DCGI Approves Phase II/III Trials of Covaxin in 2-18 Age Group

The trials will be conducted by Bharat Biotech in 525 healthy volunteers. 

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India's drug regulator, the Drugs Controller General of India (DCGI), has accepted the recommendation of the Subject Expert Committee (SEC) and granted permission to conduct Phase II/III clinical trials of Bharat Biotech's COVID-19 vaccine, Covaxin, in the age group of 2-18 years.

The trials will be conducted by Bharat Biotech in 525 healthy volunteers, the Centre said in a statement on Thursday, 13 May.

Covaxin was earlier recommended by the expert panel for the Phase II/III trials on those aged between 2 and 18. The trials are slated to take place at various sites, including AIIMS, Delhi; AIIMS Patna; and, Meditrina Institute of Medical Sciences, Nagpur. They will be conducted to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in the said age group.

“As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial in certain conditions.”
Centre’s statement

17.72 Cr Doses Administered in India So Far

Covaxin is one of the two vaccines in use among adults in India's vaccination drive, the other being Serum Institute of India's Covishield.

More than 17.72 crore vaccine doses have been administered since India’s inoculation drive began on 16 January. The government had opened the vaccination drive for the 18-44 age group on 1 May, but most states are having difficulty stepping up the pace of inoculation due to shortage of doses.

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