Bharat Biotech seeks emergency authorization of Covaxin; CDSCO to review applications soon

In a major boost to India's race for the COVID-19 vaccine, Bharat Biotech has now sought emergency use authorization for its COVID-19 vaccine candidate - Covaxin - from the central drug regulator. The Hyderabad-based pharmaceutical firm is the third applicant to seek the emergency use authorization in India after Pfizer-BioNtech and the Serum Institute of India (SII). It has been learnt that the Central Drugs Standard Control Organisation (CDSCO) will evaluate the applications for emergency use on Wednesday. 

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It has also been reported that Ambassadors and High Commissioners of 80 countries will be visiting Bharat Biotech and BE Limited in Hyderabad on December 9 to assess the progress of the vaccine. 

PM Modi visits Bharat Biotech

Earlier on November 29, PM Modi had personally visited Bharat Biotech plant in Hyderabad to review the development of coronavirus vaccine and the manufacturing process. During his visit, Modi congratulated the scientists for their progress in the trials of ‘Covaxin’ and added that the pharmaceutical company is working to facilitate speedy progress. 

READ | PM Modi Monitors Progress Of 'COVAXIN' In Hyderabad's Bharat Biotech; Hails Efforts

On November 16, Bharat Biotech announced the commencement of phase 3 trials of Covaxin, becoming the first vaccine candidate to reach the third phase. This will involve 26,000 volunteers across India and it will be the largest clinical trial conducted for a COVID-19 vaccine in the country. The vaccine trials visited a small hiccup in Haryana as Health Minister Anil Vij - who was administered with the first dose in the state - contracted COVID-19 days after the first shot. 

READ | Anil Vij Issues Statement After Testing COVID Positive Amid Bharat Biotech's COVAXIN Trial

However, Bharat Biotech clarified that the vaccine's efficacy can only be determined 14 days after the subjects are given the second dose. The vaccine manufacturer stated that Covaxin clinical trials include the subject being administered two doses given 28 days apart. It also remarked that Covaxin has been developed to be effective only after both doses are provided to the subject. Moreover, 50 per cent of the subjects who are a part of the phase-3 trial receive the COVID-19 vaccine while rest of them receive a placebo. 

READ | 'Covaxin Efficacy After Both Doses': Bharat Biotech On Anil Vij Testing Positive Mid-trial