Bharat Biotech's Covaxin gets DGCI approval for emergency use on children above 12 years

Bharat Biotech's Covaxin was granted emergency use authorisation by the Drugs Controller General of India (DCGI) on December 25, 2021 for use on children above 12 years with certain conditions. The proposal was examined in consultation with the Subject Expert Committee.

The Subject Expert Committee (SEC) had recommended DGCI to grant emergency use authorisation to Covaxin for children. The approval finally came through based on recommendations of SEC experts and the submission of additional safety data.

The DGCI has approved usage of the whole virion inactivated COVID vaccine for use in children above the age of 12 years with the same dose schedule of 0 & 28 days.  PM Modi in his address to the nation on December 25th, had announced that children between 15-18 years will get COVID-19 vaccines from January 3, 2022. 

The Drugs Controller General of India (DCGI) on Saturday granted emergency use authorisation to indigenously-developed Bharat Biotech's Covaxin for children above 12 years with certain conditions, reads DCGI letter to Bharat Biotech pic.twitter.com/WV4BTj8Rb8

— ANI (@ANI) December 26, 2021

Read More: PM Modi's 3 major announcements- Vaccines for 15-18 year old from Jan 3rd

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Bharat Biotech's statement

While announcing that Covaxin has received approval for emergency use in children aged between 12-18 years, Bharat Biotech said in a statement that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children.

The company also stressed that Covaxin has established a proven record for safety and efficacy in adults for original variants and subsequent variants and added that they look forward for Covaxin to provide similar levels of protection for adults and children alike. 

Read the full statement below. 

COVAXIN® receives approval for emergency use in Children 12 - 18 years of age.#covaxin #COVID19 #covaxinapproval#childrensafety #BharatBiotech #vaccine #safety #pandemic pic.twitter.com/3LswUG8QU4

— BharatBiotech (@BharatBiotech) December 25, 2021

Background

Bharat Biotech had submitted data of Covaxin's clinical trials on children aged between 2-18 years age group to the Central Drugs Standard Control Organisation (CDSCO) in October. The data was thoroughly reviewed by both CDSCO and SEC.