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DGCI gives nod for Covaxin Phase II/III trials on 2-18 year olds | India News – Times of India


Covaxin, was the primary Covid-19 vaccine globally to start testing on youngsters as younger as 12 years of age approach again in September 2020 within the part II trials.

HYDERABAD: The Indian medication regulator, the Drugs Controller General of India (DCGI) has granted its approval to indigenously developed Covid-19 vaccine Covaxin’s developer Bharat Biotech for conducting Phase II/III scientific trials of the desi vaccine on youngsters from 2 to 18 years of age.
The youngsters’s trials might be carried out on 525 wholesome youngsters volunteers, who might be administered two doses of the entire virion, inactivated SARS-CoV-2 vaccine at a niche of 28 days by way of intramuscular photographs.
The approval for a youngsters trial of Covaxin comes even because the US drug regulator USFDA gave its nod for use of Pfizer-BioNTech’s Covid-19 vaccine on youngsters within the 12-15 years age group earlier this week.
However, Covaxin, was the primary Covid-19 vaccine globally to start testing on youngsters as younger as 12 years of age approach again in September 2020 within the Phase II trials that examined the vaccine on 380 volunteers within the 12-65 years age bracket. The vaccine is already permitted for emergency use in these aged 18 years and above within the nation.
“The national regulator of the country, the DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (Covid vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021,” the federal government mentioned on Thursday.
“As a rapid regulatory response, the proposal was deliberated in 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 (subject) to certain conditions,” it mentioned.
It was in January that Bharat Biotech’s chairman and managing director Dr Krishna Ella had acknowledged that the corporate needs to conduct youngsters’s trials as a result of the inactivated virus platform that the corporate is utilizing for the Covid-19 vaccine has been tried and examined in a number of different vaccines like rabies and polio, amongst others, and has confirmed to be secure even for newborns.
The firm had, in February, utilized for permission to conduct Phase III trials on youngsters however was requested by the SEC to do a Phase II/III research as a substitute. Covaxin has been developed by Bharat Biotech together with Indian Council of Medical Research-National Institute of Virology (ICMR-NIV).

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