All India Institute of Medical Sciences (AIIMS) on Monday, announced that it will start screening volunteers for phase-1 testing of the indigenous COVID-19 vaccine, Covaxin, on healthy persons aged 18-55, without co-morbidities.
AIIMS, Delhi is among 12 sites listed by Indian Council of Medical Research (ICMR) cleared to conduct human trials of Covaxin, developed by Bharat Biotech.
ICMR is a collaborator on the Covaxin vaccine project.
“Safety of those recruited will be a prime concern during the study. We should be able to make available the data within about two to three months. And we expect that if everything goes well the vaccine should be ready by the end of this year or early next year,’’ said AIIMS director Randeep Guleria at a press conference.
He added that the southeast Asian region is seeing a relatively lower COVID-19 mortality. “The mortality rate is much lower than what happened in Italy and Spain or what is happening in the United States,” he said.
Stating that there is not much evidence of community transmission at national level, Dr. Guleria said certain areas, like Delhi, seem to have hit their COVID-19 case peak. The national capital is now seeing a stabilisation and decline in the number of cases, he said, adding, “But there are hotspots and we still cannot let our guards down.”
“In cities where there is spike of cases, it is likely that local community transmission in those areas is happening,”Dr Guleria said.
Speaking about COVID re-lapse and expected COVID surge during monsoon and winter season, Dr. Guleria said not enough data is currently available to say for certain that there is a re-lapse in patients.
“While there is evidence that some virus spread more during these seasons we can’t say for certain what path COVID will take. We are also seeing a minor mutation in the virus which seems to have made it more infectious but less severe,” he said.
Trials at Hyderabad
Phase-1 human trials also began at the Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad, with two healthy volunteers administered the first dose of Covaxin.
“Health condition of the volunteers will be monitored for six months,” said doctors involved in the clinical trials. They said the main focus of monitoring will be to check whether antibodies are generated in the volunteers, amount of time it took for the antibodies to kick-in, and how long they last in the body. A second dose of the vaccine will be given to them after a gap of 14 days.
NIMS is one among the 12 institutions involved in COVID vaccine trials, as listed by the ICMR. Dr Prabhakar Reddy is the principal investigator of the clinical trials at NIMS.
Apart from faculty and senior residents from the Department of Clinical Pharmacology, doctors from General Medicine, Anaesthesia, and Respiratory Medicine too are involved in the clinical trials.
The potential vaccine is derived from a strain of SARS-COV-2 isolated by National Institute of Virology, Pune. The inactivated vaccine candidate was developed by Hyderabad-based Bharat Biotech India Ltd (BBIL). They received the Drug Controller General of India (DCGI) nod on June 29 for Phase 1- and Phase-2 clinical trials.
On July 2, ICMR Director General Balram Bhargava sent a letter to heads of the 12 institutes that their institute was chosen as a clinical trial site for the vaccine. They were strictly advised to ensure that the subject enrolment was initiated not later than July 7.
Around 12 days ago, NIMS director K Manohar said that they were screening the subjects and that the vaccine doses will be administered after receiving ICMR approval. More volunteers will be administered the doses in the coming days. Doctors are expecting around 60 to 80 volunteers at NIMS.
