As the number of coronavirus cases has been rising a a pace of daily highs in the country for the past few days, India’s first indigenous COVID19 vaccine COVAXIN has got a nod from AIIMS ethics committee on Saturday to start human trials from Monday, From today, the human trails are all set to go.
What is COVAXIN?
Bharat Biotech’s Covaxin is an “inactivated” vaccine, which is made using particles of the Covid-19 virus that were killed so that they would not be able to infect or replicate in those injected with it. Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus, according to the firm.
10 things you need to know about COVAXIN:
- The AIIMS Ethics Committee gave its nod for a human clinical trial to begin from today. “Healthy volunteers having no co-morbid conditions and without a history of Covid-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial,” Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said. Anybody willing to participate in the trial can send an email to [email protected] or an SMS to or call on 7428847499, he said.
- The human trials of Covaxin has begun at the All India Institute of Medical Sciences, Patna. AIIMS-Patna chose 10 volunteers to start the human trial of Covaxin.
- AIIMS Patna was the first institute to start the trial on Wednesday and has so far vaccinated around nine people with a smaller dose to check for safety, two sources said, on condition of anonymity. After two weeks, if the vaccine is found to be safe it will be given to more people, the sources said.
- The human clinical trials for Covaxin had been initiated across the country with 375 volunteers, sources from Bharat Biotech said on Friday.
- “Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company.
What happens now?
- The sites that have begun testing Covaxin would have to finish vaccinating a smaller number of people to ensure that it is safe to continue with the phase I trials in the first place.
- For instance, AIIMS Patna is targeting a total of 18-20 participants in the first set. After it vaccinates this group with Covaxin, it will have to pause the enrolment for 7-10 days while it collects data on the vaccine’s safety from this group. This data will be submitted to a Data and Safety Monitoring Board that will study the information and decide whether it is safe to administer the vaccine in humans.
- If there are no safety issues observed, the site will be allowed to continue enrolment and vaccinate more participants as part of the first phase of the trial.