Bharat Biotech Applies For Emergency Authorization Of 'Covaxin', Becomes Second Indian Company To Seek Approval

After the application, Bharat Biotech became the second indigenous firm after the Serum Institute of India (SII), which has applied for emergency approval for vaccine and third as American drug giant Pfizer, applied first.

Bharat Biotech, Hyderabad based pharmaceutical firm on Monday, for seeking emergency authorization for its COVID-19 vaccine “Covaxin”, became the second Indian vaccine candidate that applied to the Central Drugs Standard Control Organization (CDSCO). The vaccine candidate is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). After the application, Bharat Biotech became the second indigenous firm after the Serum Institute of India (SII), which has applied for emergency approval for vaccine and third as American drug giant Pfizer, applied first. Serum Institute the First Indigenous Firm To Apply For Emergency Approval, Second On Government Records Serum Institute, the world’s largest vaccine manufacturer by volume, became the first Indian firm to apply for the emergency authorization of the Covid-19 vaccine. SII with AstraZeneca and Oxford University has been developing “Covishield”, which showed an efficacy of more than 70 per cent, in the clinical human trials, that were conducted across the world. According to Adar Poonawalla Chief Executive Officer (CEO) of SII, the vaccine will be priced around, Rs 500-Rs 600 and the production facility is manufacturing more than 100 million doses per month. Pfizer Was The First To Seek Approval The Indian Arm of the American drug giant Pfizer on December 4, sought emergency use approval for its vaccine from the central drug regulator after the firm secured such clearance in the UK and Bahrain. With the application, Pfizer became the first pharmaceutical firm to seek emergency authorization in India. The Covid-19 vaccine of the US firm, which has been developed jointly with German partner BioNTech, is based on an mRNA platform and requires an ultra-cold facility for transportation and storage. The vaccine showed an efficacy of 90 per cent, in the trials. Controversy with Bharat Biotech’s Covaxin As the trials of Bharat Biotech’s vaccine candidate are underway, Anil Vij Health Minister of Haryana, who volunteered for the phase three trials of the vaccine, was tested positive for Covid-19. After which the company clarified, that the efficacy can only be determined after 14 days and the second dose. "Covaxin clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose," the Hyderabad firm said in an official statement. One of the three Covid-19 vaccine candidates being tested in India, Covaxin - in its third phase of trials- will be administered to "26,000 subjects across 25 sites", the statement further said.