The Drugs Controller General of India on Thursday gave permission to Bharat Biotech to conduct phase two and three clinical trials of its coronavirus vaccine Covaxin on children in the age group of two to 18 years. The vaccine will be the first to be tested on children in the country.
“The trial will be conducted in 525 healthy volunteers,” the Ministry of Health and Family Welfare said. “In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.”
The centre said that the Subject Expert Committee on Tuesday discussed Bharat Biotech’s proposal to conduct clinical trials of its vaccine on children.
The committee had put forth a condition that Bharat Biotech submit the interim safety data of phase two clinical trial and recommendations of the Data and Safety Monitoring Board to the Central Drugs Standard Control Organisation before proceeding to phase three, PTI had reported on Tuesday, quoting an unidentified official.
More children are contracting the coronavirus in the second phase of the pandemic.
