Biological E Limited has received permission from the Drugs Controller General of India (DCGI) to conduct phase 2/3 clinical trials of its indigenous COVID-19 vaccine on children 5 to 18 years of age with some specific conditions, stated sources.

The trial will be conducted across 10 sites. The permission came after the recommendations by the Subject Expert Committee (SEC) on COVID-19. Biological Es COVID-19 vaccine, named Corbevax, is a RBD protein sub-unit vaccine which is being evaluated in phase 2/3 clinical trials on adults. The company is expected to supply 30 crore doses of the vaccine to the central government by December, the Union Health Ministry had announced in June.

Thus far, Zydus Cadilas indigenous needle-free vaccine, ZyCoV-D, has received Emergency Use Authorization from the DCGI, thus making it the first vaccine to be offered to 12-18-year olds in India, while the results of phase 2/3 clinical trials of Covaxin in 2- to 18-year olds are also underway… (ET Healthworld – PTI, September 2, 2021)