The Covaxin trial involves two vaccine doses injected at day 0 and day 28.
Highlights
- Bharat Biotech said the trial will be carried out on "525 volunteers"
- Drug regulator cleared trials after recommendation of expert committee
- The Covaxin trial involves two vaccine doses injected at day 0 and day 28
Covaxin trials on children from two to 18 years were cleared by the Drugs Controller General of India (DCGI) today. This is the first time in India that a Covid vaccine will be tested on children.
Covaxin maker Bharat Biotech said its phase 2 and 3 trials would be carried out on "525 healthy volunteers".
According to a government statement, the drug regulator accepted the recommendation of an expert committee on vaccines after careful thought.
The trial involves two vaccine doses injected at day 0 and day 28.
The trials are to take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
On Tuesday, the Subject Expert Committee (SEC) on COVID-19 discussed Bharat Biotech's application requesting permission to conduct phase two and three trials "to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years".
The committee has put up a condition - that the firm should submit the interim safety data of phase 2 clinical trial before proceeding to phase III, according to an unnamed source quoted by Press Trust of India.
Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology, is pitched as the only made-in-India Covid shot. The second vaccine being used in India is the Oxford-AstraZeneca jab produced by the Serum Institute as "Covishield".
Covaxin was cleared for emergency use last year while still in clinical trial stage, which raised questions and was also seen to spur vaccine hesitancy in the early stages of India's vaccination programme.
Last month, Bharat Biotech and ICMR said in a joint statement that Covaxin had proved to be 78 per cent effective against Covid and worked against most variants of the virus. They also said the vaccine was 100 per cent effective at preventing severe symptoms and hospitalisations.