Expert group recommends EUA for Covovax, Corbevax and Molnupiravir tablets
Officials confirmed on Monday that a panel of experts from the country’s central medicines authority, the Central Drugs Standard Control Organization (CDSCO) had recommended granting emergency use authorization (EUA) for the Covid vaccine. -19 from the Indian Covovax Institute and to the biological vaccine E Corbevax under certain conditions.
The Central Drugs Standard Control Organization (CDSCO) Committee of Experts on the Matter (SEC) on Covid-19 also recommended on Monday that authorization be granted to manufacture and market the anti-Covid pill Molnupiravir for use in Emergency restricted for the treatment of adult patients with 93 percent SpO2 who are at high risk of disease progression, including hospitalization or death, under certain conditions.
All recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
CDSCO’s SEC on Covid-19, which reviewed Serum Institute of India (SII) emergency use authorization (EUA) applications for the second time on Monday, after extensive deliberation recommended granting the ‘EUA to Covovax.
“The committee noted that the vaccine is manufactured by transfer of technology from Novavax and is approved by the European Medicines Agency for conditional marketing authorization and has also been granted an emergency use list by the WHO, “said an official source.
Prakash Kumar Singh, director of government and regulatory affairs at SII, had filed an application with the DCGI in October for authorization to market Covovax for restricted use in an emergency.
The DCGI office granted SII permission to manufacture and store Covovax on May 17.
Based on DCGI’s approval, so far the Pune-based company has manufactured and stored the vaccine doses.
In August 2020, US vaccine maker Novavax Inc announced a license agreement with SII for the development and commercialization of NVX-CoV2373, its Covid-19 vaccine candidate, in low- and middle-income countries and in India. .
The World Health Organization (WHO) had published on December 17 an emergency use list for Covovax, expanding the basket of jabs validated by the world health organization against viral disease.
As for Biological E’s Corbevax, in light of the recommendations of the SEC meeting on December 10, the cabinet submitted a proposal for the marketing authorization of the emergency restricted vaccine in adults as well as the data Updated Phase 2 Safety and Immunogenicity Intermediates. / 3 and update of intermediate safety and immunogenicity data for the phase 3 trial with active comparator.
The committee noted that the company submitted a six-month follow-up safety after the second dose of the Phase 1 clinical trial, 90-day safety from the phase -2 part, and 60-day safety data from the phase 2/3 and phase 3 active comparison study.
The company submitted provisional data on the immunogenicity of the Phase 3 active comparator trial which showed superiority over the comparator in viral neutralizing antibody titers, the official source said.
“After detailed deliberation, the committee recommended the granting of marketing authorization for the SARS-CoV-2 (Covid-19) vaccine containing the RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions, “the source said. noted.
The vaccine should be given intramuscularly in two doses of 0.5ml each with an interval of 28 days (days 0 and 28) and should be stored between 2 degrees Celsius and 8 degrees Celsius, the source added.
The SEC also recommended on Monday granting approval to manufacture and market the anti-Covid pill Molnupiravir for restricted emergency use for the treatment of adult Covid-19 patients with 93% SpO2 who have a high risk of disease progression, 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 200 mg capsules for approval in emergency situations as well as various supporting documents. including clinical data in the country, official sources said.
Depending on the conditions, the drug should only be sold at retail on prescription from medical specialists.
Depending on the conditions, the drug is not authorized for use in patients under the age of 18 and for the initiation of treatment in patients requiring immediate hospitalization due to Covid-19 at this stage.
However, if he was initiated before hospitalization for Covid-19, he could be prosecuted, sources said.
It is not authorized for use for more than five consecutive days and for pre-exposure or post-exposure prophylaxis for the prevention of Covid-19 in pregnant women.
The United States Food and Drug Administration recently cleared Merck’s Molnupiravir for the treatment of mild to moderate cases of Covid-19 in adults at risk for serious illness.
Prior to that, in November Britain granted conditional clearance to Merck’s coronavirus antiviral, the first pill that was successful in treating 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 in people at high risk early in the disease, Merck’s drug was shown to reduce hospitalizations and deaths by about 30%.