Pave the way for the corona vaccine for children aged 9 to 12

(PTI) New delhi date. 13

An expert panel of the Central Drug Authority of India has recommended the emergency use of the covacin vaccine of Bharat Biotech for children between the ages of 9 and 12 subject to certain conditions, sources said.

If approved by the Drug Controller General of India (DCGI), Covexin will be the second vaccine to be used for children under the age of 18, after Zydus Cadila's Needle Free Zykov-D.

Hyderabad-based Bharat Biotech has completed Phase 2/3 trials of the use of the Cavid 12 vaccine covacin in children aged 9 to 12 years and has sent the data to the Central Drugs Standards Control Organization (CDSCO). This data has been sent to the CDSC for verification and approval for emergency use.

The data was reviewed by the Subject Expert Committee (SEC) of Covid-12. After testing, the committee has recommended that emergency use of Bharat Biotech's covacin vaccine be allowed for children between the ages of 9 and 12 subject to certain conditions.

These recommendations have been sent to DCGI for final approval. If approved by DCGI, Covexin will be the second vaccine to be used for children under the age of 18, after Zydus Cadila's Needle Free Zykov-D.

Bharat Biotech has sought approval from DCGI to use its covacin vaccine in children between the ages of two and eighteen. The committee said the clinical trial was reviewed at its August 8 meeting.

However the committee has approved the use of this vaccine subject to certain conditions. These conditions require the release of safety data every fortnight for the first two months and thereafter every month.

In July, DCGI allowed the Serum Institute of India (SII) to start a phase 2/3 trial of the covavax vaccine for its children aged 9 to 12 years.