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Bharat Biotech begins Covaxin Phase III trials

The Phase III trials will involve 26,000 volunteers across India and will be conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India.

By: Express News Service | Pune | November 18, 2020 5:27:43 am
COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Bharat Biotech has announced the commencement of Phase III trials of COVAXIN. The Phase III trials will involve 26,000 volunteers across India and will be conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India.

This is India’s first phase III efficacy study for a Covid-19 vaccine. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXIN or placebo. The trial is double blinded — the investigators, participants and the company will not be aware of who is assigned to which group.

COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be over 18 years of age.

Suchitra Ella, joint managing director of Bharat Biotech, said in a statement, “The development and clinical evaluation of COVAXIN™ marks a significant milestone for vaccinology in India for a novel vaccine… COVAXIN™ has garnered interest from several countries worldwide for supplies and introduction.”

Survey finds people willing to be vaccinated

Russian Direct Investment Fund, Russia’s sovereign wealth fund, published results of a survey of 12,000 respondents in 11 countries regarding Covid-19 vaccination and preferences in vaccine selection. As per the results, 73 per cent of respondents were willing to be vaccinated. Among those aware of Russia’s Sputnik V vaccine, the number was higher – 4 out of every 5 respondents.

The survey was conducted from October 9-19 by YouGov, a UK research data and analytics group, a statement issued Tuesday said. The survey was conducted prior to the announcement that the Sputnik V is 92 per cent effective at protecting people from Covid-19, according to interim trial results. A majority of participants in India are positive about vaccination (80%), the survey found. Among those aware of Sputnik V, the percentage of those willing to be vaccinated is over 85 per cent of those surveyed.

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