As Russia begins producing vaccines for civilian use, India might have a separate Phase 3 clinical trial that would be evaluated by regulators here, according to a report in the Indian Express.
Apart from India, Russia also plans to conduct Phase 3 trials in Saudi Arabia, UAE, Brazil and Philippines, Sputnik V official website said.
At least 20 countries, including India, UAE, Saudi Arabia, Indonesia, Brazil, Mexico and Philippines have shown interest in obtaining Sputnik V vaccine.
Comprehensive data on the Sputnik V vaccine’s safety and efficacy has now been made available by Russia to India.
“We are now deeply engaged with Russia on the vaccine front,” an official source told the publication. The talks are being held by Indian Ambassador in Russia D B Venkatesh Varma and Secretary Renu Swarup of Department of Biotechnology.
Results of Phase 1 and Phase 2 of Sputnik V clinical trial have been published by The Lancet. It has also been cleared by Russian regulators for public use.
Despite scepticism from western countries, The Lancet states that Sputnik V Phase 3 trial will include 40,000 volunteers from risk groups (medics and teachers) and different age groups.
According to the Gamaleya Research Institute of Epidemiology and Microbiology, where the vaccine has been developed, vaccine candidates triggered a strong immune response in first two phases of the clinical trial which consisted of 76 people. The two open and non-randomised trials were well tolerated and did not cause serious adverse affect on their health.