15 August deadline is just to cut the red tape, Covaxin human trial will follow all norms: ICMR

As experts cautioned against rushing the method for developing a COVID-19 vaccine after the ICMR stated it plans to launch one by Assumption, the apex health research body on Saturday stressed that it’s acting in accordance with the globally accepted norms to fast-track vaccine development 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 test sites was meant to chop unnecessary bureaucratic procedure, without bypassing any necessary process, and speed up recruitment of participants.

Bhargava had on July 2 written to principal investigators of select medical institutions and hospitals to fast-track human clinical test approvals for the vaccine candidate ‘Covaxin’ being developed together with Bharat Biotech.

All other vaccine candidates across the world are similarly fast-tracked, it said, adding that the Drugs Controller General of India has accorded permission to conduct phase 1 and a couple of (human) clinical test of ‘Covaxin’ supported in-depth scrutiny of the available data from pre-clinical studies.

Just as bureaucratic procedure wasn’t allowed to become a hindrance within the means approval of latest indigenous testing kits or for introducing within the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement, it said.

“The aim is to finish these phases at the earliest, in order that population-based trials for efficacy might be initiated at once ,” ICMR said during a statement.

After intense characterization and review of all data from BBIL, ICMR said it’s supporting the clinical development because the vaccine candidate appears to be promising.

In the larger public health interest, it’s important for ICMR to expedite the clinical trials with a promising indigenous vaccine, the statement stated.

Faced with the unprecedented nature of the COVID-19 pandemic, and therefore the consequent dislocation of the traditional life, all other vaccine candidates across the world are similarly fast-tracked, it said.

“ICMR’s process is strictly 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,” it said.

Underlining ICMR was among the world’s most reputed organisations within the field of medical research and its diary of facilitating India’s globally respected and acknowledged vaccine and drug industry speaks for itself, the research body said trials are going to be done following the simplest practices and rigour.

They will be reviewed, as needed , by a knowledge Safety Monitoring Board (DSMB).

“While issues raised publicly domain from time-to-time by commentators are welcome, as they form a crucial a part of feedback circuit , the simplest of India’s medical professionals and research scientists shouldn’t be second guessed for his or her professionalism or adherence to the very best scientific rigour,” the statement stated.

“ICMR is committed to treat the security and interest of individuals of India as a topmost priority,” it said.

The Indian Council of Medical Research (ICMR) has identified 12 clinical test sites, including medical institutions and hospitals, and has asked their principal investigators to make sure that the topic enrolment is initiated no later than July 7.

Noting that this was the primary indigenous vaccine being developed by India, Bhargava in his letter to principal investigators of the 12 sites said that it’s one among the “top priority projects which is being monitored at the top-most level of the government”.