On Tuesday, a top official of the state-owned medical facility said, the process of carrying out the clinical trials for vaccine candidate COVID-19, Covaxin, had begun here at the Nizams Institute of Medical Sciences (NIMS). “We will pick healthy people and draw blood and send blood samples to approved laboratories in New Delhi, give a green letter. Then medicine will examine and proper examination will be given to the first vaccine shot,” said Dr. K Manohar, director of the NIMS, to PTI.
Two clinical trials sites have been identified by the Indian Council of Medical Research (ICMR), including the NIMS, and its key investigators have been asked to see that the subject enrollment is started no later than July 7.
“All will be sent to ICMR, and the details will be processed. We have already begun screening people. Next we will request the individual’s audiovisual consent,” said the medical officer. When asked about the total number of people needed for the clinical trial, Manohar claimed that at least 30 people were needed.
The request for the clinical trials was already brought before the NIMS Committee on Hospital Ethics. Recently, the Drug Controller General of India, in partnership with the Indian Council of Medical Research (ICMR) and the NIV (National Institute of Virology), granted permission to initiate Phase I & II human clinical trials for COVID-19 Covaxin vaccine.
