New Delhi: The Indian Council of Medical Research (ICMR) on Saturday said that the process to develop an indigenous vaccine to fight the coronavirus pandemic is as per globally accepted norms of fast-tracking, and that the safety and interest of people of India the topmost priority.
The ICMR had earlier announced an indigenous vaccine, being developed in collaboration with Bharat Biotech, and has asked clinical trials to be completed in time for a launch before August 15.
ICMR issued a press release in which it said, ''As the entire world is battling the COVID-19 pandemic, the development of an effective vaccine is a promising tool to save lives. 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.''
"An inactivated COVID-19 vaccine candidate has been developed by Bharat Biotech International Ltd. in collaboration with ICMR – National institute of Virology, Pune, the release said.
The ICMR further stated in the letter that the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trial of the indigeneous vaccine.
''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-depthn 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.''
The ICMR also justified expediting clinical trials of indigenous Covid-19 vaccine being developed by Bharat Biotech International Ltd.
''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. 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. Now that preclinical studies have been completed successfully, the phases 1 and 2 human trials are to be initiated,'' the release said.
It added 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. The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,'' it added.
''ICMR is 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 speaks 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),'' the apex Indian medical research organisation said.
While seeking feedback from commentators, the ICMR concluded by saying that it is ''committed to treat the safety and interest of people of India as a topmost priority.''
The apex research body on Friday wrote to select medical institutions and hospitals to fast-track clinical trial approvals for the coronavirus vaccine candidate Covaxin being developed in collaboration with Bharat Biotech which it plans to release on August 15.
The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.