Bharat Biotech will conduct trials in 525 healthy volunteers. the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
Published: 13th May 2021 11:38 AM | Last Updated: 13th May 2021 12:41 PM | A+A A-
A health official shows Covaxin dose. (File photo| Shekhar Yadav, EPS)
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.
Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.
The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.
West Bengal CM Mamata Banerjee snubs TMC MLA Abdul Karim for demanding separate Islampur district
Trolled over a photo, Shashi Tharoor hits back at trolls, calls them ‘organised brigade of Bhakts’
BJP will not bring down Ashok Gehlot government in Rajasthan, it will fall due to infighting: Satish Poonia
Four women stripped, thrashed on allegations of shoplifting in Pakistan
Omicron more transmissible than Delta: UK PM Boris Johnson to ministers
Suspect in Saudi journalist Jamal Khashoggi’s killing arrested in France
Copyright – newindianexpress.com 2021
The Morning Standard | Dinamani | Kannada Prabha | Samakalika Malayalam | Indulgexpress | Edex Live | Cinema Express | Event Xpress
Home | Nation | World | Cities | Business | Columns | Entertainment | Sport | Magazine | The Sunday Standard