Vastavam web: Human trials for Sputnik-V, Russia’s vaccine candidate against the raging coronavirus disease (Covid-19) pandemic is likely to start in India in the middle of this week, according to government officials. “All necessary requirements are in place, especially the mandatory regulatory approvals, for human trials to start. It is likely to commence this week,” said an official, requesting anonymity. “The phase II and III will be a combined trial. We have received permission from drug regulators and trials will start by next week,” he had said.
Russia has also submitted applications to the World Health Organisation (WHO) for accelerated registration — Emergency Use Listing (EUL) — and prequalification of its vaccine candidate. WHO manages the Prequalification of Medicines Programme, the one-of-a-kind global initiative that assesses the quality, safety, and efficacy of drugs. The phase III trial has also started for Covaxin, the Bharat Biotech and ICMR vaccine candidate.