Bharat Biotech has declared the beginning of Phase-III trials of COVAXIN.  This trial will cover 26,000 volunteers across India and will be carried out in partnership with ICMR. It is the largest clinical trial performed for a COVID-19 vaccine in India.

This is India’s first Phase-III efficacy study for a Covid-19 vaccine. The trial volunteers will get two intramuscular injections almost 28 days apart. Participants will be randomly selected to take Covaxin or placebo. The trial would be double-blinded where the investigators, participants, and the company will not be informed of who has been assigned to which group.

In Phase I and Phase II Clinical trials, COVAXIN has been assessed in approximately 1,000 subjects, giving promising safety and immunogenicity data. The volunteers who want to participate in the Phase-III trial should be over 18 years of age. Joint Managing Director of Bharat Biotech, Suchitra Ella, told that the development and clinical evaluation of COVAXIN have garnered interest from several countries worldwide for supplies and introduction.

Russia’s sovereign wealth fund, also known as Russian Direct Investment Fund, has published the 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 percent of respondents were willing to be vaccinated. Among those aware of Russia’s Sputnik V vaccine, the number was higher at 4 out of every 5 respondents.

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

In a parallel development, Biological E Ltd, a Hyderabad-based firm has started an adaptive Phase I and II human trial for its COVID-19 vaccine candidate. The firm has already sought approvals from Drugs Controller General of India (DCGI) and expects to get the results back by February, next year.

It is being developed along with Baylor College of Medicine (BCM ventures) in Houston, Texas, and Dynavax Technologies Corp. According to the press release by Biological E Ltd, the trial will test two doses of the vaccine in around 360 volunteers who are aged between 18 to 65 years. It will be administered via intramuscular injection 28 days apart. Intramuscular injection is a technique used to deliver the vaccine deep into the muscles, allowing it to be absorbed into the bloodstream quickly.

The author is a student member of Amity center of Happiness