India’s leading clinical research agency said Saturday its decision to fast-track development of a potential coronavirus vaccine was in line with international standards, after health experts raised concerns about the schedule for clinical trials.
The Indian Council of Medical Research 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 Aug. 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 pandemic.
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.
The ICMR’s timeline drew criticism from health experts in India, who expressed concern the trials would compromise patient safety and ethics.
“Everything will be dependent on the clinical trial results,” ICMR spokesman Lokesh Sharma told Reuters.
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 statement said 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.”
