COVAXIN: First part of phase 1 trials complete; results encouraging
The first part of phase I trials of India's first indigenous COVID-19 vaccine candidate has completed and the results are said to be encouraging. The potential vaccine, COVAXIN, is now undergoing the second part of the phase I trials. COVAXIN has been developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
50 people received COVAXIN; results encouraging: Trial principal investigator
The principal investigator of the vaccine trial team at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak, Dr. Savita Verma, told ANI, "First part of phase I of vaccine trial has been completed. 50 people across India were administered the vaccine and the results were encouraging." Human trials of COVAXIN had commenced at PGI Rohtak on July 17 when three volunteers received the potential vaccine.
375 people to receive COVAXIN in first phase
In the first phase, 375 people across India were to be administered COVAXIN. In the first part of phase I trials, 50 people across India were to receive the potential vaccine to assess its safety, which has been completed, Dr. Verma said. According to ANI, under the second part of phase I trials, six people were administered COVAXIN on Saturday.
Human trials started at Delhi's AIIMS earlier this week
On Friday, human trials of COVAXIN also started at the All India Institute Of Medical Sciences (AIIMS) in Delhi and a man in his 30s received the first dose. Over 3,500 volunteers are already registered for the trial at AIIMS. AIIMS-Delhi is among the 12 sites selected by the ICMR for conducting phase I and II randomized, double-blind, placebo-controlled clinical trials of COVAXIN.
750 to receive vaccine in second phase
The second phase of trials would include 750 volunteers across the 12 sites. All volunteers who will be recruited will be in the age group 12-65 years. AIIMS Director and leading pulmonologist, Dr. Randeep Guleria had earlier said, "In the first phase, we see the safety of the vaccine which is of primary importance and the dose range is also calculated."
When will this vaccine be available?
The experimental vaccine, developed by Hyderabad-based Bharat Biotech, has to clear Phase 1, 2, and the final and the largest Phase 3 of human trials to be ready for approval and public use. ICMR had previously said it aims to make the shot available by August 15, but Bharat Biotech's founder Dr. Krishna Ella believes it is too early to announce a launch date.
