‘Human trials to begin soon’

NEWDELHI:Human clinical trials are about to start on two indigenous Covid-19 vaccine candidates, the Union health ministry said on Thursday, as they join the race with 100-odd potential vaccines that are in various stages of development globally.

“For India, it is a proud moment that two of its entirely indigenous Covid-19 vaccine candidates are ready for human clinical trials. One of the two is from Bharat Biotech International Ltd. and the other is of Cadila Healthcare Ltd. Bharat Biotech’s vaccine candidate is being developed in partnership with the Indian Council of Medical Research [ICMR],” said Rajesh Bhushan, officer on special duty, Union health ministry.

On both these vaccine candidates, animal toxicity studies have been completed.

“Animal toxicity studies are conducted on mice, guinea pigs, and rabbits. These studies have already been concluded and the toxicity data in respect of both these vaccine candidates has been shared with the Drugs Controller General of India. The drugs controller has permitted these two vaccine candidates to go in for phase 1 and phase 2 (human) clinical trials,” said Bhushan.

The sites for clinical trials have already been finalised, and the trials are about to start.

“The results of animal trials data submitted to the department were found to be satisfactory to allow these to progress to next level of human trials.

There is a subject expert committee that scrutinises the data set at every level before giving their consent. Nothing substandard can pass through. This is just one step and there are several steps before the vaccine is ready for use,” said a senior official in the Central Drug Standards Control Organisation (CDSCO). Twelve sites have been finalised for the trials.