New Delhi: India’s apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech’s Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The trial will be conducted on 525 healthy volunteers.
“The National Regulator of the country, the Drugs Controller General of India (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 May 12,” the ministry said.
Hyderabad based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on COVID-19 meeting held on May 11.
The Committee, after detailed deliberation, recommended for grant of permission to conduct proposed phase II/III clinical trial to certain conditions.
Earlier the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive. (PTI)
Apple previews new software for iPhone, other gadgets
World No Tobacco Day : Quit smoking to lead a healthy life
Oxford/AstraZeneca vaccine 80 per cent effective against B1.617.2 variant: UK study
World Hypertension Day : Measure Your Blood Pressure, Control It, Live Longer
Bharat Biotech’s Covaxin approved for phase 2/3 trials on children
HDFC Bank mobile app down for 1 hr; issues resolved
Rupee surges 13 paise to 73.16 against US dollar in early trade
Gold declines Rs 464; silver cracks Rs 723
Rupee slips 14 paise to 73.21 against US dollar in early trade
Congress leaders hold protest against fuel price hike
Download 10Cric Casino app, and enjoy Indias most popular casino games, directly on your mobile!
Gamble with real money online! Play Indias favourite casino games at 7Jackpots.com, Indias most trusted online casino site.
© 2020 State Times Daily Newspaper | Powered by Ideogram Technology Solutions [P] Ltd.