AIIMS Delhi begins clinical human trial of Covaxin.
AIIMS Delhi to begin clinical human trial of Covaxin, India’s first Covid19 vaccine candidate today. Covaxin is an indigenous Covid19 vaccine developed by Bharat Biotech in association with ICMR and National Insti. The Drug Controller General of India (DCGI) gives its nod to begin the phase I/II of human clinical trials.
Around 375 volunteers have registered themselves for the vaccine trial, out of which 100 volunteers will be vaccinated at AIIMS. ICMR has selected 12 sites for conducting clinical human trials of covaxin. “Few volunteers have already registered for the trial. We would start the screening of the individuals and evaluate their health condition from Monday onwards before vaccinating them,” says Dr. Sanjay Rai, AIIMS.
The Ethics Committee of Delhi AIIMS gave the approval to begin the human trials from today. AIIMS has begin enrolling volunteers for the procedure of vaccination. Apart from Delhi AIIMS, AIIMS Patna and Post Graduate Institute of Medical Sciences, Rohtak has already started the clinical human trial of covaxin.
“Three subjects have enrolled for the trial and tolerated the vaccine very well. There are no adverse effects,” says Haryana’s Health Minister, Anil Vij.
Eligibility for Volunteers.
Volunteers who are healthy and have no Covid19 history are eligible for volunteering for vaccine trials. The age group for the volunteers to go for vaccine trials is 18 to 55. All the volunteers will undergo tests for Covid19 and other comorbidities. If found healthy, the officials will go ahead with the vaccination procedure.
“We are going to select healthy participants with no comorbidities and without a history of COVID-19. The age group of the study population is 18 to 55 years. This would be a randomised, double-blind, placebo-controlled clinical trial,” says AIIMS Professor, Dr. Sanjay Rai.
All the volunteers who are vaccinated will be under observation for 150 days. “After administering the vaccine, we will follow up with the volunteers through phone calls. They will be kept under observation for nearly 150 days,” adds Dr. Sanjay Rai.
AIIMS has set up an email id and phone number for volunteers to register themselves for the trials. Volunteers who are willing to participate in the clinical human trials for covaxin can email their details at – firstname.lastname@example.org. They can also call or send an SMS to – 7428847499.
Two Indian Covid19 Vaccines.
The first Covid19 vaccine candidate from India to get DCGI nod for phase I/II human clinical trials is Covaxin. Covaxin is an indigenous vaccine from a Hyderabad firm Bharat Biotech in association with ICMR and National Institute of Virology.
India’s second indigenous Covid19 vaccine ZyCoV to get DCGI nod is from a Gujarat-based pharmaceutical firm Zydus Cadila. ZyCov has also begun it’s human trials from this week. Over 1000 volunteers will take up the trials for ZyCoV across different sites in India.