The human clinical trial of BBV152 COVID-19 vaccine or Covaxin has started at Belagavi-based Jeevan Rekha hospital , one of the 12 centres selected by the Indian Council of Medical Research (ICMR). The clinical tests of Covaxin, the indigenously developed Covid vaccine, has already begun in some of the 12 centres including AIIMS.
Director of Jeevan Rekha, Dr Amit Bhate said, his hospital began with the screening of volunteers who have come willingly to undergo the Covaxin trials. “In the initial stage we have collected blood and swab samples which will be tested in the initial stage of the clinical trials. If the tested volunteers are found negative for Covid19 and their blood is found normal, only such volunteers will be given the first and second dose of Covaxin,” said Bhate.
It takes at least 48 hours to determine the status of volunteers once their blood and swab samples are drawn, he said. Once both the doses of Covaxin are administered to the volunteers, the hospital would keep a tab on the health condition of every volunteer tested and their blood samples are collected every month for testing. “We will have to check the tested volunteers regularly to ascertain how much anti-bodies are developed in their blood besides knowing about their immune system. Once the immune system of the tested patients reaches a certain level, the ICMR will calculate it. All the samples are regularly sent to the ICMR, which will take a final call on when to release the vaccine finally,” Dr Bhate said.
The Oxford vaccine seems to have reached a good level and plans are afoot to release it. At most of the 12 centres, the process of clinical trials have begun and are in the initial stages. The Jeevan Rekha wants to perform the entire process of clinical test of the vaccine in an ethical manner by taking the consent of each one of the volunteers. “We will stop the process mid-way if the volunteer decides to withdraw even in the last stage before the vaccine is administered to him. The consent letters of the volunteers will be submitted to DG of ICMR and then the enrolment is done as per the rules.
Jeevan Rekha has invited volunteers to come forward for the tests. The volunteers are needed to be aged between 18 and 55 years.
News source : TNIE