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.
Dr. VK Paul, member (health), Niti Aayog, had also confirmed the development last Tuesday.
“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.
Moscow-based Gamaleya Institute has developed Sputnik-V. The Russian Direct Investment Fund (RDIF) had inked a deal with Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company headquartered in Hyderabad, for trials and distribution of its vaccine candidate in the country.
The RDIF is to supply Dr. Reddy’s Laboratories 100 million doses of the vaccine.
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.
Biological E vaccine candidate is also in the early phase I and II of human trials.
In India, five Covid-19 vaccine candidates are in advanced stages of development. Four of the vaccine candidates are undergoing the phase II and III and another one phase I and II of trials.
Pune-based Serum Institute of India (SII), the largest vaccine manufacturer in the world, is conducting the phase III trial in collaboration with the Indian Council of Medical Research (ICMR) for Oxford-AstraZeneca vaccine candidate.
The phase III trial has also started for Covaxin, the Bharat Biotech and ICMR vaccine candidate.
While Cadila Healthcare’s ZyCovD, another indigenous vaccine candidate, is undergoing the phase II trial.