Bharat Biotech submits phase 2 & 3 trials data of Covaxin for children to DCGItext_fields
Hyderabad-based biotechnology company Bharat Biotech on Wednesday said the data on clinical trials for its coronavirus vaccine, Covaxin, conducted on children aged 2 to 18 has been submitted to the Drugs Controller General of India or DCGI, reported news agency Reuters.
The country has been waiting for a vaccine for children to get emergency use authorisation (EUA). Bharat Biotech conducted trials for the same two-dose Covaxin, which is being administered to adults, on children. Sources have indicated that the vaccine maker has submitted the trial data to the DCGI and has sought approval for emergency use authorisation nod from the Subject Expert Committee (SEC).
India is turning its focus towards vaccinating children against the coronavirus, having already administered more than 920 million doses to adults among its population of nearly 1.4 billion.
The Drugs Controller General of India last month allowed vaccine maker Serum Institute to enroll kids aged 7 to 11 years for its trial of US drugmaker Novavax's COVID-19 vaccine.
So far, only drugmaker Zydus Cadila's DNA-based COVID-19 vaccine has received emergency use approval in India to be used in adults and children aged atleast 12 years.