Bharat Biotech awaits further regulatory approvals before launch of Covaxin for Children

12-10-2021

New Delhi, Oct 12 (UNI) Hyderabad based vaccine maker Bharat Biotech said on Tuesday that it awaits further regulatory approval from the drug regulator before launching Covaxin for children in the market.

Earlier in the day, the Drug Controller General of India had given its approval to the firm for emergency use authorisation of Covaxin among children aged 2-18 years of age.

Bharat Biotech would use the similar formula of Covaxin that was tested and is administered to adults in India's COVID-19 immunisation programme.

The firms said the regulatory approval represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.

"Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO before product launch and market availability of COVAXIN for Children," it said in a statement.

The approval came after the COVID-19 expert panel at India's drug regulatory authority had given a go-ahead to Bharat Biotech's COVID-19 jab among the children.

“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement.

However, the permission of emergency use authorisation to the firm is subjected to four conditions, as per the sources.

"The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol," one of the conditions by the Subject Expert Committee (SEC) read.

The expert panel also directed Bharat Biotech to provide "updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet."

"The firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs & Clinical Trials Rules, 2019," the third condition by the SEC read.

Lastly, the panel demanded the firm to submit the risk management plan of its COVID-19 jab.

Covaxin has become the second COVID-19 jab to get approved for children in India. The drug regulatory body had approved Zydus Cadila's ZyCoV-D for children aged 12 and above as well as for population above 18.