Human trials of Covaxin on 375 people soon; 50 persons from WB have volunteered for trial; NO deadline fixed for developing, marketing Made in India vaccine, says ICMR

INDIA has joined the mad race to develop drugs for saving humans from dreaded novel coronavirus. New Delhi based Indian Council of Medical Research (ICMR) after waving the deadline for developing vaccines following brickbats from the scientific community has received encouraging response from several medical institutes in the country to kick off the first phase of Human Clinical Trials by registering volunteers. Several Institutes have begun enrolment process. ICMR has partnered with Bharat Biotech International Limited to develop COVAXIN, whereas Zydus Cadila is working on ZyCov-D Vaccine. Drug Controller General of India recently gave nod to the human trial for both COVAXIN and ZyCov-D vaccines marking the beginning of an end to the global pandemic. Indian manufacturers account for 60 percent of vaccine supplies made to UNICEF. Across the world, over 140 candidates claim their vaccines are under various stages of development. Indian institutions are also engaged in Research and Development for the development of vaccines in India. With the beginning of the enrolment of volunteers. The two Indian vaccine candidates will now be tested on 1,125 healthy volunteers in the two phases of trials. The vaccines will be evaluated for its safety, reactogenicity, tolerability and immunogenicity. Volunteers will be administered two intramuscular shots.

Chiranjit Dhibar, a school teacher has received a phone call from ICMR asking him to be ready for the clinical human trial of Covid-19 vaccine. While the date has not been confirmed to him as yet, however, he has been told that the test will happen at the ICMR centre either at Bhubaneshwar in Odisha or Patna in Bihar. An active RSS worker, Dhibar hails from Durgapur in East Burdwan district of West Bengal.  An official from Patna ICMR has reached  him on Sunday stating that he will be required there soon, indicating that his clinical trial in all likeness might happen at Patna, claimed Dhibar.”I had sent a request to ICMR back in April. I wanted to undergo the clinical trial of the vaccine. That’s a little effort for our vast mankind. The tests have to happen on human beings. Someone or other has to come forward and take the risk. Then why not me. It’s my service to the nation. I am mentally prepared, there is no stress at all,” said Dhibar. More than 50 people from West Bengal had applied to undergo the clinical trial of the COVID-19 vaccine, Dibar is the only one to have received a call back from the Indian Council of Medical Research. The proposed age groups for the trials are 18-55 years for Phase I and 12-65 years for Phase II. Dr.Rakesh Mishra, Director of Centre for Cellular and Molecular Biology, Hyderabad, has urged people not to lower their guards amidst the scientific progress on vaccine development. After facing brickbats for putting a deadline for developing a vaccine against coronavirus India’s first possible vaccine against COVID-19, will be tested on over 1,100 people in two phases, according to a report in Bloomberg. Bharat Biotech, an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot. The phase 1 trial of Covaxine is scheduled to start next week. The company has planned to enrol 375 people in the first phase of clinical trials, an Indian Council for Medical Research (ICMR) spokesperson told Bloomberg. The company has set July 13 as the last date of enrolment for the first trial. The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. Depending on the results of the first trial, the company has a plan to enrol 750 people in the second phase of the trial. Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received ICMR’s letter. “We are all working day and night to meet the deadline but still it will be neck to neck race,” said C. Prabhakar Reddy, a professor in Nizam’s Institute of Medical Sciences, adding that he doesn’t anticipate any shortage of volunteers “in the current scenario, “says Livemint. The ICMR on Sunday said it has not set a 15 August deadline for a Made-in-India vaccine for COVID-19, after a controversy over setting a hurried target for the drug. Zydus Cadila group chairman Pankaj Patel claims in a statement that human trials for the coronavirus vaccine will be started soon and it will take three months to finish the trials. The trials will be conducted on 1,000 volunteers. The vaccine, ZyCoV-D has showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in the statement. (Edited by PKC with inputs from Livemint)