Table of Contents
Context
- AIIMS Delhi will begin human trials of India’s first indigenous COVID-19 vaccine, Covaxin, from Monday on 100 healthy volunteers aged between 18 and 55.
- This comes after AIIMS’s Ethics Committee gave its nod for a human clinical trial for Covaxin, on 18 July, Saturday,
- The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO), and the Ministry of Health & Family Welfare granted permission
- To initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies
About Covaxin
- Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
- It 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.
When did the trials start?
- Bharat Biotech began vaccinating their first set of participants on July 15.
- The first phase of the Covaxin trials are to be conducted on 375 participants across 12 clinical trial sites in the country.
- AIIMS Patna and PGIMS Rohtak–have already begun the vaccination process.
What next?
- 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 enrollment 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 enrollment and vaccinate more participants as part of the first phase of the trial.
- With Covaxin, the participants will be vaccinated twice in the first phase of trials, fourteen days apart.
How long will the trials take?
- The first phase of the trials for Covaxin are expected to take over a month to complete,
- After which it is expected that the data from the first trial will be submitted to the Drug Controller General of India.
- Following this, it will move on to phase II trials.
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