India's Serum Institute seeks approval to make Russia's Sputnik V vaccine - sources (updated)

Panacea Biotec

03/06/2021 11:56

(Updates sourcing, adds context)
    By Neha Arora and Krishna N. Das
    NEW DELHI, June 3 (Reuters) - The Serum Institute of India
(SII) has sought regulatory approval to make Russia's Sputnik V
COVID-19 vaccine, two sources said on Thursday, joining a clutch
of drugmakers in the country that are already expected to make
around 1 billion doses annually.
    SII, the world's biggest vaccine producer, is already making
the AstraZeneca PLC  AZN.L  and Novavax vaccines in India. 
    The company has now sought preliminary approval from the
federal drug regulator for making Sputnik V, the sources said,
declining to be identified as details of the application have
not been made public.
    The drug regulator and SII did not immediately respond to a
Reuters e-mail seeking comment.
    Six Indian companies have already signed deals to produce
around 1 billion doses of Sputnik V annually.  urn:newsml:reuters.com:*:nR4N2N901F
 urn:newsml:reuters.com:*:nL4N2LE2L6  urn:newsml:reuters.com:*:nL4N2LH2IF
    The Indian government expects 156 million doses of Sputnik V
between August and December.          
    Serum is currently ramping up production of the AstraZeneca
shot, branded as Covishield, as the Indian government scrambles
to boost supplies after a huge surge in infections since April. 
 urn:newsml:reuters.com:*:nP8N2JL00E
    Indian drugmaker Dr. Reddy's is already in talks with the 
government and the private sector to supply Sputnik V vaccine,
which the company expects to commercially launch in the country
by mid-June.
    The company has signed a deal with Russian Direct Investment
Fund for 250 million doses, of which the initial 15%-20% is
expected through imports, it said last month.  urn:newsml:reuters.com:*:nL4N2N12T9
    After a devastating second wave of infections that killed
tens of thousands in April-May, the Indian government is under
fire to ramp up inoculations of its vast adult population to
curb infections.  urn:newsml:reuters.com:*:nL2N2NL04P    
    India had given emergency authorisation to Russia's Sputnik
V vaccine in mid-April, as vaccinations slowed and infections
surged.       
    Sputnik V is a two-dose shot which has been found to be
91.6% effective in preventing people from developing COVID-19, a
higher efficacy rate than the two vaccines currently approved in
India.
    The Indian government is also in talks with Dr. Reddy's to
bring the single-dose Sputnik Light COVID-19 vaccine, a
spokesperson for the company told Reuters on Monday.
 urn:newsml:reuters.com:*:nL3N2NI23J

 (Reporting by Neha Arora and Krishna N. Das; Editing by
Christopher Cushing and Kim Coghill)
 ((Krishna.Das@tr.com; +91 987111 8314;))