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

FACTBOX-J&J applies to U.S. FDA for COVID-19 vaccine authorization

 (Updates Johnson & Johnson filing EUA application)
    Feb 5 (Reuters) - Johnson & Johnson has asked U.S. health regulators to authorize its
single-dose COVID-19 vaccine for emergency use and said it will apply to European authorities in
coming weeks. The U.S. FDA will hold a meeting of its Vaccines and Related Biological Products
Advisory Committee on Feb. 26 to discuss the drugmaker's request.
    The following table gives the state of play of the main vaccine candidates.
    
 COMPANY                        STAGE OF DEVELOPMENT               EXPECTED DOSES
 Pfizer Inc         and         New Zealand was the latest to      (Nine countries for over 600 mln
 BioNTech SE                    authorize the vaccine, with a      doses)
                                total of 15 countries and the EU   
                                having authorized it. South Korea  U.S. - 200 mln+ option for 400
                                has also approved its import.      mln more UK - 40 mln; Expects to have 10
                                                                   mln doses by end of 2020 EU - 600 mln Canada - 40 mln Japan - 120 mln Colombia - 1.7 mln in Feb South Korea - 20 mln Iraq - 1.5 mln Chile - 10 mln Malaysia - 12.8 mln African Union - unspecified (via
                                                                   COVAX)               
                                                                   
 Moderna Inc                    Distribution under way in Canada,  U.S. - 200 mln, in talks for
                                the United States and EU. Delays   additional 100 mln
                                in delivery to Italy, France and   
                                Switzerland. Plans to test new     EU - 160 mln
                                booster shot aimed at the South    
                                African variant.                   UK - 17 mln Japan - 50 mln or more, to be
                                                                   distributed by Takeda         
                                                                   Switzerland - 7.5 mln Canada- 40 mln Israel - 6 mln, expects to begin
                                                                   receiving the vaccines by March
                                                                   "at the latest" Singapore - Not specified Qatar- Not specified South Korea - 20 mln The Philippines - 20 mln 
                                                                   
 Johnson & Johnson              Applied to the U.S. FDA for        U.S. - 100 mln + 200 mln more
                                authorization of its single-dose   under subsequent agreement
                                COVID-19 vaccine for emergency     
                                use; to apply to European          UK - 30 mln + option for up to 22
                                authorities in coming weeks        mln more EU - 200 mln + 200 mln additional Canada - Up to 38 mln Japan - Not Applicable South Korea - 4 mln African Union - unspecified (via
                                                                   COVAX)                       
 AstraZeneca         & Oxford   Vaccine approved for emergency     (More than 15 countries and
 University                     use by European Medicines Agency   groups for over 3 bln doses)
                                and the UK. India,  Pakistan, the  
                                Philippines, South Africa, Chile   U.S. - 300 mln 
                                and Brazil have also approved the  
                                shot. Deliveries to EU slowed      UK - 100 mln
                                down.                              
                                                                   EU - At least 300 mln + 100 mln
                                                                   additional Italy, Germany, the Netherlands
                                                                   and France - 300 mln + 100 mln
                                                                   additional Canada - Up to 20 mln Japan - 120 mln Bangladesh - 30 mln (through
                                                                   India's Serum Institute) Colombia - 10 mln South Korea - 20 mln The Philippines - 2.6 mln Malaysia - 6.4 mln India - 11 mln (through Serum
                                                                   Institute) African Union - unspecified (via
                                                                   COVAX) plus another 400 million
                                                                   doses secured
 Sinovac Biotech Ltd            Turkey and China have granted      Indonesia - 125 mln with 1.2 mln
                                emergency use authorization for    doses already secured 
                                the vaccine.                       
                                                                   Brazil - in talks for 100 mln
                                                                   doses Turkey - 50 mln doses (3 mln
                                                                   received) The Philippines to finalize
                                                                   negotiations for 25 mln doses Malaysia - 14 mln 
                                                                   Chile - 60 mln doses (first
                                                                   shipment of nearly 2 mln received
                                                                   )
                                                                   
 Gamaleya Research Institute    Filed for registration in Europe;  Supply deals with over 13
                                Russia to conduct trial of a       countries including India,
                                one-dose version; 1.5 mln have     Brazil, Algeria, Bolivia and
                                been inoculated in Russia since    Argentina for at least 280 mln
                                December. Roll out under way in    doses. 
                                Belarus and Argentina.             Mexico - in talks for 24 mln
                                                                   doses
                                                                   
 CanSino Biologics Inc          Approved for use in Chinese        Mexico - 10 mln-35 mln doses 
                                military. Late-stage trial under   
                                way in Pakistan and Mexico. China National Pharmaceutical  China and Hungary approved the     Expects to produce more than 1
 Group Corp (Sinopharm)         shot developed by an affiliate of  bln doses in 2021
                                Sinopharm. Its efficacy was        
                                pegged at 79.34% by the            Pakistan to purchase 1.2 million
                                company.                           doses The vaccine has been used on       Peru - 38 mln             
                                about 1 mln people in China in an  
                                emergency program.                 
                                                                   
 Bharat Biotech                 Vaccine granted emergency use      In talks with at least 10
                                authorization in India with        countries in South America, Asia
                                roll-out under way                 and Eastern Europe
 Novavax Inc                    Europe has begun rolling review,   U.S. - 100 mln
                                Company has applied to Canada for  
                                review. Prelim data from           UK - 60 mln    
                                late-stage UK trial shows vaccine  
                                is 89.3% effective in preventing   Canada - Up to 76 mln
                                COVID-19 and equally effective     
                                against UK variant; Late-stage     Japan - 250 mln
                                study under way in the U.S. and    
                                Mexico.                            Australia - 51 mln + option for
                                                                   additional 10 mln; initial doses
                                                                   expected by mid-2021 The Philippines - 30 mln by July 
                                                                   2021 Indonesia - 30 mln New Zealand - 10.7 mln EU - In negotiations Medicago                       Begins mid-to-late stage studies   No supply deals yet
                                of its experimental vaccine in     
                                combination with a booster from    
                                GlaxoSmithKline        .           
                                                                   
 Anhui Zhifei Longcom           Begins Phase III trials, planning  No supply deals yet
 Biopharmaceutical              to recruit 29,000 volunteers       
                                across the world (bit.ly/3mc5WUI)  
 
 (Reporting by Amruta Khandekar, Dania Nadeem, Mrinalika Roy, Vishwadha Chander, Manas Mishra,
Trisha Roy, Muvija M and Pushkala Aripaka in Bengaluru; Editing by Anil D'Silva and Arun Koyyur)
  
for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up