New Delhi: Official sources told PTI that an expert panel of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended emergency use authorization (EUA) to the biological E vaccine Corbevax, subject to certain conditions.
The Subject Expert Committee on COVID-19 of CDSCO also recommended allowing manufacturing and marketing of Molnupiravir, an anti-Covid pill, for restricted emergency use.
Organic E Vaccine Corbevax
In light of the recommendations of the SEC meeting held on December 10, Biologicals E submitted a proposal for the grant of marketing authorization to the firm’s Corbevax vaccine for restricted emergency use in adults.
The firm also presented updated interim safety and immunogenicity data from Phase 2 and 3 clinical trials and Phase 3 active comparator trials.
The firm presented safety data from the Phase 1 clinical trial with six months of safety follow-up after the second dose, 90 days of safety from the Phase 2 clinical trial, and 60 days from the Phase 2 and 3 and Phase 3 active comparator studies Yes, the committee noted.
The interim immunogenicity data from the Phase III active comparator trial showed superiority against the comparator with respect to viral neutralization antibody titers as reported, the official source said.
Quoting an official source, the PTI report said that the committee, after detailed deliberations, has decided to market the Covid-19 vaccine containing the RBD antigen of SARS-CoV-2 for restricted use in emergency situations, subject to various regulatory provisions. Authorization was recommended. ,
Restricted Emergency Use Authorization for Molnupiravir
Dr Reddy’s Laboratories in association with Cipla, Mylan, Torrent, Emcure and Sun Pharma had submitted their proposal for approval of Molnupiravir 200 mg capsules for emergency clearance, official sources said.
The conditions state that the drug should be sold by a retailer only under the prescription of medical experts.
The SEC said molanupiravir can be used to treat adult patients with 93 percent SpO2 (percentage saturation of oxygen in the blood) and who are at high risk of disease progression. Disease progression involves hospitalization or death, subject to certain conditions.
Also, the drug is not authorized for use in patients below the age of 18 years and for starting treatment in patients requiring immediate hospitalization due to COVID-19 at that stage, the report said.
Sources mentioned that if it was started before the hospitalization due to COVID 19 then it can be continued.
The pill for the prevention of COVID-19 for pregnant women is not authorized for more than five consecutive days and for pre-exposure or post-exposure prophylaxis (treatment given to prevent disease).
All the recommendations have been sent to the Drug Controller General of India (DCGI) for final approval.
(with PTI inputs)
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