The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO), has recommended granting of Emergency Use Authorisation to Serum Institute of India’s Covid-19 vaccine Covovax and Biological E’s vaccine Corbevax.

It also recommended granting permission to manufacture and market anti-Covid pill 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.

In the case of Covovax, 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.

The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.

Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.

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), on December 17, had 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.

The committee noted that the firm has submitted six months safety follow up post second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.

The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said.

"After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions," the source said.

The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius,the source added.

The SEC on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for treatment of adult Covid-19 patients with SpO2 93 per cent and who have high risk of progression of the disease, subject to certain conditions.

As per conditions, the drug should be sold by retail only under prescription of medical specialists.

The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19.