Covid-19: Bharat Biotech cuts Covaxin phase-2 clinical trial size by half

For phase-2 studies, the firm is also testing the vaccine on children above 12 years of age. In phase-1, they only tested adults.

Bharat Biotech has halved the size of the phase-2 clinical trial of its Covid-19 vaccine candidate Covaxin and would now test it on only 380 volunteers after it got good immunogenicity data from the phase-1 trials. 

The firm said volunteers did not complain of any major side effects apart from fever and body aches. The trial size for phase-1 and -2 trials was set at 1,125 candidates. Of this, 375 volunteers were vaccinated in phase-1. So, 750 were to be a part of the phase-2 studies. The company confirmed the phase-2 will test only 380 volunteers but refused to share details. 

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