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SEC recommends emergency use authorization for Covovax and Corbevax

New Delhi: After reviewing all applications and data, the Subject Experts Committee (SEC), an agency under the Indian drug regulatory authority, decided to use the COVID-19 vaccines Covovax and Hydrobad of the Indian Serum Institute for the Corbevax vaccine. We recommend that you grant an Emergency Use Authorization (EUA). Biological E, a pharmaceutical company over the age of 18, official sources told ANI.

The EUA is recommended for this age group and has certain restrictions, such as the company having to report serious adverse events of its use every 15 days.

Final approval is expected to be given by the Indian Drug Controller General (DCGI) shortly, according to official sources.

Meanwhile, the SEC also recommends molnupiravir, a COVID-19 antiviral drug.

According to sources, nearly 10 pharmaceutical companies have completed clinical trials of antiviral drugs. Antivirals have shown a 30% reduction in hospitalization and may help treat COVID-19.

A SEC meeting was held in the capital on Monday to consider applying for approval of new vaccines and antivirals.

The World Health Organization (WHO) recently granted SII’s Covovax an Emergency Use List (EUL). In particular, US-based Novovax and the Serum Institute of India have already received EUA for this vaccine in the Philippines.

Biological E submitted data on the Corbevax vaccine reviewed at the meeting on Monday. The company has submitted Corbevax Phase 3 study data and is seeking EUA.

The center has already made a prepayment of 1,500 chlores to book a Corbevax dose of 30 chlores in August.

https://www.siasat.com/sec-recommends-emergency-use-authorization-of-covovax-corbevax-2249077/ SEC recommends emergency use authorization for Covovax and Corbevax

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