The Drugs Controller General of India (DCGI) has accepted Serum Institute of India’s plan to produce a vaccine against omicron variant of coronavirus for research, test and analysis, official sources told PTI on Monday.
“With reference to your application, please find herewith the permission to manufacture SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein nanoparticle vaccine (omicron variant) for examination, test and analysis under the provisions of New Drugs and Clinical Trials Rules, 2019 to manufacture the test batches of the drug/drugs mentioned therein,” a permission order published on February 4 noted.
Director, Government and Regulatory Affairs at the SII, Prakash Kumar Singh had given in a request to the DCGI on January 6 expressing the Pune-based firm, in association with Novavax Inc, is functioning on the development of a vaccine against omicron, an official source notified, putting in that the SII has received permission and licence to produce SARS-CoV-2rS drug substance for research, test and analysis.
The PTI quoted the source saying the new coronavirus variant ‘omicron’ has already stood to be recorded in more than 60 countries and is spreading very rapidly worldwide and in our country also and so, Serum Institute worked on the progress of SARS-CoV-2 rS Protein (COVID-19) Recombinant Spike Nanoparticle Vaccine (omicron variant).
