Sanofi, GSK get nod for Phase 3 efficacy trial of their Covid -19 vaccine candidate in India

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Sanofi and GSK said they 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 U.S., Asia, Africa, and Latin America.

As part of the study design, all participants, including the control group, will be offered the study vaccine as soon as it is determined to be safe and effective, Sanofi said.

“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.

“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 programme,” she said.

“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” she added.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS- CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection, the company said in a statement.

Beta antibodies offer wide- ranging protection

Recent scientific evidence shows that antibodies created against the Beta variant may provide broad cross-protection against other more transmissible variants.

The design of the Phase 3 study also allows evaluation of the efficacy of the candidate against a variety of circulating variants, it 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.

“The Phase 3 study initiation follows the global interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95 to 100% seroconversion rates,” the company said.

In this partnership Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.

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 refrigeration temperatures, the company said.

It is also designed to offer the potential to generate high and sustained immune responses, and the potential to prevent virus transmission, it added.

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Printable version | Sep 20, 2021 8:14:44 AM |

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