Key points:
- All required requirements, especially mandatory regulatory approvals, are all in place for human trials to begin.
- The Russian Direct Investment Fund (RDIF) has entered into an agreement with Dr Reddy’s Laboratories.
- The candidate for the biological E vaccine is still in the early phases I and II of clinical trials.
- For Covaxin, the Bharat Biotech as well as the ICMR vaccine candidate, the phase III trial has also begun.
According to government officials, human testing for Sputnik-V, Russia’s vaccine candidate against raging coronavirus disease (Covid-19) pandemic, are likely to begin in India in the mid of this week.
All required requirements, especially mandatory regulatory approvals, are all in place for human trials to begin. It is likely to launch this week,’ an official said, requesting anonymity.
The development was also confirmed by Dr VK Paul, Member (Health), Niti Aayog, last Tuesday. The combined trial will be in Phase II as well as III. We have obtained approval from drug authorities and will launch trials by next week,’ he stated.
RDIF’s deal with Dr Reddy’s Laboratories:
Sputnik-V was established by the Moscow-based Gamaleya Institute. The Russian Direct Investment Fund (RDIF) has entered into an agreement with Dr Reddy’s Laboratories, a Hyderabad-based Indian multinational pharmaceutical firm, to test and distribute its candidate vaccine in the region.
The RDIF will send 100 million doses of the vaccine to Dr Reddy’s Laboratories.
Application to WHO by Russia:
Russia has also sent requests for accelerated registration — Emergency Use Listing (EUL) — and prequalification of its vaccine nominee to the World Health Organization (WHO).
The Prequalification of Medicines Program, a one-of-a-kind global initiative evaluating the quality, protection, and effectiveness of medicines, is managed by WHO.
The candidate for the biological E vaccine is still in the early phases I and II of clinical trials. In India, five candidates for the Covid-19 vaccine are at an advanced stage of growth. Four of the vaccine candidates are currently undergoing phase II and III trials, and another is undergoing phase I as well as phase II trials.
SII on the phase 3 trial:
In partnership with the Indian Council of Medical Research (ICMR), the Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer is undertaking a phase III trial for the Oxford-AstraZeneca vaccine candidate.
For Covaxin, the Bharat Biotech as well as the ICMR vaccine candidate, the phase III trial has also begun.
Another indigenous vaccine candidate, Cadila Healthcare’s ZyCovD, is conducting a phase II trial.
