DCGI Approves SII’s Proposal to Test Vaccine against Omicron
NEW DELHI, Feb 7: The Drugs Controller General of India (DCGI) has approved the proposal of the Serum Institute of India (SII) to manufacture a vaccine against omicron variant of coronavirus for examination, test and analysis, official sources said 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,” an approval order issued on February 4 stated.
The SII Director, Government and Regulatory Affairs, Prakash Kumar Singh had put in an application to the DCGI on January 6 stating the Pune-based firm, in collaboration with Novavax Inc, is working on the development of a vaccine against omicron.
“…The new coronavirus variant ‘omicron’ has already been reported in more than 60 countries and is spreading very fast worldwide and in our country also. Our CEO, Dr Adar C Poonawalla is very concerned about protection of citizens of our country and world at large against coronavirus and its new variants and we are relentlessly working on development of SARS-CoV-2 rS Protein (COVID-19) Recombinant Spike Nanoparticle Vaccine (omicron variant).
“Development of this vaccine shall be another example of vaccine production strength of our country in line with the clarion call of our prime minister ‘Making in India for the World’ and shall further keep our country’s flag flying high globally,” Singh had stated in the application,” the source said.
(Manas Dasgupta)
