Following global norms to fast-track vaccine: ICMR

COUNCIL SEEKS TO DISPEL CONCERNS

NEW DELHI: As experts cautioned against rushing the process for developing a COVID-19 vaccine after the ICMR stated it plans to launch one by August 15, the apex health research body on Saturday defended fast tracking of the clinical trials, saying it is acting in accordance with the globally accepted norms to accelerate efforts to procure a vaccine for diseases of pandemic potential.

The ICMR said that the letter by Director General of ICMR Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.

“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 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked,” ICMR said in an official press release on Saturday, adding, “ICMR’s process is exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”

The controversy erupted after ICMR wrote to the 12 institutes selected for conducting human trials for Covaxin. The letter was followed by criticism, with experts questioning the safety of such expedited trials that generally require months to complete. “Fast tracking a vaccine trial in four weeks is just not possible if things are to be done correctly,” Shahid Jameel, virologist and CEO of the Wellcome Trust/DBT India Alliance, said. Virologist Upasana Ray added that an accelerated launch of a vaccine against the novel coronavirus deserves applause but it is important to ask whether “we are rushing too much”.