Emergency use of Covaxin has been approved for kids ages 2 to 18
Covaxin, manufactured by Bharat Biotech, has received emergency use approval from the Covid-19 Subject Expert Committee for children aged 2 to 18 years.
Bharat Biotech’s Covaxin for children 2-18 years old has received emergency use approval from the Covid-19 SEC.
Covaxin Phase-2 and Phase-3 trials on children under the age of 18 were completed in September by Hyderabad-based Bharat Biotech, and the trial data was submitted to the Drugs and Comptroller General of India (DCGI) at the beginning of this month.
“After careful consideration, the committee recommended that the vaccine be granted market authorization for restricted use in emergency situations,” the expert panel on the topic said in a statement.
The Indian-made vaccine will be given in two doses, with a 20-day interval between each.
After the Central Drugs Standard Control Organization (CDSCO) and the SEC reviewed the clinical trial data, Bharat Biotech issued a statement saying the results were positive.
“Covid-19 vaccines for children ages 2 to 18 have received one of the first worldwide approvals. Thank you to the DCGI, the Subject Experts Committee, and the CDSCO for expediting the review process for Bharat Biotech. Covaxin for children will not be available for sale until it receives additional regulatory approval from the CDSCO “said the vaccine’s creator.
The authorization for emergency use, on the other hand, is conditional. In accordance with the approved clinical trial protocol, Covaxin’s creators will carry out further research as necessary.
Updated prescribing information/package inserts (PI), summaries of product characteristics (SmPC), and fact sheets will be required.
For the first two months and thereafter, the company is required to submit monthly safety information, including the data on AEFI and AESI as required by the New Drugs & Clinical Trials Rules, 2019, it said.