Phase-3 trial of Covaxin to focus on effectiveness of vaccine to prevent Coronavirus

The phase 3 trial of Covaxin, India's indigenous vaccine against COVID-19, began on Friday in Odisha. The trial for the third phase will be conducted across 21 medical institutions across the nation. 

The medical institutions, which were chosen by the Indian Council of Medical Research (ICMR) in the state of Odisha, included the Institute of Medical Sciences (IMS) and SUM Hospital in Bhubaneswar, said Dr E Venkata Rao, principal investigator of COVAXIN trial. 

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The vaccine's first phase trial was aimed at measuring its safety, while phase two was meant to test its immunogenicity, added Dr Rao. Phase three trials will evaluate if the vaccine was actually able to prevent development of the disease among the recipients of the vaccine, Dr Rao stated. 

The third phase three would also be evaluating if the vaccine was actually able to prevent the development of the disease among the recipients of the vaccine, added the principal investigator. 

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Dr Rao stated that "phase three of the trial is crucial and tedious since we have to wait till the development of the disease which is dependent on the frequency of the disease in the population". He further stated that a large number of subjects and more than 25,000 volunteers were being recruited for the trial across the country.

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Dr Rao said that in phase three, two doses will be administered to each volunteer 28 days apart. The follow-up period will extend to 12 months in order to understand its long term and side effects, he said.

 He said that while recruiting volunteers for third phase trial, the restriction of being a healthy volunteer was not compulsory. He asserted that anyone with diabetes or hypertension or with any other disease could also participate in the trial provided the disease was under control in them with medication.

Covaxin: India's indigenous vaccine against COVID-19

The Covaxin is one of the vaccines against the COVID-19 being developed in India by Bharat Biotech International Limited(BBIL) and Indian Council of Medical Research (ICMR). The first and the second phase of human trials, had been completed successfully and the Drugs Controller General of India(DGCI) gave the permission for the third phase of human trials in the month of October. 

(With Inputs from agencies)

Read | Phase-3 trial of Covaxin begins in Odisha institute