Bharat Biotech, based in Hyderabad, announced on Thursday that its Covid-19 vaccine, Covaxin, is now a universal vaccine for adults and children. The company claims to have met its goal of creating a global vaccination against Covid-19.
Bharat Biotech said, “Our goals of producing a global vaccine against Covid-19 have been met, and all product development for licensure has been completed.”
Covaxin can neutralise both the Delta and Omicron forms of Covid-19, according to Bharat Biotech. It further stated that previous research had shown that Covaxin could neutralise SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta, and Kappa.
Bharat Biotech requested regular market appr
oval for ‘Covaxin’ from the Drugs Controller General of India earlier today. The drug is presently only approved for emergency usage in India. V Krishna Mohan, Whole-Time Director of the Hyderabad-based firm, presented detailed information on chemistry, manufacturing, and controls, as well as pre-clinical and clinical data, in an application to the DCGI. Universal vaccine protects adults and children alike.
According to a source, the company has not yet submitted all of the clinical trial data for Covaxin to DCGI. Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), submitted an application to the DCGI on October 25 seeking regular market clearance for Covishield, which is also approved for emergency use in India. DCGI had requested more information in response to the application, and Singh had submitted a response along with all requested data and documents to DCGI last week.
Singh is said to have noted in the response that, in addition to the successful completion of the phase 2/3 clinical research in India, more than 100 crore doses of Covishield vaccine have been administered to patients in India and around the world. On January 3, it was granted licence to manufacture Covaxin for limited usage in emergency cases.
“All of the essential Chemistry information is included in the present submission. In five parts, Manufacturing and Controls, as well as Pre-clinical and Clinical data, have been supplied. The information in the modules has been posted to the SUGAM portal for your review. We respectfully request that you analyse the application and grant marketing authorization as soon as possible “Mohan’s application was read. As per the provisional reports as of 7 a.m. today, the country’s Covid-19 immunisation coverage had surpassed 154.61 crore with the administration of more than 76 lakh vaccine doses in less than 24 hours.
