New Delhi: The final approval for Bharat Biotech Covaxin for children aged 2-18 years is under an opinion and evaluation expert, stating government sources on Thursday.
Previously on Tuesday, the official source said that the Subject Expert Committee (SEC) had provided recommendations to the drug controller General India (DCGI) for the use of Covid-19 vaccine Bharat Biotech, Covaxin, for beneficiaries between 2-18 years.
The source told Ani today that after data evaluation, the final approval will be given by the drug controller General India (DCGI).
Bharat Biotech in an official statement said they were awaiting further approval from the drug regulator.
This is one of the first world approval for the Covid-19 vaccine for the age group of beneficiaries owned by 2-18 years.
Bharat Biotech has sent data from clinical trials in the 2-18 year age group for Covaxin (BBV152) to CDSCO.
The data has been thoroughly reviewed by the CDSCO and the subject administration committee (SEC) and has provided their positive recommendations, the vaccine maker said.
The subject expert committee in Covid-19 examined data on Monday.
Covaxin approval for children aged 2-18 years based on the opinion of experts, evaluation: Source
