New Delhi: 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 news agency IANS on the condition of anonymity.
After Pfizer and the Serum Institute of India, Bharat Biotech has become the third pharmaceutical in India to seek emergency use authorisation for its Covid vaccine in India.
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.
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.
On 16 November, 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 28 November, 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 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.”
“The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine,” the Union Health Ministry said on the matter.
The Haryana health minister too said antibodies start to develop after administration of the second dose, which is given 28 days after the first shot, and there is no protection during this period. The 67-year-old minister was given the first shot on 20 November.