SEC asks Bharat Biotech to submit Covaxin phase 3 efficacy data before seeking approval for kids' trial |
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SEC asks Bharat Biotech to submit Covaxin phase 3 efficacy data before seeking approval for kids' trial

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The Subject Expert Committee (SEC) that advises the Drugs Controller General of India (DCGI) has asked Bharat Biotech to submit efficacy and safety data from the ongoing Phase III trials of Covaxin prior to seeking approval for conducting the trials on children.

The SEC has also asked the company to revise and submit the protocol of the trial for children to a Phase II/III study. 

Bharat Biotech had sought approval to conduct Phase III trials of their vaccine on children aged 5-18 years. The SEC stated that sample size and other consequential changes must be made to the protocol, and the company should submit the revised clinical trial protocol for review… (ET Healthworld – TNN, February 27, 2021)
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