2 More COVID-19 vaccines Covovax, Corbevax and Anti-Covid pill Molnupiravir approved for emergency use in India

In a significant move, India on Tuesday has given emergency use authorization approval (EUL) to two more COVID-19 vaccines Covovax and Corbevax and Anti-viral drug Molnupiravir, said Union Health Minister Dr Mansukh Mandaviya.

arlier yesterday, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax and Biological E's vaccine Corbevax with certain conditions and antiviral Covid-19 pill molnupiravir.

The SEC recommended granting permission to manufacture and market Molnupiravir for restricted emergency use for treatment of adult patients with SpO2 93 per cent and who have high risk of progression of the disease, including hospitalisation or death, subject to certain conditions. All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax.

In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India. The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.

As for Biological E's Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.