New Delhi: An expert panel of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting emergency use authorisation (EUA) to Biological E's vaccine Corbevax with certain conditions, official sources told PTI.
The Subject Expert Committee on COVID-19 of the CDSCO also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use.
Biological E's vaccine Corbevax
In light of the recommendations of the SEC meeting held on December 10, Biological E submitted a proposal for a grant of marketing authorisation to the firm’s Corbevax vaccine for restricted emergency use in adults.
The firm also submitted the updated interim safety and immunogenicity data of Phases 2 and 3 clinical trials, and that of Phase 3 active comparator trial.
The firm has submitted six months safety follow-up post-second dose from Phase 1 clinical trial, 90 days safety from the Phase 2 clinical trial, and 60 days safety data from Phases 2 and 3 and Phase 3 active comparator study, the committee noted.
The official source said that the interim immunogenicity data from Phase 3 active comparator trial showed superiority against the comparator with respect to viral neutralization antibody titers, according to the report.
Quoting the official source, the PTI report said that the committee, after detailed deliberation, recommended for grant of marketing authorisation permission of Covid-19 vaccine containing RBD antigen of SARS-CoV-2 for restricted use in an emergency situation subject to various regulatory provisions.
Restricted Emergency Use Authorisation To Molnupiravir
In consortium with Cipla, Mylan, Torrent, Emcure, and Sun pharma, Dr Reddy's Laboratories had presented their proposal for approval of Molnupiravir 200 milligram capsules for approval an emergency situation, official sources said.
The conditions state that the drug should be sold by retail only under the prescription of medical specialists.
Molnupiravir could be used for the treatment of adult patients with SpO2 (percent saturation of oxygen in the blood) 93 percent and who have a high risk of progression of the disease, the SEC said. The progression of disease includes hospitalisation or death, subject to certain conditions.
Also, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage, the report said.
The sources noted that it may be continued if it was initiated before hospitalisation due to COVID 19.
The pill is not authorsied for use for longer than five consecutive days and for pre-exposure or post-exposure prophylaxis (treatment given to prevent disease) for prevention of COVID-19 for pregnant women.
For final approval, all the recommendations have been sent to the Drugs Controller General of India (DCGI).
(With PTI Inputs)