DCGI's SEC to review applications of Bharat Biotech, SII for full market approval to Covaxin, Covishield today: Sources
Jan 14, 2022
By Shalini Bhardwaj
New Delhi [India], January 14 : Drugs Controller General of India (DCGI)'s Subject Expert Committee will review applications of Bharat Biotech and Serum Institute of India (SII) for full market approval to Covaxin and Covishield respectively on Friday, sources said.
The SII of India had applied for market approval for the Covishield vaccine in December 2021 and Bharat biotech has also applied for the same 10 days ago.
Further, Bharat Biotech has informed that Covaxin is now a universal vaccine for adults and children. "Our goals of developing a global vaccine against COVID-19 have been achieved and all product development for licensure has been completed," it said.
However, both Covaxin and Covishield are currently authorized for emergency use only.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) met on January 1 and January 2, 2021, and made recommendations in respect of the proposal for Restricted Emergency Approval of COVID-19 virus vaccines of Serum Institute of India and Bharat Biotech.
The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, internal medicine, etc.
It had reviewed the data on the safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue.
SII and Bharat Biotech vaccines have to be administered in two doses. All three vaccines have to be stored at 2-8 degrees Celsius.
After adequate examination, CDSCO had decided to accept the recommendations of the Expert Committee and accordingly, SII's Covishied and Bharat Biotech's Covaxin were approved for restricted use in an emergency situation.
Notably, the administration of Covaxin and Covishield began on January 16, 2021, in the country.
