India approves Covaxin clinical trials for children aged 2-18 years old
pharmafile | May 13, 2021 | News story | |
The Drugs Controller General of India (DCGI) has cleared Bharat Biotech’s Covaxin trials on children from 2-18 years old.
The trial will involve two vaccine doses injected on day 1 and day 28. This is the first time in India that a COVID-19 vaccine will be tested on children.
This news comes in the wake of India’s second day in a row of more than 4,000 Covid-19 fatalities. On Wednesday India recorded a record number of deaths.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization deliberated upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin jabs in children aged 2-18 years.
The Indian government said: “The national regulator of the country, the DCGI, after careful examination, has accepted the recommendation of SEC and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2-18 years, to its manufacturer Bharat Biotech Ltd on May 12.
“As a rapid regulatory response, the proposal was deliberated in SEC on May 11. The committee, after detailed deliberation, recommended for grant of permission to conduct Phase II/III clinical trial (subject) to certain conditions.”
Bharat Biotech’s Chairman and Managing Director Dr Krishna Ella stated in January that the company wanted 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, such as rabies and polio, and has been proven to be safe even for newborns.
The news for a children’s trial of Covaxin comes shortly after the FDA approved the use of Pfizer-BioNTech’s Covid-19 vaccine on children aged 12-15.