The Drugs Controller General of India (DCGI) has cleared phase II and III clinical trials of the Covaxin COVID-19 vaccine for children from two and 18 years, officials said Thursday.
“The National Regulator of the country, the DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID-19 vaccine) in the age group 2 to 18, to its manufacturer Bharat Biotech Ltd on 12.05.2021,” reads a statement issued by the federal health ministry.
According to the ministry, Covaxin maker Bharat Biotech International Ltd., Hyderabad had proposed to carry out the clinical trials of Covaxin in the age group of 2 to 18.
The trials will be conducted in 525 healthy volunteers, the ministry said. In the trials, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
According to a government statement, the drug regulator accepted the recommendation of an expert committee on vaccines.
India has been seeing a shortage of COVID-19 vaccines, according to media reports.
India’s COVID-19 tally rose to 23,703,665 on Thursday with 362,727 new cases registered in the past 24 hours, while the death toll swelled to 258,317 with 4,120 deaths since Wednesday morning, the federal health ministry announced Thursday.
