The expert panel of CDSCO (Central Drugs Standard Control Organisation) has recommended Bharat Biotech’s COVID-19 vaccine – Covaxin for use on children between the ages of 2 and 18 years of age. Hyderabad based company Bharat Biotech has said in its release that “it submitted data from clinical trials in the 2 – 18 age group for Covaxin to Central Drugs Standard Control Organisation. The data has been thoroughly reviewed by the Subject Expert Committee (SEC) and they have provided positive recommendations.” This is one of the first approvals worldwide for COVID-19 vaccines in the 2 – 18 age group. The company also mentioned that it now awaits further regulatory approvals prior to product launch and market availability of Covaxin for Children. That final approval as a formality will be given by the Drug Controller General of India.
Covaxin will be the second vaccine cleared for use on kids in India. The first one is Zydus Cadila’s three-dose DNA jab that got approval in August this year. It has been allowed for use in people above 12 years of age. Data by Bharat Biotech in relation to trials on children was submitted last week. Though the Covaxin vaccine tested on children is of the same formulation as that which is being used on adults, a separate trials were needed to guarantee safety and efficacy on the younger age group. It is being said that tests were conducted on 1,000+ children across the country. Meanwhile, WHO is yet to grant Covaxin an emergency use authorisation. A decision In this regard is expected next week.
