India's medical research body defends timeline for coronavirus vaccine trials

WION Web Team New Delhi, Delhi, India Jul 04, 2020, 08.30 PM(IST)

Coronavirus vaccine Photograph:( Reuters )

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The vaccine, being jointly developed by India’s Bharat Biotech and ICMR, is one of several candidates being tested globally to fight the coronavirus.

The Indian Council for Medical Research (ICMR) on Saturday said its decision to fast-track development of a potential coronavirus vaccine was in line with international standards. This remark came after health experts raised concerns about the schedule for clinical trials.

The nodal agency issued a statement after a letter was leaked on Friday showing ICMR Director General Balram Bhargava as saying the agency “envisaged” launch of the vaccine for public health use by August 15, with the aim to begin patient enrolment for human trials by July 7.

The vaccine, being jointly developed by India’s Bharat Biotech and ICMR, is one of several candidates being tested globally to fight the coronavirus.

The ICMR's timeline drew criticism from health experts in India, who expressed concern the trials would compromise patient safety and ethics.

Also read | Scientists strike note of caution as 'Made in India' vaccine programme gains momentum

The ICMR’s statement said the leaked letter “was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.” The aim was “to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay," it added.

“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine.

“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”

Vaccine trials usually take years to complete, though regulators have allowed testing on some potential vaccines to be fast-tracked in light of the public health emergency.