Faced with the unprecedented nature of the covid-19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked, ICMR said
The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process
NEW DELHI :
Defending its move to fast-track clinical trials to launch the indigenous coronavirus vaccine by 15 August, Indian Council of Medical Research (ICMR) on Saturday clarified that it only meant to envisage a vaccine by Independence Day and did not fix a deadline for its launch.
“Our internal communication is being misinterpreted. We only said that that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials," a senior official from ICMR told Mint.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine," the premier medical research body said.
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, argued the ICMR.
“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."
Dr Balram Bhargava, ICMR director general and health research secretary, had written a letter to chairman of Bharat Biotech, a state-owned drug company along with its managing director Krishna Ella and senior vice-president Krishna vice-president Krishna Mohan, to expedite the clinical trials for their jointly developed covid-19 vaccine 'Covaxin' ready for launch by 15 August.
“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials," Bhargava wrote. “ln view of the public health emergency due to covid-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated no later than 7 July 2020," the letter said.
To further clarify its stance on the issue, the country’s apex biomedical research agency issued a statement on Saturday stating 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.
“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," ICMR said in a statement.
The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay, it said, adding that “Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)."
Though a large number of vaccines are under various stages of development all across the world, it is also important to promote indigenous vaccine development while at the same time ensuring safety, quality, ethics and adherence to all regulatory requirements, the ICMR statement said.
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 characterization 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.
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