E-Paper
Sanofi-GSK Covid vaccine candidate gets nod for Phase 3 trials in India
It will be a bridging trial to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate as part of the global, randomised, double-blind phase 3 study with over 35,000 volunteers aged above 18 across the US, Asia, Africa, and Latin America
The national drugs regulator has granted approval to pharma majors Sanofi and GSK to conduct phase 3 clinical trials of their Covid-19 vaccine candidate in India, the companies announced in a joint statement on Thursday.
It will be a bridging trial to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate as part of the global, randomised, double-blind phase 3 study with over 35,000 volunteers aged above 18 across the US, Asia, Africa, and Latin America.
“The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARSCoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection,” said the statement.
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According to the companies, the global interim phase 2 results have shown that the vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95 to 100% seroconversion rates. After a single injection, high neutralising antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D.614), while a second stage will evaluate a second formulation targeting the Beta variant (B.1.351).
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.
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.
“India is participating in Sanofi Pasteur’s pivotal Phase 3 study… we should soon begin enrolment 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. 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 programme in India, at the earliest.”
As part of their partnership to develop the Covid-19 vaccine, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.
“As Covid-19 vaccination becomes available, study participants are encouraged to receive an approved Covid-19 vaccine during the study, if they wish to do so. 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,” the statement said.
