DGCI Approves Phase II / III Trials of Covaxin in Children 2-18 Years | India News
Covaxin, was the first Covid-19 vaccine globally to begin testing in children as young as 12 years old in September 2020 in phase II trials.
HYDERABAD: India’s drug regulator, India’s Comptroller General of Drugs (DCGI) has granted approval to the Covid-19 vaccine developed locally by Covaxin, Bharat Biotech, for conducting phase II / III clinical trials of the desi vaccine in children 2 to 18 years of age.
The infant trials will be carried out in 525 healthy child volunteers, who will be administered two doses of the whole virion, the inactivated SARS-CoV-2 vaccine, at an interval of 28 days by intramuscular injections.
Approval for a children’s trial of Covaxin comes even as the US drug regulator. USFDA gave its go-ahead for the use of Pfizer-BioNTech’s Covid-19 vaccine in children in the 12-15 age group earlier this week.
However, Covaxin was the first Covid-19 vaccine globally to begin testing in children as young as 12 years old in September 2020 in Phase II trials that tested the vaccine in 380 volunteers in the age group. from 12 to 65 years old. The vaccine is already approved for emergency use in people over 18 years of age in the country.
“The country’s national regulator, the DCGI, after careful examination, has accepted the recommendation of Committee of experts in the field (SECOND) and granted permission to carry out 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, “said the government on Thursday .
“As a quick regulatory response, the proposal was debated at the SEC (Covid-19) on 05/11/2021. The committee, after detailed deliberation, recommended granting permission to conduct the proposed Phase II / III clinical trial (subject) to certain conditions, ”he said.
It was in January that Bharat Biotech President and Managing Director Dr. Krishna Ella stated that the company wants to conduct trials in children because the inactivated virus platform that the company is using for the Covid-19 vaccine has been tested on several other vaccines such as rabies and polio, among others, and it has been shown to be safe even for newborns.
In February, the company had applied for permission to conduct phase III trials in children, but the SEC asked it to do a phase II / III study instead. Covaxin has been developed by Bharat Biotech in conjunction with the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV).