COVID-19 India Updates: Recording a further decline in the number of COVID-19 cases in the country, the Union Health Ministry on Monday informed that India reported 4,362 new COVID-19 cases today, taking the total COVID-19 cases to 42.97 million. Additionally, India on Monday reported a steep decline in Covid-19 deaths, recording 66 Covid-19 deaths in the last 24 hours, according to health ministry data.
Meanwhile, an expert panel of the Central Drugs Authority of India has recommended allowing phase-3 clinical trials of the Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday.
The Drugs Controller General of India (DCGI) has already approved Kovovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country’s vaccination program.
The subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation, on Friday, had recommended allowing the conduct of phase-3 clinical trial of single-dose COVID-19 vaccine Sputnik Lite as a booster dose.
In February, Prakash Kumar Singh, director, government and regulatory affairs at the Serum Institute of India, conducted a phase-3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of Kovovax as a booster dose from DCGI. had demanded to do. An official source said that in adults who had been vaccinated at least 3 months ago with either Covishield or Covaxin.
Singh had said that many countries have already started giving booster doses to their citizens in view of the uncertainties of the COVID-19 pandemic.
“We are sure that your approval to conduct this clinical trial will ensure the early availability of Kovovax for booster dose use to the people of our country as well as the world, which is in line with our Prime Minister’s ‘Making in In line with the vision of ‘India for the World’.
“Our firm is committed to provide world class life saving vaccines at an affordable price under the visionary leadership of our CEO Adar C Poonawalla. We request you to kindly send us the Phase-3 Clinical for Booster Dose of Covovax. Allow testing. In Indian adults,” Singh said in the application.
Kovovax is manufactured by transfer of technology from Novavax. It has been approved by European Medicines Agency for conditional marketing authorization and also granted emergency use list by WHO.
In August 2020, US-based vaccine maker Novavax Inc. had announced a license agreement with Serum Institute of India to develop and commercialize its COVID-19 vaccine candidate NVX-CoV2373 in low- and middle-income countries and India.
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