Hyderabad-based Bharat Biotech on Monday filed an application with the Drugs Controller General of India (DCGI) for emergency use authorisation of its COVID-19 vaccine -- Covaxin. The application was filed before the apex drug regulator on Monday evening, a company source told IANS on the condition of anonymity.
Covaxin, India's indigenous COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Emergency use authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
The development comes a day after the Serum Institute of India (SII), the world's largest vaccine maker by number of doses produced, sought government approval for emergency use authorisation of its coronavirus vaccine that is being developed in collaboration with the University of Oxford and British drugmaker AstraZeneca.
The Pune-based pharmaceutical firm was the second to do so after American firm Pfizer sought approval from the drug regulator for its vaccine, which has been cleared by the UK and Bahrain.
Covaxin is an indigenous vaccine being developed and manufactured at Bharat Biotech's Bio-Safety Level 3 bio containment facility in Hyderabad. It is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.
On November 16, Bharat Biotech had announced commencement of Phase III trials of the vaccine. The trials involved 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
Covaxin has been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data.
On November 28, Prime Minister Narendra Modi had visited the Bharat Biotech facility in Hyderabad to review vaccine development. "At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid-19 vaccine. Congratulated the scientists for their progress in the trials so far. Their team is closely working with ICMR to facilitate speedy progress," the PM had tweeted.
On Saturday, a controversy had erupted around Covaxin after Haryana Health Minister Anil Vij, who was administered the first dose of Covaxin last month, tested positive for the coronavirus.
This prompted the company to clarify, "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. Covaxin has been designed to be efficacious when subjects receive both doses and post the 14 days period after the 2nd dose."