SII Seeks Permission for Covovax Phase-3 Trial as a Booster Dose for Children

The Serum Institute of India (SII) is seeking permission from the drug regulator of India to conduct a phase 3 study to evaluate the safety and immunogenicity of the COVID-19 vaccine Covovax as a booster for children aged 2 to 18 years. In March, the Drugs Controller General of India (DCGI) approved a Phase 3 clinical trial using Covovax as a booster dose for adults.

Prakash Kumar Singh, SII's Director of Government and Regulatory Affairs, has issued an application requesting permission to conduct Phase 3 observer blinds, randomization, and controlled trials for children ages 2-18 in India. Basic vaccination against COVID-19 by Covovax a few months ago.

A total of 408 eligible children aged 2-18 years who completed the two major Covovax vaccination schedules at least 6 months ago will be enrolled in the study.

Hyderabad-based Bharat Biotech recently applied to the Indian Pharmaceutical Agency for permission to conduct a Phase 2/3 trial of the Covid vaccine Covaxin as booster immunity for people aged 2-18 years. India began vaccination on health workers and frontline workers, as well as people over the age of 60 with comorbidities, on January 10, this year.