Covaxin, was the first Covid-19 vaccine globally to begin testing on children as young as 12 years of age way back in September 2020 in the phase II trials.
HYDERABAD: The Indian drugs regulator, the Drugs Controller General of India (DCGI) has granted its approval to indigenously developed Covid-19 vaccine Covaxin’s developer Bharat Biotech for conducting Phase II/III clinical trials of the desi vaccine on children from 2 to 18 years of age.
The children’s trials will be carried out on 525 healthy children volunteers, who will be administered two doses of the whole virion, inactivated SARS-CoV-2 vaccine at a gap of 28 days through intramuscular shots.
The approval for a kids trial of Covaxin comes even as the US drug regulator USFDA gave its nod for use of Pfizer-BioNTech’s Covid-19 vaccine on children in the 12-15 years age group earlier this week.
However, Covaxin, was the first Covid-19 vaccine globally to begin testing on children as young as 12 years of age way back in September 2020 in the Phase II trials that tested the vaccine on 380 volunteers in the 12-65 years age bracket. The vaccine is already approved for emergency use in those aged 18 years and above in the country.
“The national regulator of the country, the 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 12.05.2021,” the government said on Thursday.
“As a rapid regulatory response, the proposal was deliberated in SEC (Covid-19) on 11.05.2021. The committee, after detailed deliberation, recommended for grant of permission to conduct proposed Phase II/III clinical trial (subject) to certain conditions,” it said.
It was in January that Bharat Biotech’s chairman and managing director Dr Krishna Ella had stated that the company wants to conduct children’s trials because the inactivated virus platform that the company is using for the Covid-19 vaccine has been tried and tested in several other vaccines like rabies and polio, among others, and has proven to be safe even for newborns.
The company had, in February, applied for permission to conduct Phase III trials on children but was asked by the SEC to do a Phase II/III study instead. Covaxin has been developed by Bharat Biotech along with Indian Council of Medical Research-National Institute of Virology (ICMR-NIV).