Bharat Biotech issues statement as Covaxin gets SEC nod for children aged 2-18

In a significant boost to India's coronavirus vaccination drive, the Subject Experts Committee (SEC) on Tuesday gave its nod to Bharat Biotech's COVID-19 vaccine- Covaxin for children aged 2-18 years. The indigenous biotechnology company said that the clinical trials data for that age group has received positive recommendations from Central Drugs Standard Control Organisation (CDSCO) and SEC.

In a statement, Bharat Biotech said, "This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children."

Expert Committee approves Covaxin for children aged 2-18 years

According to sources, the expert committee has found results of Covaxin (BBV152) trials compatible with safety protocols. The SEC also noted that the vaccine worked the same on kids as on adults on both immunogenicity and safety. 

Applauding the accomplishment of Bharat Biotech's victory, former ICMR chief Raman Gangakhedkar said, "Big day in Indian science as a COVID vaccine will be available for children who are more prone to the viral infection than adults."

IMA president Dr JA Jayalal and Maharashtra COVID task force member Dr Shashank Joshi also congratulated Bharat Biotech and the Central government for bringing vaccines for children at a time when other nations have also started working on it. On Monday, Dr Sanjay Rai, a professor at AIIMS said that the latest trials showed that Covaxin displayed almost similar safety and immunogenicity in kids as it did in adults.

COVID vaccination drive in India

The Covid vaccination drive in India commenced on January 16 initially with the healthcare and frontline workers in the first phase. In the second phase from March 1, people over 60 years of age and those aged 45 and above with co-morbid conditions were inoculated. On April 1, the vaccination commenced for all citizens about 45 years of age. The vaccination drive was expanded to all adult populations from May 1. According to an update shared by Union Health Minister, Dr Mansukh Mandaviya, so far, 96 crore vaccine doses have been administered.