Sanofi and GSK have received approval for their Phase 3 clinical study in India to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.

The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America, Sanofi said in a statement on Thursday.

"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," Sanofi Pasteur India, Country Head, Annapurna Das said. 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," she added. Das said the vaccine can make an important contribution in the fight against COVID-19.

"We believe our COVID-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against COVID-19 and are committed to initiating our clinical program in India, at the earliest," Das said.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARSCoV-2 naive adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection, Sanofi said. 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, the statement said. 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 the partnership between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza," Sanofi said.

The recombinant technology combined with GSK's adjuvant is designed to offer the advantages of stability at temperatures used for routine vaccines, making it easily implementable and easier to distribute at a global scale through existing infrastructures where vaccines are stored at normal refrigerator temperature, it added. 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.