COVAXIN can now be administered safely to kids. The DCGI has given its approval to begin kids vaccination with the Bharat Biotech Covid-19 Vaccine. This follows the rising Omicron threat.
There has been also an constant outcry to introduce Covid-19 vaccination for Kids. Finally, 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.
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.” Bharat Biotech said in a statement.
COVAXIN has been formulated uniquely for adults and kids
Bharat Biotech added, that COVAXIN 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,” the company 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.
Covaxin is now the second vaccine in India that has received clearance for use for children.
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.
The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on October 11 after deliberating Bharat Biotech’s emergency use authorisation (EUA) application had recommended granting emergency use approval to Covaxin for use in the 2-18 years age group with certain conditions.
“The recommendations of the SEC were further evaluated and examined after which DCGI had sought additional data from the firm,” an official said. The DCGI gave its approval Friday, the official said.
“… Based on the recommendations of SEC experts and submission of additional safety data, this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC, PI, Factsheet incorporating clinical information for said age group along with pharmacovigilance & risk management plan,” the DCGI approval order issued said.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covaxin for use among those aged between 2 and 18 years, had submitted the data to CDSCO for its verification and subsequent approval for emergency use authorisation EUA for the jab in the beginning of October.
Covaxin will be given to children in two doses with a gap of 28 days between the first and second jab and as per the trial data submitted to the Union government, the gap and dosage of vaccine for adults and children will remain the same.
