A day after saying that it aims to launch the world's first COVID-19 vaccine by August 15, the Indian Council of Medical Research (ICMR) on Saturday said the development process of the indigenous vaccine is as per globally accepted norms of fast tracking, and that the safety and interest of the people of India is the topmost priority.
The statement came after experts criticised the apex medical body's decision telling select medical institutions to fast-track its clinical trial approvals.
The ICMR on Friday said it has identified 12 clinical trial sites, including medical institutions and hospitals, and asked their principal investigators to ensure the subject enrolment is initiated no later than July 7. The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu.
COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited(BBIL) in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drug Controller General of India(DCGI).
"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 said in a statement on Saturday.
"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," it added.
The ICMR said it is important to expedite the clinical trials with a promising indigenous vaccine "in the larger public health interest".
"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," it added.
In its letter to principal investigators of the 12 sites, ICMR Director General Dr Balram Bhargava noted that the clinical trial of Covaxin is one of the "top priority projects which is being monitored at the top-most level of the government".
"It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project," Bhargava said in the letter.
However, it is not clear how the clinical trials can be completed and the vaccine released on August 15 when the normal period for a vaccine to be approved is 12 to 18 months.
The ICMR said the letter by Bhargava 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, it said.
"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 a statement.
After intense characterization and review of all data from BBIL, ICMR said it is supporting the clinical development as the vaccine candidate appears to be promising. In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine, the statement said.