India. New Delhi: After receiving criticism from the scientific community on fast-tracking the launch of the COVID vaccine, the health research body ICMR on Saturday stressed that it is working in compliance with the global norms to accelerate vaccine development for COVID. ICMR, in a statement released on Saturday, indicated that they are aiming to complete the clinical trial phases in order to initiate the population-based trials for Phase 3.
On July 2, Director General of the Indian Council of Medical Research (ICMR) Dr. Balram Bhargava sent out a letter asking officials at 12 hospitals across the country to expedite the human clinical trials and fast-track vaccine testing process. Regarding the letter sent by Director General of ICMR Dr. Balram Bhargava to principal investigators of the clinical trial sites, ICMR said that it was meant to bypass the redundant rules, cut unwanted clusters without bypassing any mandatory process.
The COVID vaccine called ‘Covaxin’ has been developed by Hyderabad-based, Bharat Biotech India Ltd (BBIL). India‘s first COVID-19 vaccine is developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology (NIV) at a highly confined space.
It got approvals for clinical trials from the Drug Controller General of India (DCGI) on June 29 for phase-1 and phase-2 trials. In a note circulated on the day it received approval for trials, Bharat Biotech mentioned that the results of Phase I and Phase II trials would be out only by October 2020. Timelines for Phase 1 & 2 human clinical trials are now updated as of July 2020.
Phase 1 trials are usually carried out on a few volunteers and are meant to check the safety of the vaccine in the body. These clinical trials take a few months. In Phase 2, scientists check whether the vaccine is able to trigger the desired immune response. A large number of volunteers are required to run the Phase 2 trials for these and this could take up to several months. Phase 3 trials focus on efficacy. It is closely observed if the immune response it generates is able to fight the disease or not. The vaccine can only be approved for the public once these larger clinical trials provide satisfactory output.
Realistic or Too Optimistic?
India is focused on accelerating the development of its own COVID vaccine for Coronavirus. The ambitious deadline for the launch of the COVID vaccine surprised scientists. AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19 stated that It will be challenging and a difficult task, considering the efficacy and safety of any vaccine that is introduced. Also, if the desired results can be drawn, the other major challenge would be the process of mass production of the vaccine.
According to the latest update, The Ministry of Science and Technology issued a statement on Sunday afternoon indicating that it is unlikely to expect Coronavirus vaccine to be available for the public before 2021.