Resources

Expert panel recommends Covaxin Phase II & III trials on 2-18 age group

| Updated on May 13, 2021

The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation (CDSCO) is understood to have recommended Phase II and III clinical trials of Covaxin on children aged between 2 and 18 years.

 

Hyderabad-based maker of the vaccine, Bharat Biotech, had submitted a proposal in this regard and was asked to submit a revised clinical trial protocol.

clinical trials of Covaxin on children aged between 2 and 18 years

The company was also asked to submit the interim safety data of Phase II clinical trials along with the DSMB (Data and Safety Monitoring Board) recommendations to the CDSCO before proceeding to Phase III of the study, according to sources

 

 

Published on May 13, 2021

Follow us on Telegram, Facebook, Twitter, Instagram, YouTube and Linkedin. You can also download our Android App or IOS App.

This article is closed for comments.
Please Email the Editor