Sanofi, GSK get Indian approval for late-stage trial of COVID-19 vaccine

GlaxoSmithKline Pharmaceuticals

08/07/2021 10:08

July 8 (Reuters) - Sanofi SA  SASY.PA  and GlaxoSmithKline
Plc  GSK.L  have received an approval from Indian authorities
for a late-stage clinical trial of their protein-based COVID-19
vaccine candidate, the drugmakers said on Thursday.
    France's Sanofi and Britain's GSK in May kicked off global
trials to include more than 35,000 adults to test the shot. They
hope to get approvals by the end of 2021 after early-stage
results showed the vaccine produces a robust immune response.
 urn:newsml:reuters.com:*:nL5N2NE12M
     The Indian arm of the studies will enrol roughly 3,000
adults between the ages of 18 years and 55 years, according to
India's clinical trial registry. 
     The assessment is expected to run for a year and the first
enrolment in India is shown to have been made on Tuesday. 
     The Indian drug regulator did not immediately respond to a
request for comment.
    "As the virus continues to evolve, we are anticipating what
will be needed in the coming months and years, and accordingly,
have adapted our vaccine development program," Annapurna Das,
Sanofi's India head, said in a statement.
    India reported on Thursday nearly 46,000 new COVID-19 cases
in the last 24 hours, according to data from the health
ministry. Experts have warned that actual figures could be
higher than those reported.
    The highly contagious Delta variant of the coronavirus,
first identified in the South Asian country, is also hurting
global recovery plans as the death toll surpassed four million
worldwide.
    GSK and Sanofi's vaccine candidate uses the same technology
as one of Sanofi's seasonal influenza vaccines. It will be
coupled with an adjuvant, a substance that acts as a booster to
the shot, made by GSK.    
    Sanofi also plans to test the vaccine as a booster,
regardless of which shot a person may have received first.
    The companies said study participants can get vaccinated
with an approved COVID-19 shot during the study if they wish to.
    

 (Reporting by Pushkala Aripaka and Anuron Kumar Mitra in
Bengaluru; Editing by Rashmi Aich)
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