India Recommends Bharat Biotech’s COVAXIN for Kids Under 12 Years

Bharat Biotech’s COVID-19 vaccine for children under 12 years of age has got India’s Subject Expert Committee nod. This recommendations given by SEC today makes the first vaccine maker in the country to get such an approval after a review of its trial data for the 2-18 age-group.

The decision is a big bolster to India’s vaccination program to not only cover adults but also its younger population. Most importantly, vaccinating children against the coronavirus, having already rolled out more than 950 million doses to adults among its population of nearly 1.4 billion.

Bharat Biotech‘s Covaxin, which uses an inactivated coronavirus with an immunity booster, is among the three shots that are being used in India as part of the vaccination drive for adults.

More than 110 million doses of Covaxin have been administered and the company is in the process of securing an emergency use listing from the World Health Organization, a decision that is expected later this month.

Bharat Biotech Covid 19 vaccine is the first in the world for age group from 2-18 years

COVAXIN
Covaxin for children under 12 year old gets India SEC recommendation

“This represents one of the first recommendations worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” Bharat Biotech said in a statement.

Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and SEC and have provided their positive recommendations, the vaccine maker said.

“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated.

The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.

Share

Latest Updates

Related Articles

“The Archies Premiere” From Jaya to SRK, Social Media Reactions

Netflix’s upcoming film ‘The Archies’, based on the popular Archie Comics franchise, has received...

Kohli’s captaincy exit was his own choice, not ours: Ganguly Denies Rift

Sourav Ganguly has denied role in Virat Kohli’s captaincy exit, says he was not...

Karni Sena Chief Sukhdev Singh Killed in Jaipur; Claimant Emerges

Karni Sena Chief Sukhdev Singh Gogamedi, officially the National President of Karni Sena, was...

Martin Scorsese’s ‘Killers of the Flower Moon’ Debuts On Prime Video

Martin Scorsese’s critically acclaimed film, “Killers of the Flower Moon,” is set to make...