Indian clinical research body defends schedule for coronavirus vaccine trials

MUMBAI (Reuters) – India’s leading clinical research agency said on Saturday that its decision to accelerate the development of a possible coronavirus vaccine was in line with international standards, after health experts expressed concern about the clinical trial schedule.

The Indian Council for Medical Research released a statement after a letter was leaked on Friday showing ICMR Director-General Balram Bhargava saying the agency “planned” to launch the vaccine for public health use before 15 May. August, with the goal of beginning patient enrollment for human trials by July 7.

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

Vaccine trials generally take years to complete, although regulators have allowed testing of some potential vaccines to be expedited in light of the public health emergency.

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

“Everything will depend on the results of clinical trials,” ICMR spokesman Lokesh Sharma told Reuters.

The ICMR statement said the leaked letter “was intended to cut unnecessary bureaucracy, without overlooking any necessary process and speeding up the recruitment of participants.”

The statement said the goal was “to complete these phases as soon as possible so that population-based efficacy trials could be started without delay.”

He added: “In the interest of public health in general, it is important that ICMR streamlines clinical trials with a promising indigenous vaccine.

“The ICMR process is exactly in accordance with globally accepted standards to accelerate the development of vaccines for diseases of pandemic potential in which human and animal testing can continue in parallel.”