“CDSCO has received results from Bharat Biotech’s Covaxin clinical studies in the 2 – 18 age group (Central Drugs Standard Control Organisation). The Subject Expert Committee (SEC) thoroughly analyzed the data and made positive recommendations “According to the Hyderabad-based firm. The final approval is pending and will be given by the Drug Controller General of India (DGCI).

After its final approval, Covaxin will be only the second vaccination approved for use on children in India; Zydus Cadila’s three-dose DNA vaccine was approved for use on adults and children over the age of 12 in August.

The Covaxin manufacturer Bharat Biotech said it had submitted data on vaccine trials on children last week on October 6. The Covaxin vaccination used on children is the same as that used on adults, but separate trials were required to ensure the vaccine’s safety and efficacy in children.

After administering about 96 crore doses to adults, India is quietly shifting its focus to vaccination children against the coronavirus.

Meanwhile, Covaxin has failed to receive an EUA, or emergency use authorization, from the World Health Organization. Following delays in the process (the WHO had requested additional trial data from Bharat Biotech), a verdict is likely next week.