Covaxin gets approval for clinical trials for phase 2/3 on Children

New Delhi: The Drugs Controller General of India (DCGI) has approved the second / third phase clinical trial of COVAXIN in the age group of 2 to 18 years. Now India will conduct trials on Biotech 525 Health Volunteers. In this trial, two doses will be given to Volunteers at intervals of 0 to 28 days.

Covaxin for children:

An expert panel of Bharat Biotech's Covaxin Bharat Biotech on Tuesday recommended approval for the second and third stage trials for ages 2 to 18.

This trial can be done in places like AIIMS Delhi, AIIMS Patna, Meditrina Institute of Medical Sciences Nagpur. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Tuesday discussed the application of Bharat Biotech in Hyderabad.

DGCI gives permit for vaccine trial:

The committee recommended to approve the second and third phase clinical trials of 2 to 18 years of age of Covaxin. The committee had recommended the clinical trial on the condition that along with the submission of the second stage safety data, the recommendation of the DSMB would also have to be presented to the CDSCO before the phase three trial.

Covaxin, made by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is currently being used on 18+ in India's ongoing COVID-19 vaccination campaign. Bharat Biotech, which manufactures COVAXIN, says that direct covaxin is being supplied in 18 states from May 1.

Corona in India:

According to report, On Wednesday 4 thousand 127 patients in the country have lost their lives due to covid-19. The good news was that 3,51,740 patients returned home after recovering. At the same time, the number of infected in the capital Delhi is continuously increasing.

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