Sanofi - GSK Get DCGI Nod For Conducting Phase 3 Trial Of Their COVID Vaccine In India; All You Need To Know

In the trial, Sanofi and GSK's COVID-19 vaccine showed 95 percent to 100 percent seroconversion after a second injection was administered.

Mumbai: Sanofi and Glaxo Smith Kline (GSK) received the necessary approval from the Drugs Controller General of India (DCGI) for conducting Phase-3 clinical study of its recombinant protein COVID-19 vaccine candidate in India.

The global, randomised, double-blind Phase-3 study will involve more than 35,000 volunteers aged 18 and above across sites in the US, Asia, Africa, and Latin America as well as from India. The trials will determine the safety, efficacy and immunogenicity of the adjuvanted recombinant-protein COVID-19 vaccine candidate.

Sanofi and Glaxo Smith Kline (GSK) on Thursday released a statement informing about the DCGI approval.

"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," Annapurna Das, Country Head, Sanofi Pasteur India, wrote in the statement.

"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," she added.

In the two-stage approach, the study is going to initially probe the efficacy of a vaccine formulation targeting the original virus strain (D614) and then the second stage will evaluate a second formulation targeting the Beta variant (B1351).

Recent scientific evidence suggests that antibodies created against the Beta COVID variant can provide broad cross-protection against other more transmissible mutations.

Sanofi and GSK will also run clinical studies to determine the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response irrespective of the type of vaccine initially received.

The Phase 3 study will be started after the global interim Phase 2 results showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups.

The Phase-2 trial involved 722 adult volunteers from the US and Honduras between 18 to 95 years old. It did not raise any concerns regarding safety and also produced a strong immune response across all age groups.

According to inputs, the trial showed 95 percent to 100 percent seroconversion after a second injection was administered, while a single jab produced high neutralising antibody levels among people with prior SARS-CoV-2 infection. This indicated the vaccine's strong potential for development as a booster shot.

The French pharma company Sanofi and its British peer GSK are planning to produce up to 1 billion doses in 2021.