New Delhi: The Drugs Controller General of India (DCGI) has granted permission to conduct the Phase II-III clinical trial of Covaxin (Covid vaccine) in the age group of two to 18-years-old to its manufacturer Bharat Biotech Ltd, Union Health Ministry said on Thursday.
“The trial will be conducted in 525 healthy volunteers,” said the Ministry. In the trial the vaccine will be given by intramuscular route in two doses at day 0 and day 28, the Ministry added.
After much consideration, the DCGI accepted the recommendation of Subject Expert Committee (SEC). The national drug regulator of the country on Wednesday gave the approval to conduct the clinical trial in the age group of youngest age group till now paving way for them to be saved from the deadly pandemic outbreak.
Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology, is touted 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” for emergency use authorisation against novel coronavirus.
Hyderabad-based Bharat Biotech International Ltd (BBIL) had proposed to carry out a Phase II-III clinical trial of Covaxin in the age group of two to 18 years.
For adults, Covaxin was cleared for emergency use last year while still in its final clinical stage, raising eye brows about it safety and efficacy.