Bhargava's letter on Covid-19 vaccine only intends to cut red tape: ICMR

After the furore in the medical and scientific community following the letter from the head of the country’s premier, state-run medical research organisation, the Indian Council of Medical Research (ICMR), on Saturday clarified its stand. It claimed that the process to develop vaccine to fight Covid-19 pandemic is according to globally accepted norms of fast-tracking. The aim is to cut 'red-tape' and speed up recruitment of participants.

Standing by the letter issued by its director general Dr. Balram Bhargava, the ICMR said that "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." On Thursday, Bhargava wrote a letter to the investigators of the sites for clinical trials asking them to expedite the process as it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.

Thus, the ICMR claimed that the letter by DG-ICMR to investigators of the clinical trial sites was meant to 'cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.'  It further noted that just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits, the indigenous vaccine development process has also been sought to be insulated from slow file movement. "The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay," ICMR said.

In strict words, the ICMR said that while issues raised in public domain from time to time by commentators are welcome, 'the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour.'

Claiming that the ICMR is committed to treat the safety and interest of people of India as a topmost priority, it said "Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)."

In its statement, the health research institute said that that it was important to 'promote' indigenous vaccine development while at the same time 'ensure safety, quality, ethics and adherence to all regulatory requirements.'

An inactivated Covid-19 vaccine candidate has been developed by Bharat Biotech International (BBIL), in collaboration with ICMR – National institute of Virology, Pune. ICMR said that after intense characterisation and review of all data from BBIL, ICMR is supporting the clinical development as the vaccine candidate appears to be promising.

Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India(DCGI)  has accorded permission to conduct phase 1 and 2 clinical trial.

The statement further noted that, "In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked."

However, it is unclear which global vaccine candidate has set a timeline of 40-days from beginning of phase 1 human trials to the launch. Health experts have said that it is unprecedented that a deadline for launch is announced even before the phase 1 trials start.

The ICMR, however, claimed that its 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.' Pre-clinical studies have been completed. Announcing the DCGI nod for phase 1 and 2 human trials, BBIL had  said "Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses."

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