CDSCO panel recommends EUA for anti-COVID pill Molnupiravir, vaccines Covovax & Corbevax

An expert panel of the country's central drug regulator has suggested granting emergency use authorisation to Serum Institute of India's (SII) COVID-19 vaccine Covovax and Biological E's vaccine Corbevax, subject to specific restrictions, PTI reported, citing official sources, on December 27. Moreover, the Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (SEC) on COVID-19 recommended granting permission to manufacture and market the anti-COVID pill Molnupiravir for limited emergency use in adult patients with a SpO2 of 93% and a high risk of disease progression, including hospitalisation or death, subject to certain conditions.

However, all of the recommendations have been referred to the Drugs Controller General of India (DCGI) for final clearance. The CDSCO's SEC on COVID-19, which assessed the SII's emergency use authorisation (EUA) applications for the second time on Monday, has recommended that Covovax be granted EUA.

"The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO," PTI reported citing official sources.

DCGI gave SII permission to manufacture and stock Covovax in May

In October, Prakash Kumar Singh, SII's director of government and regulatory affairs, applied to the DCGI for a market authorisation for Covovax for limited usage in emergency situations. On May 17, the DCGI office gave SII permission to manufacture and stock Covovax. The Pune-based firm has manufactured and stockpiled vaccine doses based on DCGI authorisation.

On December 17, the World Health Organization (WHO) added Covovax to the list of vaccines approved by the global health body for use against viral illness. In the case of Biological E's Corbevax, the company submitted a proposal for the vaccine's marketing authorisation for restricted emergency use in adults, along with updated interim safety and immunogenicity data from the phase 2/3 clinical trial and updated interim safety and immunogenicity data from the phase 3 active comparator trial, following the recommendations of the SEC meeting on December 10.

The committee noted that the company had provided six months of safety data from a phase-1 clinical trial after the second dose, 90 days of safety data from a phase-2 component, and 60 days of safety data from a phase 2/3 and phase 3 active comparator research. According to the official source, the company has presented interim immunogenicity data from a phase 3 active comparator trial that indicated superiority over the comparator in terms of viral neutralising antibody titres, PTI reported.

SEC proposed giving approval to manufacture and commercialise Molnupiravir

On Monday, the SEC proposed giving approval to manufacture and commercialise Molnupiravir, an anti-COVID tablet, for limited emergency use in adult patients infected with COVID-19 with a SpO2 of 93% and a high risk of disease progression, subject to specified criteria. Dr Reddy's Laboratories, in collaboration with Cipla, Mylan, Torrent, Emcure, and Sun Pharma, submitted a proposal for approval of Molnupiravir 200mg capsules for emergency use, along with different supporting documentation. 

The medicine should only be sold by retail under the supervision of medical specialists, according to the terms. The medicine is not approved for use in patients under the age of 18 or for the commencement of treatment in patients who require immediate hospitalisation due to COVID-19 at that time. Sources say it might be continued if it was started before the COVID 19 hospitalisation.

(With inputs from PTI)

Image: AP