The Phase III trial of Bharat Biotech's COVID-19 vaccine 'COVAXIN' has been completed. On Tuesday, the Subject Expert Committee (SEC) under the Drug Controller General of India (DCGI) will review Phase 3 data of the country's first fully homegrown Covid vaccine.
Meanwhile, this meeting is taking place ahead of Bharat Biotech's 'pre-submission' meeting with the World Health Organization (WHO) on Wednesday. In addition, it takes the vaccine one step closer to a WHO emergency use listing. According to government sources, Hyderabad-based vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) at the end of the week. Meanwhile, confirming this, a senior government official said, "We have received the data from Phase III trials."
Let us tell you that Covaxin is among three vaccines approved for emergency use in India's vaccination drive against Covid-19. At the same time, the other vaccines administered in the country include Covishield, developed by AstraZeneca and Serum Institute of India, and Russia's Sputnik V.
Meanwhile, the company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR). In a press briefing by the Union Health Ministry a few days ago, Dr VK Paul, Member (Health) of NITI Aayog, who also heads the country's COVID Task Force, had said that the company would submit the data in seven to eight days. In May, Bharat Biotech said it had submitted an emergency use list (EUL) application to the WHO, with regulatory approval expected between July and September.
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