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An expert panel of the country's central drug authority has recommended granting emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax and Biological E's vaccine Corbevax with certain conditions, official sources said on Monday.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for the treatment of adult patients with SpO2 93% and who have a 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.
"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," an official source said.
Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.
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) had on December 17 issued an 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 a 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 for the post second dose from a phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days of safety data from phase 2/3 and phase 3 active comparator study.
The firm has submitted interim immunogenicity data from the 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 an 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 intervals 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 the treatment of adult COVID-19 patients with SpO2 93 per cent and who have a high risk of progression of the disease, subject to certain conditions.
Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in the emergency situation along with various supporting documents. including clinical data in the country, official sources said.
As per conditions, the drug should be sold by retail only under the prescription of medical specialists.
According to the conditions, 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.
However, if it was initiated before hospitalisation due to COVID 19, it may be continued, sources said.
It is not authorised for use for longer than five consecutive days and for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 for pregnant women.
The US Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.
Before that in November Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat Covid-19.
The pill is intended to be taken twice a day for five days by people at home with mild to moderate COVID-19.
In a clinical trial of high-risk people during the early course of illness, Merck's drug was shown to reduce hospitalisations and deaths by around 30%.
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