NEW DELHI: India’s first coronavirus vaccine COVAXIN human trials are beginning today at the All India Institute of Medical Science (AIIMS), Delhi after its Ethics Committee gave its nod.
COVAXIN is an indigenously developed COVID-19 vaccine candidate following which country’s premier hospital is all set to begin the exercise by enrolling healthy volunteers.
The country’s top drug regulator Drug Controller General of India (DCGI) had recently given a green signal for human clinical trials for COVID-19 vaccine candidate Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV).
How to participate in human trials of COVAXIN
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 institute may also put up these contact details on its website.
The DCGI has permitted two vaccines — one developed by the Bharat Biotech in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.
The two vaccine candidates have undergone successful toxicity studies in rats, mice and rabbits and these data was submitted to DCGI following which both got clearance to start the early phase human trials early this month.
Approximately 1,000 human volunteers would be participating in the exercise for each of the two indigenously developed vaccine candidates, he had said.
The first phase of clinical trials will involve around 300 people, and the subsequent phase will add another 700, according to the earmarked hospitals.
Bharat Biotech produces billions of vaccine doses fighting infections including rotavirus and hepatitis. In 2015, the manufacturer produced the first India-made rotavirus vaccine priced at $1 (€0.89) a dose and now part of the World Health Organization’s immunization program.
- AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin.
- In phase I, the vaccine would be tested on 375 volunteers and a maximum of 100 of them would be from AIIMS.
- Healthy volunteers having no comorbid 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.
- A few volunteers have already registered for the trial. AIIMS will start the screening of the individuals and evaluate their health condition from Monday (today) onwards before vaccinating them.
- COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI).
- Noting that this was the first indigenous vaccine being developed by India, ICMR Director-General Dr Balram Bhargava in a letter to principal investigators of the 12 sites recently had asked them to fast-track the human clinical trial approvals stating it is one of the “top priority projects which is being monitored at the top-most level of the government”.
- The trials have so far started in AIIMS, Patna and some more sites.
Vaccine development takes place in phased clinical trials, each with more test subjects to determine if a vaccine candidate produces the desired antibody response with a correspondingly low level of side effects.
A global race is underway to develop and mass-produce an effective vaccine against SARS-CoV-2.
There are more than 100 vaccine candidates in pre-clinical development by pharmaceutical companies, academic institutions, government agencies, and others.
According to the WHO, as of July 7, there are 17 vaccine candidates undergoing clinical trials in several countries. Although governments are pre-ordering billions of doses of promising candidates, no vaccine is expected to be approved for use over the next several months.