Indian drug regulator DGCI clears Covaxin phase 2, 3 clinical trials for children
India's drug regulator body has cleared the second and third phase of clinical trials of the indigenous anti-COVID-19 vaccine Covaxin for children
India's drug regulator body has cleared the second and third phase of clinical trials of the indigenous anti-COVID-19 vaccine Covaxin for children. The trials have been permitted by the Drugs Controller General of India (DGCI) for children aged two to 18, IBNS said.
Bharat Biotech, the manufacturer of Covaxin, has stated it will carry out the trials on "525 healthy volunteers".
The trial will involve the injection of two doses on day 0 and 28.
The Subject Expert Committee (SEC) has put up a condition to Bharat Biotech that the firm should submit its interim safety data of phase two trial before proceeding to the next phase.
For all adults, i.e. individuals aged 18 or more, the government has permitted two vaccines, Covaxin and Oxford University's Covishield, which is developed by Serum Institute of India in the country.
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