Tuesday, March 19, 2024
News

DCGI approves Phase 2, 3 clinical trials of COVAXIN on children aged 2 to 18 years

   SocialTwist Tell-a-Friend    Print this Page   COMMENT

New Delhi | May 13, 2021 11:44:17 AM IST
The Drugs Controller General of India (DCGI) on Thursday approved Phase 2 and 3 clinical trial of Bharat Biotech's COVAXIN vaccine in the age group of 2 to 18 years, informed the Ministry of Health and Family Welfare.

"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, 2021," the ministry said.

Bharat Biotech will conduct trials in 525 healthy volunteers.

"In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28," it said.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11, 2021.

The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2 and 3 clinical trials to certain conditions.

Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.

The firm on Tuesday informed that it has been supplying its COVID-19 vaccine directly to 18 states since May 1. (ANI)

 
  LATEST COMMENTS ()
POST YOUR COMMENT
Comments Not Available
 
POST YOUR COMMENT
 
 
TRENDING TOPICS
 
 
CITY NEWS
MORE CITIES
 
 
INDIA WORLD ASIA
Tamil Nadu: PMK announces alliance with ...
Lok Sabha polls: Congress leader Rohan G...
'Congress not getting candidates to cont...
Lok Sabha polls: BJP holds core committe...
Indian Navy's Remotely Piloted Aircraft ...
Part of ongoing anti-piracy operation: A...
More...    
 
 Top Stories
US Supreme Court blocks Texas from ... 
White House urges Pakistan, Afghani... 
Karnataka: Cash worth over Rs 3 lak... 
UN Chief urges Israel to ensure "co... 
People exude confidence in PM Modi ... 
Israeli Forces kill Hamas internal ... 
Judge denies Donald Trump's request... 
Odisha govt asks District Collector...