After SII, Bharat Biotech seeks emergency use authorization for COVID-19 vaccine, Covaxin

Bharat Biotech has filed an application with the Drugs Controller General of India for emergency use authorisation of its COVID-19 vaccine, Covaxin.

By: Jahnavi Sarma | | Published: December 8, 2020 9:17 am

Covaxin is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.

With COVID-19 cases surging in India and elsewhere, people are eagerly waiting for the rollout of vaccines. In India, some sites have been identified for the cold storage of vaccines that is expected to arrive in the country this month itself. Now, an Indian firm has applied for emergency use authorization for a vaccine in the country. If granted, it would take us one step closer to having a vaccine in the market. Also Read - To vaccinate or not? Medical expert clears the air around Covid-19 vaccines

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). Also Read - Recovered from Covid-19? Your immune system may fight coronavirus variants

Clearing the road for vaccine rollout

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, the world’s largest vaccine maker by number of doses produced, sought government approval for emergency use authorisation of its coronavirus vaccine that it 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. Also Read - UK COVID Strain May Be More Infectious But There Is No Need To Panic: Experts

India’s indegenous inactivated vaccine

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 November 16, Bharat Biotech had announced commencement of Phase III clinical 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.

Vaccine efficacy is determined 14 days after 2^nd dose

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 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.”

(With inputs from IANS)

Published : December 8, 2020 9:17 am

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