Clinical trials in India’s first COVID-19 vaccine to start next week

Over 1,100 people are expected to enrol in the first two phases of human clinical trials for COVAXIN, which is India’s first COVID-19 vaccine. This is according to vaccine developers Bharat Biotech. The Phase I clinical trials are scheduled to start next week and 13 July is set as the date for participant enrolment.

Results from Phase I will decide the start of the next phase of testing. The Indian Council for Medical Research (ICMR)) has selected 12 institutes to conduct these trials, including the All India Institute of Medical Sciences (AIIMS) in Delhi and Patna. These will be fast-tracked.

375 participants will take part in Phase I. They will be split into three groups of 125 and be given two doses – one each of the candidate and control vaccine – 14 days apart. Pending satisfactory completion of Phase I, a further 750 participants will be registered for Phase II of the clinical trials.

According to the application made by Hyderabad-based Bharat Biotech, the timeframe for Phase I is 28 days, which means the trial must start by 18 July to meet the government’s promise of releasing a vaccine by 15 August.
It is unclear, however, if a COVID-19 vaccine can be released after finishing just one of three trial phases.

Two of the world’s leading vaccine candidates – AZD1222 (British firm AstraZeneca) and MRNA-1273 (US-based Moderna) – have been cleared for Phase II, III trials. Across the world over 1.14 crore COVID-19 cases have been reported, including 5.34 lakh deaths. India is now the third worst-affected country, with over seven lakh infections.

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