Indian Council for Medical Research (ICMR), in joint partnership with Bharat Biotech has developed India’s very own COVID-19 vaccine named Covaxin. The vaccine will be tested on 375 people in phase 1 trial and on 750 people in the subsequent phase. In all, it will be tested on more than 1000 people. The indigenous COVID-19 vaccine had received nod from DCGI (Drug Controller General of India) for phase 1 and 2 trials.
Among the 12 medical institutes that have been selected by ICMR, All India Institute of Medical Sciences (AIIMS), Patna, will begin the clinical human trials this week.
Earlier this week the AIIMS-Patna Superintendent Dr CM Singh had said that the clinical trials would start in the next two days. And they are in the process of completion of some guidelines and formalities related to logistics and other procedures.
The encouraging news is that the vaccine passed the animal trial phase successfully and has now entered the human trial phase. While the first phase will test 1000 people, the second phase of the trial will have a bigger number, which ultimately depends on the final outcome of the study. The estimated time frame for clinical trials is expected to be 6-8 months.
To ensure faster outcomes, the selected medical institutes have been asked to fast track their clinical trials and make it their top priority project.
Yesterday, Hyderabad-based Nizam’s Institute of Medical Sciences (NIMS) had said that they have begun the process of enrolling participants for the first stage of human trial.
For the uninitiated, Covaxin is an inactivated vaccine, which has been made with dead particles of the SARS-CoV-2, disabling them from infecting or replicating. Once this vaccine is injected into healthy individuals, the body will produce antibodies to fight the foreign body and is expected to get equipped to handle the live virus – basically how vaccines really work.
The trials will be done on healthy individuals between the age group of 22 and 50 years. Even global clinical trials are choosing approximately the same age group for testing their vaccines, which can be an area of concern because we may not know if the vaccines being developed will actually help those in their 70s and 80s, who are the vulnerable group. It is yet to be seen if the devised treatment will also benefit the older people or if the same vaccine that works on the younger lot will also work on the older population.