Covaxin coronavirus vaccine enters human trials: What it means, what happens next and how long it will take

Covaxin coronavirus vaccine enters human trials: What it means, what happens next and how long it will take

India's first experimental novel coronavirus vaccine -- Covaxin developed by Bharat Biotech -- is beginning human trials at AIIMS, New Delhi this week. We break down how the Covaxin was developed, what will happen in the vaccine's human trials, and how long it might take for this to be completed
Covaxin is an inactivated novel coronavirus vaccine and has been developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research
Covaxin is an inactivated novel coronavirus vaccine and has been developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research


Covaxin, an experimental novel coronavirus vaccine developed by Hyderabad-based Bharat Biotech, is beginning human trials at New Dehi's All India Institute of Medical Sciences this week. AIIMS-New Delhi is one the 12 sites chosen by the Indian Council of Medical Research, which is a collaborator on the Covaxin novel coronavirus vaccine project, for conducting human trials of the Covid-19 vaccine candidate.

AIIMS-New Delhi will begin by screening volunteers to take part in phase I human trials of the Covaxin Covid-19 vaccine. Those selected to take part in the trial will be administered a dose of the experimental vaccine later this week. Similar processes will be undertaken at the other pan-India sites that have been chosen to test the Covaxin vaccine.

Read on, as we break down what's happened so far and what will happen in upcoming days and weeks as human trials begin for this novel coronavirus vaccine candidate. (The following information has been sourced from Bharat Biotech and the Covaxin's human trials registration document.)


What is Covaxin?


Covaxin is a novel coronavirus vaccine candidate developed by the Hyderabad-based biotech firm Bharat Biotech in collaboration with the Indian Council of Medical Research. Covaxin is an 'inactivated vaccine,' i.e. it is made up of novel coronavirus particles that have been treated in a laboratory and made to lose their ability to cause an infection.

The idea is that once the vaccine is in your system, your immune system will learn how to recognise and fight the novel coronavirus without your body being at risk of an actual infection. This is a traditional approach to vaccination.



What has happened with Covaxin so far?


Work on Covaxin began in May this year when the ICMR isolated a strain of the novel coronavirus and transferred it to Bharat Biotech. Bharat Biotech then started work on 'weakening' or 'inactivating' the strain for a potential vaccine. The work was carried out at a BSL-3 (Bio-Safety Level 3) facility in Genome Valley, Hyderabad.

Late June, Bharat Biotech announced it had completed pre-clinical studies, i.e. studies in a laboratory and on animals, and managed to demonstrate "safety and immune response". Following this, Bharat Biotech was given the go-ahead by the government to test Covaxin on human volunteers.


When will Covaxin's human trials begin?


Technically, they have already begun. This weekend, AIIMS-New Delhi's Ethics Committee gave the go-ahead for the hospital to begin human trials of Covaxin. (An Ethics Committee, which is based out of a hospital, is responsible for on-ground oversight of individual human trials.)

Following this, AIIMS-New Delhi began screening participants for the human trials. The Covaxin trial at AIIMS-New Delhi aims to start dosing participants later this week. Similar processes will take place at 11 other hospitals across the country once their respective Ethics Committees give their go-aheads.
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