Bharat Biotech's Covaxin approved for phase 2/3 trials on children
New Delhi, May 13: 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.
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Congress names candidates for 8 Haryana LS seats, fields Kumari Selja, Deepender Hooda
Chandigarh (PTI): The Congress on Thursday announced candidates for eight of the nine Lok Sabha seats it is contesting in Haryana, fielding former Union minister Kumari Selja, Rajya Sabha MP Deepender Hooda and youth leader Divyanshu Budhiraja, besides two sitting MLAs.
The party has also fielded former MP Jai Prakash and leaders Satpal Brahmachari and Mahendra Pratap, according to the list released late Thursday evening.
The Congress is contesting nine of the 10 Lok Sabha seats in Haryana. It has not yet announced its candidate for the Gurugram constituency.
The Aam Aadmi Party, a constituent of the opposition INDIA bloc, will contest the Kurukshetra seat.
Congress general secretary and former Union minister Selja will contest from the Sirsa (reserved) seat and sitting MLAs Varun Choudhary and Rao Dan Singh from the Ambala (reserved) and the Bhiwani-Mahendragarh Lok Sabha seats, respectively.
Deepender Hooda, son of former chief minister Bhupinder Singh Hooda, will enter the fray from Rohtak. He has represented the Rohtak parliamentary constituency three times in the past.
Jai Prakash has been fielded from Hisar, the Congress' Haryana youth wing president Divanshu Budhiraja from Karnal, Satpal Brahmachari from Sonipat and Mahendra Pratap from Faridabad.
