Bharat Biotech has sought full market approval for its Covid vaccine Covaxin from the country’s drug regulator, CNN-News18 has learnt from government sources.
The Serum Institute of India had already filed a similar plea for Covishield and both the applications will be reviewed by the subject expert committee (SEC) of the Drugs Controller General of India (DCGI) post noon on Friday, said the sources.
For full market authorisation, the regulator would need to evaluate more data about the vaccines collected over a longer period of time.
The indigenous Covaxin was approved on January 3, 2021, in emergency-use authorisation (EUA) mode and has been administered to crores of people across the country, including children.
EUA does not represent approval of a vaccine in the full statutory term but authorises the use of an unapproved product or unapproved use of an approved product in a declared state of emergency such as a pandemic. A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions.
Covaxin was given approval to be administered in children over 12 years of age and has been given to children over 15 from January 3, 2022. About 3 crore children have already been vaccinated.
Bharat Biotech’s Covaxin has also been exported to several counties through India’s Vaccine Maitri programme as well as commercially.
The full market authorisation for the vaccine will further help the company in exports.
On October 25, SII had filed an application with the DCGI, seeking regular market approval for Covishield, which is also authorised for emergency use in the country.
In addition to the successful completion of phase 2-3 clinical trials in India, over 100 crore doses of the vaccine had been administered to people in India and worldwide, the application said.