Covaxin trials: Only adult volunteers to be involved in Phase III

Sunit Dhawan
Tribune News Service
Rohtak, November 17

While volunteers in the age-group of 12-65 years were involved in the second phase of the clinical human trials of indigenous Covid-19 vaccine Covaxin, only adult volunteers (above the age of 18 years) will be involved in the third phase of the trials.

Some 25,800 volunteers will be given measured doses of Covaxin in the third phase at 20 centres across the country, of which nearly 1,100 are likely to be administered the vaccine at Rohtak PGIMS.

Talking to The Tribune here on Tuesday, Dr Ramesh Verma, a co-investigator of the project, said fresh doses of Covaxin are likely to arrive at the PGIMS within a couple of days, after which Phase III of the human trials of the vaccine will begin.

It may be pertinent to mention here that the healthcare workers, including doctors, nurses and other paramedical staffers, will also be included as volunteers in the third phase of the trials.

As per the project investigators, the clinical trials have been largely successful so far, though a few volunteers had mild reactions after the administration of the vaccine in the first two phases.

In Phase I, two doses of Covaxin were given to healthy volunteers in the age-group of 18 to 55 years, while in Phase II, two doses of the vaccine were given to a different set of volunteers in the age-group of 12 to 65 years.

While only healthy volunteers were involved in Phase 1, the volunteers who have controlled diabetes, hypertension or asthma etc were involved in Phase 2 of the trials.

Patients who are suffering from chronic diseases but whose blood sugar, liver and kidney function test reports are normal will be involved in the third phase of the trials.

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