Vaccine maker Bharat Biotech on Tuesday said that it isawaiting further regulatory approval from the Central Drugs Standard ControlOrganisation (CDSCO) for its Covid-19 vaccine Covaxin for the 2-18 years agegroup.
However, earlier in morning, the Hyderabad-based pharmamajor Bharat Biotech's Covaxin said it has got the emergency use approval forchildren in the age group of 2 to 18 years from the Drugs Controller General ofIndia (DCGA).
Meanwhile, now they claim to have submitted data fromclinical trials of the vaccine in the 2-18 years age group to CDSCO.
The data has been thoroughly reviewed by the CDSCO andSubject Experts Committee (SEC) and have given their positive recommendations,the company said.
According to the form, this represents one of the firstapprovals worldwide for Covid-19 vaccines for the 2-18 age group.
"Bharat Biotech sincerely thank the DCGI, SubjectExperts Committee, and CDSCO for their expedited review process. We now awaitfurther regulatory approvals from the CDSCO prior to product launch and marketavailability of Covaxin for children," it said.