Amid the Omicron threat, the Drugs Controller General of India (DCGI) has given nod to Bharat Biotech's COVID-19 vaccine Covaxin (BBV152) for kids between 12 -18 years of age for emergency use.
In a statement, 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.
Earlier, Bharat Biotech had submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to Central Drugs Standard Control Organisation (CDSCO). The data was thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and had provided their positive recommendations, Bharat Biotech had said.
"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, 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," it had added.
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.
Like most vaccines for adults, children between 12 to 18 years of age will be administered Covaxin in two doses. The interval and dosage are likely to be the same as adults.
Meanwhile, 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.