Sanofi and GSK have received approval from India’s drug controller for the global phase 3 clinical trial of the French pharmaceutical company Sanofi’s Covid-19 vaccine candidate in the country. This would be the first global study for a foreign Covid-19 vaccine in India.
will include more than 35,000 volunteers ages 18 and up in locations in the United States, Asia, Africa, and Latin America. (Photo: Reuters / Representative)
The Drug Controller General of India (DCGI) has approved the global phase 3 clinical trial of the Covid-19 vaccine candidate from the French pharmaceutical company Sanofi. Sanofi is developing the vaccine together with the British company GlaxoSmithKline (GSK).
In a press release, Sanofi said it had received a green signal for the Phase 3 trial in India to “evaluate the safety, efficacy and immunogenicity of its adjuvanted recombinant protein Covid-19 vaccine candidate”.
This would be the first worldwide study for a Covid-19 vaccine in India.
The randomized, double-blind phase 3 study is being conducted worldwide and includes more than 35,000 volunteers aged 18 and over at locations in the US, Asia, Africa and Latin America.
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“India is enrolling in Sanofi Pasteur’s pivotal Phase 3 trial and, subject to subsequent approvals, we should begin enrolling in the country soon,” said Annapurna Das, Country Head, Sanofi Pasteur India.
“As the virus evolves, we are anticipating what will be needed in the months and years to come and have adjusted our vaccine development program accordingly. We believe that our adjuvanted, recombinant vaccine against Covid-19 can make a significant contribution to the ongoing fight against Covid-19 and are determined to start our clinical program in India at the earliest, ”she added.
Before participating in the study, participants can get any approved Covid-19 vaccine if they so choose, the company said in a statement. The statement goes on to say that as part of the study design, all participants, including the control group, will be offered the study vaccine once it is found to be safe and effective.
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