New Delhi: On Monday, Hyderabad-based Bharat Biotech filed an application with the Drugs Controller General of India (DCGI) to have its Covid-19 vaccine—Covaxin—approved for emergency use.
Bharat Biotech has developed Covaxin, India's indigenous Covid-19 vaccine, in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Authorisation of emergency use is a process to promote the availability and use during public health emergencies.
The development comes a day after the Serum Institute of India sought government approval for its coronavirus vaccine for emergency use. SII is developing the vaccine in partnership with the University of Oxford and the British drugmaker AstraZeneca.
After American firm Pfizer obtained clearance from the drug regulator for its vaccine, which has been approved by the UK and Bahrain, the Pune-based pharmaceutical firm was the second to do so.
Covaxin is an indigenous, inactivated vaccine being developed and manufactured at Bharat Biotech's Bio-Safety Level 3 bio containment facility. It is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.
Covaxin is an indigenous, inactivated vaccine. It is developed on a platform for the development of vero cells.
Bharat Biotech announced the launch of Phase III trials of the vaccine on November 16. The experiments, conducted in collaboration with ICMR, included 26,000 volunteers across India. It is the largest clinical study carried out in India for a Covid-19 vaccine.
Covaxin, with promising safety and immunogenicity results, has been evaluated in 1,000 subjects in Phase I and Phase II clinical trials.
On November 28, Prime Minister Narendra Modi visited Hyderabad's Bharat Biotech facility to study the production of vaccines.
"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.
A controversy broke out over Covaxin on Saturday after Haryana's health minister, Anil Vij, who was given the first dose of Covaxin last month, tested positive for Covid-19.
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."