New Delhi: After reviewing all applications and data, the Subject Expert Committee (SEC), a body under India’s drug regulator, has recommended granting the Emergency Use Authorization (EUA) to Serum Institute of India’s COVID-19 vaccine Covovax and Corbevax vaccine that is manufactured by Hyderabad-based pharmaceutical firm Biological E, for those above 18 years of age, official sources told ANI.
The EUA has been recommended for this age group with certain restrictions like the firms have to report after every 15 days about serious adverse events of its usage, official sources have informed.
It is expected that the final approval will be soon given by the Drugs Controller General of India (DCGI), official sources said.
Meanwhile, the SEC has also recommended COVID-19 antiviral pill, Molnupiravir.
Almost 10 pharma companies have completed clinical trials of antiviral pills, as per sources. The antiviral pill has shown a 30 per cent reduction in hospitalization and will be useful in the treatment of COVID-19.
A meeting of the SEC was held on Monday in the national capital to review the applications for granting approval to the new vaccines and the antiviral drug.
The World Health Organization (WHO) has recently granted emergency use listing (EUL) to SII’s Covovax. Notably, the US-based Novovax and Serum Institute of India have already received EUA for this vaccine in the Philippines.
Biological E had submitted data on Corbevax vaccine, which was reviewed in the meeting on Monday. The company has submitted phase-3 trials data of Corbevax and seeking EUA for same.
The Centre has already made an advance payment of Rs 1,500 crore to reserve 30 crore Corbevax doses in August.
