Home » DGCI nod to Bharat Biotech’s Covax for emergency use for children aged 12-18

DGCI nod to Bharat Biotech’s Covax for emergency use for children aged 12-18

by Raju Vernekar
0 comment 2 minutes read

IT Correspondent
Mumbai, Dec 26:

Amid the Omicron threat, the Drugs Controller General of India (DGCI) has given permission to the Hyderabad-based Bharat Biotech’s Covid-19 vaccine-”Covaxin-(BBV152)” for children between 12-18 years of age for emergency use.
In a statement on Saturday, the Bharat Biotech said that it has been formulated uniquely in such a way that the same dosage can be administered to adults and children. “Covaxin” has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. We have documented excellent safety and immunogenicity data readouts in Children. We look forward for Covaxin to provide similar levels of protection for adults and children alike,” it added.
“This 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(SEC), 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,” the Bharat Biotech said.
Like most vaccines for adults, children between 12 to 18 years of age will be administered Covaxin in two doses, with a gap of 28 days between the first and second doses. According to the trial data submitted to the government, the gap and dosage of vaccine for adults and children will be the same. The regulatory process is being streamlined to make children’s registrations on the CoWin platform, sources said.
Covaxin is now the second vaccine in India that has received clearance for use for children. The first one is Zydus Cadila’s three-dose jab which was allowed to be administered on adults as well as kids over 12 years of age in August this year. 
The Bharat Biotech recently sought the DCGI’s approval to conduct phase 3 trials of its intranasal COVID-19 vaccine (BBV154) to use as a booster dose. The application has been filed and the biotechnology company is awaiting approval from the drug regulator. The intranasal vaccine will be given to those who have already taken their two-dose vaccine.
In the meanwhile the number of Omicron cases across the country rose up to 400 with detection of 21 new cases in Rajasthan on Saturday. The number of Omicron cases reached up to 110. However of them 57 patients found by asymptomatic and were discharged.

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