AIIMS begins phase-1 clinical trials for Covaxin

A 30-year-old male, on Friday, became the first person to be administered the first dose of India’s indigenous COVID vaccine , Bharat Biotech’s Covaxin at the All India Institute of Medical Sciences (AIIMS) , Delhi, one of the 12 sites selected to test the vaccine.

Also read: Coronavirus | ICMR looks at COVID-19 vaccine launch by August 15

The subject, who was monitored for two hours at the hospital, has been discharged and will be under medical supervision for the next two weeks, said doctors at AIIMS.

Speaking to The Hindu , Professor at the Centre for Community Medicine, AIIMS, Sanjay Rai said: “The screening process has been on for voluntary participants who wanted to be enrolled for the first phase of human clinical trial of Covaxin. Of the candidates, 50% were found eligible and we selected this subject to administer the first dose of India's COVID-19 vaccine at AIIMS, Delhi.”

Dr. Rai said the first dose of 0.5 ml intramuscular injection was given to the subject around 1.30 p.m. and he was at the hospital where no immediate side-effects were observed. “Tomorrow onwards we will be administering the proposed vaccine to other volunteers,” Dr. Rai he said.

Also read: Covaxin trial to start at Belagavi hospital

Speaking about the volunteers who have come forward to help in the testing of the vaccine, Dr. Rai said in the first round, they have a ratio of 60:40 (female: male). 

“The screening process is done to ensure that the subject is healthy with no co-morbid medical complications. Two other centres in India have started trials and administered the proposed vaccine to human volunteers,” he said. 

Also read: COVID-19 vaccine | Bharat Biotech starts human trial at PGI Rohtak

“There are three formulations of the COVID-19 vaccine candidate. Each subject will be given any one of the formulation in two doses two weeks apart. The first 50 will get the lowest strength dose of the vaccine. If it is found to be safe in them, then it will be given to another 50 patients in high doses,” added Dr. Rai.

The vaccine has been developed by the Hyderabad-based pharmaceutical company in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR). AIIMS, Delhi was selected by the ICMR for conducting phase I and II trials. Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune.

Also read: AIIMS to start phase-1 testing of indigenous COVID-19 vaccine

AIIMS director Randeep Guleria had earlier said the first phase of the trial is to ensure the safety of the vaccine and the dose range.

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Printable version | May 22, 2022 3:22:16 pm |