Mumbai: DGCI has approved Sanofi and Glaxo Smith Kline (GSK) to conduct Phase III study of their corona vaccine in India. The Covid vaccine candidate in India announced this on Thursday by the pharma giant. The double-blind phase-3 study will involve more than 35,000 volunteers over the age of 18. The main objective of the trial is to prevent corona infection as well as reduce serious illness and asymptomatic infection.
Annapurna Das, Country Head, Sanofi Pasteur India, said in a statement that as India is participating in the Sanofi Pasteur Phase III study, we would like to start enrolling participants for the study in the country soon. He said, ‘We are anticipating what will be necessary to stop it as the virus develops in the coming months and years. We believe that our Corona Adjuvanted, Recombinant Vaccine can make a significant contribution to the ongoing fight against Corona.
Trial will be done in two phases
This will happen in two phases. The initial study will examine the efficacy of a vaccine formulation targeting the virus strain (D614). While the second phase will evaluate another formulation targeting the beta version (B1351). Recent scientific evidence suggests that antibodies made against the beta variant may provide broad crossprotection against other more permeable variants. The Phase II trial involved 722 adults aged between 18 and 95 years from the US and Honduras. The test produced a strong immunity in people of all ages.
The Phase III study launch follows the results of the Global Interim Phase 2. As noted, recent scientific evidence suggests that antibodies created against the beta variant may provide broader protection against other more permeable variants, so French pharma company Sanofi and its British peer GSK are aiming for a new one in 2021. Billion doses to be produced.
read this also-
PM Modi expressed concern over non-compliance of Corona rules, said – there should be no place for negligence
Modi government announced new corona package, every district hospital will have facility of ten thousand liters of oxygen storage