The European Medicines Agency said on Wednesday that
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, Late stage   June 2021 (reut.rs/3kdU2J1)
 Germany        Recruiting/Active        June 2021
 Japan          Not yet recruiting       Nov. 2021 (reut.rs/32tz0Qr)
 South Africa   Recruiting               June 2021
 Turkey         Recruiting               June 2021
 U.S.           Recruiting/Active        June 2021 (bit.ly/35IlXfW)
 
    REGULATORY REVIEWS
    (most recent first)
    
 REGION          SUBMISSION/REVIEW  STATUS    FORMAL           FURTHER
                                              APPLICATION      
 Britain         Rolling Review     Launched  Not submitted                
                                    in late                    
                                    Oct                        
 Canada          Rolling review     Launched  Not submitted                
                                    in Oct                     
 Europe          Rolling review     Launched  Not submitted                
                                    in Oct                     
 
    
     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 million    Unknown                    
                                   euros  ($446                  
                                   million)                      
 Japan     120 million             Undisclosed    First half of              
                                                  2021           
 Europe    Up to 300 million       Undisclosed    To start by                
                                                  end of 2020    
 Canada    Unknown                 Undisclosed    Unknown                    
 U.S.      100 million plus        $1.95 billion  Unknown                    
           option for 500 million  for 100                       
           more                    million doses                 
 UK        Increased to 40         Undisclosed    10 million by              
           million in Nov., had                   the end of     
           agreed 30 million in                   2020           
           July                                                  
 
    (Sources: Reuters reporting, press releases, clinical trial
registries, World Health Organization)
    
    ($1 = 0.8405 euros)

    
 (Reporting by Pushkala Aripaka and Vishwadha Chander in
Bengaluru; Editing by Josephine Mason, Carmel Crimmins and
Aurora Ellis)
  
for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up