COVAXIN gets DCGI nod for kids aged 6-12; Bharat Biotech assures it is 'safe, efficacious'

India's drug regulator has granted restricted emergency use authorisation for Bharat Biotech's COVAXIN for children in the age group of six to twelve years. The approval by the Drugs Controller General of India (DCGI) for inoculating children below 12 years paves the way for giving protection to a majority of school going children and holds major significance ahead of Prime Minister Narendra Modi's meeting with CMs on the emerging COVID-19 situation in the country on Wednesday through video conferencing. 

Bharat Biotech issues statement over DCGI approval

After the approval, Bharat Biotech on Tuesday issued an official statement which said, "Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity COVAXIN in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI during December 2021."

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “We have established COVAXIN as an universal vaccine for adults and children. Safety of the vaccine is critical for children and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children.”

The Subject Expert Committee had last week reviewed the application of Bharat Biotech seeking emergency use authorisation for Covaxin for use in children of six to twelve years age group. COVAXIN has been granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021.

COVID vaccination for children in India

India had started vaccinating children aged 12-14 years on March 16. So far, more than 2.70 crore adolescents have been administered with the first dose of COVID-19 vaccine.The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year. The next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions. India launched vaccination for all people aged more than 45 years from April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last year.

The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 years. India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10. Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10.  The cumulative COVID-19 vaccine doses administered in the country has exceeded 187.95 crore.

(With PTI Inputs)