After facing criticism from doctors, experts and Opposition, the Indian Council of Medical Research (ICMR) on Saturday issued a clarification on fast-tracking the launch of  Covaxin, India's Covid-19 vaccine candidate being developed by Indian company Bharat Biotech International Ltd. Defending the move, ICMR said that the decision to expedite clinical trials was taken in the larger public interest and that the process of developing the vaccine was in line with the globally accepted norms.

"In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid 19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked," ICMR said in a press release.

The medical body received backlash after its Director-General Balram Bhargava wrote to the 12 institutes selected for conducting human trials for Covaxin, asking them to expedite the human trials and set the deadline to launch the vaccine on August 15.

 

Letter meant to cut the "unnecessary red tape"

Several experts and doctors said that the six-week deadline for a candidate vaccine was "unrealistic" and Opposition said that the ICMR was compromising with the safety of people by setting the Independence Day launch date to help Prime Minister Narendra Modi score political points.

ICMR, however, clarified that the safety of all the Indians was its topmost priority and that its letter to researchers was meant to cut the "unnecessary red tape" without bypassing the due process to develop a vaccine for a pandemic-level disease.

 

"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. The aim is to complete these phases at the earliest so that population-based trials for efficacy could be initiated without delay," it said.