Bharat Biotech applies for emergency use authorisation for Covaxin
After vaccine major Serum Institute of India (SII), Bharat Biotech on Monday applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed coronavirus vaccine called 'Covaxin', news agency PTI quoted sources as saying.
Days back, Bharat Biotech, which is developing the vaccine in collaboration with the Indian Council of Medical Research, had said that its potential vaccine was safe and efficacious. The clarification had come after Haryana Home Minister Anil Vij tested positive for the highly-infectious virus despite taking the first shot of the medication.
Vij had offered to be the first volunteer in the phase three trials for Covaxin. The drug firm said its vaccine Covaxin is based on two-dose schedule and its efficacy is determined 14 days post the second dosage. "COVAXIN clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose," Bharat Biotech had said in a statement. The vaccine has been designed to be efficacious when subjects receive both doses and post the 14-day period after the second dose, it said without directly commenting on Vij who had received the first shot of the vaccine on November 20.
Earlier on Monday, the Serum Institute of India had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for AstraZeneca-Oxford COVID-19 vaccine in the country.
READ MORE: Serum Institute seeks emergency use nod for Covishield in India
Recently, the Indian arm of US pharmaceutical giant Pfizer became the first company to seek a similar approval from India's drug regulator for Pfizer/BioNTech vaccine against COVID-19 in the country, after securing such clearance in the UK and Bahrain.
Pune-based SII has collaborated with AstraZeneca and Oxford University for manufacturing the vaccine and is conducting phase-three clinical trials of the Covishield vaccine in India.
The applications of Bharat Biotech, Serum Institute of India and Pfizer will be reviewed by the subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) in the coming days. "However, none of the applications has so far been forwarded to the committee and no date has been fixed as on when the SEC will meet for assessing and evaluating the applications," an official source told PTI.
READ MORE: Country will not have to wait too long for COVID-19 vaccine: PM Modi
