The results from the first part of phase-1 trial of Covaxin, India's first indigenous covid vaccine candidate, are "encouraging", said principal investigator of the vaccine trial team at PGI Rohtak. The human trial of the first part of phase-1 of the vaccine candidate was over on Saturday at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak. Human trials of Covaxin had started PGI Rohtak on July 17, with three volunteers getting Covaxin on that day.
Covaxin has been developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. It is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology (NIV), Pune.
Here are updates from human trial of covid vaccine Covaxin:
"First part of phase-1 of vaccine trial (Covaxin) has been completed. 50 people across India were administered the vaccine and the results were encouraging. Six people were administered vaccine on Saturday under second part of phase-1," Dr Savita Verma, principal investigator of the vaccine trial team, told news agency ANI.
Also on the same day, the six people were administered the vaccine under the second part of phase-1.
Earlier this week, human trials of Covaxin had started at AIIMS-Delhi, with the first dose of the injection given to a man, who is in his 30s.
No immediate side-effects have been observed so far, said the principal investigator of the study at AIIMS-Delhi on Friday.
Already, over 3,500 volunteers have already registered themselves for the trial at AIIMS.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.
The second phase would include around 750 volunteers from all 12 sites together. And they will be recruited between 12-65 years.
"In the first phase we see the safety of the vaccine which is of primary importance and the dose range is also calculated," AIIMS Director Dr Randeep Guleria had said.
Meanwhile, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2 and 3 human clinical trials of the potential vaccine, Press Trust of India reported citing sources.
(With Agency Inputs)