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Human trials of Russia’s Covid-19 vaccine candidate to begin in India this week


Human trials of Sputnik-V, Russia’s candidate vaccine against the coronavirus disease (Covid-19) pandemic, are likely to begin in India in the middle of this week, according to government officials.

“All the necessary requirements are in place, especially the mandatory regulatory approvals, for human trials to begin. It is likely to start this week, ”said an official, requesting anonymity.

Dr VK Paul, Member (Health), Niti Aayog, had also confirmed the development last Tuesday.

“Phase II and III will be a combined test. We have received permission from drug regulators and trials will begin next week, ”he said.

The Gamaleya Institute, based in Moscow, has developed Sputnik-V. The Russian Direct Investment Fund (RDIF) had signed an agreement with Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company based in Hyderabad, for the testing and distribution of its candidate vaccine in the country.

RDIF will supply Dr. Reddy’s Laboratories with 100 million doses of the vaccine.

Russia has also submitted requests to the World Health Organization (WHO) for expedited registration (Emergency Use List (EUL)) and prequalification of its vaccine candidate.

WHO administers the Drug Prequalification Program, the only global initiative of its kind that assesses the quality, safety and efficacy of drugs.

Biological vaccine candidate E is also in early phases I and II of human trials.

In India, five Covid-19 vaccine candidates are in advanced stages of development. Four of the candidate vaccines are in phase II and III and another phase I and II trials.

Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer, is conducting the phase III trial in collaboration with the Indian Council of Medical Research (ICMR) for the Oxford-AstraZeneca vaccine candidate.

Phase III trial has also started for Covaxin, the Bharat Biotech vaccine candidate vaccine and ICMR.

While Cadila Healthcare’s ZyCovD, another indigenous vaccine candidate, is in the phase II trial.

Original source