The clinical trial of the first Indian vaccine against Covid-19 will take place in about a dozen hospitals, including one in Karnataka and two AIIMS at Delhi and Patna, but ironically it is the ongoing Covid-19 pandemic that may delay the process a bit.
Belgavi’s Jeevan Sakhi Multi-speciality hospital would be among the units where the multi-city clinical trial of the vaccine will be conducted. Two All India Institute of Medical Sciences and Hyderabad’s Nizam Institute of Medical Sciences would also be a part of the trial.
Developed by Hyderabad-based Bharat Biotech, the first few batches of the vaccine named Covaxin have been sent to the Central Research Institute, Kasauli, for certification following which they would be dispatched to hospitals involved in the trial. In a parallel process, ethical committee approvals are being taken.
“Even though the trial is slated to begin in July 2020, arranging the logistics of vaccine transportation in the middle of so many restrictions imposed by the government due to the Covid-19 pandemic has turned out to be a challenge. I can’t commit now on when the trial would start and when we would receive the results,” Krishna Ella, Chairman and Managing Director of Bharat Biotech told DH.
The Drugs Controller General of India has granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. The phase-1 trial is to check the vaccine’s safety in human beings while phase-II would look at the efficacy in a limited way.
During the trial, medical researchers will examine the vaccine’s efficacy with a single dose as well as with a double dose on the 1st and 14th day. The vaccine was made from an ineffective strain of the Covid-19 virus isolated at the National Institute of Virology, Pune.
Inactivated vaccines have been around for decades. Several such vaccines are used to fight against seasonal influenza, polio, rabies, Pertussis and Japanese Encephalitis.
Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves the immune system as a dead virus and mounts an antibody response towards the virus.
Bharat Biotech produced the first GMP-grade batch of the vaccine within 40 days of receiving the isolate from the NIV.