SEC asks for more data to grant full market approval to Covaxin and Covishield
The Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) will continue thorough review of data submitted by the Serum Institute of India (SII) and Bharat Biotech for granting full market approval to Covaxin and Covishield, sources told ANI.
The Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) will continue thorough review of data submitted by the Serum Institute of India (SII) and Bharat Biotech for granting full market approval to Covaxin and Covishield, sources told ANI. The SEC has also asked both the companies to submit more data before granting full market approval. Another SEC meeting is expected next week. The Serum Institute of India had applied for market approval for the Covishield in December 2021 and Bharat Biotech has also applied for the same 10 days ago.
The market authorisation for vaccine means that it can be authorized for use without reservation and conditions. Further, Bharat Biotech has said that Covaxin is now a universal vaccine for adults and children. However, both Covaxin and Covishield are currently authorised for emergency use only. The subject expert committee of the Central Drugs Standard Control Organisation (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, paediatrics, internal medicine etc. It had reviewed the data on the safety and immunogenicity of the vaccine and recommended 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 vaccination especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue. The Serum Institute of India and Bharat Biotech vaccines have to be administered in two doses and all the vaccines have to stored at 2-8 degrees Celsius. (ANI)
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