Thursday, 09 December 2021

Bharat Biotech's Covaxin receives SEC nod for children aged 2-18 years

12 October 2021 | News

One of the first recommendations worldwide for COVID-19 vaccines for the 2-18 age group

image credit- shutterstock

image credit- shutterstock

Hyderabad-based Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to Central Drugs Standard Control Organisation (CDSCO). The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations.

This represents one of the first recommendations worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech is now awaiting further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children.

Taking note of this development, Dr Kanchan Channawar, Consultant Pediatrician, Kamineni Hospitals, Hospital, Hyderabad says, "Covaxin has proven very effective in adult population without significant side effects, so hopefully it will have a similar effect in the pediatric population from above 2 years. It will not only give the protection but also help to restore the faith among parents to send their kids to school."

On the other hand, Dr Bipin Singh, Assistant Professor School of Engineering & Technology, BML Munjal University (BMU), Gurugram is of the opinion, "It would have been better if it was first approved for  children within the age bracket of 10-18 years and based on a larger and diverse pool of clinical trails data and long term evaluations it should have been recommended for use in younger kids of age less than 10 years."

 

 

 

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