The Subject Expert Committee (SEC) on Covid-19 has granted an emergency use authorization to Covaxin, a COVID-19 vaccine for children ages 2-18, developed by Bharat Biotech. This is one of the world’s first approvals of the COVID-19 vaccine for groups aged 2-18.
This is the second COVID-19 vaccine approved for emergency use in Indian children. In early August 2021, India granted an emergency use authorization to ZyCov-D, a COVID-19 vaccine for children ages 12-18, developed by the pharmaceutical company Zydus Cadila. This vaccine is the world’s first approved DNA vaccine.
Bharat Biotech announced the completion of Phase 2 and Phase 3 trials of covacin in children under the age of 18 in September 2021. Jab approval earlier this month.
The data submitted has been thoroughly reviewed by the Central Drugs Standard Control Organization (CDSCO) and the SEC on Covid-19 and market approval for this vaccine in the age group of 2-18 years with restricted use in emergencies. Was recommended to give. ..
The vaccine is given twice, with a 20-day gap between the first and second doses.
Covaxin developers continue their research according to approved clinical trial protocols and provide updated prescribing information / packages.
The company is currently awaiting further regulatory approval from the CDSCO before launching the product in the children’s market.
In addition, in accordance with the requirements of the 2019 New Drug and Clinical Trial Regulations; the company submits safety data, including AESI and AEFI data, every 15 days for the first two months and then monthly, with appropriate analysis. is needed.