Tribune News Service
New Delhi, July 4
A day after health researchers questioned ICMR’s projected launch of India’s first indigenous vaccine COVAXIN by August 15 this year, the health research body rejected apprehensions, saying the fast tracking process was as per globally accepted norms and the safety of Indians was the top priority for the Council.
The ICMR also said categorically that while issues raised in public domain 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 as the ICMR is committed to treat the safety and interest.
The Council had yesterday asked principal investigators at the 13 clinical trial sites for the indigenous vaccine to enrol subjects by July 7 and ensure compliance of timelines as the launch of the vaccine for public use was envisaged latest by August 15.
Former Health Secretary K Sujatha Rao was among many researchers who attacked the ICMR for trying to push science, asking if it had a magic wand to finish the trials in 45 days.
The Council today said that in larger public health interest, it is important for the ICMR to expedite the clinical trials with a promising indigenous vaccine and the idea is to cut red tape.
“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. 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,” the body said, adding that the inactivated vaccine ICMR has developed with Bharat Biotech is promising.
The council also said that since preclinical studies have been completed successfully, the phases 1 and 2 human trials are to be initiated.
“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.
Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, 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,” said the council exuding confidence of meeting its stipulated August 15 deadline for COVAXIN launch.
The ICMR also reiterated that it was among the world’s most reputed organisations in the field of medical research and regulation and its track record of facilitating India’s globally respected and acknowledged vaccine and drug industry spoke for itself.
“Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB),” ICMR said assuring people safety.
An inactivated COVID-19 vaccine candidate has been developed by Bharat Biotech International ltd. in collaboration with ICMR – National institute of Virology, Pune.
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 has accorded permission to conduct phase 1 and 2 clinical trial,” said the Council.