COVID-19: ICMR clarifies August 15 not a deadline for vaccine; aims at completing clinical trials phases at earliest

COVID-19: ICMR clarifies August 15 not a deadline for vaccine; aims at completing clinical trials phases at earliest

After setting an ambitious deadline of August 15 to launch India's indigenous vaccine named COVXIN, which experts believe is unrealistic, the Indian Council of Medical Research (ICMR) clarified on Sunday, August 15 is not a set deadline for the launch of COVAXIN, rather it's just an effort at fast-tracking the trials.

ICMR said, just like the other vaccine candidates in other countries even India is trying to complete the trials at a fast pace to contain the spread of coronavirus.

In a statement made by the apex body, they said, “Just as red tape was not allowed to become a hindrance in the fast-track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement."

On Thursday, Balram Bhargava the ICMR director-general and health research secretary sent a letter to Krishna M Ella, chairman and managing director of Bharat Biotech International Ltd, directing them to 'fast-track' the process of clinical trials of COVAXIN, so that it can be released as early as August 15. In his letter to all the designated companies around the country, he requested them to accelerate approvals process and subjects for trails must be enrolled by July 7.

In a report by Livemint, an ICMR official said, “Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials."

Bharat Biotech International Ltd in Hyderabad in partnership with National Institute of Virology, Pune developed India's first indigenous vaccine and recently received approvals from Drugs Controller General of India for clinical trials.

According to media reports, the biomedical research agency aims to complete all the five stages of clinical trials of vaccine at the earliest. The ICMR officials added, “Our trials will be done following the best practices and will be reviewed by a data safety monitoring board."

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