Coronavirus vaccine latest update: Covaxin trial begins at AIIMS Delhi; 30-year-old man given the first dose

While the Oxford vaccine candidate continues to garner headlines for its promising results of early trials, India is also taking great strides in vaccine development. The clinical trials of India’s first coronavirus vaccine candidate ‘Covaxin’ have already commenced in All India Institute of Medical Sciences (AIIMS), Delhi on Friday. The first dose of the indigenously developed Covaxin was given to a 30-year-old man at AIIMS, Delhi and the volunteer was kept under observation for two hours at the hospital. There were no immediate side-effects of the vaccine candidate and he will be monitored for the next seven days as well.

India’s first homegrown vaccine has been developed using an inactivated version of the spike protein of the novel coronavirus and aims to trigger an immune system response in the body with the production of protective antibodies. The potential vaccine has been produced by the Hyderabad-based Bharat Biotech, which is a renowned vaccine manufacturer. After the Drug Comptroller of India (DCGI gave the go-ahead to conduct Phase I/II trials of Covaxin, 12 medical institutes across India were selected to start clinical trials, including AIIMS Delhi and Patna by the Indian Council for Medical Research.

The first jab of indigenous vaccine çanditate ‘Covaxin’ in AIIMS, Delhi was given to a 30-year-old healthy man, who was screened in two days ago for the Phase I/II clinical trials. The volunteer, who is a resident of Delhi, did not have any co-morbid conditions and his health parameters were also checked, according to a report published in PTI.

“The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days," said Dr Sanjay Rai, who is a professor at the Centre for Community Medicine at AIIMS.

He further stated that Covaxin was will be administered in three different strength doses and the first 50 volunteers will be dosed with the lowest strength. If the lowest dose is found to be safe, then the next 50 volunteers will be administered with a high strength dose.

As of now, more than 1800 volunteers have already signed in to take part in Phase I/II randomised, double-blind, placebo-controlled clinical trials going on in AIIMS Delhi. In Phase 1 of the trials, 375 volunteers will be dosed with the vaccine candidate and Phase 2 will be conducted on 750 volunteers.

For the first stage of human trials, healthy volunteers between the ages of 18 to 55 will be recruited (who do not have any co-morbidities), while for Phase 2, people between the ages of 12-65 will be enrolled. AIIMS director Dr Randeep Guleria said, “In the first phase we see the safety of the vaccine which is of primary importance and the dose range is also calculated.”

As of now, there are at least 7 Indian companies working on an effective vaccine to combat the novel coronavirus. Drugmaker Zydus Cadila has also started human dosing of its vaccine candidate,ZyCoV-D and the others include Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.