Covid-19: India approves Phase 3 clinical trials of Sanofi-GSK protein-based vaccine candidate

In a crucial development that has the potential to add another Covid vaccine to the Indian basket, French pharma company Sanofi and British pharma major GlaxoSmithKline’s joint Covid-19 vaccine candidate will conduct phase 3 trials in India. The Indian regulator has approved the clinical phase 3 trials, which will be undertaken to check the efficacy of the vaccine candidate. As per the release issued by the pharma majors, the clinical phase 3 trials for the vaccine will include more than 35,000 participants spread over different parts in India, the US, Asia, Africa, and Southern America.

The release said that participants aged above 18 will be administered with the company’s vaccine candidate to test its efficacy, safety, and immunogenicity against Coronavirus. Amidst fears of newer variants of Covid-19 and vaccine availability problems, the addition of another vaccine has the potential to boost the fight against Coronavirus.

The Sanofi and GSK have already conduced initial phase clinical trials of the vaccine with phase 2 clinical trials results showing 95% to 100% seroconversion rates and production of neutralising antibodies in all adult age groups, the release said. It also said the clinical trials will progress taking a two-pronged approach where the efficacy of the vaccine will be first tested against the original strain of Coronavirus whereas later on its efficacy will be put to test against the Beta variant (B.1.351).

Subsequent to the vaccine candidate getting India’s approval for clinical trials, Annapurna Das, Country Head, Sanofi Pasteur India, said that the company will begin enrollment of participants from India for the phase 3 clinical trials of the vaccine candidate. Realising the critical factor of time in turning the tide over Coronavirus, she added that the company is committed to begin the clinical trials in India at the earliest.

She added that the virus is currently evolving and the company is anticipating what will be needed in the future to fight the pandemic. She also said the adjuvanted, recombinant vaccine candidate produced by Sanofi and GlaxoSmithKline will offer a significant contribution to the fight against the pandemic. So far, India has given its nod for the emergency use approval for the Covid-19 vaccine to Bharat Biotech-developed Covaxin, Serum Institute of India-manufactured Covishield, Russia’s Gamalaya’s Institute developed Sputnik V, and US major Moderna’s vaccine candidate.