Sanofi and GSK have received the drug regulator's nod to conduct the phase 3 clinical trial of their COVID-19 vaccine in India. The study will assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein vaccine candidate.
"India is participating in Sanofi Pasteur's pivotal phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," said Annapurna Das, Country Head, Sanofi Pasteur India.
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The global, randomised, double-blind phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the United States, Asia, Africa and Latin America, news agency PTI quoted Sanofi as saying in a statement.
As the novel coronavirus continues to evolve, "we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program," Das added.
The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection, Sanofi said.
Read: Sanofi and GSK’s vaccine said to produce strong immune responses in mid-stage study
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain, while a second stage will evaluate a second formulation targeting the Beta variant, it added.
The design of the phase 3 study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants, according to the statement.
Read: Pfizer to seek US authorization for COVID booster shot
Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.
In addition to the adjuvanted recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio.
(With inputs from PTI)
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